CHAPTER 6800
BOARD OF PHARMACY
PHARMACIES AND PHARMACISTS
DEFINITIONS.6800.0100
RESPONSIBILITY FOR ACTION BY A PHARMACY.6800.0110
LICENSING PHARMACIES
FORM OF APPLICATION AND LICENSE.6800.0200
PHARMACY LICENSE AND FEE REQUIRED.6800.0300
LICENSE CATEGORIES.6800.0350
ANNUAL LICENSE RENEWAL DATE AND FEES.6800.0400
SEPARATE LICENSE REQUIRED.6800.0500
POSTING LICENSE.6800.0600
PHARMACY, SPACE, AND SECURITY.6800.0700
LOCATION, DIMENSION, OR SECURITY CHANGES.6800.0800
PATIENT ACCESS TO PHARMACIST.6800.0910
REQUIREMENT FOR A SUPERVISED PHARMACY AREA.6800.0950
CLOSING A PHARMACY.6800.1010
REQUIRED REFERENCE BOOKS AND EQUIPMENT.6800.1050
LICENSING PHARMACISTS
ANNUAL RENEWAL, FEES, AND POSTING.6800.1150
INACTIVE STATUS AND EMERITUS LICENSE.6800.1210
APPLICATIONS FOR LICENSURE.6800.1250
LICENSURE TRANSFER (RECIPROCITY).6800.1300
LICENSING MANUFACTURERS AND WHOLESALERS
DRUG MANUFACTURER OR WHOLESALER LICENSE.6800.1400
MINIMUM INFORMATION REQUIRED FOR LICENSURE.6800.1410
MINIMUM QUALIFICATIONS.6800.1420
PERSONNEL.6800.1430
REQUIREMENTS FOR WHOLESALE DRUG DISTRIBUTORS.6800.1440
MANUFACTURING PROCEDURES.6800.1460
CONTINUING EDUCATION
CONTINUING EDUCATION.6800.1500
CONTINUING EDUCATION ADVISORY TASK FORCE.6800.1600
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
MINNESOTA RULES1
OPERATION OF PHARMACIES
PHARMACIST ON DUTY.6800.2150
PHARMACY WORK CONDITIONS.6800.2160
UNPROFESSIONAL CONDUCT.6800.2250
SANITATION.6800.2300
PHARMACEUTICAL WASTE.6800.2350
PHARMACIST-IN-CHARGE.6800.2400
CHANGE OF BUSINESS OR RESIDENCE ADDRESS.6800.2500
AUTOMATED COUNTING AND DISTRIBUTION.6800.2600
RETURN OF DRUGS AND DEVICES.6800.2700
PRESCRIPTION BLANKS.6800.2900
PRESCRIPTIONS AND DISTRIBUTION OF DRUGS.6800.3000
COMPOUNDING AND DISPENSING.6800.3100
PATIENT MEDICATION PROFILES.6800.3110
TRANSFER OF PRESCRIPTIONS BETWEEN PHARMACIES.6800.3120
PREPACKAGING AND LABELING.6800.3200
COMPOUNDING STANDARDS.6800.3300
PHARMACEUTICALS BEYOND-USE DATES.6800.3350
PRESCRIPTION LABELING.6800.3400
LABELING OF OUTPATIENT INTRAVENOUS ADMIXTURE DRUGS.6800.3450
REFILL LIMITATIONS.6800.3510
UNIT DOSE DISPENSING.6800.3750
PHARMACY TECHNICIANS.6800.3850
ELECTRONIC DATA PROCESSING; COMPUTER USAGE.6800.3950
DRUG IDENTIFICATION.6800.4050
CENTRALIZED PRESCRIPTION PROCESSING AND FILLING.6800.4075
CONTROLLED SUBSTANCES
LABELING OF CONTROLLED SUBSTANCES AND OTHER DRUGS.6800.4150
INCLUSIONS AND EXCEPTIONS.6800.4200
SCHEDULE I CONTROLLED SUBSTANCES.6800.4210
SCHEDULE II CONTROLLED SUBSTANCES.6800.4220
SCHEDULE III CONTROLLED SUBSTANCES.6800.4230
SCHEDULE IV CONTROLLED SUBSTANCES.6800.4240
SCHEDULE V CONTROLLED SUBSTANCES.6800.4250
DISPENSING SCHEDULE II CONTROLLED SUBSTANCES FOR PATIENTS IN LONG-TERM
CARE FACILITIES AND TERMINALLY ILL PATIENTS.
6800.4300
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
2MINNESOTA RULES
REGISTRATION OF CONTROLLED SUBSTANCE RESEARCHERS.6800.4400
PERPETUAL INVENTORY.6800.4600
CONTROLLED SUBSTANCE VERIFICATION.6800.4700
REPORTING CONTROLLED SUBSTANCE LOSSES.6800.4800
INTERNSHIP
DEFINITIONS.6800.5100
INTERNSHIP.6800.5200
REGISTRATION AND REPORTING.6800.5300
PRECEPTORS.6800.5350
TRAINING.6800.5400
LICENSURE TRANSFER STANDARDS.6800.5500
ADVISORY COMMITTEE.6800.5600
OPERATIONS IN LONG-TERM CARE FACILITIES
SCOPE.6800.6100
PRESCRIPTION ORDER COMMUNICATION.6800.6200
PRESCRIPTION LABELING.6800.6300
CONSULTING SERVICES TO LICENSED NURSING HOMES.6800.6500
FREEDOM OF CHOICE.6800.6600
DRUGS FOR USE IN EMERGENCY KITS.6800.6700
STAFF PROTECTION FROM HIV TRANSMISSION.6800.6800
OPERATIONS IN HOSPITALS
DEFINITIONS.6800.7100
SCOPE.6800.7200
PHARMACISTS AND SUPPORT PERSONNEL.6800.7300
HOSPITAL PHARMACIST-IN-CHARGE.6800.7400
HOSPITAL SERVICE POLICIES
PATIENT CARE.6800.7510
PHARMACEUTICAL SERVICE POLICIES.6800.7520
MAINTAINING SECURITY AND EMERGENCY ACCESS.6800.7530
DRUG HANDLING AND STORAGE.6800.7700
PHARMACEUTICAL SERVICE SPACE.6800.7800
PRESCRIPTION LABELING.6800.7900
EXTENSION OF PHARMACY SERVICES UNDER LICENSE.6800.7950
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
MINNESOTA RULES3
OPERATION OF PARENTERAL-ENTERAL/HOME HEALTH
CARE PHARMACIES
SCOPE AND PURPOSE.6800.8000
POLICY AND PROCEDURES MANUAL.6800.8001
PHYSICAL REQUIREMENTS.6800.8002
PERSONNEL.6800.8003
DRUG DISTRIBUTION AND CONTROL.6800.8004
CYTOTOXIC AGENTS.6800.8005
DRUG USE REVIEW.6800.8006
PATIENT CARE GUIDELINES.6800.8007
QUALITY ASSURANCE.6800.8008
RADIOACTIVE DRUGS
DEFINITIONS.6800.8100
SCOPE.6800.8200
MINIMUM STANDARDS.6800.8300
PHARMACISTS HANDLING RADIOPHARMACEUTICALS.6800.8400
PHARMACIST-IN-CHARGE.6800.8500
LABELING OF RADIOPHARMACEUTICALS.6800.8550
ACQUISITION, STORAGE, AND DISTRIBUTION.6800.8600
RECORD KEEPING.6800.8700
DISCIPLINARY PROCEEDINGS
DEFINITIONS.6800.9100
INITIATING PROCEEDINGS.6800.9200
PROCEDURE UPON FILING COMPLAINT.6800.9300
STYLE OF PLEADINGS.6800.9400
FORM OF CHARGES.6800.9500
ORDER FOR AND NOTICE OF HEARING.6800.9600
SERVICE AND FILING OF PAPERS.6800.9700
VARIANCES
VARIANCES.6800.9900
LEGEND MEDICAL GASES
DISPENSING AND DISTRIBUTION OF LEGEND MEDICAL GASES.6800.9920
REGISTRATION.6800.9921
RESTRICTED SALES.6800.9922
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
4MINNESOTA RULES
LABELING.6800.9923
RECORDS.6800.9924
DISPENSING BY PRACTITIONERS
DISPENSING BY PRACTITIONERS.6800.9950
DRUG STORAGE.6800.9951
DISPENSING.6800.9952
LABELING.6800.9953
RECORDS.6800.9954
6800.0100 DEFINITIONS.
Subpart 1. Scope. The terms in this chapter have the meanings given in this part and in
Minnesota Statutes, section 151.01.
Subp. 1a. Board. "Board" means the Board of Pharmacy.
Subp. 1b. Beyond-use date. "Beyond-use date" means the date after which a drug should not
be used.
Subp. 1c. Central service pharmacy. "Central service pharmacy" means a pharmacy that
may provide dispensing functions, drug utilization review (DUR), packaging, labeling, or delivery
of a filled prescription for another pharmacy.
Subp. 2. Community/outpatient pharmacy. "Community/outpatient pharmacy" means an
established place in which prescriptions, drugs, medicines, chemicals, and poisons are prepared,
compounded, dispensed, vended, distributed, or sold to or for the use of nonhospitalized patients
and from which related pharmaceutical care services are provided. Practitioners, as defined in
Minnesota Statutes, section 151.01, subdivision 23, dispensing prescription drugs to their own
patients in accordance with parts 6800.9950 to 6800.9954 are not included within this definition.
Subp. 2a. Community satellite. "Community satellite" means a site affiliated with a licensed
community pharmacy, which is dependent on the licensed community pharmacy for administrative
control, staffing, and drug procurement. A community satellite must be under the direction of a
licensed pharmacist and comply with the requirements of part 6800.0800, subpart 3.
Subp. 2b. Expiration date. "Expiration date" means the date placed on the container or label
of a drug product designating the time during which the product is expected to remain within the
approved shelf life specifications if stored under defined conditions, and after which it may not be
used.
Subp. 3. Hospital pharmacy. "Hospital pharmacy" means an established place located in a
licensed hospital in which prescriptions, drugs, medicines, chemicals, and poisons are prepared,
compounded, dispensed, vended, distributed, or sold to hospitalized patients and from which related
pharmaceutical care services are delivered.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.0100MINNESOTA RULES5
Subp. 3a. Hospital satellite. "Hospital satellite" means a site in a licensed hospital, which is
not physically connected with the centrally licensed pharmacy, but is within the same facility or
building and is dependent on the centrally licensed pharmacy for administrative control, staffing,
and drug procurement. A hospital satellite must be under the direction of a licensed pharmacist,
comply with the requirements of part 6800.0800, subpart 3, and provide pharmacy services to
hospital patients only.
Subp. 4. Long-term care pharmacy. "Long-term care pharmacy" means an established place,
whether or not in conjunction with a hospital pharmacy or a community/outpatient pharmacy, in
which prescriptions, drugs, medicines, chemicals, or poisons are prepared, compounded, dispensed,
vended, distributed, or sold on a regular and recurring basis to or for the use of residents of a licensed
nursing home, boarding care home, assisted living facility, or supervised living facility and from
which related pharmaceutical care services are delivered.
Subp. 4a. Assisted living facility. For the purposes of this chapter, the term "assisted living
facility" means a registered housing with services establishment, as defined in Minnesota Statutes,
section 144D.01, subdivision 4, that provides central storage of medications for residents.
Subp. 5. Nuclear pharmacy. "Nuclear pharmacy" is an area, place, or premises described in
a license issued by the board with reference to plans approved by the board where radioactive drugs
are stored, prepared, manufactured, derived, manipulated, compounded, or dispensed and from
which related clinical services are provided.
Subp. 6. Home health care pharmacy. "Home health care pharmacy" means an established
place, whether or not in conjunction with a hospital pharmacy, long-term care pharmacy, or a
community/outpatient pharmacy, in which parenteral or enteral drugs or medicines are prepared,
compounded, and dispensed for the use of nonhospitalized patients and from which related
pharmaceutical care services are provided.
Subp. 7. Pharmaceutical care. "Pharmaceutical care" means the responsible provision of
drug therapy and other pharmaceutical patient care services by a pharmacist intended to achieve
definite outcomes related to the cure or prevention of a disease, the elimination or reduction of a
patient's symptoms, or the arresting or slowing of a disease process.
Subp. 8. Pharmacist-in-charge. "Pharmacist-in-charge" means a pharmacist licensed in
Minnesota who has been so designated.
Subp. 9. Pharmacist-intern; intern. "Pharmacist-intern" and "intern" has the meaning given
in part 6800.5100, subpart 5.
Subp. 10. [Repealed, 23 SR 1597]
Subp. 11. Prescription drug order. "Prescription drug order" means a lawful written, oral,
or electronic order of a practitioner for a drug for a specific patient. A prescription drug order must
contain the information specified in this chapter and in Minnesota Statutes, section 151.01,
subdivision 16.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6MINNESOTA RULES6800.0100
Subp. 11a. Prescription. "Prescription" means a prescription drug order that is written or
printed on paper, an oral order reduced to writing by a pharmacist, or an electronic order. To be
valid a prescription must be issued for an individual patient by a practitioner within the scope and
usual course of the practitioner's practice, and must contain the date of issue, name and address of
the patient, name and quantity of the drug prescribed, directions for use, the name and address of
the practitioner, and a telephone number at which the practitioner can be reached. A prescription
written or printed on paper that is given to the patient or an agent of the patient, or transmitted
facsimile-to-facsimile must contain the practitioner's manual signature. An electronic prescription
must contain the practitioner's electronic signature.
Subp. 11b. Chart order. "Chart order" means a prescription drug order for a drug that is to
be dispensed by a pharmacist, or by a pharmacist-intern under the direct supervision of a pharmacist,
and administered by an authorized person only during the patient's stay in a hospital or long-term
care facility. The chart order shall contain the name of the patient, another patient identifier such
as a birth date or medical record number, the drug ordered, and any directions as the practitioner
may prescribe concerning strength, dosage, frequency, and route of administration. The manual or
electronic signature of the practitioner must be affixed to the chart order at the time it is written or
at a later date in the case of verbal chart orders.
Subp. 12. Prospective drug review. "Prospective drug review" means a review of a patient's
drug therapy record and prescription drug order prior to the time of dispensing for purposes of
promoting therapeutic appropriateness.
Subp. 13. [Repealed, 31 SR 1673]
Subp. 14. Nonsterile preparation compounding. "Nonsterile preparation compounding"
means the preparation, mixing, assembling, altering, packaging, and labeling of a nonsterile drug
preparation, according to United States Pharmacopeia Chapter 795.
Subp. 15. Sterile preparation compounding. "Sterile preparation compounding" means the
preparation, mixing, assembling, altering, packaging, and labeling of a drug preparation that achieves
sterility, according to United States Pharmacopeia Chapter 797.
Subp. 16. Limited service pharmacy. "Limited service pharmacy" means a pharmacy to
which the board may assign a restricted license to perform a narrow range of the activities that
constitute the practice of pharmacy.
Subp. 17. Unique identifier. "Unique identifier" means a manual signature or initials, a
biometric identifier, or a board-approved electronic means of identifying only one individual.
Subp. 18. High-alert drug. "High-alert drug" means a drug that bears a heightened risk of
causing significant patient harm when it is used in error.
Statutory Authority: MS s 151.06; 151.102; 152.02
History: 17 SR 1279; 18 SR 1145; 23 SR 1597; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.0100MINNESOTA RULES7
6800.0110 RESPONSIBILITY FOR ACTION BY A PHARMACY.
Whenever an applicable rule requires or prohibits action by a pharmacy, responsibility for said
action shall be that of the owner and pharmacist-in-charge thereof, whether said owner is a sole
proprietor, partnership, association, corporation, or otherwise.
Statutory Authority: MS s 151.06
Published Electronically: September 21, 2011
LICENSING PHARMACIES
6800.0200 FORM OF APPLICATION AND LICENSE.
Applications for the licensing of a pharmacy and renewal thereof shall be on such form or forms
as the Board of Pharmacy may from time to time prescribe, and the license of such pharmacy shall
be issued by the Board of Pharmacy in such form as it may from time to time prescribe.
Statutory Authority: MS s 151.06
Published Electronically: September 21, 2011
6800.0300 PHARMACY LICENSE AND FEE REQUIRED.
No person or persons shall conduct a pharmacy in or outside of Minnesota that dispenses legend
drugs for Minnesota residents and mails, ships, or delivers the legend drugs into this state unless
the pharmacy is licensed by the Board of Pharmacy. A fee established in Minnesota Statutes, chapter
151, shall be charged for a license.
A completed new pharmacy license application together with a blueprint of the proposed
pharmacy showing size, layout, and security and a check for the proper fee must be received in the
board office at least 60 days prior to the proposed opening date of the pharmacy.
An application for a pharmacy license which has not been completed within 12 months of the
date on which the board received the application is no longer valid.
Statutory Authority: MS s 151.06
History: 18 SR 1145; 36 SR 237
Published Electronically: September 21, 2011
6800.0350 LICENSE CATEGORIES.
A pharmacy must be licensed in one or more of the following categories:
A. community/outpatient;
B. hospital;
C. home health care;
D. long-term care;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
8MINNESOTA RULES6800.0110
E. nuclear;
F. central service;
G. nonsterile preparation compounding;
H. sterile preparation compounding;
I. veterinary; and
J. limited service.
Licensing of a pharmacy in more than one category shall not result in an increase in the license
fee.
No pharmacy may engage in providing products or services in categories for which it is not
licensed. A pharmacy must designate its category or categories on license renewal or application
for an initial license. Effective July 1, 2012: an initial or renewed license issued by the board shall
list each license category for which the pharmacy has received board approval; a pharmacy must
receive board approval before providing services in a license category not listed on its license; a
pharmacy must notify the board if the pharmacy no longer provides services in a license category;
and the board shall issue a revised license without imposing an additional fee, if it approves a
pharmacy's request to provide services in additional license categories or if a pharmacy no longer
provides services in one or more license categories.
The board may establish special conditions for licensure, appropriate to the situation, before
approving a license application for a pharmacy with a limited service license category. Such
pharmacies must also apply for and receive any necessary variances, according to part 6800.9900,
before an application for licensure is approved.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.0400 ANNUAL LICENSE RENEWAL DATE AND FEES.
Each pharmacy license shall expire on June 30 of each year and shall be renewed annually by
filing an application for license renewal, on or before June 1 of each year, together with a fee
established in Minnesota Statutes, chapter 151. Renewal applications received on or after July 1
are subject to a late filing fee of an amount equal to 50 percent of the renewal fee in addition to the
renewal fee.
Statutory Authority: MS s 16A.128; 151.06; 151.07; 151.12; 151.13; 151.19; 151.25; 151.47;
151.48; 151.49; 214.06
History: 9 SR 1656; 11 SR 335; 22 SR 1547; 25 SR 81; 36 SR 237
Published Electronically: September 21, 2011
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.0400MINNESOTA RULES9
6800.0500 SEPARATE LICENSE REQUIRED.
Subpart 1. Transfer of license restrictions. A separate license shall be required for each
pharmacy and is not transferable. The following shall be considered a transfer of ownership requiring
relicensure:
A. the sale of all or substantially all of the assets of the pharmacy;
B. the addition or deletion of one or more partners in a partnership to which a pharmacy
license has been issued;
C. the change of ownership of 20 percent or more of the issued voting stock of a corporation
pharmacy since the issuance of the license or the last renewal; this does not apply to any corporation
the voting stock of which is actively traded on any securities exchange or in any over-the-counter
market; or
D. the change in ownership from one form to another: sole proprietor, partnership, or
corporation.
Subp. 2. Transfer of ownership. For a transfer of ownership, the new owner must submit a
completed pharmacy license application prior to the effective date of the transfer. Upon a transfer
of ownership, the new owner can continue operation of the pharmacy under the license issued to
the prior owner for 14 days after the effective date of the change of ownership or until the board
issues a new license, whichever is earlier. After the 14-day period, the license issued to the prior
owner is void and must be surrendered to the director of the board.
Statutory Authority: MS s 151.06
History: 18 SR 1145; 36 SR 237
Published Electronically: September 21, 2011
6800.0600 POSTING LICENSE.
Each pharmacy license shall be posted in a conspicuous place in the pharmacy for which the
license has been issued.
Statutory Authority: MS s 151.06; 151.19
Published Electronically: September 21, 2011
6800.0700 PHARMACY, SPACE, AND SECURITY.
Subpart 1. Minimum requirements. No person shall be issued a license to conduct a pharmacy
located in Minnesota unless the pharmacy:
A. contains more than 250 square feet in the dispensing and drug storage area;
B. maintains a prescription dispensing counter at least 18 inches deep that provides two
linear feet, which must be kept clear and free of all merchandise and other materials not currently
in use in the practice of compounding and dispensing, for each pharmacist and each technician
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
10MINNESOTA RULES6800.0500
working concurrently on compounding and dispensing; this counter shall provide an additional
space for computers if they are used in the dispensing process;
C. maintains an aisle behind the prescription dispensing counter at least 36 inches wide,
extending the full length of the counter, which shall be kept free of obstruction at all times;
D. is surrounded by a continuous partition or wall extending from the floor to the permanent
ceiling, containing doors capable of being securely locked to prevent entry when the pharmacy is
closed;
E. in the case of a community/outpatient pharmacy, contains an area where consultation
between the patient and the pharmacist may be conducted with a reasonable assurance of privacy.
All new and remodeled community/outpatient pharmacies must meet the standards of this item. A
pharmacy licensed before January 1, 2011, must meet the standards within two years of that date,
unless the pharmacy has an existing counseling area that has been deemed by the board to provide
a reasonable assurance of privacy. If pharmacies use partitions to create a consultation area in which
the patient will typically remain standing, the partitions must be sound-dulling and at least seven
feet high and 24 inches deep. The patient must be able to enter the partitioned area so that the
partitions are on each side of the patient. Consultation areas without partitions may be approved if
the board deems the consultation area will provide a reasonable assurance of privacy. Consultation
areas must not contain any item for sale apart from the articles needed for counseling sessions.
Pharmacists must have access to patient profiles in order to comply with part 6800.0910. Consultation
areas must be accessible to the patient from the outside of the prescription dispensing area and be
open at all times when the pharmacy is open; and
F. is lighted to a level of not less than 75-foot candles measured in the major work areas.
Subp. 2. Satellite waiver. In the interest of public health, the board may waive subpart 1, item
A, for satellite pharmacies located in hospitals.
Statutory Authority: MS s 151.06; 151.102; 152.02
History: 18 SR 1145; 23 SR 1597; 27 SR 260; 36 SR 237
Published Electronically: September 21, 2011
6800.0800 LOCATION, DIMENSION, OR SECURITY CHANGES.
Subpart 1. Change in location. Before a licensed pharmacy changes the location of its business,
it shall first submit to the Board of Pharmacy a new application for a license setting forth the changes
and shall submit the information and documents required in an initial application for license. The
new application and supporting documents shall be submitted at least 60 days before the proposed
change in location. If the Board of Pharmacy approves the application, no additional charge shall
be made for the new license.
Subp. 2. Change in dimension or security. No licensed pharmacy in Minnesota shall change
its physical dimensions or elements of physical security until it has submitted documents and plans
of the proposed changes to the Board of Pharmacy. The documents and plans shall be submitted
at least 60 days before the proposed changes. The board shall, within 30 days after receipt of the
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.0800MINNESOTA RULES11
proposed changes, notify the licensee that the proposed changes either comply or do not comply
with part 6800.0700. Failure of the board to respond in writing within 30 days shall be considered
to be approval of the proposed changes.
Subp. 3. Establishment of satellite. No licensed pharmacy in Minnesota shall establish a
community or hospital satellite until it has submitted documents, plans, and operational policies
and procedures for the proposed satellite to the Board of Pharmacy. The documents and plans must
be submitted at least 60 days before the proposed establishment of the satellite. The board must,
within 60 days after receipt of the proposal, notify the licensee that the proposed satellite either
complies or does not comply with part 6800.0700. Failure of the board to respond in writing within
60 days shall be considered to be approval of the proposed satellite.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 31 SR 1673
Published Electronically: September 21, 2011
6800.0900 Subpart 1. [Renumbered 6800.2250, subpart 1]
Subp. 2. [Renumbered 6800.2250, subp 2]
Subp. 3. [Repealed, 9 SR 260]
Subp. 4. [Renumbered 6800.2250, subp 3]
Published Electronically: September 21, 2011
6800.0910 PATIENT ACCESS TO PHARMACIST.
Subpart 1. Patient consultation procedure required. Each licensed pharmacy in Minnesota
required to provide patient counseling under this part must develop and maintain a written patient
consultation procedure providing for direct oral communication between the patient and the
pharmacist designed to improve the patient's understanding of and compliance with the patient's
drug therapy to enhance or optimize the outcome of the patient's drug therapy.
Subp. 2. Description of procedure. When dispensing a filled prescription for a patient, a
pharmacist must consult with the patient or the patient's agent or caregiver and inquire about the
patient's understanding of the use of the drug according to this part.
A. Upon receipt of a new prescription, following a review of the patient's record, a
pharmacist shall personally initiate discussion of matters which in the professional judgment of the
pharmacist will enhance or optimize drug therapy with each patient or the agent or caregiver of the
patient. The discussion shall be in person, whenever applicable, may be supplemented with written
material, and shall include appropriate elements of patient counseling. These elements include the
following:
(1) the name and description of the drug;
(2) the dosage form, dose, route of administration, and duration of drug therapy;
(3) intended use of the drug and expected action;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
12MINNESOTA RULES6800.0800
(4) special directions and precautions for preparation, administration, and use by the
patient;
(5) common severe side effects, adverse effects, or interactions and therapeutic
contraindications that may be encountered, including their avoidance, and the action required if
they occur;
(6) techniques for self-monitoring of drug therapy;
(7) proper storage;
(8) prescription refill information;
(9) action to be taken in the event of a missed dose; and
(10) pharmacist comments relevant to the patient's drug therapy, including any other
information peculiar to the specific patient or drug.
B. The pharmacist must counsel the patient on a refilled prescription if deemed necessary
according to the pharmacist's professional judgment. The consultation must be in person whenever
applicable.
A pharmacist may vary or omit the patient information if, in the pharmacist's professional
judgment, the variation or omission serves the best interest of the patient because of the particular
individual circumstances involved. If there is any material variation from the minimal information
required by this subpart in the information provided or, if consultation is not provided, that fact
and the circumstances involved shall be noted on the prescription, in the patient's records, or in a
specially developed log.
Personal communication by the pharmacist is not required for inpatients of a hospital or other
institution, such as a licensed nursing home, where other licensed health care professionals are
authorized to administer the drugs, or where a patient or patient's agent or caregiver has expressed
a desire not to receive the consultation. When a new filled prescription or a refilled prescription
for which counseling is required is being mailed or delivered to the patient by common carrier or
delivery services, the consultation must still be provided but may be accomplished by providing
written information to the patient regarding the medication being dispensed and the availability of
the pharmacist to answer questions, and through the provision of a toll-free phone number for long
distance calls.
Nothing in this part shall prohibit pharmacists from charging for these services.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 27 SR 260; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.0950 REQUIREMENT FOR A SUPERVISED PHARMACY AREA.
The Board of Pharmacy shall refuse to grant a pharmacy license to any existing or proposed
facility or place of business unless the facility or place of business has an area that meets the
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.0950MINNESOTA RULES13
definition of and the requirements for a pharmacy according to this chapter. The pharmacy area
must be under the supervision of a licensed pharmacist. The board may issue a pharmacy license
for a limited service pharmacy according to part 6800.0350.
Statutory Authority: MS s 151.06
History: 9 SR 1656; 17 SR 1279; 18 SR 1145; 36 SR 237
Published Electronically: September 21, 2011
6800.1000 [Renumbered 6800.1150]
Published Electronically: September 21, 2011
6800.1010 CLOSING A PHARMACY.
Subpart 1. Before closing. At least 14 days before a licensed pharmacy closes and ceases
operation it shall notify the board of the intended closing.
Subp. 2. At time of closing. Effective with the closing date, the pharmacist-in-charge shall:
A. return the pharmacy license to the board office, noting the closing date;
B. notify the board as to the disposition of the prescription files, legend drugs, insulin,
hypodermic syringes and needles, contraceptive drugs and devices, chemicals, and nonprescription
drugs;
C. if the pharmacy that is closing has been computerized, give a printout of all patient
profiles to the pharmacy that is receiving the prescription files;
D. ensure that all legend drugs are removed from the pharmacy at the time of closing and
stored in a licensed pharmacy; legend drugs must not be stored elsewhere, including in the custody
of a pharmacist;
E. inform the succeeding business occupying the premises and the landlord, if any, that it
is unlawful to use the words "drugs," "drug store," or "pharmacy," or similar words in connection
with the place of business unless it is a licensed pharmacy; and
F. take a controlled substances inventory as described in subitems (1) to (4). The inventory
shall serve as the final inventory of the closing pharmacy and the initial inventory of the pharmacy
receiving the controlled substances, and a copy of the inventory shall be included in the records of
both. It is not necessary to file a copy of the inventory with the Drug Enforcement Administration
unless requested by the regional administrator.
(1) If controlled substance drugs are to be destroyed, the pharmacist-in-charge must
contact the local Drug Enforcement Administration for instructions.
(2) If controlled substance drugs, Schedule III-V, are being transferred, they shall be
transferred on duplicate invoices, with each pharmacy keeping a copy.
(3) If Schedule II narcotics are being transferred, the transferee must submit a new Drug
Enforcement Administration 222 Form to the transferor for the Schedule II substances only.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
14MINNESOTA RULES6800.0950
(4) If the Drug Enforcement Administration does not approve of the transfer, instructions
must be given to the pharmacy that is closing to dispose of the drugs according to the written
instructions provided by the regional director.
Subp. 3. Public notification. A licensed pharmacy must provide the following public
notification when closing a pharmacy: distribution, by at least one of the following means, of a
notice that informs patients that the pharmacy will close on a specified date and that gives the name,
address, and telephone number of the pharmacy to which prescription files will be transferred:
A. publication of the notice in a local newspaper for one week prior to the date on which
the pharmacy is to be closed;
B. a direct mailing to patients who have had at least one prescription filled at that pharmacy
during the six months preceding the date of closing, with the mailing designed to reach patients no
later than one business day prior to the closing; and
C. distribution of the notice to patients who are picking up prescriptions at least 30 days
prior to the date on which the pharmacy will be closed.
In the case of patients who are residents of long-term care facilities, the pharmacy shall provide
a written notice to the patients, the caregivers of the patients, or the long-term care facilities in
which the patients reside at least 30 days prior to the date on which the pharmacy will be closed.
Statutory Authority: MS s 151.06; 151.102; 152.02
History: 18 SR 1145; 23 SR 1597; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.1050 REQUIRED REFERENCE BOOKS AND EQUIPMENT.
Subpart 1. Reference books. Except as indicated, the references in this subpart may be in
electronic or hard copy form. In addition to the most recent editions of the laws relating to the
practice of pharmacy, the rules of the Board of Pharmacy, and the current copy of the Drug
Enforcement Agency regulations, Code of Federal Regulations, title 21, parts 1300 to 1316, each
pharmacy in Minnesota must have on file at least one current reference from each of the categories
in items A to C. At least one dosage and toxicology reference must be in hard copy form that is
appropriate to the majority of the patient base of the pharmacy. An equivalent reference approved
by the board in writing may be used in an appropriate category.
A. Examples of pharmacotherapy references are:
(1) Goodman and Gilman's The Pharmacological Basis of Therapeutics;
(2) Applied Therapeutics: The Clinical Use of Drugs;
(3) Pharmacotherapy: A Pathophysiologic Approach; and
(4) Conn's Current Therapy.
B. Examples of dosage and toxicology references are:
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.1050MINNESOTA RULES15
(1) American Hospital Formulary Service;
(2) Facts and Comparisons; and
(3) Drug Information Handbook.
C. Examples of general references are:
(1) Handbook of Nonprescription Drugs;
(2) Physician's Desk Reference;
(3) Remington: The Science and Practice of Pharmacy;
(4) United States Pharmacopeia - National Formulary;
(5) United States Pharmacopeia - Pharmacists' Pharmacopeia;
(6) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations;
and
(7) The Merck Manual.
In addition to items A to C, long-term care pharmacies must have on file the most recent edition
of Minnesota Department of Health rules pertaining to medication handling in long-term care
facilities and a current general reference on geriatric pharmacotherapy. In addition to items A to
C, specialty pharmacies serving a unique population must have a current general reference appropriate
to the patient base served.
Subp. 2. Equipment. Each pharmacy must have the following minimum equipment, clean
and in good working order:
A. one prescription balance, Class A as defined in United States Pharmacopeia - National
Formulary, with one set of accurate metric weights from 50 mg to 100 g, or an electronic balance
of equal or greater accuracy;
B. measuring devices capable of accurately measuring volumes from 1 ml to at least 500
ml;
C. mortars, pestles, spatulas, funnels, stirring rods, and heating apparatus as necessary to
meet the needs of that pharmacy;
D. other equipment as necessary to comply with the requirements of United States
Pharmacopeia, chapter 795;
E. a refrigerator used only for drug storage or a separate compartment used only for drug
storage within a general use refrigerator, manual, electromechanical, or electronic temperature
recording equipment, devices, or logs shall be used to document proper storage of legend drugs
every business day;
F. a sink with hot and cold running water; and
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
16MINNESOTA RULES6800.1050
G. a toilet with a hand-washing lavatory and disposable towels in a location that is reasonably
accessible.
Subp. 3. Required resources. In addition to the requirements of subparts 1 and 2, pharmacies
preparing compounded sterile products are required to have:
A. minimum equipment to comply with the United States Pharmacopeia, chapter 797,
appropriate to risk-level requirements;
B. current reference materials or books for sterile products or intravenous incompatibilities;
and
C. a current copy of United States Pharmacopeia, chapter 797.
Statutory Authority: MS s 151.06; 152.02
History: 9 SR 1656; 18 SR 1145; L 2001 1Sp4 art 6 s 1; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.1100 [Renumbered 6800.1250]
Published Electronically: September 21, 2011
LICENSING PHARMACISTS
6800.1150 ANNUAL RENEWAL, FEES, AND POSTING.
A pharmacist license expires on March 1 of each year and shall be renewed annually by filing
an application for license renewal on or before February 1 of each year, together with a fee of $105.
A pharmacist license renewal application received after March 1 is subject to a late filing fee of an
amount equal to 50 percent of the renewal fee in addition to the renewal fee.
A pharmacist shall post the license or renewal most recently issued by the board or a copy of
it in a conspicuous place within the pharmacy in which the pharmacist is practicing. For community
pharmacies, this place shall be a place which is readily visible to the public.
Statutory Authority: MS s 16A.128; 151.03; 151.06; 151.07; 151.12; 151.13; 151.19; 151.25;
151.47; 151.48; 151.49; 214.06
History: 9 SR 1656; 13 SR 1775; 16 SR 2239; 18 SR 1145; 22 SR 1547; 25 SR 81
Published Electronically: September 21, 2011
6800.1200 [Renumbered 6800.1300]
Published Electronically: September 21, 2011
6800.1210 INACTIVE STATUS AND EMERITUS LICENSE.
Subpart 1. Inactive status. A pharmacist currently licensed in Minnesota who is not in active
practice in Minnesota may apply for an inactive status license with the board. Requests for inactive
status licensure shall be made at the time of license renewal.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.1210MINNESOTA RULES17
The board shall grant an inactive status license to a pharmacist making the request on submission
of a sworn statement stating that the pharmacist is not in active practice in Minnesota.
A pharmacist granted an inactive status license must continue to pay the renewal fee for licensure
but shall not be required to comply with the continuing education requirements of the board. A
pharmacist granted inactive status is not authorized to practice pharmacy in Minnesota while on
inactive status.
If an individual's license is on inactive status and that individual maintains an active status
license in good standing in another state that requires continuing education, the individual may
reactivate the Minnesota license by showing compliance with the continuing education requirements
of the other state. If an individual in this category has been on inactive status in Minnesota for
longer than five years, the individual must also take and pass the jurisprudence examination described
in part 6800.1300, subpart 5, offered to candidates for licensure by reciprocity.
If an individual's license is on inactive status in Minnesota and that individual is not licensed
in another state that requires continuing education and now seeks to reactivate the license in
Minnesota, the individual must show that continuing pharmaceutical education has been completed
at a rate of 15 hours per year for each year that the license has been on inactive status up to a
maximum of 75 hours. If the license has been on inactive status for longer than five years, the
individual must also take and pass the jurisprudence examination described in part 6800.1300,
subpart 5, offered to candidates for licensure by reciprocity.
An individual whose license has lapsed before November 1, 1993, and who wishes to be
relicensed must apply under Minnesota Statutes, section 151.14.
Subp. 2. Emeritus. A pharmacist who is completely retired from active pharmacy practice
may apply to the board for an emeritus license providing the pharmacist has not been disciplined
by the board. An emeritus license is not a license to practice, but is a formal recognition of completion
of that individual's pharmacy career in good standing.
An emeritus pharmacist is not subject to renewal fees or continuing education requirements.
A pharmacist interested in an emeritus license may obtain an application form by requesting it
on the annual renewal form or by writing or calling the board office.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.1250 APPLICATIONS FOR LICENSURE.
Subpart 1. Graduates of colleges or schools of pharmacy accredited by the Accreditation
Council for Pharmacy Education (ACPE). An applicant for licensure by examination who is a
graduate of a college or school of pharmacy accredited by ACPE shall submit a completed eligibility
application, affidavits of internship, a copy of the applicant's official and certified birth record, and
a recent photograph. An applicant shall provide the board with an official certified final transcript
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
18MINNESOTA RULES6800.1210
from an ACPE accredited college or school of pharmacy showing the date on which the applicant
graduated with a bachelor of science degree or doctor of pharmacy degree, as the first professional
undergraduate degree in pharmacy. The documents in this subpart, together with a check for the
application fee under Minnesota Statutes, chapter 151, and made payable to the Minnesota Board
of Pharmacy, must be received by the board prior to approval being granted to sit for the
examinations. Applicants must register with and pay the required fees to the National Association
of Boards of Pharmacy for the North American Pharmacy Licensing Exam and the Multistate
Pharmacy Jurisprudence Exam, both of which must be passed before licensure as a pharmacist is
granted.
Subp. 1a. Graduates of colleges or schools of pharmacy accredited by the Canadian Council
for Accreditation of Pharmacy Programs (CCAPP).
A. Applicants who graduated between 1993 and June 30, 2004, from a CCAPP-accredited
pharmacy program with a curriculum taught in English must:
(1) submit a letter to the Board of Pharmacy which outlines work experience as an
intern or pharmacist in Canada. The board shall determine if the reported experience is comparable
to the experience gained by individuals completing the internship requirement specified in part
6800.5400. If the board finds that the reported experience is not comparable, the board shall require
the applicant to obtain additional experience as an intern or pharmacist prior to permitting the
applicant to sit for the required licensure examinations;
(2) submit to the board a completed eligibility application, a copy of the applicant's
official certified birth record, a recent photograph, an official certified final transcript from a
CCAPP-accredited college or school of pharmacy showing the date on which the applicant graduated
with a first professional pharmacy degree, and a check for the application fee under Minnesota
Statutes, chapter 151; and
(3) register with and pay the required fees to the National Association of Boards of
Pharmacy for the North American Pharmacy Licensing Exam and the Multistate Pharmacy
Jurisprudence Exam, both of which must be passed before licensure as a pharmacist is granted.
B. Applicants who graduated before 1993 or after June 30, 2004, from a CCAPP-accredited
pharmacy program with a curriculum taught in English or who graduated from a CCAPP-accredited
pharmacy program with a curriculum that is not taught in English or licensed Canadian pharmacists
who graduated from a college of pharmacy located outside of the United States or Canada must:
(1) pass the Foreign Pharmacy Graduate Equivalency Examination and become certified
by the Foreign Pharmacy Graduate Equivalency Commission (FPGEC), including demonstrating
proficiency in the English language by passing the Test of English as a Foreign Language (TOEFL)
and the Test of Spoken English, or the TOEFL Internet-based Test;
(2) obtain 1,600 hours of internship after becoming certified by the FPGEC. Applicants
obtaining their internship in Minnesota must register as interns according to part 6800.5300 and
complete the internship manual as specified in that part. Applicants obtaining their internship outside
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.1250MINNESOTA RULES19
of Minnesota must have the licensing agency of the state in which the internship was completed
certify to the board completion of the internship hours;
(3) submit to the board a completed eligibility application form, a copy of the applicant's
official certified birth record, a recent photograph, and a check for the application fee under
Minnesota Statutes, chapter 151; and
(4) register with and pay the required fees to the National Association of Boards of
Pharmacy for the North American Pharmacy Licensing Exam and the Multistate Pharmacy
Jurisprudence Exam, both of which must be passed before licensure as a pharmacist is granted.
Subp. 1b. Foreign pharmacy graduates.
A. Except as provided in subpart 2, graduates of foreign schools, colleges, or programs of
pharmacy must:
(1) pass the Foreign Pharmacy Graduate Equivalency Examination and become certified
by the Foreign Pharmacy Graduate Equivalency Commission (FPGEC), including demonstrating
proficiency in the English language by passing the Test of English as a Foreign Language (TOEFL)
and the Test of Spoken English, or the TOEFL Internet-based Test;
(2) obtain 1,600 hours of internship after becoming certified by the FPGEC. Applicants
obtaining their internship in Minnesota must register as interns according to part 6800.5300 and
complete the internship manual as specified in that part. Applicants obtaining their internship outside
of Minnesota must have the licensing agency of the state in which the internship was completed
certify to the board completion of the internship hours;
(3) submit to the board a completed eligibility application form, a copy of the applicant's
official certified birth record, a recent photograph, and a check for the application fee under
Minnesota Statutes, chapter 151; and
(4) register with and pay the required fees to the National Association of Boards of
Pharmacy for the North American Pharmacy Licensing Exam and the Multistate Pharmacy
Jurisprudence Exam, both of which must be passed before licensure as a pharmacist is granted.
B. Graduates of four-year foreign pharmacy schools, colleges, or programs are not eligible
for licensure as pharmacists.
Subp. 1c. Social Security number required. No license will be issued to an applicant for
licensure by any method described in this part who does not supply the board with a valid United
States Social Security number as required by Minnesota Statutes, section 270C.72, subdivision 4.
Subp. 1d. Authorization to practice. An applicant who obtains a passing score on the required
examinations is authorized to practice pharmacy only after paying an original licensure fee under
Minnesota Statutes, chapter 151, to the board.
Subp. 2. Retaking exam. Any applicant who has failed to pass an examination required by
Minnesota Statutes, section 151.06, 151.07, 151.10, or 151.12, may retake the examination within
the next ensuing 18 months, provided that no applicant who has failed in three examinations shall
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
20MINNESOTA RULES6800.1250
be permitted to take a further examination, except upon petition setting forth facts acceptable to
the board. The board reserves the right to request resubmission of a full and complete application,
including the application fee under Minnesota Statutes, chapter 151.
Subp. 2a. Deadline for completion of licensing process. The board shall consider an
application for licensure or a NAPLEX or MPJE registration to be invalid 18 months after the date
that the board receives an application for licensure.
Subp. 3. Fees not refunded. Fees paid to the board according to this part will not be returned
or refunded.
Statutory Authority: MS s 16A.128; 151.06; 151.07; 151.12; 151.13; 151.19; 152.02; 214.06
History: 9 SR 1656; 11 SR 335; 12 SR 2393; 16 SR 2239; 18 SR 1145; 22 SR 1547; L 2001
1Sp9 art 15 s 32; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.1300 LICENSURE TRANSFER (RECIPROCITY).
Subpart 1. Applications. An application for licensure transfer (licensure as a pharmacist on
the basis of licensure as a pharmacist in another state) together with an application fee under
Minnesota Statutes, chapter 151, shall be filed with the director of the board. An applicant must
register with and pay the required fees to the National Association of Boards of Pharmacy for the
Minnesota version of the Multistate Pharmacy Jurisprudence Exam, which must be passed before
licensure as a pharmacist is granted.
Subp. 2. Eligibility. To be found eligible for consideration by the board:
A. an applicant, if examined and licensed before January 1, 1973, shall show that the
applicant has acquired 2,080 hours of practical pharmacy experience under the instruction of a
licensed pharmacist;
B. an applicant, if examined and licensed between January 1, 1973, and May 1, 2003, shall
show that the applicant has acquired 1,500 hours of practical pharmacy experience under the
instruction of a licensed pharmacist, to be acquired after the successful completion of the first
professional academic year of the standard five-year or six-year pharmacy curriculum, 400 hours
of which may be acquired: concurrently with college attendance, in clinical pharmacy programs,
or in demonstration projects which have been approved by the Tripartite Committee on Internship
and the board of the active member state from which the applicant applies; and
C. an applicant, if examined and licensed after May 1, 2003, shall show that the applicant
has acquired 1,600 hours of practical pharmacy experience under the instruction of a licensed
pharmacist, acquired after the successful completion of the first professional academic year of the
standard six-year pharmacy curriculum, with 800 of the hours being of a traditional compounding,
patient counseling, and dispensing nature.
Subp. 3. Substitution for internship. Defects in internship experience will not preclude an
applicant from being considered eligible provided that the applicant has practiced as a licensed
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.1300MINNESOTA RULES21
pharmacist for one week at 40 hours per week for each week or portion of a week that the applicant
is deficient in internship experience, for example, the number of weeks the applicant has practiced
as a licensed pharmacist before applying for reciprocity must be equal to or greater than the number
of weeks or portions of weeks that the applicant is deficient in internship experience.
Subp. 4. NAPLEX examination. The board may compel applicants who have not engaged
in practice as a licensed pharmacist for the two years immediately preceding the time of filing of
their application for reciprocity to take the NAPLEX examination.
Subp. 5. Examination. Applicants for licensure transfer shall be required to display their
familiarity with the laws regulating the practice of pharmacy in Minnesota by passing the Minnesota
version of the Multistate Pharmacy Jurisprudence Exam that is offered by the National Association
of Boards of Pharmacy.
Subp. 6. [Repealed, 36 SR 237]
Statutory Authority: MS s 16A.128; 151.06; 151.07; 151.12; 151.13; 151.19; 151.25; 151.47;
151.48; 151.49; 152.02; 214.06
History: 9 SR 1656; 13 SR 1775; 16 SR 2239; 18 SR 1145; 22 SR 1547; 25 SR 81; 27 SR 260;
31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
LICENSING MANUFACTURERS AND WHOLESALERS
6800.1400 DRUG MANUFACTURER OR WHOLESALER LICENSE.
Subpart 1. Licensing; fees. Every person engaged in manufacturing, wholesale distribution,
or selling of drugs, medicines, chemicals, or poisons for medicinal purposes other than to the
consuming public or patient, except as allowed under part 6800.9921, shall annually be licensed
by the board. Upon the filing of an application, and upon payment of a fee under Minnesota Statutes,
chapter 151, the board may issue or renew a license in such form as it may prescribe to the
manufacturer or wholesale distributor. The license shall be exposed in a conspicuous place in the
manufacturer's or wholesaler's place of business for which it is issued, shall expire at midnight on
June 1 of each year, and shall be renewed annually upon the filing of an application therefor, on or
before May 1 of each year together with the applicable fee. Renewal applications received after
June 1 shall be subject to a late filing fee of one-half of the renewal fee in addition to the amount
of the renewal fee. An application for a manufacturer or wholesaler license which has not been
completed within 12 months of the date on which the board received the application is no longer
valid.
Subp. 2. Prohibition. No license may be issued to any manufacturer or wholesale distributor
whose intended place of business is a personal residence.
Subp. 3. Separate licenses required. A separate license is required for each separate location
involved in wholesale drug distribution within this state and each separate out-of-state location
from which drugs are shipped into this state. A manufacturer that does not ship drugs into this state
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
22MINNESOTA RULES6800.1300
from any location that it directly operates must still obtain a license according to Minnesota Statutes,
section 151.25, if it does business with accounts in this state. Doing business in this state includes
any sale of a manufacturer's drug to any individual or business in Minnesota.
Statutory Authority: MS s 151.06; 151.12; 151.13; 151.19; 151.25; 151.42; 151.47; 151.48;
151.49; 152.02; 214.06
History: 16 SR 1913; 25 SR 81; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.1410 MINIMUM INFORMATION REQUIRED FOR LICENSURE.
The following information is required from each wholesale drug distributor applying for licensure
or renewal:
A. the name, full business address, and telephone number of the licensee;
B. all trade or business names used by the licensee;
C. addresses, telephone numbers, and the names of contact persons for all facilities used
by the licensee for the storage, handling, and distribution of drugs;
D. whether the ownership or operation is a partnership, corporation, or sole proprietorship;
and
E. the name of the owner and operator of the licensee, including:
(1) if an individual, the name of the individual;
(2) if a partnership, the name of each partner, and the name of the partnership;
(3) if a corporation, the name and title of each corporate officer and director, the
corporate names, and the name of the state of incorporation; and
(4) if a sole proprietorship, the full name of the sole proprietor, and the name of the
business entity.
Changes in any information in items A to E shall be submitted to the board within 30 days of
the change.
Statutory Authority: MS s 151.06; 151.42
History: 16 SR 1913
Published Electronically: September 21, 2011
6800.1420 MINIMUM QUALIFICATIONS.
The board may deny, suspend, revoke, or refuse to renew any license for a wholesale drug
distributor based on the board's finding of any of the following factors:
A. any convictions of the applicant under any federal, state, or local laws relating to drug
samples, wholesale or retail drug distribution, or distribution of controlled substances;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.1420MINNESOTA RULES23
B. any felony convictions of the applicant under federal, state, or local laws;
C. the lack of previous experience on the part of the applicant in the manufacture or
distribution of drugs, including controlled substances;
D. the furnishing by the applicant of false or fraudulent material in any application made
in connection with drug manufacturing or distribution;
E. the suspension or revocation by federal, state, or local government bodies of any license
currently or previously held by the applicant for the manufacture or distribution of any drugs,
including controlled substances;
F. the lack of compliance by the applicant with licensing requirements under previously
granted licenses, if any;
G. the lack of compliance by the applicant with requirements to maintain or make available
to the Board of Pharmacy or to federal, state, or local law enforcement officials those records
required under this part; and
H. the lack of compliance by the applicant with requirements for the storage and handling
of drugs as specified in part 6800.1440.
Statutory Authority: MS s 151.06; 151.42
History: 16 SR 1913
Published Electronically: September 21, 2011
6800.1430 PERSONNEL.
Each wholesale drug distributor shall require each person employed in any drug wholesale
activity to have enough education, training, and experience, in any combination, sufficient for that
person: (1) to do assigned work in a manner that maintains the quality, safety, and security of the
drug products in accordance with parts 6800.1400 to 6800.1440; and (2) to assume responsibility
for compliance with the licensing requirements of parts 6800.1400 to 6800.1440.
Statutory Authority: MS s 151.06; 151.42
History: 16 SR 1913; 36 SR 237
Published Electronically: September 21, 2011
6800.1440 REQUIREMENTS FOR WHOLESALE DRUG DISTRIBUTORS.
Subpart 1. Application. The minimum requirements in this part apply to all wholesale drug
distributors located in this state and to their officers, agents, representatives, and employees.
Subp. 2. Incorporation by reference. "United States Pharmacopeia/National Formulary"
means the United States Pharmacopeia/National Formulary published by the United States
Pharmacopeia, which is incorporated by reference. The United States Pharmacopeia/National
Formulary is subject to frequent change. The book is available for inspection and copying at the
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
24MINNESOTA RULES6800.1420
Biomedical Library, University of Minnesota, Diehl Hall, 505 Essex Street S.E., Minneapolis,
Minnesota 55455, or through the Minitex interlibrary loan system.
Subp. 3. Facilities. All facilities at which drugs are stored, warehoused, handled, held, offered,
marketed, or displayed shall:
A. be of suitable size and construction to facilitate cleaning, maintenance, and proper
operations;
B. have storage areas designed to provide adequate lighting, ventilation, temperature,
sanitation, humidity, space, equipment, and security conditions;
C. have a physically separate area for storage of all drugs that are outdated, damaged,
deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers
that have been opened;
D. be maintained in a clean and orderly condition; and
E. be free from infestation by insects, rodents, birds, or vermin of any kind.
Subp. 4. Security. The requirements in items A to C govern security.
A. All facilities used for wholesale drug distribution shall be secure from unauthorized
entry as follows:
(1) access from outside the premises shall be kept to a minimum and be well-controlled;
(2) the outside perimeter of the premises shall be well-lighted; and
(3) entry into areas where drugs are held shall be limited to authorized personnel.
B. All facilities shall be equipped with an alarm system to detect entry after hours.
C. All facilities shall be equipped with a security system that will provide suitable protection
against theft and diversion. When appropriate, the security system shall provide protection against
theft or diversion that is facilitated or hidden by tampering with computers or electronic records.
Subp. 5. Storage. Items A to D govern storage of drugs.
A. All drugs shall be stored at temperatures and under conditions in accordance with the
requirements, if any, in the labeling of such drugs, or with requirements in the current edition of
the United States Pharmacopeia/National Formulary.
B. If no storage requirements are established for a drug, the drug may be held at "controlled
room temperature," as defined in the United States Pharmacopeia/National Formulary, to help
ensure that its identity, strength, quality, and purity are not adversely affected.
C. Manual, electromechanical, or electronic temperature and humidity recording equipment,
devices, or logs shall be used to document proper storage of prescription drugs.
D. The record keeping requirements in subpart 8 shall be followed for all stored drugs.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.1440MINNESOTA RULES25
Subp. 6. Examination of materials. Upon receipt, each outside shipping container shall be
visually examined for identity and to prevent the acceptance of contaminated drugs or drugs that
are otherwise unfit for distribution. This examination shall be adequate to reveal container damage
that would suggest possible contamination or other damage to the contents.
Each outgoing shipment shall be carefully inspected for identity of the drug products and to
ensure that there is no delivery of drugs that have been damaged in storage or held under improper
conditions.
The record keeping requirements in subpart 8 shall be followed for all incoming and outgoing
drugs.
Subp. 7. Returned, damaged, and outdated drugs. Items A to D govern returned, damaged,
outdated, deteriorated, misbranded, and adulterated drugs.
A. Drugs that are damaged, outdated, deteriorated, misbranded, or adulterated shall be
physically separated from other drugs until they are destroyed or returned to their supplier.
B. Any drugs whose immediate or sealed outer or sealed secondary containers have been
opened or used shall be identified as such, and shall be physically separated from other drugs until
they are either destroyed or returned to the supplier.
C. If the conditions under which a drug has been returned cast doubt on the drug's safety,
identity, strength, quality, or purity, then the drug shall be destroyed or returned to the supplier,
unless examination, testing, or other investigation proves that the drug meets appropriate standards
of safety, identity, strength, quality, and purity. In determining whether the conditions under which
a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the
wholesale drug distributor shall consider, among other things, the conditions under which the drug
has been held, stored, or shipped before or during its return and the condition of the drug and its
container, carton, or labeling, as a result of storage or shipping.
D. The record keeping requirements in subpart 8 shall be followed for all damaged, outdated,
deteriorated, misbranded, or adulterated drugs.
Subp. 8. Record keeping. Items A to C govern record keeping.
A. Wholesale drug distributors shall establish and maintain inventories and records of all
transactions regarding the receipt and distribution or other disposition of drugs. These records shall
include the following information:
(1) the source of the drugs, including the name and principal address of the seller or
transferor, and the address of the location from which the drugs were shipped;
(2) the identity and quantity of the drugs received and distributed or disposed of; and
(3) the dates of receipt and distribution or other disposition of the drugs.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
26MINNESOTA RULES6800.1440
B. Inventories and records shall be made available for inspection and photocopying by
authorized federal, state, or local law enforcement agency officials for a period of two years following
disposition of the drugs.
C. Records described in this part that are kept at the inspection site or that can be
immediately retrieved by computer or other electronic means shall be readily available for authorized
inspection during the retention period. Records kept at a central location apart from the inspection
site and not electronically retrievable shall be made available for inspection within two working
days of a request by an authorized official of a federal, state, or local law enforcement agency.
Subp. 9. Written policies and procedures. Wholesale drug distributors shall establish,
maintain, and adhere to written policies and procedures, which shall be followed for the receipt,
security, storage, inventory, and distribution of drugs. They must include policies and procedures
for identifying, recording, and reporting losses or thefts and for correcting all errors and inaccuracies
in inventories. Wholesale drug distributors shall include the written policies and procedures described
in items A to D.
A. A procedure where the oldest approved stock of a drug product is distributed first. The
procedure may permit deviation from this requirement, if the deviation is temporary and appropriate.
B. A procedure to be followed for handling recalls and withdrawals of drugs. The procedure
shall be adequate to deal with recalls and withdrawals due to:
(1) any action initiated at the request of the Food and Drug Administration or other
federal, state, or local law enforcement or other government agency, including the Board of
Pharmacy;
(2) any voluntary action by the manufacturer to remove defective or potentially defective
drugs from the market; or
(3) any action undertaken to promote public health and safety by replacing of existing
merchandise with an improved product or new package design.
C. A procedure to ensure that wholesale drug distributors prepare for, protect against, and
handle any crisis that affects security or operation of any facility in the event of strike, fire, flood,
or other natural disaster, or other situations of local, state, or national emergency.
D. A procedure to ensure that any outdated drugs shall be segregated from other drugs and
either returned to the manufacturer or destroyed. This procedure shall provide for written
documentation of the disposition of outdated drugs. This documentation shall be maintained for
two years after disposition of the outdated drugs.
Subp. 10. Responsible persons. Wholesale drug distributors shall establish and maintain lists
of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage,
and handling, including a description of their duties and a summary of their qualifications.
Subp. 11. Compliance with federal, state, and local law. Wholesale drug distributors shall
operate in compliance with applicable federal, state, and local laws and regulations.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.1440MINNESOTA RULES27
Wholesale drug distributors shall permit the Board of Pharmacy and authorized federal, state,
and local law enforcement officials to enter and inspect both their premises and delivery vehicles
and to audit their records and written operating procedures, at reasonable times and in a reasonable
manner, to the extent authorized by law.
Wholesale drug distributors who deal in controlled substances shall register with the Board of
Pharmacy and with the Drug Enforcement Administration, and shall comply with all applicable
state, local, and Drug Enforcement Administration regulations.
Subp. 12. Salvaging and reprocessing. Wholesale drug distributors are subject to any
applicable federal, state, or local laws or regulations that relate to drug product salvaging or
reprocessing, including Code of Federal Regulations, title 21, parts 207, 210, and 211, and Minnesota
Statutes, section 151.39.
Statutory Authority: MS s 151.06; 151.42
History: 16 SR 1913; 36 SR 237
Published Electronically: September 21, 2011
6800.1460 MANUFACTURING PROCEDURES.
A person engaged in the manufacturing of drugs, medicines, chemicals, or poisons for medicinal
purposes whose place of business is located in Minnesota must comply with the current Good
Manufacturing Practices regulations for finished pharmaceuticals published by the United States
Food and Drug Administration.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
CONTINUING EDUCATION
6800.1500 CONTINUING EDUCATION.
Subpart 1. Definitions.
A. "Approved continuing education" means those continuing pharmacy or pharmacy
technician education programs approved by the board or made available by an approved provider.
These programs may take the form of classes, conferences, correspondence study courses, institutes,
lectures, professional meetings, programmed learning courses, journal readings, seminars, study
groups, or other program formats commonly accepted by educators as legitimate adult educational
activities.
B. "Approved provider" means any association, corporation, educational institution,
organization, group, or person who has been recognized by the Board of Pharmacy, in accordance
with subpart 3, as having met its criteria indicative of the ability to provide quality continuing
education programs or who has been recognized by the board as being approved by the Accreditation
Council for Pharmacy Education (ACPE) for the provision of quality continuing education programs.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
28MINNESOTA RULES6800.1440
C. "Continuing pharmacy education" is a planned learning experience beyond a formal
undergraduate degree program designed to promote the continual development of professional
knowledge, professional skills, and professional attitudes on the part of the pharmacist and shall
include but is not limited to professional postgraduate education in any of the following subjects:
(1) properties and actions of drugs and drug dosage forms;
(2) etiology, characteristics, and therapeutics of the disease state;
(3) pharmacy practice; or
(4) legal, psychological, and socioeconomic aspects of health care delivery.
D. "Continuing pharmacy technician education" is a planned learning experience beyond
initial technician training designed to promote the continued development of the knowledge, skills,
and attitudes that enable a technician to adequately perform the tasks that a technician is allowed
to perform under this part.
Subp. 2. Minimum hours required for pharmacists; reporting. Beginning March 4, 1975,
no annual license renewal shall be issued to a pharmacist under Minnesota Statutes, section 151.13,
until the pharmacist has submitted to the board satisfactory evidence that the pharmacist has
completed at least 30 hours of approved continuing education during the previous two-year period.
Thereafter, a pharmacist shall submit the evidence every two years. Pharmacists exempted from
the payment of all renewal fees and from the filing of any application for renewal under Minnesota
Statutes, section 326.56, subdivision 2, shall also be exempted from the requirements of this subpart
for a concurrent period of time. Beginning with the 1981-1983 reporting period, participation in
continuing education shall be reported by September 30 of each even-numbered year. The board
may grant a pharmacist, on application, an extension of time not to exceed one year to comply with
the requirements of this subpart. The extension shall not relieve the pharmacist from complying
with the continuing education requirements for any other two-year period. Each pharmacist is
responsible for maintaining a complete record of the pharmacist's continuing education participation
during each continuing education reporting cycle.
Subp. 2a. Minimum hours required for technicians; reporting.
A. A pharmacy technician's registration renewal for calendar year 2014 shall not be issued
unless the technician has completed 20 hours of approved continuing pharmacy technician education
during the two-year period between August 1, 2011, and July 31, 2013. Thereafter, no annual
pharmacy technician registration renewal shall be issued unless the technician presents the board
with satisfactory evidence of completion of 20 hours of approved continuing pharmacy technician
education per two-year reporting period. Each reporting period shall end on July 31 of odd-numbered
years.
B. Continuing education must focus on the competencies that the technician must carry
out and the specific duties that the technician performs. Technicians exempted from the payment
of all renewal fees and from the filing of any application for renewal under Minnesota Statutes,
section 326.56, subdivision 2, shall also be exempted from the requirements of this subpart for a
concurrent period of time. The board may grant a technician, on application, an extension of time
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.1500MINNESOTA RULES29
not to exceed one year to comply with the requirements of this subpart. The extension shall not
relieve the technician from complying with the continuing education requirements for any other
two-year period. Each technician is responsible for maintaining a complete record of continuing
education participation during each continuing education reporting cycle.
Subp. 3. Approval of providers. Application may be made by an association, corporation,
educational institution, organization, or person to be designated as an approved provider on forms
provided by the board. The applicant shall provide, at a minimum, information regarding
administrative and record keeping procedures used for past programs; a history of the content,
methods of delivery, and faculty qualifications for past programs; methods of program needs
assessment and development that the applicant has used; and evaluation mechanisms that the
applicant has used. The applicant shall agree to maintain records of program content, evaluation
summary, and attendance for at least three years following completion of each program. The
application must cover the two-year reporting period for which provider approval is sought.
The board shall approve an applicant as a continuing education provider based on the applicant's
compliance with the following criteria:
A. The continuing education programs must have had an identifiable administrative authority
who was responsible for meeting all quality criteria and for maintaining records of program content,
planning, delivery, evaluation, and attendance.
B. The programs' administrative requirements must have included:
(1) promotion and advertising of continuing education activities in a responsible fashion
clearly indicating in promotional material the educational objectives of the particular activity, the
nature of the audience that may best benefit from the activity, the schedule of the activity, the cost
of the activity to the participant and the items covered by that cost, the amount of continuing
education credit that can be earned through participation in the activity, and the credentials of the
faculty;
(2) maintenance and availability of records of participation in continuing education
activities adequate to serve the needs of the participants and others requiring this information; and
(3) provision of evidence to the participant, in the form of a certificate or other document,
of satisfactory completion of a continuing education activity as reasonably required by the participant.
C. The educational content development must have included:
(1) Advance planning that includes a statement of educational goals, behavioral
objectives, or both, that are measurable.
(2) Activities designed to satisfy educational needs which the board has determined to
be appropriate.
(3) Involvement of members of the intended audience in identifying their own continuing
education needs.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
30MINNESOTA RULES6800.1500
(4) Activities designed to explore one subject or a group of closely related subjects. If
an activity involves multiple components, such as a lecture series, all segments must be devoted to
integrally related subjects.
(5) Appropriate mediated material and supportive instructional material. Previously
offered activities, including those in mediated forms, must have been reviewed by the provider
prior to being offered to new audiences, with a view toward maintaining technical quality, timeliness,
and currency of content, and faculty must have had the opportunity to update material, if they
desired, before an activity was offered to a new audience.
D. The methods of delivery must have been consistent with the special needs of the program.
E. The teaching staff for a particular continuing education activity must have been competent
in the subject matter and qualified by experience or preparation to the tasks and method of delivery.
F. An evaluation mechanism must have been provided to allow the participants to assess
their achievement of program objectives.
G. The provider must have developed and employed evaluation techniques that assess the
effectiveness of the continuing education activities, and the level of fulfillment of the stated
objectives, for the purpose of provider and activity improvement if indicated.
Applicants with no history of program development in compliance with items A to G or with
an incomplete history will be judged on their willingness and ability to comply with these criteria
in the future.
Subp. 3a. Approval of programs. Application may be made by an association, corporation,
educational institution, organization, group, or person, not presently approved as a provider, to
have a program designated as an approved program. The board shall approve a continuing education
program if it complies with the following criteria:
A. The provider shall submit evidence that promotion and advertising of the program will
be done in a responsible fashion. For example, the promotional material should state the educational
objectives of the program, the nature of the audience for which the program is intended, the program
schedule, the cost of the program and the items covered by that cost, the amount of continuing
education credit that can be earned through the program, and the credentials of the program faculty.
B. The provider agrees to maintain records of participation in or attendance at the program
for not less than three years and agrees to make them available to the board upon request.
C. The provider agrees to provide evidence to the participant of satisfactory completion of
the program.
D. The program provider submits evidence that:
(1) program planning involved members of the intended audience;
(2) the program is designed to satisfy identified educational needs;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.1500MINNESOTA RULES31
(3) the program includes a statement of educational goals, behavioral objectives, or
both, that are measurable;
(4) the program, if it involves multiple components, is devoted to integrally related
subjects; and
(5) any mediated and supportive instructional material is designed to be used in a suitable
and appropriate manner.
E. The method of program delivery is consistent with the special needs of the program.
F. The teaching staff appears to be competent in the subject matter and is qualified by
experience or preparation to the task and method of delivery.
G. An evaluation mechanism is provided for the purpose of allowing the participants to
assess their achievement of program objectives.
H. The provider has developed and will employ evaluation techniques that assess the
effectiveness of the continuing education activities, and the level of fulfillment of the stated objectives
for the purpose of provider and activity improvement if indicated.
Applications for program approval must be submitted not less than 45 days prior to the
commencement of the program. The board shall assign the number of credit hours to each program
and shall grant approval or deny approval of such application within 60 days of receiving the
application.
Subp. 4. Revocation or suspension of approval. The board may deny, refuse to renew, revoke,
or suspend authorization, recognition, or approval previously furnished to programs or providers
if the program or provider fails to conform to its application approved by the board, fails to furnish
program content as publicized, or if the program or provider violates any provision of Minnesota
Statutes, section 214.12, or this chapter.
Subp. 4a. Programs not previously submitted for approval. A pharmacist or pharmacy
technician may apply for credit for attendance at programs not previously submitted to the board
for approval provided that the pharmacist or pharmacy technician completes a continuing education
program approval form, obtainable from the board, and submits it to the board within 90 days after
completing the program. The applicant shall provide, at a minimum, the title, site, date, type, and
length of the program being proposed for approval, a program outline, and a description of the type
of evaluation mechanism used at the program. Approval of the program is subject to all the standards
of Minnesota Statutes, section 214.12, and subparts 1, item C, and 3a, items B to G.
Subp. 5. Hours of credit. Credit shall be earned on the basis of attendance at or, in the case
of correspondence courses, completion of a program. Credit for an identical program may be given
only once to any individual during any reporting period.
Subp. 6. Credit for presentation of professional lectures. Pharmacists may apply for credit
for presentation of in-service training programs or lectures consisting of subjects included in the
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
32MINNESOTA RULES6800.1500
definition of Continuing Pharmacy Education. Credit for these presentations will be granted only
once to any individual during any reporting period.
Subp. 6a. Credit for preceptor training program. A pharmacist who applies shall be given
continuing education credit for participation in any instructional program for pharmacist preceptors
that is developed or approved by the board.
Subp. 7. Record of approved programs. The board shall maintain a record of approved
providers and approved programs including the hours of credit assigned to each program.
Subp. 8. [Repealed, 10 SR 2007]
Subp. 9. Program promotion. No reference shall be made by a program provider in publicizing
a program that it is an "approved program provider" unless the provider is so approved by the board
or the Accreditation Council for Pharmacy Education (ACPE). No other reference indicating
endorsement by the board may be made except as follows: "This program is approved by the
Minnesota Board of Pharmacy for ____ hours of continuing education credit."
Statutory Authority: MS s 151.06; 152.02
History: 10 SR 2007; 18 SR 1145; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.1600 CONTINUING EDUCATION ADVISORY TASK FORCE.
The Continuing Education Advisory Task Force shall consist of not more than ten members.
Three members of the advisory task force shall be pharmacists designated by the Minnesota State
Pharmaceutical Association, three members shall be pharmacists designated by the Minnesota
Society of Hospital Pharmacists, two members shall be pharmacists designated by the College of
Pharmacy of the University of Minnesota, and two members shall be designated by the board. The
Continuing Education Advisory Task Force shall meet at least quarterly and shall annually elect a
chair and vice chair from its membership. The executive director of the Board of Pharmacy shall
act as secretary to the task force.
Statutory Authority: MS s 151.06; 151.07; 152.02; 214.06
History: 10 SR 2007; 12 SR 2393
Published Electronically: September 21, 2011
6800.2000 [Renumbered 6800.2150]
Published Electronically: September 21, 2011
6800.2100 [Renumbered 6800.1050]
Published Electronically: September 21, 2011
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.2100MINNESOTA RULES33
OPERATION OF PHARMACIES
6800.2150 PHARMACIST ON DUTY.
Subpart 1. Requirement to have a pharmacist on duty. A pharmacy or satellite pharmacy
shall have at least one licensed pharmacist on duty and physically present in the pharmacy at all
times that the pharmacy is open for the transaction of business except for brief absences of the
pharmacist arising out of and in the course of pharmacy practice.
Subp. 2. Limiting access to pharmacies. When a pharmacy is closed or there is no pharmacist
on duty, other individuals shall not be allowed access to the pharmacy except as provided in part
6800.7530.
Statutory Authority: MS s 151.06; 152.02
History: 9 SR 1656; 18 SR 1145; 27 SR 260; 41 SR 1382
Published Electronically: June 5, 2017
6800.2160 PHARMACY WORK CONDITIONS.
Subpart 1. Limitation on continuous hours worked. A pharmacy licensed under Minnesota
Statutes, section 151.19, subdivision 1, which is located within Minnesota, shall not require a
pharmacist, pharmacist-intern, or pharmacy technician to work longer than 12 continuous hours
per day, inclusive of the breaks required under subpart 2.
Subp. 2. Requirements for breaks.
A. A pharmacist, pharmacist-intern, or pharmacy technician working longer than six
continuous hours per day shall be allowed during that time period to take a 30-minute, uninterrupted
break.
B. A pharmacist, pharmacist-intern, or pharmacy technician shall be allowed adequate time
from work within each four consecutive hours of work to utilize the nearest convenient restroom.
C. A pharmacy may, but is not required to, close when a pharmacist is on a break. If the
pharmacy does not close, the pharmacist shall either remain within the licensed pharmacy or within
the establishment in which the licensed pharmacy is located in order to be available for emergencies.
In addition, the following apply:
(1) pharmacy technicians, pharmacist-interns, and other supportive staff, authorized by
the pharmacist on duty, may continue to perform duties as allowed under this chapter;
(2) no duties reserved to pharmacists and pharmacist-interns under any part of this
chapter, or that require the professional judgment of a pharmacist, may be performed by pharmacy
technicians or other supportive staff; and
(3) only prescriptions that have been certified by a pharmacist, as required by part
6800.3100, may be dispensed while the pharmacist is on break; except that prescriptions that require
counseling by a pharmacist, including all new prescriptions and those refill prescriptions for which
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
34MINNESOTA RULES6800.2150
a pharmacist has determined that counseling is necessary, may be dispensed only if the following
conditions are met:
(a) the pharmacy develops a list of drugs that may not be dispensed while a
pharmacist is taking an allowed break, without the patient receiving counseling from a pharmacist,
when counseling would normally be required;
(b) the patient, or other individual who is picking up the prescription on behalf of
the patient, is told that the pharmacist is on a break and is offered the chance to wait until the
pharmacist returns from break in order to receive counseling;
(c) if the patient or caregiver declines to wait, a telephone number at which the
patient or a caregiver can be reached is obtained;
(d) after returning from the break, the pharmacist makes a reasonable effort to
contact the patient or a caregiver by telephone and provides counseling; and
(e) the pharmacist documents the counseling that was provided or documents why
counseling was not provided, including a description of the efforts made to contact the patient or
caregiver. The documentation shall be retained by the pharmacy, and be made available for inspection
by the board or its authorized representatives, for a period of at least two years.
D. In pharmacies staffed by two or more pharmacists, the pharmacists shall stagger breaks
so that at least one pharmacist remains on duty at all times that the pharmacy remains open for the
transaction of business.
Subp. 3. Exceptions for emergencies. Subpart 1 and subpart 2, item A, shall not apply in the
event that an emergency necessitates that a pharmacist, pharmacist-intern, or pharmacy technician
work longer than 12 continuous hours, work without taking required meal breaks, or have a break
interrupted in order to minimize immediate health risks for patients.
Statutory Authority: MS s 151.06
History: 41 SR 1382
Published Electronically: June 5, 2017
6800.2200 [Renumbered 6800.0950]
Published Electronically: September 21, 2011
6800.2250 UNPROFESSIONAL CONDUCT.
Subpart 1. Prohibited conduct. Unprofessional conduct shall include, but is not limited to,
the following acts of a pharmacist or pharmacy:
A. The assertion or inference in a public manner of material claims of professional
superiority in the practice of pharmacy that cannot be substantiated.
B. The publication or circulation of false, misleading, or otherwise deceptive statements
concerning the practice of pharmacy.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.2250MINNESOTA RULES35
C. Refusing to compound or dispense prescription drug orders that may reasonably be
expected to be compounded or dispensed in pharmacies by pharmacists, except as provided for in
Minnesota Statutes, sections 145.414 and 145.42.
D. Participation in agreements or arrangements, with any person, corporation, partnership,
association, firm, or others involving rebates, "kickbacks," fee-splitting, or special charges in
exchange for professional pharmaceutical services, including but not limited to the giving, selling,
donating, or otherwise furnishing or transferring, or the offer to give, sell, donate, or otherwise
furnish or transfer money, goods, or services free or below cost to any licensed health care facility
or the owner, operator, or administrator of a licensed health care facility as compensation or
inducement for placement of business with that pharmacy or pharmacist. Monetary rebates or
discounts which are returned to the actual purchaser of drugs as a cost justified discount or to meet
competition are permitted if the rebates or discounts conform with other existing state and federal
rules and regulations.
E. Discriminating in any manner between patients or groups of patients, for reasons of race,
color, creed, religion, disability, national origin, marital status, sexual orientation, sex, or age.
F. Refusing to consult with patrons or patients, attempting to circumvent the consulting
requirements, or discouraging the patient from receiving consultation concerning contents, therapeutic
values, uses, and prices of legend or nonlegend drugs, chemicals, or poisons.
G. Requiring an individual patient to be a member of any organization, association, or other
group as a condition for obtaining the professional services of a pharmacist.
H. The violation of any law, rule, regulation, or ordinance of the state or any of its political
subdivisions, including the Board of Pharmacy, or the United States government, or any agency
thereof relating to the practice of pharmacy.
I. Divulging or revealing to others the nature of professional pharmaceutical services
rendered to a patient without the patient's expressed consent orally or in writing or by order or
direction of a court (this shall not prevent pharmacies from providing information copies of
prescriptions to other pharmacies or to the person to whom the prescription was issued and shall
not prevent pharmacists from providing drug therapy information to physicians for their patients).
J. Participation in institutional drug distribution as a consultant without providing
pharmaceutical services in accordance with accepted principles of pharmacy practice and in
compliance with federal and state laws or rules.
K. Engaging in any pharmacy practice which constitutes a danger to the health, welfare,
or safety of a patient or the public, including but not limited to, practicing in a manner which
substantially departs from the standard of care ordinarily exercised by a pharmacist and which
harms or could harm a patient.
Subp. 2. Improper advertising. Legend drug price information may be provided to the public
only by a pharmacy, so long as it is not violative of any federal or state laws applicable to the
advertisement of such articles generally and if all of the following conditions are met:
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
36MINNESOTA RULES6800.2250
A. No representation or suggestion concerning the drug's safety, effectiveness, indications
for use, or competitive comparison shall be made.
B. No reference shall be made to controlled substances listed in schedule II-IV of the latest
revision of the Federal Controlled Substances Act, and the rules of the Minnesota Board of Pharmacy.
C. The termination date for the prices listed shall be stated in the ad.
Subp. 3. Accessories to illegal drug traffic. The selling, giving away, or otherwise disposing
of accessories (i.e., glassine papers, empty capsules, quinine, lactose, or similar products), chemicals,
or drugs found in illegal drug traffic is unprofessional conduct by a pharmacist when the pharmacist
knows or should have known of their intended use in illegal activities.
Subp. 4. Drug diversion. It is unprofessional conduct for a pharmacist to sell, purchase, or
trade, or offer to sell, purchase, or trade, any drug that was purchased by a public or private hospital
or other health care entity or that was donated or supplied at a reduced price to a charitable
organization. This subpart does not apply to:
A. a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among
hospitals or other health care entities that are under common control;
B. a sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for
emergency medical reasons;
C. a sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the
dispensing of a drug pursuant to a prescription; or
D. the sale, purchase, or trade of a drug or the offer to sell, purchase, or trade a drug between
members of a group purchasing organization as described in Minnesota Statutes, section 151.44,
paragraph (a), clause (2).
For purposes of this subpart, "entity" does not include a wholesale distributor of drugs or a
retail pharmacy licensed by the board, and "emergency medical reasons" includes transfers of a
drug between health care entities or from a health care entity to a retail pharmacy undertaken to
alleviate temporary shortages of the drug arising from delays in or interruptions of regular distribution
schedules.
Statutory Authority: MS s 151.06; 151.102
History: 9 SR 260; 9 SR 1656; 10 SR 2007; 17 SR 1279; 18 SR 1145; 23 SR 1597; 36 SR 237
Published Electronically: September 21, 2011
6800.2300 SANITATION.
A pharmacy shall maintain orderly, clean, and sanitary conditions at all times.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.2300MINNESOTA RULES37
6800.2350 PHARMACEUTICAL WASTE.
Hazardous pharmaceutical waste disposal shall comply with chapter 7045 as enforced by the
Pollution Control Agency (MPCA) and other authorized state agencies.
Statutory Authority: MS s 151.06; 152.02
History: 31 SR 1673
Published Electronically: September 21, 2011
6800.2400 PHARMACIST-IN-CHARGE.
Subpart 1. Responsibilities and duties. No person shall conduct a pharmacy without a
pharmacist-in-charge, who shall be a pharmacist regularly employed in the pharmacy department
and shall be designated in the application for license, each renewal thereof or pursuant to subpart
4. It is the pharmacist-in-charge's duty and responsibility, consistent with the accepted standards
of professional conduct and practice and in compliance with all applicable laws:
A. to establish policies and procedures for the employees of the pharmacy for the
procurement, storage, compounding, and dispensing of drugs and the communication of information
to the public in relation to drug therapy;
B. to supervise all of the professional employees of the pharmacy;
C. to assure that all persons participating in an internship, residency, or fellowship program
at the pharmacy are appropriately licensed or registered with the board;
D. to supervise all of the nonprofessional employees of the pharmacy insofar as their duties
relate to the procurement, sale, and/or storage of drugs;
E. to develop appropriate detailed written procedures directing activities of pharmacy
technicians and to make these procedures available to the board, and to ensure that all persons
working as pharmacy technicians are registered with the board, in accordance with part 6800.3850;
F. to establish and supervise the method and manner for the storing and safekeeping of
drugs;
G. to establish and supervise the record keeping system for the purchase, sale, possession,
storage, safekeeping, and return of drugs;
H. to notify the board immediately upon receiving knowledge that his or her services as
pharmacist-in-charge have been or will be terminated;
I. to respond to deficiency reports; and
J. to ensure that staffing and operational quality assurance policies are developed,
implemented, and followed for the purpose of decreasing and monitoring prescription errors.
Subp. 2. Deficiency reports. The pharmacist-in-charge of any pharmacy wherein deficiencies
are noted upon inspection by the board or its staff shall, within 30 days of receiving notice of such
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
38MINNESOTA RULES6800.2350
deficiency, submit in writing to the board the steps taken or proposed to eliminate the deficiency.
Failure to submit such report or to eliminate deficiency shall be grounds for the institution of
disciplinary action by the board.
Subp. 3. More than one location. No pharmacist shall be designated pharmacist-in-charge
of more than one pharmacy. In the interest of public health, this requirement may be waived in the
case of a pharmacist serving a hospital pharmacy on a part-time basis.
Subp. 4. Termination of service. Each pharmacy shall notify the Board of Pharmacy
immediately upon knowledge of the termination of the services of the pharmacist-in-charge and
further, shall immediately designate a successor pharmacist-in-charge and immediately notify the
Board of Pharmacy of such designation. The Board of Pharmacy upon receiving such notice shall
furnish the successor pharmacist-in-charge such form or forms as it may from time to time prescribe
which form or forms must be completed by the successor pharmacist-in-charge and filed with the
Board of Pharmacy within ten days after receipt thereof. The successor pharmacist-in-charge shall
submit, on the approved form, an acknowledgment of an awareness and understanding of any
variances that the pharmacy has been granted according to part 6800.9900. The successor
pharmacist-in-charge shall be responsible for ensuring that any conditions imposed by the board
on granted variances continue to be met.
Statutory Authority: MS s 151.06; 151.102
History: 9 SR 1656; 17 SR 1279; 18 SR 1145; 23 SR 1597; 36 SR 237
Published Electronically: September 21, 2011
6800.2500 CHANGE OF BUSINESS OR RESIDENCE ADDRESS.
A pharmacist or pharmacist-intern shall notify the Board of Pharmacy immediately of any
change in location of employment or any change of residence address.
Statutory Authority: MS s 151.06
History: 17 SR 1279; 18 SR 1145
Published Electronically: September 21, 2011
6800.2600 AUTOMATED COUNTING AND DISTRIBUTION.
Subpart 1. Generally. It is unlawful to count, distribute, dispense, or vend any legend drug
through the use of an automated counting device or automated drug distribution system, or a vending
machine except as provided in this part.
A. Notification. The board must be provided with written notification of the location of
the automated counting device or automated drug distribution system, the name and address of the
pharmacy responsible for control of the device or system, written policies and procedures that
govern the operation of the device or system, and the name of the pharmacist-in-charge of the
pharmacy. Notification must be provided to the board at least 60 days in advance of the initial use
of the device or system. Policies and procedures must address staff training and the requirements
listed in subparts 2 and 3. The pharmacy responsible for the control of the automated counting
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.2600MINNESOTA RULES39
device or automated drug distribution system may proceed with its use unless the board has provided
written notification to the pharmacy that the device or system may not be used. The board must
provide written notification within 60 days of receiving the documents required under this item.
The written notification must specify the steps that the pharmacy must take in order to use the
system.
B. Training. Training for all staff who use an automated counting device or automated
drug distribution system shall be conducted by qualified individuals on a continuing basis and with
sufficient frequency to ensure that employees remain familiar with the relevant policies and
procedures and with the safe operation of the device. Documentation of training must be maintained
and must include the names and unique identifiers of staff members trained, the name and unique
identifier of the trainer, and the date of training. Training documentation shall be made available
to the board or the board's staff upon request.
Subp. 2. Automated counting devices. In addition to the requirements in subpart 1, the
following requirements apply to automated counting devices.
A. The filling of cells or cassettes is subject to the requirements of part 6800.3200, subpart
1, items A, B, E, F, G, and H, except that item F only applies if the pharmacy's policies and
procedures require a pharmacist to verify the accuracy of the filling of the cell or cassette. Only
one cell or cassette may be filled at a time.
B. The labeling of cells and cassettes is subject to the requirements of part 6800.3200,
subpart 2, items A, B, C, and F. The requirements of part 6800.3200, subpart 2, items D and E, also
apply unless the information required under those items is maintained in the packaging control
record.
C. The pharmacy shall have a method to calibrate and verify the accuracy of the automated
counting device and document the calibration and verification on a regular basis, consistent with
the recommendations of the manufacturer of the device.
D. The pharmacy shall have procedures in place to prevent cross-contamination of cells
and cassettes.
E. If the manufacturer's stock container is not available as required in part 6800.3100,
subpart 3, a method for verifying that the correct drug is being dispensed must be specified in the
policies and procedures. All other certification requirements in part 6800.3100, subpart 3, shall
apply.
F. The pharmacy must have continuous quality assurance policies and procedures developed
specifically for the automated counting device.
Subp. 3. Automated drug distribution systems. In addition to the requirements in subpart
1, the following requirements apply to automated drug distribution systems.
A. A pharmacist employed by the pharmacy, which is responsible for the control of the
system, must review, interpret, and approve all prescription drug orders before any drug is distributed
from the system to be administered to a patient. Access to drugs when a pharmacist has not reviewed
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
40MINNESOTA RULES6800.2600
and approved the prescription drug order is permitted only when a formal and written decision to
allow such access is issued by the pharmacy and therapeutics committee or its equivalent. The
committee must specify the patient care circumstances in which such access is allowed, the drugs
that can be accessed, and the staff that are allowed to access the drugs.
B. Access to any automated medication distribution system must be limited to pharmacy
and nonpharmacy personnel authorized to procure drugs from the system. Each person authorized
to access the system must be assigned an individual, specific access code. Alternatively, access to
the system may be controlled through the use of biometric identification procedures. A policy
specifying time access parameters, such as time-outs, log-offs, and lock-outs must be in place.
C. At a minimum, the system must maintain records of:
(1) the identity of all personnel who access the automated unit, including any personnel
who are required to witness a transaction;
(2) the reason for access;
(3) the date and time of access;
(4) the name, strength, dosage form, and quantity of the drug removed, returned, or
wasted;
(5) the name of the patient for whom the drug was ordered; and
(6) any additional information the pharmacist in charge may deem necessary.
These records shall be reviewed for discrepancies on a periodic basis. The pharmacist-in-charge is
responsible for the quality, accuracy, and timeliness of the review and must ensure that appropriate
actions are taken to deal with any discrepancies found.
D. The pharmacy and therapeutics or relevant committee shall develop and regularly review
a list of drugs or categories of drugs that are prohibited from being distributed through an automated
distribution system. The review must take place at least annually. A high-alert drug may be
distributed through an automated distribution system only if the pharmacy and therapeutics or
relevant committee has determined that the drug need not be included on the list of drugs prohibited
from being distributed through an automated distribution system. Patient-specific drug additions
or deletions to the automated distribution device or system shall be determined by a pharmacist.
E. The use of an open matrix drawer that allows access to more than one drug at a time
must be limited to noncontrolled substance drugs, unless the entire drawer contains only one
controlled substance drug product. Noncontrolled substance drugs may be stored in the open matrix
drawer if they are:
(1) large bulky items such as intravenous infusion bags;
(2) nonlegend drugs that are safely arranged;
(3) legend drugs that are not look-alike products; or
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.2600MINNESOTA RULES41
(4) drugs properly packaged and labeled for an individual patient.
F. Removal of a high-alert drug from the system must be checked by a second licensed
health care professional to ensure that the prescription drug order is being correctly interpreted and
that the correct drug has been removed. This requirement does not apply when:
(1) a pharmacist has reviewed and approved the prescription drug order prior to the
removal of the high-alert drug from the system;
(2) a licensed practitioner controls the ordering, preparation, and administration of the
medication during a medical procedure; or
(3) the prescribing practitioner has determined that the high-alert drug must be
administered before the drug order can be reviewed by a pharmacist or a second licensed health
care professional.
G. A pharmacist must certify all packaging, labeling, and stocking associated with the use
of an automated drug distribution system. Unless the certification process utilizes a fail-safe bar
coding, certification must be performed by a pharmacist. Certification must be documented and
records must be retained for at least two years.
H. Automated distribution devices must be secured or kept in a locked medication room
when not in actual use.
I. Unused drugs must be returned to the pharmacy or to the system's secure, designated
return bin or equivalent area. Restocking of the system may only be performed by designated
pharmacy personnel with required certification.
J. Assessments of automated distribution devices must be performed to ensure, at a
minimum, that:
(1) drugs are properly stored in their assigned locations and in pharmacy-approved
configurations;
(2) outdated drugs are removed and replaced;
(3) only approved drugs are in the device;
(4) inventory levels are appropriate based on usage; and
(5) the device and drugs are secure.
Each of the five requirements in item J must be assessed at least on a monthly basis, but all
need not be assessed at the same time.
K. Pharmacy personnel must conduct, at least monthly, an audit of controlled substances
to ensure accuracy of distribution and proper record keeping.
L. The system must provide for maintenance of patient confidentiality, so that unauthorized
individuals do not have access to patient data.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
42MINNESOTA RULES6800.2600
M. Policies and procedures must be in place for return of unused drugs and for drug wastage
and the documentation of drug wastage.
N. Continuous quality assurance must be developed specifically for the automated drug
distribution system or device. An ongoing failure mode effect analysis or quality assurance process
must be in place and address possible system failures, process failures, high-alert drugs, medication
errors, and controlled substance discrepancies.
Statutory Authority: MS s 151.06; 151.102; 152.02
History: 23 SR 1597; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.2700 RETURN OF DRUGS AND DEVICES.
Subpart 1. Reuse. Pharmacists and pharmacies are prohibited from accepting from patients
or their agents for reuse, reissue, or resale any drugs, prescribed medications, chemicals, poisons,
or medical devices; except that in a hospital with a licensed pharmacy, drugs, devices, or other
items dispensed for hospital inpatient use only, which have not left the span of control of the
pharmacy, may be returned to the pharmacy for reuse or disposal in accordance with good
professional practice.
Subp. 2. Drugs from nursing homes and assisted living facilities. Drugs from nursing homes
and assisted living facilities may be returned to the dispensing pharmacy. The returned drugs may
be redispensed if:
A. the consultant pharmacist can assure proper storage conditions for the drugs in the facility
as specified in the United States Pharmacopeia, (United States Pharmacopeial Convention, Inc.,
Rockville, Maryland) and the drugs are stored within the facility in a secure area;
B. the facility has 24-hour, on-site licensed nursing coverage seven days a week;
C. the drugs are returned to the same pharmacy, which dispensed the drugs;
D. the integrity of such packaging remains intact (no reconstituted drugs, drugs requiring
refrigeration, or controlled substances may be so returned); and
E. the drugs are received by the pharmacy in the original manufacturer's packaging or
pharmacist packager's unit-dose, unit-of-use, or strip packaging with each tablet or capsule
individually wrapped and labeled, or in blister cards, which indicate the drug name and strength,
the packager's name, and the manufacturer's or packager's lot or batch number. Drugs packaged by
a pharmacy may be returned only if the pharmacy can demonstrate to the board that its packaging
material and procedures will provide a package that will meet or exceed the criteria for class B
packaging established by the United States Pharmacopeia, (United States Pharmacopeial Convention,
Inc., Rockville, Maryland), and that procedures have been developed and implemented to prevent
the commingling of dosage units of different lot numbers or beyond-use dates.
Subp. 3. Commingling. Commingling of returned medication or mixing of lot numbers of
returned medication, upon or prior to repackaging, shall result in such medication being deemed
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.2700MINNESOTA RULES43
misbranded and subject to embargo under Minnesota Statutes, section 151.38. This prohibition
shall not apply to the return of medical devices provided that proper sanitary procedures are used
prior to the reuse, resale, or rerent thereof.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 31 SR 1673
Published Electronically: September 21, 2011
6800.2800 [Repealed, 13 SR 1775]
Published Electronically: September 21, 2011
6800.2810 [Repealed, 31 SR 1673]
Published Electronically: September 21, 2011
6800.2900 PRESCRIPTION BLANKS.
No licensed pharmacy or pharmacist shall accept, furnish, or cause to be furnished to any
practitioner authorized by law to prescribe drugs and medicines prescription blanks referring to
any specific licensed pharmacy or pharmacist in any manner whatsoever. No licensed pharmacy
or pharmacist shall actively or passively participate in any arrangement or agreement whereby
prescriptions are prepared, written, or issued in a manner which refers to a specific pharmacy or
pharmacist.
Statutory Authority: MS s 151.06
Published Electronically: September 21, 2011
6800.3000 PRESCRIPTIONS AND DISTRIBUTION OF DRUGS.
Subpart 1. Acceptance of prescription drug orders and distribution of drugs.
A. Restrictions on pickup or delivery of prescription drug orders or filled
prescriptions. No licensed pharmacist shall participate in any arrangement or agreement whereby
prescription drug orders or filled prescriptions may be left at, picked up from, accepted by, or
delivered to any place of business not licensed as a pharmacy. Provided, however, that nothing in
this part prohibits a licensed pharmacist or a licensed pharmacy, by means of its employee or by
use of a common carrier, from picking up prescription drug orders or delivering filled prescriptions
at the office or home of the prescriber, at the residence of the patient, or at the hospital or long-term
care facility in which a patient is confined. A pharmacy may deliver filled prescriptions at the place
of employment of the patient or a designated caregiver of the patient only if the pharmacy:
(1) obtains and documents the authorization of the patient or patient's caregiver for
delivery at the place of employment;
(2) ensures the filled prescription order is delivered directly to the patient or the patient's
caregiver as authorized; and
(3) ensures the security of protected health information.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
44MINNESOTA RULES6800.2700
B. Direct prescription delivery. A pharmacy that employs the United States Postal Service
or other common carrier to deliver a filled prescription directly to a patient must, based on the
professional judgment of the pharmacist:
(1) use adequate storage or shipping containers and shipping processes to ensure drug
stability and potency. The shipping processes must include the use of appropriate packaging material
and devices, according to the recommendations of the manufacturer or the United States
Pharmacopeia Chapter 1079, in order to ensure that the drug is kept at appropriate storage
temperatures throughout the delivery process to maintain the integrity of the medication;
(2) use shipping containers that are sealed in a manner to detect evidence of opening
or tampering;
(3) develop and implement policies and procedures to ensure accountability, safe
delivery, and compliance with temperature requirements. The policies and procedures must address
when drugs do not arrive at their destination in a timely manner or when there is evidence that the
integrity of a drug has been compromised during shipment. In these instances, the pharmacy must
make provisions for the replacement of the drugs; and
(4) provide for an electronic, telephonic, or written communication mechanism for a
pharmacist, or a pharmacy intern working under the direct supervision of a pharmacist, to offer
counseling to the patient. The patient must receive information indicating what the patient should
do if the integrity of the packaging or medication has been compromised during shipment.
C. Adulteration. A drug is adulterated if it has been exposed to conditions of fire, water,
or extreme temperature, which may have rendered it injurious to health.
Subp. 2. Fax machines. Prescription drug orders may be transmitted to a pharmacy via the
use of a fax machine only in accordance with this subpart and as permitted by law. For a pharmacy
other than a hospital pharmacy that is transmitting solely within the institution, the procedures must
provide for the identification of the person sending the prescription drug order. Unless the fax
transmission is received on a machine generating a copy that is readily readable for at least five
years, all fax transmissions of prescription drug orders shall be followed up within 72 hours with
the original hard copy of the order or the pharmacist shall reduce the order received by fax to writing
that is of permanent quality. Prescription drug orders for Schedule II-IV controlled substances
received by fax shall be handled according to the rules of the federal Drug Enforcement
Administration. Prescriptions faxed to the pharmacy by the patient are not to be filled or dispensed.
Subp. 3. Electronic prescriptions. Any electronic prescription transmitted from the prescriber
to the pharmacy must comply with Minnesota Statutes, section 62J.497, chapter 325L, and any
applicable rules. Electronic prescriptions for controlled substance drugs must conform to the rules
of the federal Drug Enforcement Administration. Except for prescription drug orders for drugs to
be administered in an acute care hospital, an electronically transmitted prescription shall be
transmitted only to the pharmacy of the patient's choice.
Subp. 4. Answering machines and electronic voice recording devices. Only a practitioner
or a practitioner's agent may transmit a prescription to a pharmacy's answering machine or electronic
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.3000MINNESOTA RULES45
voice recording device. Prescriptions transmitted to a pharmacy's answering machine or an electronic
voice recording device shall only be retrieved by a licensed pharmacist or registered pharmacist-intern
working under the immediate and direct supervision of a pharmacist. A technician may not retrieve
a prescription from these devices, except in the case where the practitioner or authorized agent of
the practitioner is approving additional refills of a prescription previously dispensed from the
pharmacy and no other changes are made to the prescription. Personnel used for clerical duties
according to part 6800.3850, subpart 7, may not retrieve any prescription information from these
devices. Prescriptions retrieved from these devices are considered verbal prescription drug orders
that must be reduced to writing and are subject to the requirements of part 6800.3100, subpart 1.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 31 SR 1673; 36 SR 237
Published Electronically: November 28, 2012
6800.3100 COMPOUNDING AND DISPENSING.
Subpart 1. Duties. The practice of compounding and dispensing a prescription drug order
includes, but is not limited to, the following acts, which shall be performed only by a pharmacist,
practitioner, or pharmacist-intern under the immediate and direct supervision of a pharmacist:
A. determination of brands and suppliers;
B. receipt of verbal prescription drug orders which must include documentation of the
individual communicating the order and the pharmacist or pharmacist intern receiving the order;
C. verification of the prescription drug order;
D. selection of the drug to be used in filling the prescription drug order;
E. establishment and validation of the initial formulation record of all compounded
preparations according to part 6800.3300;
F. certification of the filled prescription drug order;
G. ensuring that, when required by law or by the best professional practice, permission to
refill is obtained from authorized practitioners or other individuals allowed to prescribe legend
drugs according to Minnesota Statutes, section 151.37, subdivision 2, and then noting on the reverse
side of the prescription drug order or in the electronically maintained record of the prescription
drug order the following data: date refilled; name of practitioner or other authorized prescriber
personally authorizing the refill, and the name of the practitioner's agent transmitting or
communicating the refill authorization, if applicable; quantity of drug dispensed, if different from
the original prescription; and the unique identifier of the pharmacist refilling the prescription;
H. supervising clerical personnel in limited nonprofessional duties such as typing that does
not involve prescription data entry, record keeping, filing, and completing sales transactions; and
I. supervising pharmacy technicians utilized in the performance of certain pharmacy tasks
not requiring professional judgment in accordance with part 6800.3850.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
46MINNESOTA RULES6800.3000
Subp. 2. Verification. Verification of validity and propriety under subpart 1, item C, must be
of the original prescription drug order. A rewritten, verbal, or electronically produced copy is not
acceptable except as provided in parts 6800.3000, subpart 2, 6800.3120, subpart 7, and 6800.3950,
subpart 1a.
Subp. 3. Certification. In certifying and documenting the filled prescription under subpart 1,
item F, an individual pharmacist, practitioner, or pharmacist-intern shall:
A. check the original labeled container from which the medication was withdrawn, except
as provided in part 6800.2600, or when the pharmacy uses a computerized process to identify oral,
solid drugs through the use of images;
B. check the labeling on the medication container that will be dispensed;
C. check the contents of the medication container that will be dispensed and the appearance
of the total product to ensure that all of the doses that are dispensed are of the correct drug, strength,
and dosage form prescribed;
D. review the patient's medication profile for purposes of conducting a prospective drug
review and checking the accuracy of the addition to the profile of the medication dispensed; and
E. place the pharmacist's, practitioner's, or pharmacist-intern's unique identifier on the
prescription drug order or other permanently maintained record. Those pharmacists using automated
medication management dispensing systems must develop written policies and procedures which
provide that all certification steps are performed and documented before the medication is dispensed
to the patient. These policies and procedures must be made available for inspection by the board
upon request.
Subp. 3a. Accountability. For prescriptions filled in a pharmacy, the unique identifier of each
pharmacist, pharmacist-intern, or pharmacy technician who performs any portion of the prescription
filling process must be documented, with the documentation maintained for a minimum of two
years. The documentation must indicate which portion of the prescription filling process each
pharmacist, pharmacist-intern, or pharmacy technician completed. For prescriptions filled by a
practitioner, the unique identifier of each practitioner and each individual who assists the practitioner
according to part 6800.9952 must be documented and the documentation maintained for a minimum
of two years. This subpart does not waive the requirement for an individual pharmacist, practitioner,
or pharmacist-intern to certify a filled prescription drug order according to subpart 3.
Subp. 3b. Notice required. A pharmacy utilizing a central service pharmacy to provide
dispensing functions, drug utilization review, packaging, labeling, delivery of a filled prescription,
or other services must notify the pharmacy's patients of that fact.
Subp. 4. Exception. This part applies to all pharmacies. Provided, however, that nothing in
this part prevents pharmacists in hospitals from dispensing to hospital inpatients according to parts
6800.7100 to 6800.7950.
Statutory Authority: MS s 151.06; 151.102; 152.02
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.3100MINNESOTA RULES47
History: 9 SR 1656; 10 SR 2007; 18 SR 1145; 23 SR 1597; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.3110 PATIENT MEDICATION PROFILES.
Subpart 1. System required. A patient profile record system must be maintained in all
pharmacies for persons for whom filled prescription drug orders are dispensed. The patient profile
record system must be designed for the immediate retrieval of information necessary for the
dispensing pharmacist to identify previously dispensed medication at the time a prescription drug
order is presented for dispensing. One profile record may be maintained for all members of a family
living at the same address and possessing the same family name.
Subp. 2. Minimum information required; generally. A reasonable effort must be made by
the pharmacy to obtain, record, and maintain at least the following information regarding individuals
obtaining prescription services at the pharmacy:
A. name, address, telephone number, date of birth or age, and gender;
B. individual history where significant, including disease state or states, known allergies
and drug reactions, and a comprehensive list of medications and relevant devices being used showing
the prescription number, the name and strength of the drug or device, the quantity and date received
by the patient, and the name of the prescriber; if this information is obtained by someone other than
the pharmacist, the pharmacist must review the information with the patient; and
C. pharmacist comments relevant to the individual's drug therapy, including, where
appropriate, documentation of the following for each prescription:
(1) the pharmaceutical care needs of the patient;
(2) the services rendered by the pharmacist; and
(3) the pharmacist's impression of the patient's drug therapy.
This documentation is not required for residents of a licensed nursing home where a consultant
pharmacist is performing regular drug regimen reviews.
Subp. 2a. [Repealed, 27 SR 260]
Subp. 3. Drug interactions, generally. Upon receiving a prescription drug order, a pharmacist
shall examine the patient's profile record before dispensing the medication to determine the possibility
of a harmful drug interaction or reaction.
Upon recognizing a potentially harmful interaction or reaction, the pharmacist shall take
appropriate steps to avoid or resolve the problem which shall, if necessary, include consultation
with the prescriber.
Subp. 4. Drug use review for patients. Upon receiving a prescription drug order, or prescription
refill request for a patient, a pharmacist shall examine the patient's profile record and conduct a
prospective drug review to identify:
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
48MINNESOTA RULES6800.3100
A. overutilization or underutilization;
B. therapeutic duplication;
C. drug-disease contraindications;
D. drug-drug interactions;
E. incorrect drug dosage or duration of drug treatment;
F. drug-allergy interactions; or
G. clinical abuse or misuse.
Upon recognizing any of these drug-related problems, the pharmacist shall take appropriate
steps to avoid or resolve the problem which shall, if necessary, include consultation with the
prescriber.
For the purpose of meeting the requirements of this subpart, a pharmacist may rely on
computerized medication profile review, provided that it includes all medication dispensed by the
pharmacy for the patient during at least the preceding six months. The pharmacist-in-charge must
develop procedures for handling alerts generated by the computerized medication profile review
and include these procedures in the written procedures required under part 6800.3950. Only a
pharmacist or a pharmacist-intern working under the immediate and direct supervision of a
pharmacist may override the alerts.
Subp. 5. Duration of record keeping. A patient profile record must be maintained for a period
of not less than two years from the date of the last entry in the profile record. This record may be
in a hard copy or a computerized form.
Subp. 6. [Repealed, 36 SR 237]
Statutory Authority: MS s 151.06; 152.02
History: 10 SR 2007; 18 SR 1145; 27 SR 260; 36 SR 237
Published Electronically: September 21, 2011
6800.3120 TRANSFER OF PRESCRIPTIONS BETWEEN PHARMACIES.
Subpart 1. Label, copy, or report. A prescription label, a written copy of the prescription, or
a telephone report of a prescription from another pharmacy may be used for informational purposes
only and has no legal status as a valid prescription drug order. A pharmacist who receives a label,
copy, or report of a prescription from another pharmacist shall either contact the prescribing
practitioner for authorization to dispense the prescription or shall comply with subparts 2 to 6.
Subp. 2. Conditions of transfer. A pharmacy may transfer prescription drug order information
for the purpose of refilling a prescription if the information is communicated directly by one licensed
pharmacist or registered intern to another licensed pharmacist or registered intern. A pharmacy
may transfer prescription drug order information for the purpose of the initial filling of the order
only according to subpart 8a. Schedule II prescription drug orders may not be transferred. Schedules
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.3120MINNESOTA RULES49
III-V prescription drug orders may be transferred in accordance with the limitations placed on such
transfers by the Drug Enforcement Administration (DEA).
Subp. 3. Duties of transferring pharmacist or intern. The transferring pharmacist or intern
shall:
A. write the word "VOID" across the face of the current prescription drug order to make
it invalid or, if records are electronically maintained, void all remaining refills previously authorized
and carried in the electronic record;
B. record on the reverse side of the invalidated prescription drug order or in the electronically
maintained record of the prescription drug order the name, address, and telephone number of the
receiving pharmacy and the name of the receiving pharmacist or intern; and
C. record the date of the transfer.
Recording of prescription drug order transfers by cancellation of the electronic version of the
prescription drug order is acceptable only when the quality assurance check required by part
6800.3950, subpart 4, has been completed on the prescription drug order being transferred.
For controlled substances in Schedules III-V, parts 6800.4230 to 6800.4250, the transferring
pharmacist or intern shall also record on the reverse side of the invalidated prescription drug order
or in the electronically maintained record of the prescription drug order, the Drug Enforcement
Administration registration number of the receiving pharmacy and the names of the receiving and
transferring pharmacists or interns.
Subp. 4. Duties of receiving pharmacist or intern. The pharmacist or intern receiving the
transferred prescription drug order information shall write the word "transfer," "copy," or a word
of similar import on the face of the transferred prescription, and shall obtain from the transferring
pharmacist or intern all information required by law to be on a prescription, plus:
A. the date of issuance and of filling of the original prescription;
B. the original number of refills authorized;
C. the number of valid refills remaining;
D. the date of last refill from original prescription;
E. the original prescription number from which the prescription information was transferred;
and
F. the transferring pharmacy's name, address, and telephone number and the name of the
transferring pharmacist or intern. In the case of a controlled substance listed in Schedules III-V,
parts 6800.4230 to 6800.4250, the receiving pharmacist or intern must obtain the transferring
pharmacy's Drug Enforcement Administration registration number.
Subp. 5. Retention of prescription. The transferring pharmacy shall keep the original
prescription drug order on file for at least two years from the date of last filling. The receiving
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
50MINNESOTA RULES6800.3120
pharmacy shall keep the transferred prescription drug order on file for at least two years from the
date of last filling.
Subp. 6. Notice to patient of prescription invalidation. The pharmacist conferring with the
patient at the time of the transfer request shall inform the patient that the original prescription has
been invalidated at the pharmacy from which it was obtained.
Subp. 7. Computerized prescription record keeping system. A computerized prescription
record keeping system must satisfy all the requirements of subparts 2 to 6 including invalidation
of the original prescription drug order. Pharmacies accessing a common electronic file or data base
used to maintain required dispensing information are not required to transfer prescription drug
orders or information for dispensing purposes between or among pharmacies participating in the
same common prescription file or data base; provided, however, that any such common file or
database must contain complete records of each prescription drug order and refill dispensed and
further, that a hard copy record of each prescription drug order transferred or accessed for purposes
of refilling must be generated and maintained at the pharmacy refilling the prescription or to which
the prescription has been transferred.
Subp. 8. Transfer of prescription drug order. Except as provided in subpart 7, when the
transfer of original prescription drug order information is initiated by the receipt of a prescription
container previously filled at another pharmacy, the receiving pharmacist shall notify the transferring
pharmacist that the prescription is being transferred. All information required by subparts 2 to 6
must be exchanged.
Subp. 8a. Transfer of nondispensed drug orders. Prescription drug orders that are entered
into a computer system but never dispensed to the patient may be transferred to another pharmacy
if all of the following conditions are met:
A. all prescription drug order information has been entered into the computer system of
the transferring pharmacy;
B. the information is displayed on the patient's profile in a manner that indicates the
prescription drug order was not filled at the transferring pharmacy;
C. there is present, either in the computer system or on the hard copy prescription drug
order, the unique identifier of the person who entered the prescription drug order information into
the system and of the pharmacist who certified this entry, and of the pharmacist who performed
the quality assurance verification as required by part 6800.3950, subpart 4. If the quality assurance
verification has not occurred, then the prescription information exchanged must be from the original
written prescription drug order;
D. the original prescription drug order is kept on record according to Minnesota Statutes,
section 151.211; and
E. all other requirements of this part are met.
Subp. 9. Unprofessional conduct. The board shall consider it evidence of unprofessional
conduct to reveal to others the nature of professional pharmaceutical services rendered to a patient
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.3120MINNESOTA RULES51
without the express oral or written consent of the patient or without an order or direction of a court.
A pharmacist or a pharmacist-intern may provide informational copies of a prescription drug order
to another pharmacist or pharmacist-intern who is currently providing services to or acting at the
request of the patient, as provided in this part; or to the person for whom the prescription drug order
was issued. A pharmacist may also provide drug therapy information to a physician or other licensed,
registered, or certified health care professional who is currently providing services to or acting on
the behalf of the patient.
The board shall consider it evidence of unprofessional conduct for a pharmacist to refuse to
provide a transfer of original prescription drug order information to another pharmacist who is
acting on behalf of a patient and who is making a legal request for this information under this part.
Subp. 10. Schedule II controlled substances. Nothing in this part authorizes the transfer of
a prescription drug order for a Schedule II controlled substance. All prescription drug orders for
Schedule II controlled substances must conform to the requirements of the federal Controlled
Substances Act and to the regulations of the Drug Enforcement Administration.
Subp. 11. Shared information. Prescription drug order information shared between two
pharmacies which are accessing the same real-time, online database, according to the operation of
a board-approved central service operation shall not be considered a prescription copy and is not
subject to the requirements of this part.
Statutory Authority: MS s 151.06; 151.102; 152.02
History: 10 SR 2007; 18 SR 1145; 23 SR 1597; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.3200 PREPACKAGING AND LABELING.
Subpart 1. Prepackaging. Pharmacies may prepackage and label drugs in convenient quantities
for subsequent complete labeling and dispensing. Prepackaging into unit-dose containers shall be
done according to United States Pharmacopeia, chapter 1146. Such drugs shall be prepackaged by
or under the direct supervision of a pharmacist. The supervising pharmacist shall cause to be prepared
and kept a packaging control record containing the following information:
A. date;
B. identification of drug: name, dosage form, manufacturer or distributor, lot number
assigned by manufacturer or distributor, strength, and expiration date assigned by manufacturer or
distributor, if any;
C. container specification;
D. copy of the label;
E. unique identifier of the packager;
F. unique identifier of the supervising pharmacist;
G. quantity per container; and
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
52MINNESOTA RULES6800.3120
H. internal control number or date.
Subp. 2. Labeling. Each prepackaged container shall bear a label containing the following
information:
A. name of drug;
B. strength;
C. name of the manufacturer or distributor of the finished dosage form of the drug;
D. a beyond-use date as provided in part 6800.3350, or any earlier date which, in the
pharmacist's professional judgment, is preferable;
E. internal control number or date;
F. after July 1, 2008, a physical description, including any identification code that may
appear on tablets and capsules or a bar code based on the National Drug Code (NDC). Such a
description does not need to be placed on individual unit-doses, provided that the pharmacy dispenses
the unit-doses in outer packaging that contains a physical description of the drug or the pharmacy
dispenses less than a 72-hour supply of the unit-doses; and
G. radiopharmaceuticals must be labeled according to the requirements of part 6800.8550.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.3300 COMPOUNDING STANDARDS.
Subpart 1. Standards for nonsterile compounding. All licensed Minnesota pharmacies that
compound nonsterile drug preparations must follow United States Pharmacopeia, chapter 795,
standards.
Subp. 2. Standards for sterile compounding. Any licensed Minnesota pharmacy compounding
a sterile product must follow the United States Pharmacopeia, chapter 797, standards.
Subp. 3. [Repealed, 31 SR 1673]
Subp. 4. [Repealed, 31 SR 1673]
Subp. 5. [Repealed, 31 SR 1673]
Subp. 6. Certifying compounding procedure effective January 2, 2013. A pharmacy must
develop a list of high-alert compounded preparations for which a pharmacist shall certify that each
component used in the compounding of the drug preparation has been accurately weighed, measured,
or subdivided, as appropriate, at each stage of the compounding procedure in order to verify
conformance with the formula being prepared. Subsequent stages of the compounding process may
not be completed until this certification occurs. This subpart is effective January 2, 2013.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.3300MINNESOTA RULES53
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 31 SR 1673; 36 SR 237
Published Electronically: October 2, 2012
6800.3350 PHARMACEUTICALS BEYOND-USE DATES.
Subpart 1. Prepackaged into prescription vials. A beyond-use date of not more than one
year from the prepackaging date or the time remaining to the manufacturer's expiration date,
whichever is less, shall be placed on every container of drugs prepackaged into prescription vials
by the pharmacist.
Subp. 2. [Repealed, 31 SR 1673]
Subp. 3. Unit-of-use and blister card packages. A beyond-use date of not more than one
year from the packaging date or the time remaining to the manufacturer's expiration date, whichever
is less, shall be placed on all unit-of-use and blister card packaging whether prepared by the
pharmacist at the time of dispensing or prepared earlier in anticipation of the dispensing.
Subp. 4. Prescription vials. When a drug is dispensed in a prescription vial, a beyond-use
date need not be printed on the label. Drugs dispensed in prescription vials that are labeled with a
beyond-use date shall bear a beyond-use date of not more than one year from the dispensing date
or the time remaining to the manufacturer's expiration date, whichever is less.
Nothing in this part supersedes the pharmacist's professional judgment.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 27 SR 260; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.3400 PRESCRIPTION LABELING.
Subpart 1. Requirements applicable to all drugs. Except for radiopharmaceuticals, all drugs
dispensed to or for a patient, other than an inpatient of a hospital must be labeled with the following
information:
A. name, address, and telephone number of the pharmacy filling the prescription drug order,
except that central service pharmacies shall use the name, address, and telephone number of the
pharmacy dispensing the medication to the patient;
B. patient's name;
C. prescription number;
D. name of prescribing practitioner;
E. directions for use;
F. name of manufacturer or distributor of the finished dosage form of the drug;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
54MINNESOTA RULES6800.3300
G. auxiliary labels as needed;
H. date of original issue or renewal;
I. generic or trade name of drug and strength, except when specified by prescriber to the
contrary. In the case of combining premanufactured drug products, the names of the products, or
a category of use name shall suffice. In the case of compounding basic pharmaceutical ingredients,
the common pharmaceutical name, if such exists, the names and strengths of the principal active
ingredients or a category of use name shall suffice;
J. prescription drug orders filled as part of a central service operation must bear an identifier
that indicates the central service pharmacy at which they were filled; and
K. after July 1, 2008, any dispensed legend drug, or nonlegend drug not dispensed in the
manufacturer's original container, must be labeled with its physical description, including any
identification code that may appear on tablets and capsules. This requirement does not apply to
drugs dispensed as part of an investigational drug study.
Subp. 2. Small container labeling. In cases where the physical characteristics of the immediate
container of the medication do not permit full labeling, a partial label containing, at a minimum,
the patient name and the prescription number may be placed on the container and the complete
labeling applied to an appropriate outer container.
Subp. 3. Customized patient medication packages. In lieu of dispensing two or more
prescribed drug products in separate containers, a pharmacist may, with the consent of the patient,
the patient's caregiver, or the prescriber, provide a customized patient medication package as defined
in the United States Pharmacopeia (USP), chapter 661, standards.
Subp. 4. Veterinary prescription drug label. The label for a filled veterinary prescription
that is dispensed by a licensed pharmacy must include:
A. in the case of non-food-producing animals, the name of the client or animal. In the case
of food-producing animals, the name of the owner and the specific name and address of the facility
at which the filled prescription will be used;
B. identification of the species for which the drug is prescribed or ordered;
C. the name, strength, and quantity of the drug, except when specified by the prescriber to
the contrary. In the case of combining premanufactured drug products, the names of the products,
or category of use may suffice;
D. the name of the manufacturer or distributor of the finished dosage form of the drug;
E. the date of issue;
F. directions for use;
G. withdrawal time, excluding non-food-producing animals;
H. cautionary statements if appropriate for the drug;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.3400MINNESOTA RULES55
I. the name, address, and telephone number of the pharmacy, except that central service
pharmacies must use the name, address, and telephone number of the pharmacy dispensing the
medication to the client;
J. the name and address of the prescribing veterinarian, except that the address of the
prescribing veterinarian is not required if the prescription is for a non-food-producing animal; and
K. the prescription number.
When the veterinary drug is in the manufacturer's original package and the information that is
required on the label includes the drug or drugs, strength of the drug or drugs, directions for use,
withdrawal time for food-producing animals, and cautionary statements, a label will be required
on each individual bottle or package.
Subp. 5. Radiopharmaceutical labeling. Radiopharmaceutical labeling shall comply with
the requirements in part 6800.8550.
Statutory Authority: MS s 151.06; 151.212; 152.02
History: 18 SR 1145; 31 SR 1673; 36 SR 237
Published Electronically: April 24, 2013
6800.3450 LABELING OF OUTPATIENT INTRAVENOUS ADMIXTURE DRUGS.
Subpart 1. Labeling requirements. Intravenous admixture drugs dispensed to or for a patient,
other than a hospitalized patient, shall be labeled according to the requirements of part 6800.3400,
subpart 1, items A to J, and in addition shall contain the following:
A. date of compounding;
B. beyond-use date;
C. storage requirements if other than room temperature;
D. infusion or administration rate;
E. administration times, administration frequency, or both; and
F. other accessory cautionary information which in the professional judgment of the
pharmacist is necessary or desirable for proper use by and safety of the patient.
Subp. 2. Additions to admixtures. When an additional drug is added to intravenous admixtures,
the admixtures shall be labeled on the original label or with a distinctive supplementary label
indicating the name and the amount of the drug added, date and time of addition and expiration,
and the unique identifier of the person adding the drug.
Subp. 3. Audit trail. A pharmacy engaged in the dispensing of outpatient intravenous
admixtures shall develop a five-year audit trail system that will identify the dispensing pharmacist
for each unit dispensed.
Statutory Authority: MS s 151.06; 152.02
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
56MINNESOTA RULES6800.3400
History: 18 SR 1145; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.3500 [Renumbered 6800.4150]
Published Electronically: September 21, 2011
6800.3510 REFILL LIMITATIONS.
No prescription drug order may be filled or refilled more than 12 months after the date on which
it was issued. Refills originally authorized in excess of 12 months are void 12 months after the
original date of issuance of the prescription drug order. After 12 months from the date of issuance
of a prescription drug order, no additional authorizations may be accepted for that prescription drug
order. If the prescriber desires continued therapy, a new prescription drug order must be generated
and a new prescription number assigned.
Statutory Authority: MS s 151.06
History: 18 SR 1145; 36 SR 237
Published Electronically: September 21, 2011
6800.3550 [Repealed, 23 SR 1597]
Published Electronically: September 21, 2011
6800.3600 [Renumbered 6800.3550]
Published Electronically: September 21, 2011
6800.3650 [Repealed, 23 SR 1597]
Published Electronically: September 21, 2011
6800.3700 [Renumbered 6800.3650]
Published Electronically: September 21, 2011
6800.3750 UNIT DOSE DISPENSING.
Subpart 1. Control. A unit dose system shall be under the control of the pharmacist-in-charge.
The act of drug dispensing is reserved for licensed pharmacists and registered pharmacist-interns
acting under the supervision of licensed pharmacists, as set forth in part 6800.3100. A unit dose
system may be used as an alternative to part 6800.3100, subpart 1, items D, F, and G, according to
the following subparts.
Subp. 2. Unit dose packaging. Unit dose packaging is the packaging of individual doses of
medication in containers which will preserve the identity and integrity of the drug from the point
of packaging to the point of administration to the patient. Packaging may be accomplished by a
manufacturer or by a pharmacy in accordance with part 6800.3200.
Individual doses of medication shall be properly labeled from the manufacturer with the name
of the drug, dosage form and strength, manufacturer's name and lot number, and expiration date of
all time dated drugs, or labeled in accordance with part 6800.3200 if prepackaged by the pharmacy.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.3750MINNESOTA RULES57
Unit dose packaging may provide individual doses of medication attached to each other by
placement in a card or other container. Such packaging shall be labeled in accordance with part
6800.3200 in such a manner as to provide continuous identification of the contents and, when
dispensed, the name and location of the patient, name of the prescribing practitioner, prescription
number, date, the directions for use, and identification of the pharmacy.
Subp. 3. Unit dose system. The unit dose system is that drug distribution system which is
pharmacy based and which uses unit dose packaging in a manner which removes traditional drug
stocks from patient care areas and enables the selection and distribution of unit dose packaging to
be pharmacy based and controlled.
The system must provide and the pharmacist must utilize:
A. a means of separating medications by patient name and bed number;
B. a means of separating medications by day of administration;
C. a means of identifying individual doses dispensed, doses administered, and doses returned;
D. a means of identifying the dosage regimen of each drug, including the date of the original
prescription drug order and the date of changes, if any, made to the prescription drug order;
E. a means of identifying the total dosage regimen of each patient;
F. a means of identifying the time of administration of each drug;
G. a means for the pharmacist to verify the original prescription drug order; and
H. a means for the pharmacist to certify the accuracy of the selected medication before the
dose is delivered for administration to the patient.
Subp. 4. Written policies. Each pharmacy utilizing a unit dose dispensing system shall establish
written policies specifying the categories of drugs which will or which will not be dispensed under
the unit dose distribution system. Such policies shall be available in the pharmacy for inspection
by the board.
Subp. 5. Unit dose preferred. Proper utilization of the unit dose system requires that in as far
as is practicable all medications be in unit dose packaging when dispensed.
Subp. 6. Controlled substances. Schedule II, III, and IV controlled substances may be included
in the unit dose system if the methods of including such drugs in the system are in compliance with
applicable federal and state laws and rules.
Subp. 7. Legend drugs. Legend drugs not dispensed under the unit dose dispensing system
must be dispensed in accordance with part 6800.3100 and labeled in accordance with parts 6800.3400
and 6800.4150.
Subp. 8. Who may perform non-dispensing functions. Selection of individual unit dose
packaging for placement in individual patient containers, bins, compartments, or drawers is not
dispensing under part 6800.3100, and may be performed by supportive personnel. Dispensing
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
58MINNESOTA RULES6800.3750
occurs upon the certification of the accuracy of the selected unit dose packages, which shall be
done by the pharmacist before the dose is delivered for administration to the patient.
Subp. 9. Storage of medications.
A. All controlled substances must be stored in a locked area or locked cart at all times.
B. All noncontrolled substances must be stored in a locked area or locked cart when a
patient care area is not staffed. An area in which staff is actively providing patient care or preparing
to receive patients is considered a secure area and locked storage of noncontrolled substances is
not required.
Subp. 10. Compliance. Unit dose system shall comply with existing law with respect to
provisions of pharmaceutical services to hospitals and nursing homes and as set forth in parts
6800.6100 to 6800.7950.
Statutory Authority: MS s 151.06
History: 9 SR 1656; 36 SR 237
Published Electronically: October 11, 2013
6800.3800 [Renumbered 6800.3750]
Published Electronically: September 21, 2011
6800.3850 PHARMACY TECHNICIANS.
Subpart 1. Technician registration required. Pharmacy technicians may be used in performing
pharmacy tasks not specifically reserved in this chapter to a licensed pharmacist only when the
technician is properly registered with the board. An individual may not, under any circumstances,
perform pharmacy tasks as a pharmacy technician prior to being registered as a pharmacy technician
according to this part. Registration does not include any determination of the competency of the
registered individual.
Subp. 1a. Denial and suspension of registration. The board may deny, suspend, revoke,
refuse to renew, or place conditions and limitations on the registration of a technician for any
violation of the rules of the board or the laws of this state, another state, or the United States relating
to the practice of pharmacy, prescription drugs, or controlled substances.
Subp. 1b. Registration, renewals.
A. A pharmacy technician registration expires each year on December 31 and shall be
renewed annually by filing an application for registration renewal on or before December 1 of each
year, together with the fee listed in subpart 1c.
B. Initial registration shall not be prorated.
Subp. 1c. Registration fee, late fee.
A. The fee for an initial registration is the amount established in Minnesota Statutes, chapter
151.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.3850MINNESOTA RULES59
B. The fee for each annual renewal is the amount established in Minnesota Statutes, chapter
151.
C. The fee must be paid at the time when a new application or a renewal application is
submitted to the board.
D. Persons required to renew their registration under this part, who file an application which
is received by the board after the date on which it is due, must pay a late fee of 50 percent of the
renewal fee in addition to the renewal fee.
Subp. 1d. Notifications to board. A pharmacy technician must report any changes in name,
residence, or place of employment to the board within ten days of the change.
Subp. 1e. Identification of technician.
A. A pharmacy technician must wear a name badge while on duty which clearly identifies
the person as a "Pharmacy Technician," except when complying with the requirements of United
States Pharmacopeia Chapter 797.
B. Pharmacy technicians must not represent themselves as pharmacists in any manner.
Subp. 1f. Posting of registration. A pharmacy technician shall post the registration most
recently issued by the board in a conspicuous place within the pharmacy in which the technician
is working. For all pharmacies, this place shall be a place which is readily accessible to the board.
Subp. 1g. Minimum age. Prior to January 1, 2012, the board shall not register as a pharmacy
technician any individual who is less than 16 years of age. Effective January 1, 2012, the board
shall not register as a pharmacy technician any individual who is less than 18 years of age. An
individual who is less than 18 years of age and who was registered by the board as a pharmacy
technician prior to January 1, 2012, may renew registration provided that all other requirements
for renewal are met.
Subp. 1h. Education and training requirements.
A. Initial registration. Effective January 1, 2013, the board shall not issue an initial
pharmacy technician registration to any individual who does not present the board with evidence
of high school graduation or possession of a commissioner of education-selected high school
equivalency certification. An individual who is not a high school graduate or who does not possess
a commissioner of education-selected high school equivalency certification who was registered by
the board prior to January 1, 2013, may renew the individual's registration provided that all other
requirements for renewal are met and provided the individual maintains a pharmacy technician
registration on an uninterrupted basis. Any individual whose registration lapses for a period of more
than one year must meet the registration requirements in effect at the time the individual applies
for reinstatement of registration.
B. Renewal of registration. Effective January 1, 2014, the board shall not renew the
registration of a pharmacy technician who was initially registered after January 1, 2013, or who
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
60MINNESOTA RULES6800.3850
was initially registered prior to that date but did not maintain continuous registration, unless the
individual provides the board with evidence of completion of one of the following:
(1) a pharmacy technician training program offered by a board-approved, accredited
vocational/technical institution or college;
(2) a pharmacy technician training program accredited by a board-approved, national
organization that accredits pharmacy technician training programs;
(3) a pharmacy technician training program provided by a branch of the United States
armed forces or Public Health Service; or
(4) an employer-based pharmacy technician training program that includes a minimum
total of 240 hours on a one-year period to include both theoretical and practical instruction. An
employer utilizing such a program must develop and regularly update a technician training manual
that must be available for board inspection upon request. The employer must also supply a technician
who completes the training program with written evidence of completion. The employer-based
pharmacy technician training program must include written guidelines, policies, and procedures
that define the specific tasks the technician will be expected to perform. A pharmacy technician
who has not completed this training, but is otherwise eligible for renewal of his or her registration,
may apply for renewal provided that: less than six months has elapsed between the date of initial
registration as a pharmacy technician and the date of the pharmacy technician's first renewal of
registration; or the pharmacy technician shows satisfactory evidence of being enrolled in a pharmacy
technician training program offered by a board-approved, accredited vocational/technical institution
or college, when the program is longer than six months in length.
C. Pharmacy-specific training. Notwithstanding the fact that a technician has completed
a training program as specified in item B, it is the responsibility of the pharmacist-in-charge of a
pharmacy to ensure that a technician receives adequate training in the tasks performed by technicians
working at that pharmacy.
Subp. 2. Permissible duties. Pharmacy technicians may perform pharmacy tasks not specifically
reserved in this chapter to a licensed pharmacist or pharmacist-intern and that do not involve the
use of professional judgment.
Subp. 3. Certifying. Pharmaceutical products prepared or processed, in whole or in part, by
a pharmacy technician must be certified for accuracy by a licensed pharmacist, practitioner, or
pharmacist-intern as provided for in part 6800.3100, subpart 1, item F, prior to release for patient
use.
Subp. 4. Written procedures. Written procedures for the use of pharmacy technicians in a
pharmacy shall be prepared by the pharmacist-in-charge. A copy of the procedures must be given
to each technician and a copy must be kept on file in the pharmacy. The written procedures must
be made available for inspection by the board upon request. These procedures must comply with
the standards in this chapter and will be reviewed for compliance on that basis.
These procedures must indicate in detail the tasks performed by the pharmacy technician; the
name, address, and registration number of the pharmacy technician; and the certification steps
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.3850MINNESOTA RULES61
performed by the licensed pharmacist in verifying the technician's work. Procedures must be updated
at least every five years and whenever a significant change in the way in which pharmacy technicians
are utilized occurs. The pharmacist-in-charge shall ensure that each technician has reviewed the
procedures when the technician is first employed by the pharmacy as a technician and when any
substantial changes to the procedures have been made. The pharmacist-in-charge must ensure that
proper documentation of training is maintained in the pharmacy for a period of at least two years
after the training occurs.
Subp. 5. Supervision. Pharmacy technicians shall be supervised by a licensed pharmacist
stationed within the same work area who has the ability to control and is responsible for the action
of the pharmacy technician. The ultimate responsibility for the actions of a pharmacy technician
working under a licensed pharmacist's supervision shall remain with the licensed pharmacist.
Subp. 6. Ratios. The basic ratio of pharmacy technicians to pharmacists on duty in a pharmacy
is two technicians to one pharmacist. Specific functions are excepted from the basic ratio as follows:
A. intravenous admixture preparation (parts 6800.7510 to 6800.7530), 3:1;
B. setting up or preparing patient specific prescriptions in unit dose or modified unit dose
packaging (part 6800.3750), 3:1;
C. prepackaging (part 6800.3200), 3:1; and
D. compounding (part 6800.3300), 3:1.
Subp. 7. Persons not included. Personnel used solely for clerical duties such as typing or
keyboarding that does not involve prescription data entry, record keeping, filing, billing, and
completing sales transactions need not be included when determining compliance with the ratios
listed in this part. Personnel used solely for the delivery of filled prescription drug orders need not
be included when determining compliance with the ratios listed in this part.
A pharmacist-intern submitting hours toward completion of the 1,600-hour requirement is not
considered a pharmacy technician for the purpose of determining the number of pharmacy technicians
supervised by a licensed pharmacist.
Subp. 8. [Repealed, 23 SR 1597]
Subp. 9. Unprofessional conduct. The use of pharmacy technicians in the performance of
delegated tasks not included in written procedures may be considered unprofessional conduct on
the part of the pharmacist supervising the technician, the pharmacist-in-charge, and the pharmacy
technician. Falsification of any documents pertaining to the training of pharmacy technicians shall
be considered unprofessional conduct on the part of any pharmacist or pharmacy technician involved
in such act.
Statutory Authority: MS s 151.06; 151.102; 151.12; 151.13; 151.19; 151.25; 151.47; 151.48;
151.49; 214.06
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
62MINNESOTA RULES6800.3850
History: 9 SR 1656; 18 SR 1145; 23 SR 1597; 25 SR 81; 36 SR 237; L 2012 c 187 s 74; L
2017 1Sp5 art 10 s 7
Published Electronically: August 21, 2017
6800.3900 [Renumbered 6800.3850]
Published Electronically: September 21, 2011
6800.3950 ELECTRONIC DATA PROCESSING; COMPUTER USAGE.
Subpart 1. Policy and procedures. Up-to-date written policy and procedures shall be developed
and maintained that explain the operational aspects of the electronic data processing system and
shall:
A. include examples of output documentation provided by the electronic data processing
system that pertain to dispensing or drug control records;
B. outline steps to be followed when the electronic data processing system is not operational
due to scheduled or unscheduled system interruption;
C. outline regular and routine backup file procedures and file maintenance; and
D. outline audit procedures, personnel code assignments, and personnel responsibilities.
Subp. 1a. Entering prescription drug orders. When electronic data processing equipment
is employed by any pharmacy, input of drug information may be performed by a prescriber or a
pharmacist. If prescription drug orders are entered by other personnel, the pharmacist or the prescriber
must certify the accuracy of the information entered and verify the prescription drug order prior to
the dispensing of the medication. The unique identifier of the person entering the prescription drug
order must be retained in the computer record.
Subp. 2. Minimum requirements. Electronic data processing equipment, when used to store
prescription information, must:
A. be structured in such a manner that all prescription drug orders, communicated to a
pharmacy by way of electronic transmission, will be transmitted with no intervening person having
access to the information contained in the prescription drug order;
B. not infringe on a patient's freedom of choice of pharmacy provider;
C. guarantee the confidentiality of the information contained in the system's storage devices
and databases;
D. produce a hard copy daily summary of controlled substance transactions and be capable
of producing a hard copy printout of legend drug transactions going back two years, except that if
this information is already available in hard copy form it is not necessary to duplicate the data
through a computer-generated hard copy;
E. be capable of recording and carrying in the record all dates of refills of any prescription
drug order and the unique identifier of the pharmacist;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.3950MINNESOTA RULES63
F. be capable of producing a patient profile indicating all drugs being taken and the dates
and quantities of fills or refills of prescription drug orders dispensed for the patient and:
(1) in the case of hospital or long-term care inpatients, these records shall be kept in
the computer system or on hard copy and be immediately retrievable for two years; and
(2) in all other cases the data shall be kept in the computer system and be immediately
retrievable for at least two years;
G. be capable of being reconstructed in the event of a computer malfunction or accident
resulting in destruction of the system's storage devices or databases;
H. be capable of producing a printout providing a refill-by-refill audit trail for any specified
strength and dosage form of any controlled substance. The audit trail must include the name of
prescribing practitioner, the name and location of patient, the quantity dispensed on each refill, the
date of dispensing of each refill, the name or unique identifier of the dispensing pharmacist, and
the prescription number;
I. be capable of identifying any authorized changes in drug, quantity, or directions for use
of any prescription drug order including the date of change, the identity or unique identifier of the
individual making the change, and what the original information was; alternatively a new prescription
drug order may be created for each authorized change; and
J. be capable of preventing unauthorized access, modification, or manipulation of patient
prescription data.
Subp. 3. Original prescription retained. In all cases where electronic data processing
equipment is used the original prescription must be retained on file according to law to assure access
to the information contained thereon in the event of a computer breakdown. Original prescriptions
or any other patient specific records stored outside the licensed pharmacy area must be stored in a
secure area accessible only to registered or licensed pharmacy staff, or others delegated by the
pharmacist-in-charge and trained on the policies and procedures relating to protected health
information.
Subp. 4. New prescriptions.
A. A pharmacy must develop and implement a written quality assurance plan that includes
a pharmacist, or a pharmacist-intern working under the immediate and direct supervision of a
pharmacist, comparing the original written prescription or an image of the original written
prescription, to the information entered into the computer, and documenting the completion and
accuracy of this comparison with the date and unique identifier of the pharmacist or pharmacist-intern
completing the task. This process must not occur prior to two hours after the prescription has been
initially certified, unless it is completed by a second individual pharmacist as soon as possible after
the initial certification has occurred. The process must be completed within 72 hours.
B. As an alternative to the requirements of item A, hospitals providing inpatient pharmacy
services may elect instead to develop a plan to provide safeguards against errors being made and
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
64MINNESOTA RULES6800.3950
perpetuated due to inaccurate prescription data being entered into the pharmacy's computer. This
written quality assurance plan shall be made available to the board surveyors upon request.
Subp. 5. Report to Board of Pharmacy. If dispensing information is lost due to unscheduled
system interruption, the Board of Pharmacy shall be notified within 72 hours.
Subp. 6. Computer-generated material. Any computer-generated material, such as labels,
receipts, duplicate prescriptions, or other printed matter, that is intended to be attached to the hard
copy prescription to meet legal requirements shall be affixed so that the face of the prescription is
unobstructed.
Statutory Authority: MS s 151.06; 151.102; 152.02
History: 9 SR 1656; 18 SR 1145; 23 SR 1597; 31 SR 1673; 36 SR 237
Published Electronically: October 11, 2013
6800.4000 [Renumbered 6800.3950]
Published Electronically: September 21, 2011
6800.4050 DRUG IDENTIFICATION.
Subpart 1. Minimum requirement. The finished dosage form of any legend drug in solid oral
dosage form manufactured, packaged, or distributed for sale in this state after January 1, 1983, shall
be clearly marked or imprinted with a symbol, number, name, word, letter, national drug code
number, or other mark identifying the drug and the manufacturer or distributor of the drug.
Subp. 2. Imprints. Each manufacturer and distributor shall publish and provide to the board
printed material which will identify each imprint or mark currently used by the manufacturer or
distributor. The board shall also be notified of any changes in the published list.
Subp. 3. Exemptions. Drug manufacturers, packagers, or distributors seeking an exemption
from the requirements of subpart 1 or 2 shall submit to the board a documentation of facts related
to the product which would make impractical compliance with the imprinting required by Minnesota
Statutes, section 151.361, subdivision 2. The documentation must include specifics on the physical
characteristics of the drug upon which the exemption request is based.
Statutory Authority: MS s 152.02
History: 9 SR 1656
Published Electronically: September 21, 2011
6800.4075 CENTRALIZED PRESCRIPTION PROCESSING AND FILLING.
Subpart 1. Licensure.
A. A central service pharmacy located in another state that provides any services listed in
part 6800.0100, subpart 1c, to a pharmacy located in this state shall be licensed as a nonresident
pharmacy according to Minnesota Statutes, section 151.19, subdivision 2.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4075MINNESOTA RULES65
B. A central service pharmacy located in this state that provides any services listed in part
6800.0100, subpart 1c, to a pharmacy located in any state shall be licensed as a pharmacy according
to Minnesota Statutes, section 151.19, subdivision 1.
Subp. 2. Requirements; policy and procedures.
A. A pharmacy may perform or outsource centralized prescription drug order filling or
centralized prescription drug order processing services provided:
(1) the parties have the same owner or have a written contract outlining the services to
be provided and the responsibilities and accountabilities of each party in fulfilling the terms of said
contract in compliance with federal and state laws and regulations;
(2) the parties share a common electronic file or have appropriate technology to allow
access to sufficient information necessary or required to fill or refill a prescription drug order;
(3) the central service pharmacy is licensed according to part 6800.0300; and
(4) the parties provide the board with a copy of the policy and procedures manual
described in item B at least 30 days before centralized prescription drug order processing services
begin.
B. The parties performing or contracting for centralized prescription drug order processing
services shall maintain a policy and procedures manual and documentation that operations are
occurring in a manner consistent with the manual. The manual shall be made available to the board
for review upon request and shall include, at a minimum, the following:
(1) a description of how the parties will comply with federal and state laws and
regulations;
(2) the maintenance of appropriate records to identify the responsible pharmacist in the
dispensing and counseling processes;
(3) the maintenance of a mechanism for tracking the prescription drug order during
each step in the dispensing process;
(4) the maintenance of a mechanism to identify on the prescription label all pharmacies
involved in dispensing the prescription drug order;
(5) the provision of adequate security to protect the integrity and prevent the illegal use
or disclosure of protected health information; and
(6) the maintenance of a continuous quality improvement program for pharmacy services
designed to objectively and systematically monitor and evaluate the quality and appropriateness of
patient care, pursue opportunities to improve patient care, and resolve identified problems.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
66MINNESOTA RULES6800.4075
Subp. 3. Certification and counseling.
A. A pharmacist or pharmacist intern at the pharmacy that dispenses, delivers, mails, or
ships the completed prescription drug order to the patient is responsible for certifying the completed
prescription drug order, except as provided for in Minnesota Statutes, section 151.215.
B. A pharmacist or pharmacist intern at the pharmacy that dispenses, delivers, mails, or
ships the completed prescription drug order to the patient is responsible for counseling the patient
according to part 6800.0910.
Subp. 4. Notification. A pharmacy utilizing a central service pharmacy to provide dispensing
functions, drug utilization review, packaging, labeling, delivery of a completed prescription drug
order, or other services must notify its patients of that fact.
Statutory Authority: MS s 151.06; 152.02
History: 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
6800.4100 [Renumbered 6800.4050]
Published Electronically: September 21, 2011
CONTROLLED SUBSTANCES
6800.4150 LABELING OF CONTROLLED SUBSTANCES AND OTHER DRUGS.
Drugs administered systemically as controlled substances under Minnesota Statutes, chapter
152, and parts 6800.4200 to 6800.4250, and other drugs deemed appropriate in the professional
judgment of the pharmacist and dispensed to or for an adult patient, other than an inpatient of a
hospital or nursing home, shall be labeled according to the requirements of part 6800.3400 and in
addition shall contain the following:
"Caution: Taking this drug alone or with alcohol may impair your ability to drive."
Controlled substances shall also be labeled:
"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for
whom it was prescribed."
Statutory Authority: MS s 151.06
History: 9 SR 1656; 18 SR 1145
Published Electronically: September 21, 2011
6800.4200 INCLUSIONS AND EXCEPTIONS.
Subpart 1. Substances included. The substances in parts 6800.4210 to 6800.4250 are, because
of their potential for abuse, defined and controlled in the following schedules and are, therefore,
subject to the provisions of Minnesota Statutes, chapter 152.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4200MINNESOTA RULES67
Subp. 2. Exceptions. Drugs which are not required by federal law to bear any one of the
following symbols, C-I, C-II, C-III, C-IV, or C-V, I, II, III, IV, or V, are exempt from the provisions
of Minnesota Statutes, chapter 152. Provided, however, that drugs containing any quantity of
phenobarbital shall be dispensed only according to a prescription drug order.
Statutory Authority: MS s 151.06
History: 9 SR 1656; 36 SR 237
Published Electronically: September 21, 2011
6800.4210 SCHEDULE I CONTROLLED SUBSTANCES.
Schedule I shall consist of the drugs and other substances, by whatever official name, common
or usual name, chemical name, or brand name designated, listed in this part.
A. Opiates. Unless specifically excepted or unless listed in another schedule, any of the
following opiates, including their isomers (whether optical, positional, or geometric), esters, ethers,
salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers,
or salts is possible within the specific chemical designation:
(1) Acetylmethadol;
(2) Allylprodine;
(3) Alphacetylmethadol (except levo-alphacetylmethadol, also known as
levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM);
(4) Alphameprodine;
(5) Alphamethadol;
(6) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta-phenyl)ethyl-4-piperidyl]
propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-propanilido) piperidine);
(7) Benzethidine;
(8) Betacetylmethadol;
(9) Betameprodine;
(10) Betamethadol;
(11) Betaprodine;
(12) Clonitazene;
(13) Dextromoramide;
(14) Diampromide;
(15) Diethylthiambutene;
(16) Difenoxin;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
68MINNESOTA RULES6800.4200
(17) Dimenoxadol;
(18) Dimepheptanol;
(19) Dimethylthiambutene;
(20) Dioxaphetyl butyrate;
(21) Dipipanone;
(22) Ethylmethylthiambutene;
(23) Etonitazene;
(24) Etoxeridine;
(25) Furethidine;
(26) Hydroxypethidine;
(27) Ketobemidone;
(28) Levomoramide;
(29) Levophenacylmorphan;
(30) Methyl substituted isomers of Fentanyl:
(a) 3-Methylfentanyl;
N-[3-Methyl-1-(2-phenylethyl)-4-piperidyl]-N-phenylpropanamide;
(b) Acetyl-alpha-methylfentanyl;
N-[1-(1-methyl-2-phenylethyl)-4-piperidinyl]-N-phenylacetamide;
(c) Alpha-methylthiofentanyl;
N-[1-methyl-2-(2-thienyl)ethyl-4-piperidinyl-N-phenylpropanamide;
(d) Benzylfentanyl; N-[1-benzyl-4-piperidyl]-N-phenylpropanamide;
(e) Beta-hydroxyfentanyl;
N-[1-(2-hydroxy-2-phenylethyl-4-piperidinyl]-N-phenylpropanamide;
(f) Beta-hydroxy-3-methylfentanyl;
N-[1-(2-hydroxy-2-phenylethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide;
(g) 3-methylthiofentanyl;
N-[3-methyl-1-(2-thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide;
(h) Thenylfentanyl; N-[1-(2-thienyl)Methyl-4-piperidyl]-N-phenylpropanamide;
(i) Thiofentanyl; N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]-propanamide;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4210MINNESOTA RULES69
(j) para-fluorofentanyl;
N-[1-(2-phenylethyl)-4-piperidyl]-N-(4-fluorophenyl)-propanamide, its optical isomers, salts and
salts of isomers;
(31) Morpheridine;
(32) MPPP; 1-Methyl-4-phenyl-4-Propionoxypiperidine;
(33) Noracymethadol;
(34) Norlevorphanol;
(35) Normethadone;
(36) Norpipanone;
(37) PEPAP; 1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine;
(38) Phenadoxone;
(39) Phenampromide;
(40) Phenomorphan;
(41) Phenoperidine;
(42) Piritramide;
(43) Proheptazine;
(44) Properidine;
(45) Propiram;
(46) Racemoramide;
(47) Tilidine; and
(48) Trimeperidine.
B. Opium derivatives. Unless specifically excepted or unless listed in another schedule,
any of the following opium derivatives, its salts, isomers, and salts of isomers, whenever the
existence of such salts, isomers, and salts of isomers is possible within the specific chemical
designation:
(1) Acetorphine;
(2) Acetyldihydrocodeine;
(3) Benzylmorphine;
(4) Codeine methylbromide;
(5) Codeine-N-Oxide;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
70MINNESOTA RULES6800.4210
(6) Cyprenorphine;
(7) Desomorphine;
(8) Dihydromorphine;
(9) Drotebanol;
(10) Etorphine (except hydrochloride salt);
(11) Heroin;
(12) Hydromorphinol;
(13) Methyldesorphine;
(14) Methyldihydromorphine;
(15) Morphine Methylbromide;
(16) Morphine Methylsulfonate;
(17) Morphine-N-Oxide;
(18) Myrophine;
(19) Nicocodeine;
(20) Nicomorphine;
(21) Normorphine;
(22) Pholcodine; and
(23) Thebacon.
C. Hallucinogenic substances. Unless specifically excepted or unless listed in another
schedule, any material, compound, mixture, or preparation which contains any quantity of the
following hallucinogenic substances, or which contains any of its salts, isomers (whether optical,
positional, or geometric), and salts of isomers, whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
4-bromo-2,5-dimethoxy-α-
methylphenethylamine;4-bromo-2,5-DMA
4-Bromo-2,5-Dimethoxyamphetamine(1)
2,5-dimethoxy-α-methylphenethylamine;
2,5-DMA
2,5-Dimethoxyamphetamine(2)
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4210MINNESOTA RULES71
4-methoxy-α-Methylphenethylamine;
paramethoxyamphetamine, PMA
4-Methoxyamphetamine(3)
MMDA5-Methoxy-3, 4-Methylenedioxyamphetamine(4)
4-methyl-2,5-dimethoxy-α-
methylphenethylamine; "DOM"; and "STP"
4-Methyl-2,5-Dimethoxyamphetamine(5)
MDA3,4-Methylenedioxy Amphetamine(6)
MDMA3,4-Methylenedioxymeth-amphetamine(7)
N-ethyl-alpha-methyl-3,4(Methylenedioxy)
phenethylamine; N-ethyl MDA; MDE;
MDEA
3,4-Methylenedioxy-N-ethylamphetamine(8)
N-hydroxy-alpha-methyl-3,
4(Methylenedioxy) phenethylamine;
N-hydroxy MDA
N-hydroxy-3, 4-Methylenedioxy-amphetamine(9)
TMA3,4,5-Trimethoxy Amphetamine(10)
Etryptamine; monase;
α-Ethyl-1H-indole-3-ethanamine;
3-(2-aminobutyl)indole; α-ET; and AET
Alpha-Ethyltryptamine(11)
3-(b-Dimethylaminoethyl)-5-hydroxyindole;
3-(2-dimethylaminoethyl)-5-indolol; N,
Bufotenine(12)
N-dimethylserotonin;
5-hydroxy-N,N-dimethyltryptamine; mappine
N,N-Diethyltryptamine; DETDiethyltryptamine(13)
DMTDimethyltryptamine(14)
7-Ethyl-6,6b,7,8,9,10,12,
13-octahydro-2-methoxy-6,9-methano-
Ibogaine(15)
5H-pyrido [1', 2':1,2] azepino [5,4-b] indole;
Tabernanthe iboga
LSDLysergic acid diethylamide(16)
Marijuana(17)
Mescaline(18)
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
72MINNESOTA RULES6800.4210
3-Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,
6,9-trimethyl-6H-dibenzo[b,d]pyran;
Synhexyl
Parahexyl(19)
Peyote(20)
Meaning all parts of the plant presently
classified botanically as Lophophora williamsii
Lemaire, whether growing or not, the seeds
thereof, any extract from any part of such plant,
and every compound, manufacture, salt,
derivative, mixture, or preparation of such plant,
its seeds or extracts
N-ethyl-3-piperidyl Benzilate(21)
N-methyl-3-piperidyl Benzilate(22)
Psilocybin(23)
Psilocyn(24)
THCTetrahydrocannabinols(25)
Meaning Tetrahydrocannabinols naturally
contained in a plant of the genus Cannabis
(cannabis plant), as well as synthetic equivalents
of the substances contained in the cannabis
plant, or in the resinous
extractives of such plant and/or synthetic
substances, derivatives, and their isomers with
similar chemical structure and pharmacological
activity to those substances contained in the
plant,
such as the following: 1 cis or trans
tetrahydrocannabinol, and their optical isomers,
excluding dronabinol in sesame oil and
encapsulated in a soft gelatin capsule in a drug
product approved by the U.S. Food and Drug
Administration.
6 cis or trans tetrahydrocannabinol, and their
optical isomers; 3,4 cis or trans
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4210MINNESOTA RULES73
tetrahydrocannabinol, and its optical isomers
(Since nomenclature of these substances is not
internationally standardized, compounds of
these structures, regardless of numerical
designation of atomic positions covered)
N-ethyl-1-phenylcyclohexylamine,
(1-phenylcyclohexyl)ethylamine,
Ethylamine analog of phencyclidine(26)
N-(1-phenylcyclohexyl)ethylamine,
cyclohexamine, PCE
1-(1-phenylcyclohexyl)-pyrrolidine, PCPy,
PHP
Pyrrolidine analog of phencyclidine(27)
1-[1-(2-thienyl)-cyclohexyl]-piperidine,
2-thienyl analog of phencyclidine, TPCP,
TCP
Thiophene analog of phencyclidine(28)
1-[1-(2-thienyl)cyclohexyl]-pyrrolidine,
TCPy
2-thienyl Pyrrolidine analog of Phencyclidine(29)
2-(4-bromo-2,5-dimethoxyphenyl)
-1-aminoethane;alpha-desmethyl
DOB; 2C-B (nexus)
4-bromo-2,5-dimethoxyphenethylamine(30)
DOET2,5-dimethoxy-4-ethylamphetamine(31)
2C-T-72,5-dimethoxy-4-(n)-
propylthiophenethylamine
(32)
AMTAlpha-methyltryptamine(33)
5-MeO-DIPT5-methoxy-N,N-diisopropyltryptamine.(34)
D. Peyote. The listing of peyote as a controlled substance in schedule I does not apply to
the nondrug use of peyote in bona fide religious ceremonies of the Native American Church; and
members of the Native American Church, however, are required to obtain federal registration
annually and to comply with all other requirements of law.
E. Depressants. Unless specifically excepted or unless listed in another schedule, any
material, compound, mixture, or preparation which contains any quantity of the following substances
having a depressant effect on the central nervous system including its salts, isomers, and salts of
isomers:
(1) Flunitrazepam;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
74MINNESOTA RULES6800.4210
(2) Gamma-hydroxybutyric acid, including its esters and ethers (some other names
include GHB, gamma-hydroxybutyrate, 4-hydroxybutanoic acid, sodium oxybate, sodium
oxybutyrate);
(3) Mecloqualone;
(4) Methaqualone.
F. Stimulants. Unless specifically excepted or unless listed in another schedule, any material,
compound, mixture, or preparation which contains any quantity of the following substances having
a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
Aminoxaphen;
2-Amino-5-phenyl-2-oxazoline;
4,5-Dihydro-5-phenyl-2-oxazolamine
Aminorex(1)
2-Amino-1-phenyl-1-propanone;
alpha-Aminopropiophenone;
2-Aminopropiophenone; Norephedrone
Cathinone(2)
Fenethylline(3)
2-(Methylamino)-Propiophenone;
alpha-(Methylamino)-propiophenone;
Methcathinone(4)
2-(Methylamino)-1-Phenylpropan-1-one;
alpha-N-Methylaminopropiophenone;
monomethylpropion; ephedrone;
N-Methylcathinone; Methylcathinone
(±) cis-4,5-dihydro-4-methyl-5-phenyl-
2-oxazolamine
(±) cis-4-Methylaminorex(5)
N-ethylamphetamine(6)
N,N-alpha-trimethly-benzene-ethanamine;
N,N-alpha-trimethylphenethylamine
N,N-dimethylamphetamine(7)
BZP, 1-benzylpiperazineN-benzylpiperazine.(8)
Statutory Authority: MS s 151.02; 151.06; 151.07; 152.02
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4210MINNESOTA RULES75
History: 9 SR 1656; 11 SR 1113; 12 SR 2393; 18 SR 1145; 20 SR 2592; 27 SR 260; 34 SR
1205
Published Electronically: October 11, 2013
6800.4220 SCHEDULE II CONTROLLED SUBSTANCES.
The following items are listed in Schedule II:
A. Schedule II shall consist of the drugs and other substances, by whatever official name,
common or usual name, chemical name, or brand name designated, listed in this part.
B. Substances, vegetable origin, or chemical synthesis. Unless specifically excepted or
unless listed in another schedule, any of the following substances whether produced directly or
indirectly by extraction from substances of vegetable origin or independently by means of chemical
synthesis, or by a combination of extraction and chemical synthesis:
(1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or
opiate, excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, nalmefene,
naloxone, and naltrexone, and their respective salts, but including the following:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
(a) Raw opium
(b) Opium extracts
(c) Opium fluid
(d) Powdered opium
(e) Granulated opium
Laudanum(f) Tincture of opium
Methylmorphine(g) Codeine
(h) Dihydroetorphine
Dionin(i) Ethylmorphine
(j) Etorphine hydrochloride
Dihydrocodeinone(k) Hydrocodone
Dihydromorphinone, Dilaudid(l) Hydromorphone
(m) Metopon
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
76MINNESOTA RULES6800.4210
(n) Morphine
Dihydrohydroxycodeinone, Percodan,
Nucodan, OxyContin
(o) Oxycodone
Dihydrohydroxymorphinone, Numorphan(p) Oxymorphone
(q) Thebaine
(r) Oripavine.
(2) Any salt, compound, derivative, or preparation thereof which is chemically equivalent
or identical with any of the substances referred to in subitem (1), except that these substances shall
not include the isoquinoline alkaloids of opium.
(3) Opium poppy and poppy straw.
(4) Coca leaves and any salt, cocaine compound, derivative, or preparation of coca
leaves (including cocaine and ecgonine and their salts, isomers, derivatives, and salts of isomers
and derivatives), and any salt, compound, derivative, or preparation thereof which is chemically
equivalent or identical with any of these substances, except that the substances shall not include
decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or
ecgonine.
(5) Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid,
or powder form which contains the phenanthrene alkaloids of the opium poppy).
C. Opiates. Unless specifically excepted or unless listed in another schedule any of the
following opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers
whenever the existence of such isomers, esters, ethers, and salts is possible within the specific
chemical designation, dextrorphan and levopropoxyphene excepted:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
AlfentaAlfentanil(1)
NisentilAlphaprodine(2)
LeritineAnileridine(3)
Bezitramide(4)
Bulk Dextropropoxyphene
(nondosage forms)
(5)
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4220MINNESOTA RULES77
Carfentanil(6)
ParacodinDihydrocodeine(7)
DilaudidDihydromorphinone(8)
Diphenoxylate(9)
Sublimaze, InnovarFentanyl(10)
Isomethadone(11)
LAAMLevo-alpha-acetylmethadol(12)
Levomethorphan(13)
Levo-DromoranLevorphanol(14)
Metazocine(15)
Dolophine, Amidone, AdanonMethadone(16)
Methadone-Intermediate
4-cyano-2-dimethylamino-4, 4-diphenylbutane
(17)
Moramide-Intermediate
2-methyl-3-morpholino-1,
1-diphenyl-propane-carboxylic acid
(18)
Meperidine, DemerolPethidine (meperidine)(19)
Isonipecaine, Mepadin, MeperganPethidine-Intermediate-A,
4-cyano-1-methyl-4-phenylpiperidine
(20)
Pethidine-Intermediate-B,
ethyl-4-phenylpiperidine-4-carboxylate
(21)
Pethidine-Intermediate-C,
1-methyl-4-phenylpiperidine-4-
carboxylic acid
(22)
PrinadolPhenazocine(23)
AlvodinePiminodine(24)
Racemethorphan(25)
DromoranRacemorphan(26)
Remifentanil(27)
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
78MINNESOTA RULES6800.4220
SufentaSufentanil(28)
Tapentadol.(29)
D. Stimulants. Unless specifically excepted or unless listed in another schedule, any material,
compound, mixture, or preparation which contains any quantity of the following substances having
a stimulant effect on the central nervous system:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
Dexedrine, Dexamyl, Benzedrine,
Raphetamine, Biphetamine
Amphetamine, its salts, optical isomers, and
salts of its optical isomers
(1)
Desoxyn, Methedrine, Drinalfa,
Desoxyephedrine Hydrochloride, Syndrox,
Efroxine, Norodin, Obedrin, Ambar
Methamphetamine, its salts, isomers, and salts
of its isomers
(2)
PreludinPhenmetrazine and its salts(3)
RitalinMethylphenidate(4)
VyvanseLisdexamfetamine.(5)
E. Depressants. Unless specifically excepted or unless listed in another schedule, any
material, compound, mixture, or preparation which contains any quantity of the following substances
having a depressant effect on the central nervous system, including its salts, isomers, and salts of
isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the
specific chemical designation:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
AmytalAmobarbital(1)
DoridenGlutethimide(2)
Nembutal, TuinalPentobarbital(3)
Sernyl, SernylarPhencyclidine(4)
SeconalSecobarbital.(5)
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4220MINNESOTA RULES79
F. Immediate precursors. Unless specifically excepted or unless listed in another schedule,
any material, compound, mixture, or preparation which contains any quantity of the following
substances:
(1) Immediate precursor to amphetamine and methamphetamine:
Some trade or other namesStatutory Name
phenyl-2-propanone, P2P, benzyl methyl
ketone, methyl benzyl ketone
Phenylacetone
(2) Immediate precursor to phencyclidine (PCP):
(a) 1-phenylcyclohexylamine
(b) 1-piperidinocyclohexane carbonitrile (PCC).
G. Hallucinogenic substances. Nabilone [another name for Nabilone:
(±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1- hydroxy-6,6-dimethyl-9H-dibenzo
[b,d] pyran-9-one].
Statutory Authority: MS s 151.02; 151.06; 151.07; 152.02; 214.06
History: 9 SR 1656; 11 SR 1113; 12 SR 2393; 18 SR 1145; 20 SR 2592; 27 SR 260; 34 SR
1205
Published Electronically: October 11, 2013
6800.4230 SCHEDULE III CONTROLLED SUBSTANCES.
The following items are listed in Schedule III:
A. Schedule III shall consist of the drugs and other substances, by whatever official name,
common or usual name, chemical name, or brand name designated, listed in this part.
B. Stimulants. Unless specifically excepted or unless listed in another schedule, any material,
compound, mixture, or preparation which contains any quantity of the following substances having
a potential for abuse associated with a stimulant effect on the central nervous system, including its
salts, isomers (whether optical, positional, or geometric), and salts of such isomers whenever the
existence of such salts, isomers, and salts of isomers is possible within the specific chemical
designation:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
Amphetamine, Methamphetamine,
Methylphenidate and Phenmetrazine, when
(1)
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
80MINNESOTA RULES6800.4220
required by federal law to be labeled with
either of the following symbols: C-III or III
DidrexBenzphetamine(2)
Pre-SateChlorphentermine(3)
VoranilClortermine(4)
Plegine, Stim-35, Melfiant, BarcaratePhendimetrazine.(5)
C. Depressants. Unless specifically excepted or unless listed in another schedule, any
material, compound, mixture, or preparation which contains any quantity of the following substances
having a potential for abuse associated with a depressant effect on the central nervous system:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
Any compound, mixture, or preparation
containing:
(1)
(a) Amobarbital;
(b) Secobarbital;
(c) Pentobarbital, or any salt thereof and one
or more other active medicinal ingredients
which are not listed in any schedule
Any suppository dosage form containing:(2)
(a) Amobarbital;
(b) Secobarbital;
(c) Pentobarbital, or any salt of any of these
drugs and approved by the Food and Drug
Administration for marketing only as a
suppository
Butabarbital, Vinbarbital, Delvinal, Talbutal,
Lotusate, Pentothal, Brevital
Any substance which contains any quantity of
a derivative of barbituric acid, or any salt of a
(3)
derivative of barbituric acid, except those
substances which are specifically excepted or
listed in other schedules
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4230MINNESOTA RULES81
Chlorhexadol(4)
Any drug product containing gamma
hydroxybutyric acid, including its salts,
(5)
isomers, and salts of isomers, for which an
application is approved under section 505 of
the federal Food, Drug, and Cosmetic Act
Ketamine, its salts, isomers, salts of isomers(6)
Lysergic acid(7)
Lysergic acid amide(8)
NoludarMethyprylon(9)
Sulfondiethylmethane(10)
Sulfonethylmethane(11)
Sulfonmethane(12)
TelazolTiletamine and zolazepam and any salt thereof(13)
Embutramide.(14)
NallineD. Nalorphine
E. Narcotic Drugs. Unless specifically excepted or unless listed in another schedule, any
material, compound, mixture, or preparation containing any of the following narcotic drugs, or
their salts calculated as the free anhydrous base or alkaloid, in limited quantities as follows:
(1) Not more than 1.80 grams of codeine per 100 milliliters or not more than 90
milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium:
Copavin.
(2) Not more than 1.80 grams of codeine per 100 milliliters or not more than 90
milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic
amounts: Cheracol, Elixir, Terpin Hydrate and Codeine, Cosadein, Prunicodeine, Robitussin A.C.
(3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more
than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid
of opium.
(4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more
than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts: Ambenyl, Tussend, Hycomine, Tussionex.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
82MINNESOTA RULES6800.4230
(5) Not more than 1.80 grams of dihydrocodeine per 100 milliliters or not more than
90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts.
(6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than
15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized
therapeutic amounts: Cidicol.
(7) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not
more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in
recognized therapeutic amounts: Paregoric, Camphorated Opium Tincture.
(8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with
one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
F. Anabolic Steroids.
Clostebol, Chorionic gonadotropin,
Dehydrochlor-methyltestosterone,
Ethylestrenol, Fluoxymesterone, Human
growth hormones, Mesterolone,
Methandienone, Methandrostenolone,
Methenolone, Methyltestosterone,
Nandrolone, Nandrolone phenpropionate,
Norethandrolone, Oxandrolone,
Oxymesterone, Oxymetholone, Stanozolol,
Testosterone propionate, Testosterone-like
related compounds
G. Hallucinogenic substances. Dronabinol (synthetic) in sesame oil and encapsulated in a
soft gelatin capsule in a United States Food and Drug Administration approved product.
H. Any material, compound, mixture, or preparation containing any of the following narcotic
drugs or their salts: Buprenorphine.
Statutory Authority: MS s 151.02; 151.06; 152.02
History: 9 SR 1656; 18 SR 1145; 20 SR 2592; 27 SR 260; 31 SR 1673; 34 SR 1205
Published Electronically: October 11, 2013
6800.4240 SCHEDULE IV CONTROLLED SUBSTANCES.
The following items are listed in Schedule IV:
A. Schedule IV shall consist of the drugs and other substances, by whatever official name,
common or usual name, chemical name, or brand name designated, listed in this part.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4240MINNESOTA RULES83
B. Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any
material, compound, mixture, or preparation containing any of the following narcotic drugs, or
their salts calculated as the free anhydrous base or alkaloid, in limited quantities as follows:
(1) Not more than one milligram of difenoxin and not less than 25 micrograms of
atropine sulfate per dosage unit.
(2) Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-methyl-2-
propionoxybutane), for example, Darvon, Darvocet.
C. Depressants. Unless specifically excepted or unless listed in another schedule, any
material, compound, mixture, or preparation which contains any quantity of the following substances,
including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
XanaxAlprazolam(1)
BarbitoneBarbital(2)
Bromazepam(3)
Camazepam(4)
Beta-ChlorChloral betaine(5)
Noctec, SomnosChloral hydrate(6)
Librium, LibritabsChlordiazepoxide(7)
Clobazam(8)
ClonopinClonazepam(9)
TranxeneClorazepate(10)
Clotiazepam(11)
Cloxazolam(12)
Delorazepam(13)
ValiumDiazepam(14)
Dichloralphenazone(15)
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
84MINNESOTA RULES6800.4240
Estazolam(16)
PlacidylEthchlorvynol(17)
ValmidEthinamate(18)
Ethyl Loflazepate(19)
Fludiazepam(20)
DalmaneFlurazepam(21)
PaxipamHalazepam(22)
Haloxazolam(23)
Ketazolam(24)
Loprazolam(25)
AtivanLorazepam(26)
Lormetazepam(27)
Mebutamate(28)
Medazepam(29)
Equanil, Miltown, Equagesic, EqualysenMeprobamate(30)
BrevitalMethohexital(31)
Mebaral, MephobarbitalMethylphenobarbital(32)
Midazolam(33)
Nimetazepam(34)
Nitrazepam(35)
Nordiazepam(36)
SeraxOxazepam(37)
Oxazolam(38)
ParalParaldehyde(39)
PericlorPetrichloral(40)
Luminal, Phenobarbitone, EskabarbPhenobarbital(41)
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4240MINNESOTA RULES85
Pinazepam(42)
CentraxPrazepam(43)
Quazepam(44)
RestorilTemazepam(45)
Tetrazepam(46)
HalcionTriazolam(47)
Zaleplon(48)
Zolpidem(49)
Zopiclone.(50)
D. Fenfluramine. Any material, compound, mixture, or preparation which contains any
quantity of the following substances, including its salts, isomers (whether optical, positional, or
geometric), and salts of such isomers, whenever the existence of such salts, isomers, and salts of
isomers is possible:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
PondaminFenfluramine(1)
E. Stimulants. Unless specifically excepted or unless listed in another schedule, any material,
compound, mixture, or preparation which contains any quantity of the following substances having
a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
Cathine ((+)-Norpseudoephedrine)(1)
Tenuate, TepanilDiethylpropion(2)
Fencamfamine(3)
Fenproporex(4)
SanorexMazindol(5)
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
86MINNESOTA RULES6800.4240
Mefenorex(6)
Modafinil(7)
CylertPemoline (including organometallic complexes
and chelates thereof)
(8)
Wilpo, Fastin, IonaminPhentermine(9)
Pipradrol(10)
Sibutramine(11)
SPA ((-)-1-dimethylamino-1,
2-diphenylethane).
(12)
F. Other substances. Unless specifically excepted or unless listed in another schedule, any
material, compound, mixture, or preparation which contains any quantity of the following substances,
including its salts:
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Name
TalwinPentazocine(1)
Butorphanol (including its optical isomers).(2)
Statutory Authority: MS s 151.02; 151.06; 152.02
History: 9 SR 1656; 11 SR 1113; 18 SR 1145; 20 SR 2592; 27 SR 260; 34 SR 1205
Published Electronically: October 11, 2013
6800.4250 SCHEDULE V CONTROLLED SUBSTANCES.
The following items are listed in Schedule V:
A. Schedule V shall consist of the drugs and other substances, by whatever official name,
common or usual name, chemical name, or brand name designated, listed in this part.
B. Narcotic drugs containing nonnarcotic active medicinal ingredients. Any compound,
mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as
the free anhydrous base or alkaloid, in limited quantities as follows, which shall include one or
more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound,
mixture, or preparation valuable medicinal qualities other than those possessed by narcotic drugs
alone:
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4250MINNESOTA RULES87
Some examples of common names, trade
names, or names of products which contain
a controlled substance
Statutory Names
Not more than 100 milligrams of
dihydrocodeine per 100 milliliters or per 100
grams.
(1)
Not more than 100 milligrams of
ethylmorphine per 100 milliliters or per 100
grams.
(2)
LomotilNot more than 2.5 milligrams of diphenoxylate
and not less than 25 micrograms of atropine
sulfate per dosage unit.
(3)
Parapectolin, Donnagel P.G.Not more than 100 milligrams of opium per
100 milliliters or per 100 grams.
(4)
Not more than 0.5 milligrams of difenoxin and
not less than 25 micrograms of atropine sulfate
per dosage unit.
(5)
C. Stimulants. Unless specifically exempted or excluded or unless listed in another
schedule, any material, compound, mixture, or preparation that contains any quantity of the following
substance having a stimulant effect on the central nervous system, including its salts, isomers, and
salts of isomers: Pyrovalerone.
D. Depressants. Unless specifically exempted or excluded or unless listed in another
schedule, any material, compound, mixture, or preparation that contains any quantity of the following
substance having a depressant effect on the central nervous system, including its salts, isomers, and
salts of isomers:
Pregabalin(1)
Lacosamide ((R)-2-acetoamido-N-benzyl-3-methoxy-propionamide).(2)
Statutory Authority: MS s 151.06; 152.02
History: 9 SR 1656; 11 SR 1113; 18 SR 1145; 31 SR 1673; 34 SR 1205
Published Electronically: October 11, 2013
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
88MINNESOTA RULES6800.4250
6800.4300 DISPENSING SCHEDULE II CONTROLLED SUBSTANCES FOR PATIENTS
IN LONG-TERM CARE FACILITIES AND TERMINALLY ILL PATIENTS.
Subpart 1. Authorization. Prescription drug orders for Schedule II controlled substances
written for patients in long-term care facilities and terminally ill patients may be dispensed in partial
quantities, including individual dosage units.
Subp. 2. Records. For each partial dispensing, the dispensing pharmacist shall record on the
back of the prescription drug order, or on another appropriate record uniformly maintained and
readily retrievable, the date of the partial dispensing, the quantity dispensed, the remaining quantity
authorized to be dispensed, and the unique identifier of the dispensing pharmacist. The pharmacist
must record on the prescription drug order whether the patient is "terminally ill" or an "LTCF
patient."
Subp. 3. Quantity dispensed. The total quantity of schedule II controlled substances dispensed
in all partial dispensings must not exceed the total quantity prescribed.
Subp. 4. Validity of prescription. Schedule II prescription drug orders for patients in a
long-term care facility and terminally ill patients shall be valid for a period not to exceed 60 days
from the issue date unless terminated sooner by the discontinuance of medication.
Subp. 5. Computerization of information. Information pertaining to current Schedule II
prescription drug orders for patients in a long-term care facility and terminally ill patients may be
maintained in a computerized record keeping system if the system has the capability to permit:
A. output by display or printout of the original prescription number; date of issue;
identification of prescribing individual practitioner; identification of patient; identification of
long-term care facility; identification of medication authorized, including dosage form, strength,
and quantity; listing of partial dispensings that have been dispensed under each prescription drug
order; and the information required in subpart 2;
B. immediate or real time updating of the prescription drug order record each time a partial
dispensing of the prescription is conducted; and
C. retrieval of partially dispensed Schedule II prescription drug order information, the same
as required by federal law for Schedule III and IV prescription refill information.
Statutory Authority: MS s 151.06; 151.102; 152.02
History: 23 SR 1597; 36 SR 237
Published Electronically: September 21, 2011
6800.4400 REGISTRATION OF CONTROLLED SUBSTANCE RESEARCHERS.
Subpart 1. Application; fee; permit. A person who engages in research, teaching, or
educational projects involving the use, study, or testing of controlled substances shall annually, on
or before June 1 of each year, apply for registration by the board. On the filing of an application,
including documentation of an approved protocol, payment of a fee of $25, and authentication of
the application by the board, the board shall issue a permit.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.4400MINNESOTA RULES89
Subp. 2. [Repealed, 18 SR 1145]
Subp. 3. Registrant requirements. Each registrant must have policies and procedures that
address effective controls to protect against theft and diversion of all stocked controlled substances,
restricting access, drug wastage, and returns. Adequate records must be maintained to show purchase,
receipt, use, transfer, and disposal of controlled substances. An inventory must be done annually
to document control of each stocked controlled substance.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 31 SR 1673
Published Electronically: September 21, 2011
6800.4500 [Repealed, 31 SR 1673]
Published Electronically: September 21, 2011
6800.4600 PERPETUAL INVENTORY.
Each pharmacy located in this state shall maintain a perpetual inventory system for Schedule
II controlled substances. The system shall be established in a manner that will provide total
accountability in all aspects of Schedule II drug distribution. The inventory shall be reconciled with
the actual inventory monthly and the reconciliations shall be documented. Reconciliation
documentation shall be retained for at least two years.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.4700 CONTROLLED SUBSTANCE VERIFICATION.
Each hospital pharmacy shall develop and implement a written quality assurance plan that
provides for pharmacist verification of drug distribution records relating to the distribution of
controlled substance drugs from the pharmacy to the nursing stations or other drug storage locations
within the hospital.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.4800 REPORTING CONTROLLED SUBSTANCE LOSSES.
Any pharmacy, drug wholesaler, drug manufacturer, or controlled substance researcher detecting
the theft or significant loss of any controlled substance drug, where the loss is attributable to other
than inadvertent error, must report the loss, in writing, to the board and to the Drug Enforcement
Administration immediately. The report must include a description of how the loss occurred, if
known, the date the loss occurred, if known, the steps being taken to prevent future losses, and an
inventory of the missing drugs.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
90MINNESOTA RULES6800.4400
Statutory Authority: MS s 151.06; 151.102
History: 23 SR 1597
Published Electronically: September 21, 2011
INTERNSHIP
6800.5100 DEFINITIONS.
Subpart 1. [Repealed, 36 SR 237]
Subp. 2. Experiential education program. "Experiential education program" means the
pharmacy practice experience component of the professional pharmacy curriculum of an accredited
college or school of pharmacy.
Subp. 3. Concurrent time internship. "Concurrent time internship " means internship
experience gained during the second, third, and fourth professional academic years only, while a
person is a full-time student carrying, in any given school term, 12 or more credits.
Subp. 4. Hour. "Hour" means the standard 60-minute division of time.
Subp. 5. Pharmacist-intern; intern. "Pharmacist-intern" and "intern" mean:
A. a natural person satisfactorily progressing toward the degree in pharmacy required for
licensure;
B. a graduate of the University of Minnesota College of Pharmacy, or other pharmacy
college approved by the board, who is registered by the Board of Pharmacy for the purpose of
obtaining practical experience as a requirement for licensure as a pharmacist;
C. a qualified applicant awaiting examination for licensure; or
D. a participant in a residency or fellowship program, not licensed to practice pharmacy in
the state of Minnesota, who is a licensed pharmacist in another state or who is a graduate of the
University of Minnesota College of Pharmacy or another pharmacy college approved by the board.
Subp. 6. Preceptor. "Preceptor" means a natural person licensed as a pharmacist by the Board
of Pharmacy, or a licensed pharmacist working in a federal health care facility, who participates in
instructional programs approved by the board and is providing instruction and direction to
pharmacist-interns related to their practical experience.
Subp. 7. [Repealed, 36 SR 237]
Subp. 8. [Repealed, 36 SR 237]
Subp. 9. [Repealed, 36 SR 237]
Subp. 10. [Repealed, 36 SR 237]
Statutory Authority: MS s 151.06; 151.101; 152.02
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.5100MINNESOTA RULES91
History: 17 SR 1279; 18 SR 1145; 27 SR 260; 36 SR 237
Published Electronically: September 21, 2011
6800.5200 INTERNSHIP.
The purpose of parts 6800.5100 to 6800.5600 is to define and regulate the internship experience
of prospective pharmacists as required by Minnesota Statutes, sections 151.10 and 151.101. These
parts take effect immediately but do not nullify any period of internship service by any individual
previous to their adoption if the period of internship is filed in a proper manner with the director
of the Board of Pharmacy.
Statutory Authority: MS s 151.06; 151.101
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.5300 REGISTRATION AND REPORTING.
Subpart 1. Registration. Every person shall register with the board before beginning a pharmacy
internship in Minnesota. Every person participating in a pharmacy residency or fellowship shall
either register as an intern or be licensed as a pharmacist. Applications for the registration of a
pharmacist-intern shall be on a form or forms the Board of Pharmacy prescribes and shall be
accompanied by a fee established in Minnesota Statutes, chapter 151. Registration remains in effect
if notices of employment, progress report affidavits, or similar forms are submitted as required by
the board, and if the board is satisfied that the registrant is in good faith and with reasonable diligence
pursuing a degree in pharmacy, is a qualified applicant awaiting an examination for licensure, or
is completing a pharmacy residency or fellowship. Registration as an intern for purposes of
participating in a residency or fellowship program remains in effect until the individual obtains
licensure as a pharmacist, for two years, or until the completion of the residency or fellowship
program, whichever occurs first. Credit for internship hours will not be granted unless registration
forms and materials, notices of employment, and progress report affidavits are submitted as required
by the board.
Subp. 2. Identification. The pharmacist-intern shall be so designated in professional
relationships, and shall in no manner falsely assume, directly or by inference, to be a pharmacist.
The board shall on proper registration issue to the intern a pocket registration card for purposes of
identification and verification of the intern's registration.
Subp. 3. Change of address. All registered interns shall notify the board immediately upon
change of employment or residence address.
Subp. 4. [Repealed, 36 SR 237]
Subp. 5. Manual. Interns completing 400 hours or more of their internship requirement in
Minnesota must complete an internship manual, provided by the board, before the board will
recognize the completed hours as acceptable for use in meeting the board's internship requirement.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
92MINNESOTA RULES6800.5100
Subp. 6. Termination. No person who terminates efforts toward the completion of the
educational or other prerequisites of licensure, or of completion of a residency or fellowship, is
entitled to the continued privileges of internship registration.
Subp. 7. Improper use of title. No person not properly registered with the board as a
pharmacist-intern shall take, use, or exhibit the title of pharmacist-intern, pharmacist-apprentice,
pharmacist-extern, or any other term of similar or like import.
Statutory Authority: MS s 151.06; 151.101; 151.102; 152.02
History: 17 SR 1279; 18 SR 1145; 23 SR 1597; 27 SR 260; 36 SR 237
Published Electronically: September 21, 2011
6800.5350 PRECEPTORS.
Subpart 1. Certificates. Pharmacists intending to act as preceptors for pharmacist-interns must
register as preceptors with the board by submitting an application and any supporting documentation
required by the board. A preceptor registration shall expire every other year on the anniversary of
its issuance. The board shall grant registrations or renewals to applicants who fulfill the requirements
of subparts 2 and 3.
Subp. 2. Training and practice. Applicants must show that:
A. they are participating in the Experiential Education Program of the University of
Minnesota College of Pharmacy as an approved preceptor; or
B. they have completed at least 4,000 hours of practice as a licensed pharmacist, with at
least 2,000 hours of that practice occurring within the state of Minnesota.
Subp. 3. Other requirements. In addition to fulfilling the requirements of subpart 2, item A
or B, applicants must show that:
A. they are currently in practice at least 20 hours per week as a pharmacist;
B. they have a history of exemplary practice with respect to compliance with state and
federal laws;
C. they will provide time on a regular basis, at least three times each month, for the purpose
of helping their interns meet the competencies of the internship requirement; and
D. for renewal of a registration only, that they have participated in an instructional program
specifically for preceptors, provided by or approved by the board, within the previous 24 months.
Statutory Authority: MS s 151.06; 151.102
History: 18 SR 1145; 23 SR 1597; 36 SR 237
Published Electronically: September 21, 2011
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.5350MINNESOTA RULES93
6800.5400 TRAINING.
Subpart 1. Intent. The intent of this rule is to establish minimum standards for the training of
interns so that they are provided with a proper preceptor-intern relationship and a broad base of
practical experience that supplements didactic academic training in a manner which prepares them
for all aspects of the practice of pharmacy.
Subp. 2. Nonreciprocity. Nothing in this rule shall imply that the standards described herein
are acceptable to other states on a reciprocal basis.
Subp. 3. Training in other state. When an intern desires to obtain credit for training received
in a state other than Minnesota, the intern shall abide by the internship rules in that state, and shall
provide evidence from that state's Board of Pharmacy confirming completion of the number of
internship hours for which credit is being requested. The board may deny requests for approval of
credit for training received in a state other than Minnesota if the training does not meet the standards
for internship described in this subpart.
Subp. 4. Maximum number of interns. A licensed pharmacist shall not be the preceptor for
more than two interns at one time.
Subp. 4a. Supervision: intern dispensing and compounding. An intern performing tasks
associated with dispensing or compounding shall be immediately and directly supervised by a
licensed pharmacist stationed within the same work area who has the ability to control and is
responsible for the actions of the intern. Except in the case of internship experience conducted as
part of the experiential education program of an accredited college or school of pharmacy, a licensed
pharmacist may not supervise more than one intern who is performing tasks associated with
dispensing or compounding. In the case of an internship experience conducted as part of the
experiential education program of an accredited college or school of pharmacy, a licensed pharmacist
may supervise two interns who are performing tasks associated with dispensing or compounding.
The ultimate responsibility for the actions of an intern performing tasks associated with dispensing
or compounding shall remain with the licensed pharmacist who is supervising the intern.
Subp. 4b. Supervision, generally. Immediate and direct supervision by a licensed pharmacist
is not required when an intern completes a medication history, gathers information for the purpose
of formulating a pharmaceutical care plan or making a drug therapy recommendation, conducts
educational activities for patients or staff, provides patient counseling, participates in patient rounds,
or performs similar tasks that do not involve dispensing and compounding. However, all drug
therapy and related recommendations that an intern proposes to make to other health professionals
and patients must be reviewed and approved by a licensed pharmacist before they are made. An
intern's supervising pharmacist is responsible for the accuracy and completeness of statements made
by the intern while providing counseling to patients or health-related education to patients or staff.
Subp. 5. Competencies. Upon registration, interns and preceptors will be furnished a copy of
the board's internship manual, which lists the minimum competencies that should be the focus of
internship training. The competencies are furnished to suggest appropriate types and order of training
experience and shall be used to ensure that the intern's practical experiences are commensurate
with the intern's educational level, and broad in scope.
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94MINNESOTA RULES6800.5400
Subp. 6. Evidence of completion. Applicants for licensure as pharmacists who are examined
and licensed after September 17, 1973, shall submit evidence that they have successfully completed
not less than 1,500 hours of internship under the instruction and supervision of a preceptor. Effective
May 1, 2003, candidates for licensure shall submit evidence that they have successfully completed
not less than 1,600 hours of internship under the direction and supervision of a preceptor. Credit
for internship shall be granted only to registered interns who have completed the third year of the
five-year or six-year pharmacy curriculum, provided, however, that:
A. no more than 400 hours of concurrent time internship will be granted to an intern; and
B. 800 hours of internship credit may be acquired through experiential education program
experiences that do not have as their focus traditional compounding, dispensing, and related patient
counseling activities. The remaining 800 hours of the 1,600 hour total requirement must focus on
traditional compounding, dispensing, and related patient counseling activities.
Statutory Authority: MS s 151.06; 151.101; 151.102; 152.02
History: 17 SR 1279; 18 SR 1145; 23 SR 1597; 27 SR 260; 36 SR 237
Published Electronically: October 11, 2013
6800.5500 LICENSURE TRANSFER STANDARDS.
The board may accept internship credit from applicants for licensure transfer who have submitted
evidence of completion of internship training in another state, provided that the training is, in the
opinion of the board, substantially equivalent to the standards herein provided, and is in compliance
with the internship standards of the National Association of Boards of Pharmacy.
Statutory Authority: MS s 151.06; 151.101
History: 9 SR 1656; 36 SR 237
Published Electronically: September 21, 2011
6800.5600 ADVISORY COMMITTEE.
The board shall appoint an advisory committee on internship to advise the board on the
administration of parts 6800.5100 to 6800.5600. The committee shall include practicing pharmacists,
pharmacist-educators, pharmacist-interns, and representatives of the board.
Statutory Authority: MS s 151.06; 151.101
History: 18 SR 1145
Published Electronically: September 21, 2011
OPERATIONS IN LONG-TERM CARE FACILITIES
6800.6100 SCOPE.
The provisions of parts 6800.6100 to 6800.6700 are applicable to pharmaceutical services
provided to patients in long-term care facilities, provided, however, that parts 6800.0100 to
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.6100MINNESOTA RULES95
6800.5600 shall also be applicable to such pharmaceutical services, unless specifically exempted
by parts 6800.6100 to 6800.6700 or are in direct conflict therewith, in which case parts 6800.6100
to 6800.6700 shall apply.
Statutory Authority: MS s 151.06
Published Electronically: September 21, 2011
6800.6200 PRESCRIPTION ORDER COMMUNICATION.
Subpart 1. Verbal or telephone orders. Notwithstanding any other provisions of parts
6800.0100 to 6800.9700, a licensed pharmacist, registered nurse, or licensed practical nurse who
is employed by a licensed facility and who is authorized by the facility's administrator and is acting
on the behalf of the prescriber, may communicate to the pharmacy provider a prescription drug
order lawfully ordered by a practitioner authorized to prescribe drugs or devices pursuant to
Minnesota Statutes, section 151.37. Whenever possible, these prescription drug orders shall be
transmitted via facsimile or secure electronic format, to the pharmacy in an order format which
produces a direct copy of the chart order, which the prescriber will sign at a later date. The pharmacy
provider shall record on the prescription drug order the name of the person who transmits the order
in addition to the other required information. This subpart does not apply to prescription drug orders
for Schedule II controlled substances as defined by part 6800.4220.
Subp. 2. Written orders. A copy of a written prescription drug order, signed by the prescriber,
may be delivered to the pharmacy by an individual authorized by the facility.
Subp. 3. Schedule II orders. Except as provided in part 6800.3000, subparts 2 and 3, Schedule
II controlled substances shall be dispensed only upon receipt of an original written prescription
drug order manually signed by the prescribing individual practitioner or upon an oral order reduced
to writing given in emergency situations as allowed by these criteria:
A. immediate administration of the controlled substance is necessary for the proper treatment
of the intended ultimate user;
B. no appropriate alternative treatment is available, including administration of a drug
which is not a controlled substance under schedule II of Minnesota Statutes, chapter 152 and parts
6800.4200 to 6800.4250; and
C. it is not reasonably possible for the prescribing practitioner to provide a written
prescription drug order to be presented to the person dispensing the controlled substance, prior to
dispensing.
Statutory Authority: MS s 151.06; 151.102; 152.02
History: 18 SR 1145; 23 SR 1597; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
96MINNESOTA RULES6800.6100
6800.6300 PRESCRIPTION LABELING.
Subpart 1. Minimum information. All prescription containers, other than those dispensed
pursuant to part 6800.3750, shall be properly labeled in accordance with part 6800.3400 and shall
also contain at least the following additional information: quantity of drug dispensed; date of original
issue, or in the case of a refill, the most recent date; and expiration date of all time dated drugs.
Subp. 2. Directions for use. Directions for use on labels of medications shall be changed only
by a pharmacist acting on the instructions of the prescriber or the prescriber's agent. Personnel of
the facility may affix supplemental labels alerting staff to a change in the directions for use when
a corresponding change is made on the appropriate medication administration record, in accordance
with procedures approved by the facility's quality assurance and assessment committee. Subsequent
refills of the medication shall be appropriately labeled with the directions for use in effect at the
time of dispensing.
Statutory Authority: MS s 151.06
History: 9 SR 1656; 17 SR 1279; 18 SR 1145
Published Electronically: September 21, 2011
6800.6400 [Repealed, 23 SR 1597]
Published Electronically: September 21, 2011
6800.6500 CONSULTING SERVICES TO LICENSED NURSING HOMES.
Subpart 1. Written agreement. A pharmacist providing pharmacy consultative services to a
licensed nursing home shall devote a sufficient number of hours during regularly scheduled visits
to the facility for the purpose of reviewing the quality of the pharmaceutical services provided to
the facility residents. There shall be a written agreement, separate and apart from that provided to
pharmacists supplying prescription drug services to residents, for the pharmaceutical consultative
services between the facility and the consulting services provider which shall be available for review
by the board.
Subp. 2. Responsibilities. The pharmacist shall be responsible for, but not limited to, the
following:
A. preparation and revision of policies and procedures governing the pharmaceutical
services;
B. development, coordination, and direction or supervision of all pharmaceutical services
provided in the facility;
C. review of the drug regimen of each resident and preparation of appropriate reports and
recommendations including at least a review of all drugs currently ordered; information concerning
the patient's condition as it relates to drug therapy; and medication administration records, physician
progress notes, nurses' notes, and laboratory test results;
D. reporting, in writing, irregularities in the storage, dispensing, and administration of drugs
and other matters relating to the review of the drug regimen, to the administrator, and other
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.6500MINNESOTA RULES97
appropriate health professionals as may be determined by the administrator and consultant
pharmacist;
E. preparing, at least quarterly, a written report on the status of the pharmaceutical service
and staff performance and submitting this report to the administrator and the quality assurance and
assessment committee;
F. developing policies for destroying, in the prescribed manner, any unused portion of
prescription drugs remaining in the facility after the death or discharge of the patient or resident
for whom they were prescribed or any prescriptions permanently discontinued;
G. providing in-service training to nursing personnel;
H. developing policies for the issuance of medications to residents who are going on leave
from the facility. These policies may allow the preparation, by the facility's licensed or registered
nurses responsible for overseeing medication administration, of up to a 72-hour supply of medications
in paper envelopes or other more suitable containers for use by a resident temporarily leaving the
facility at times when the resident's pharmacy is closed or cannot supply the needed medication in
a timely manner. A container may hold only one medication. A label on the container shall include
the date, the resident's name, the facility, the name of the medication, its strength, dose, and time
of administration, and the initials of the person preparing the medication and label; and
I. preparation of policies and procedures for the disposition of medications. The policies
and procedures must conform with the requirements of parts 4658.1350 and 6800.2350.
Subp. 3. [Repealed, 36 SR 237]
Statutory Authority: MS s 151.06
History: 18 SR 1145; 36 SR 237
Published Electronically: September 21, 2011
6800.6600 FREEDOM OF CHOICE.
No pharmacist shall participate in any agreement or plan which infringes on any patient's right
to freedom of choice as to the provider of prescription services.
Statutory Authority: MS s 151.06
Published Electronically: September 21, 2011
6800.6700 DRUGS FOR USE IN EMERGENCY KITS.
Subpart 1. Authorization upon request. A pharmacy may provide, upon a written or oral
request from the quality assurance and assessment committee, limited supplies of drugs for use in
an emergency kit. The drugs remain the property of the pharmacy.
Subp. 2. Emergency drug supplies. Only emergency drug supplies determined by the quality
assurance and assessment committee necessary for patient care in life threatening emergencies may
be made available. The drugs in the emergency kit are the responsibility of the pharmacist and,
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98MINNESOTA RULES6800.6500
therefore, shall not be used or altered in any way except as outlined in this subpart. The emergency
drug supplies shall comply with the following in items A to F.
A. The drugs shall be limited to the extent possible to a 72-hour supply of any one emergency
drug in either sealed ampules, vials, or prefilled syringes. If an emergency drug is not available in
parenteral form, a supply in an alternate dosage form may be provided. Notwithstanding these
restrictions, if the quality assurance and assessment committee considers it necessary, up to a
72-hour supply of each of a maximum of 15 different oral pharmaceuticals, not counting oral
antibiotics, restricted to therapeutic categories related to symptomatic patient distress or emergencies
may be stocked. An unlimited number of oral antibiotics may be stocked in 72-hour supplies of
each. Inclusion of other oral legend drugs is permissible only through the granting of a variance by
the board. Drugs in the supply shall be properly labeled, including beyond-use dates and lot numbers.
B. The emergency drug supply shall be stored in a container which is sealed by the
pharmacist or the pharmacist's agent with a tamperproof seal that must be broken to gain access to
the drugs, and shall be placed in a locked area.
C. The pharmacist shall be notified by the health care facility when drugs from the
emergency kit have been used or when the seal has been broken.
D. Drugs used from the kit shall be replaced by submitting a prescription drug order for
the used item to the pharmacist within 72 hours and the supply shall be resealed by the pharmacist
or the pharmacist's agent.
E. The pharmacist shall see that the contents of the kit are accurately listed on the container
and accounted for.
F. The supply shall be checked and inventoried monthly by the pharmacist who is responsible
for control of the kit.
Subp. 3. Controlled substances. Emergency kits may contain limited supplies of controlled
substances only if:
A. the controlled substances are supplied by a licensed pharmacy duly registered with the
Federal Drug Enforcement Administration;
B. the emergency kit is kept in a locked medicine room or medicine cabinet;
C. access to the emergency kit is limited to the following individuals:
(1) a licensed professional nurse who is employed by the facility and who has been
directed by a physician to administer a drug from the kit;
(2) a consultant pharmacist or other licensed pharmacist designated by the facility's
pharmaceutical services committee; or
(3) a licensed medical practitioner;
D. the emergency kit does not contain more than six single doses of any controlled substance
narcotic analgesic;
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6800.6700MINNESOTA RULES99
E. the dispensing pharmacy keeps a complete record of each controlled substance stored
in the emergency kit, including the name of the drug, the strength of the drug, and the number of
doses provided;
F. the facility keeps a complete record of the use of controlled substances from the kit for
two years, including the patient's name, the date of use, the name of the drug used, the strength of
the drug, the number of doses used, and the signature of the person administering the dose; and
G. the controlled substances stored in the emergency kit are used only in a situation deemed
an emergency by a licensed practitioner in conformity with the following provisions:
(1) immediate administration of the controlled substance is necessary for the proper
treatment of the intended ultimate user;
(2) no appropriate alternative treatment is available, including administration of a drug
which is not a controlled substance; and
(3) it is not reasonably possible for the prescribing practitioner to provide prior to
administration a written prescription drug order to be presented to a pharmacist for dispensing of
the controlled substance.
Subp. 4. Excluded controlled substances. Controlled substance stimulants in oral dosage
forms may not be included in emergency kits.
Subp. 5. Penalty. If any of the provisions of this part are violated, the board may suspend or
revoke a pharmacy's privilege to maintain an emergency kit of drug supplies at the noncompliant
facility.
Statutory Authority: MS s 151.06; 151.102
History: 18 SR 1145; 23 SR 1597; 36 SR 237
Published Electronically: October 11, 2013
6800.6800 STAFF PROTECTION FROM HIV TRANSMISSION.
A pharmacy may provide to a nursing home a separate supply of medications containing the
prophylaxis regimen currently recommended by the Centers for Disease Control for the prevention
of HIV due to accidental contact with contaminated body fluids by health care workers.
Statutory Authority: MS s 151.06; 151.102
History: 23 SR 1597
Published Electronically: September 21, 2011
OPERATIONS IN HOSPITALS
6800.7100 DEFINITIONS.
Subpart 1. Credentialed. "Credentialed" means registered with, certified by, or similarly
recognized by a health-related agency or department of the state of Minnesota.
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100MINNESOTA RULES6800.6700
Subp. 2. Drug administration. "Drug administration" means to deliver by or pursuant to the
lawful order of a licensed practitioner a single dose of a drug to a patient by injection, inhalation,
ingestion, or by any other immediate means and shall include:
A. preparing the individual dose from a previously dispensed, properly labeled container;
B. verifying the dose as prescribed;
C. giving the individual dose by the proper route to the correct patient at the proper time;
D. assuring that the dose is taken; and
E. promptly recording the time and dose given.
Subp. 3. Drug dispensing. "Drug dispensing" means to deliver one or more doses of a drug
for subsequent administration to, or use by a patient or human research subject. Such drug dispensing
shall be performed by the pharmacist in compliance with part 6800.3100 or 6800.3750, subparts 2
to 10, with delivery being made in a suitable container properly labeled.
Subp. 4. Pharmaceutical service. "Pharmaceutical service" means the control of the utilization
of drugs, biologicals, and chemicals including procuring, manufacturing, compounding, dispensing,
distribution, and storing of drugs, biologicals, and chemicals under the conditions prescribed by
this part. The provision of drug information and related pharmaceutical care services to patients
and to other health professionals is included within the meaning of pharmaceutical services.
Subp. 5. Supervision. "Supervision," as used in connection with parts 6800.7100 to 6800.7950,
means stationed within the same work area, coupled with the ability to control and responsibility
for an action.
Statutory Authority: MS s 151.06
History: 9 SR 1656; 18 SR 1145
Published Electronically: September 21, 2011
6800.7200 SCOPE.
The provisions of parts 6800.7100 to 6800.7950 are applicable to pharmaceutical services
provided to patients in hospitals, including state hospitals, provided, however, that parts 6800.0100
to 6800.5600 and 6800.8100 to 6800.9700 shall also be applicable to such pharmaceutical services,
unless specifically exempted by parts 6800.7100 to 6800.8100 or unless in direct conflict therewith,
in which case parts 6800.7100 to 6800.8100 shall apply.
Statutory Authority: MS s 151.06
Published Electronically: September 21, 2011
6800.7300 PHARMACISTS AND SUPPORT PERSONNEL.
Pharmaceutical services in hospitals shall be organized and directed by a pharmacist.
Pharmaceutical services shall be provided only by pharmacists and other personnel under a
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.7300MINNESOTA RULES101
pharmacist's supervision. The use of supportive personnel shall be in accordance with the provisions
of part 6800.3850.
Statutory Authority: MS s 151.06
History: 9 SR 1656
Published Electronically: September 21, 2011
6800.7400 HOSPITAL PHARMACIST-IN-CHARGE.
Subpart 1. Qualifications. The pharmacist-in-charge, regardless of title or designation, shall
be a pharmacist licensed in this state.
Subp. 2. On-site pharmacies. A pharmacist providing pharmaceutical services to a hospital
maintaining an on-site pharmacy shall be engaged by the hospital and shall provide at least part-time,
five-day-per-week services.
Subp. 3. Drug room. A pharmacist providing pharmaceutical services from off-site to a hospital
maintaining a drug room shall schedule on-premises visits on at least a weekly basis.
Subp. 4. Responsibilities. The responsibilities and duties of the hospital pharmacist-in-charge
include at least the following specific duties in addition to the duties of the pharmacist-in-charge
found in part 6800.2400:
A. the procurement, identification, security, storage, and distribution of all drugs, as well
as the disposition of drugs whose effectiveness has expired or which, for other reasons, are deemed
no longer usable;
B. the development, implementation, coordination, supervision, and review of
pharmaceutical services in the hospital and policies related thereto;
C. the supervision of the preparation and sterilization of parenteral drugs in the hospital;
D. the supervision of bulk compounding of pharmaceuticals;
E. the establishment of specifications for procurement of drugs and chemicals for direct
patient use;
F. the development of a hospital formulary system;
G. the dispensing of drugs and chemicals for direct patient use;
H. the maintaining of a stock of antidotes and emergency drugs in the hospital;
I. the maintaining of pharmaceutical service records; and
J. cooperating in the teaching and research programs of the hospital.
Subp. 5. Span of control. The pharmacist's span of supervision shall extend to all areas of the
hospital where drugs are stored. No less than every month inspections of these areas shall be
conducted and substantiated by records so as to verify at least proper drug storage, documentation
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102MINNESOTA RULES6800.7300
of distribution and administration of controlled substances, absence of outdated drugs, and the
integrity of the required emergency drug supply.
Subp. 6. [Repealed, 18 SR 1145]
Statutory Authority: MS s 151.06; 152.02
History: 17 SR 1279; 18 SR 1145; 31 SR 1673
Published Electronically: September 21, 2011
HOSPITAL SERVICE POLICIES
6800.7510 PATIENT CARE.
Pharmaceutical service policies shall cover at least the following:
A. the providing of drug information to patients and health professionals;
B. the limiting of drug administration;
C. an ongoing proactive program to identify risks to patient safety and reducing errors;
D. the immediate reporting of adverse drug reactions;
E. the self-administration of drugs by patients;
F. the use of drugs brought into the hospital by or with the patient. If the drugs are not to
be used while the patient is hospitalized, they shall be packaged, sealed, stored, and returned to the
patient at the time of discharge;
G. the use of investigational drugs;
H. the preparation, use, and disposal of chemotherapy drugs;
I. the preparation of compounded sterile products; and
J. the preparation of compounded nonsterile products.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 31 SR 1673
Published Electronically: September 21, 2011
6800.7520 PHARMACEUTICAL SERVICE POLICIES.
Subpart 1. Dispensing drugs. Pharmaceutical service policies shall cover at least the following
measures related to the control, accessibility, dispensing, and administration of drugs:
A. developing, implementing, and maintaining a system assuring the availability of
prescribed drugs at all times;
B. dispensing of legend drugs;
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6800.7520MINNESOTA RULES103
C. changing of labels or the transfer of drugs from one container to another;
D. maintaining security and emergency access in accordance with part 6800.7530;
E. supplying of prepackaged legend drugs which are accessible for use without entering
either the pharmacy or drug room maintained for use when a pharmacist is not available. Such
supply may be located in nursing units, with access limited to designated registered nurses. No
hospital pharmacy shall utilize a floor stock drug distribution system of this or any other type as
its primary system of drug delivery;
F. maintaining a supply of drugs for use in medical emergencies;
G. specifying the maintenance of permissible supplies of nonprescription drugs in nursing
service units;
H. assuring that unused patient drugs, discontinued and outdated drugs, and containers with
worn, illegible, or missing labels be returned to a pharmacist for disposition;
I. maintaining a drug recall procedure which can be implemented no more than 24 hours
after recall notification by the manufacturer;
J. permitting the dispensing of drugs only pursuant to orders initiated by a licensed
practitioner;
K. assuring that orders for drugs are transmitted to the pharmacy by the prescriber or by
an order format which produces a direct copy of the order as it is documented in the patient chart;
L. providing for a system of accountability for inpatient dispensing meeting the intent of
the certification requirement of part 6800.3100;
M. establish a pharmacist monitoring system that reconciles a nurse prepared medication
administration record (MAR) to the pharmacy profile;
N. requiring authorization for a standing order to be noted on the patient's medical record.
Standing orders shall specify the circumstances under which the drug is to be administered, the
drug, dosage, route, frequency of administration, and duration;
O. assuring that when drug therapy is not renewed on an established regular basis the
therapy is limited either by the prescriber's specific indication or by automatic stop orders;
P. assuring that precautionary measures, including quality control documentation, for the
safe admixture of parenteral products are developed in writing. Admixture preparation shall be
limited to pharmacists, pharmacist-interns, supportive personnel under the supervision of a
pharmacist, licensed practitioners, and licensed nurses. Furthermore, sterile admixtures shall be
labeled as required in part 6800.7900 and must be prepared as required in part 6800.3300, subpart
2;
Q. assuring that investigational drug use is in accordance with state and federal law: basic
information concerning the dosage form, route of administration, strength, actions, uses, side effects,
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104MINNESOTA RULES6800.7520
adverse effects, interactions, and symptoms of toxicity of such drugs shall be available in the
pharmacy (investigational drugs shall be distributed only from the pharmacy);
R. assuring that the practice of drug reconstitution is performed only by pharmacists,
licensed practitioners, licensed nurses, or hospital-authorized personnel under the supervision of
licensed pharmacists, licensed practitioners, or licensed nurses;
S. developing, implementing, and maintaining a system of controlled substance and narcotic
control in accordance with subitems (1) to (7);
(1) controlled substances must be accounted for by either:
(a) a "proof-of-use" sign-out sheet where each dose given is accounted for by the
licensed health care professional who procures the drug. No controlled substance may be kept on
floor stock unless it is accompanied by the sign-out sheet and each dose is documented by the
licensed health care professional at the time the drug is procured from the stock. The proof-of-use
sheets must include at least the date and time, the patient's name, the dose administered, and the
licensed health care professional's signature;
(b) the dispensing of the drug to a specific patient after the pharmacy receives an
individual drug order; or
(c) a computer system which utilizes electronic distribution records of controlled
substance transactions as long as the system complies with the following requirements:
i. allows for retrieval of all information required by this regulation for all
distribution and dispensing transactions for two years;
ii. provides for at least weekly transaction printouts, except that this requirement
does not have to be met if a secure daily 24-hour backup is performed which allows for restoration
of required information in case of a system failure;
iii. maintains a complete online transaction file that is printable on request, or
have a "lock-out" feature that prevents editing of distribution or dispensing information; and
iv. allows for the printing of a report of all distribution and dispensing
transactions for a minimum of two years. The system must be capable of retrieving and printing a
report listing variables which include, but are not limited to: the identity of a user accessing the
system; the date and time controlled substances are distributed to or removed from the automated
distribution machine; the quantity of a controlled substance distributed to or removed from the
automated distribution machine; drug name, strength, and dosage form; patient name; and practitioner
name;
(2) wasting of doses must be carried out by two licensed individuals who are authorized
to have access to controlled substances. The wasting of doses must be documented, with the accuracy
of the documentation being certified by the licensed individuals who carried out the wasting.
Certification must include the signature or other unique identifier of the licensed individuals who
carried out the wasting;
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6800.7520MINNESOTA RULES105
(3) there must be a system for reconciling the proof-of-use sheets in the pharmacy to
assure accountability of all sheets sent to the various nursing stations;
(4) controlled substances must be stored under lock on the nursing stations or other
patient care area;
(5) access to the main supply of Schedule II controlled substances in the pharmacy
must be restricted to a limited number of persons in the pharmacy. The main supply of Schedule
II controlled substances in the pharmacy must be kept locked when not being used;
(6) single unit-of-use dosage forms should be used when possible; and
(7) a perpetual inventory of Class II controlled substances must be accurately maintained;
and
T. developing policies for the issuance of medications to patients who are going on leave
from the facility. These policies may allow the preparation, by the facility's registered nurses
responsible for overseeing medication administration, of a supply of medications, not to exceed a
72-hour supply, in paper envelopes or other more suitable containers for use by a patient temporarily
leaving the facility at times when the facility's pharmacy is closed or cannot supply the needed
medication in a timely manner. A container may hold only one medication. A label on the container
shall include the date, the patient's name, the facility, the name of the medication, its strength, dose,
and time of administration, and the initials of the person preparing the medication and label.
Subp. 2. Maintenance of documents. Pharmaceutical service policies shall cover at least the
following measures related to the maintenance of documents.
A. The pharmacist-in-charge shall maintain at least the following written documents:
(1) a statement of service philosophy and objectives;
(2) a job description for each classification of personnel;
(3) a list of pharmaceutical service committees, and other hospital committees on which
the pharmaceutical service is represented, with minutes of proceedings and attendance records;
(4) procurement records for controlled substances for two years or as required by law;
(5) prescriptions or other forms initiated by the prescriber, for two years or as required
by law;
(6) records of packaging, bulk compounding, or manufacturing for two years or as
required by law;
(7) records of action taken pursuant to drug recalls for two years or as required by law;
(8) special reports concerning narcotics and other drugs for two years or as required by
law;
(9) records of pharmacist's inspections of drug supplies maintained outside the pharmacy
or drug room, as permitted under subpart 1, items E and F, for two years; and
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106MINNESOTA RULES6800.7520
(10) records of withdrawals by nonpharmacists of prepackaged drugs from the pharmacy
or drug room, as permitted under subpart 1, item D and part 6800.7530, for two years.
B. The following documents relative to pharmaceutical services shall also be maintained:
(1) a current organization chart delineating intraservice structure and lines of authority,
and describing the pharmaceutical service's relationship to the administration, organized medical
staff, and other relevant hospital services;
(2) a list of all licensed and/or credentialed personnel, with verification of the present
validity of those licenses or credentials;
(3) a record of the number of persons, by job description, employed full-time and
part-time in the pharmaceutical services;
(4) copies of current staffing patterns and weekly work schedules for two years;
(5) receipted invoices for drugs, chemicals, and pharmaceutical service supplies
purchased and received over the immediately preceding two years; and
(6) any agreement or contract between an off-premises pharmacy and the hospital.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 27 SR 260; 31 SR 1673; 36 SR 237
Published Electronically: October 11, 2013
6800.7530 MAINTAINING SECURITY AND EMERGENCY ACCESS.
Subpart 1. Limited access. Only a pharmacist may have access to the pharmacy except in the
following situations and under the following conditions set forth in subparts 2 and 3.
Subp. 2. Disaster. In the case of disaster, the hospital administrator may allow access for
purposes of emergency maintenance, disaster prevention and control, and patient safety.
Subp. 3. Emergencies. For purposes of withdrawing limited doses of drugs for administration
to inpatients in emergencies when the pharmacy is closed, a designated registered nurse may make
emergency withdrawal of a dose required by a patient. Only a designated registered nurse in any
given shift may have emergency access.
The person withdrawing from a bulk stock container the limited doses for administration shall
leave in the pharmacy, on a form developed by the pharmacy, a record of the drugs withdrawn
showing the patient's name, the name of the drug and dose prescribed, drug strength, the amount
taken, the time and date, and the signature of nurse withdrawing drug.
The person withdrawing the drug from a bulk stock container or unit dose packaging bin shall
place upon the record of withdrawal the container from which the limited doses were taken so that
the withdrawal may be verified by the pharmacist.
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6800.7530MINNESOTA RULES107
Subp. 4. Emergency access procedure. The pharmacist-in-charge shall develop an emergency
access procedure and may make provisions for prepackaged drugs for emergency withdrawal,
provided the number of doses does not exceed the number usually required by a patient during the
time the pharmacy is closed.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.7600 [Repealed, 23 SR 1597]
Published Electronically: September 21, 2011
6800.7700 DRUG HANDLING AND STORAGE.
At least the following provisions for the safe handling and secure storing of drugs shall be
observed. Storage areas shall be safeguarded by an effective security system, with the pharmacist
responsible for maintaining security. Drugs shall be protected from contamination. Drugs shall be
stored at temperatures recommended by the U.S.P./N.F. or by the individual drug label or package
insert.
Statutory Authority: MS s 151.06
Published Electronically: September 21, 2011
6800.7800 PHARMACEUTICAL SERVICE SPACE.
Subpart 1. Pharmacy security. The pharmacy or drug room shall be surrounded by a continuous
partition or wall extending from floor to ceiling. All doors and windows shall be securely locked
when the pharmacy or drug room is closed, so as to prevent entry by unauthorized persons.
Subp. 2. Nursing service units. When drugs are stored on nursing service units space shall
be available at each unit for the storage, safeguarding, and preparation of medication doses, and
shall include provision of at least the following:
A. A well-illuminated, locked drug cabinet or room shall be equipped with clearly labeled
cubicles to ensure physical separation of individual patient prescribed medications. Medications
may be stored in secured individual patient storage areas or secured portable storage carts providing
separate compartments for individual patients.
B. A container or compartment that is capable of securing controlled substances with a
lock or other safeguard system shall be permanently attached to storage carts or medication rooms.
Statutory Authority: MS s 151.06
Published Electronically: October 11, 2013
6800.7900 PRESCRIPTION LABELING.
Subpart 1. Outpatient prescriptions. Labels for filled outpatient prescription drug orders
shall comply with parts 6800.3400 and 6800.4150. Labels for outpatient nonprescription drugs
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
108MINNESOTA RULES6800.7530
shall comply with the federal regulations. Drugs originally dispensed to an inpatient shall be returned
to the pharmacy for proper labeling before leaving the hospital premises.
Subp. 2. Inpatient chart orders. The containers of all drugs dispensed to inpatients on the
basis of chart orders, other than those dispensed pursuant to part 6800.3750, shall be labeled with
the following information:
A. name of patient;
B. name of drug;
C. route of administration of drug when necessary for clarification;
D. strength of drug;
E. auxiliary labels as needed;
F. expiration date, if applicable; and
G. date dispensed.
Subp. 3. Drugs prepackaged for emergency use. All drugs dispensed under part 6800.7520,
subpart 1, item E shall be labeled with the following information:
A. identification of pharmacy or other source;
B. name of drug or list of ingredients;
C. strength of drug or amount of ingredients;
D. auxiliary labels as needed;
E. expiration date, if any;
F. usual dose; and
G. control number or date of issue.
Subp. 4. Supplemental label. Whenever a drug is added to a parenteral solution, a distinctive
supplemental label shall be firmly affixed to the container. The supplemental label should be placed
to permit visual inspection of the infusion contents and to allow the name, type of solution, and lot
number on the manufacturer's label to be read.
Subp. 5. Intravenous admixtures. Intravenous admixtures must be labeled with the following
information:
A. name of solution and volume of solution;
B. patient's name;
C. bottle sequence number or other control number system, if appropriate;
D. name and quantity of each additive;
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6800.7900MINNESOTA RULES109
E. infusion or administration rate, if appropriate;
F. storage requirements if other than room temperature;
G. date and time of administration if appropriate;
H. beyond-use date; and
I. ancillary precaution labels.
Subp. 6. Responsibility. The hospital pharmacy service is responsible for ensuring proper
labeling of all medications.
Statutory Authority: MS s 151.06; 151.212
History: 9 SR 1656; 18 SR 1145; 36 SR 237
Published Electronically: September 21, 2011
6800.7950 EXTENSION OF PHARMACY SERVICES UNDER LICENSE.
A licensed pharmacy in a hospital may utilize additional locations within the hospital in
conformity with part 6800.0800, subpart 3, without the necessity of securing additional licenses
provided, however, that the pharmacist-in-charge of the hospital pharmacy informs the board of
the location of each satellite and assumes professional responsibility, in accordance with parts
6800.2400 and 6800.3850, for the practice of pharmacy and for staffing in each additional location.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
OPERATION OF PARENTERAL-ENTERAL/HOME HEALTH
CARE PHARMACIES
6800.8000 SCOPE AND PURPOSE.
The purpose of parts 6800.8000 to 6800.8008 is to provide standards for the preparation, labeling,
and distribution of sterile products by licensed home health care pharmacies pursuant to a prescription
drug order. The standards are intended to apply to sterile products compounded by the pharmacist,
notwithstanding the location of the patient, such as a private home, nursing home, hospice, or
doctor's office.
Statutory Authority: MS s 151.06
History: 18 SR 1145; 36 SR 237
Published Electronically: September 21, 2011
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
110MINNESOTA RULES6800.7900
6800.8001 POLICY AND PROCEDURES MANUAL.
To obtain a pharmacy license as a parenteral-enteral home health care pharmacy, a policy and
procedures manual shall be available for inspection at the pharmacy. The manual shall be reviewed
and revised on an annual basis. The manual shall include the policy and procedures for:
A. compliance with the official compendium United States Pharmacopeia, chapter 797;
B. clinical services;
C. cytotoxics handling, storage, and disposal;
D. disposal of unused supplies and medications;
E. drug destruction and returns;
F. drug dispensing;
G. drug labeling and relabeling;
H. drug storage;
I. duties and qualifications for professional and nonprofessional staff;
J. equipment;
K. handling of infectious waste, pharmaceutical waste, and hazardous waste;
L. infusion devices and drug delivery systems;
M. investigational drugs;
N. obtaining a protocol on investigational drugs from the principal investigator;
O. public safety;
P. quality assurance procedures, including:
(1) recall procedures;
(2) storage and dating;
(3) educational procedures for professional staff, nonprofessional staff, and patients;
(4) sterile procedures including a log of the temperature of the refrigerator, routine
maintenance, and report of hood certification; and
(5) sterility testing of the product;
Q. record keeping;
R. reference materials;
S. sanitation;
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6800.8001MINNESOTA RULES111
T. security;
U. sterile product preparation procedures; and
V. transportation.
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 31 SR 1673
Published Electronically: September 21, 2011
6800.8002 PHYSICAL REQUIREMENTS.
Subpart 1. Space. The pharmacy shall meet United States Pharmacopeia, chapter 797,
compendium requirements.
Subp. 2. Equipment. The licensed pharmacy shall meet United States Pharmacopeia, chapter
797, compendium requirements.
Subp. 3. [Repealed, 31 SR 1673]
Statutory Authority: MS s 151.06; 152.02
History: 18 SR 1145; 31 SR 1673
Published Electronically: September 21, 2011
6800.8003 PERSONNEL.
Subpart 1. Pharmacist-in-charge. In addition to the pharmacist-in-charge requirements of
part 6800.2400, the section of the pharmacy providing home health care pharmacy services must
be managed by a pharmacist licensed to practice pharmacy in Minnesota who is knowledgeable in
the specialized functions of preparing and dispensing compounded, sterile parenteral products,
including the principles of aseptic technique and quality assurance. The knowledge is usually
obtained through residency training programs, continuing education programs, or experience in an
intravenous admixture facility. The pharmacist-in-charge is responsible for the purchasing, storage,
compounding, repackaging, dispensing, and distribution of drugs and pharmaceuticals and for the
development and continuing review of policies and procedures, training manuals, and quality
assurance programs. The pharmacist-in-charge may be assisted by additional pharmacists adequately
trained in this area of practice.
Subp. 2. Supportive personnel. The pharmacist managing the section of the pharmacy
providing home health care pharmacy services may be assisted by supportive personnel. The
personnel must have specialized training in the field and must work under the immediate supervision
of a licensed pharmacist. The training provided to the personnel must be described in writing in a
training manual. Their duties and responsibilities must be consistent with their training and experience
and must remain in conformity with the requirements of part 6800.3850.
Subp. 3. Staffing. A pharmacist must be accessible at all times to respond to patients' and
other health professionals' questions and needs.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
112MINNESOTA RULES6800.8001
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.8004 DRUG DISTRIBUTION AND CONTROL.
Subpart 1. General. This part governs the mechanism by which a practitioner's prescription
drug order is executed, from the time the drug is ordered and received in the pharmacy to the time
the prescribed drug is dispensed to the patient.
Subp. 2. Prescription. The pharmacist, or pharmacist-intern acting under the immediate
supervision of a pharmacist, must receive a prescription drug order from a practitioner before
dispensing any compounded, sterile parenteral product. Prescriptions must be filed as required by
law or rules of the board.
Subp. 3. Labeling. Each compounded intravenous admixture product must be labeled in
accordance with part 6800.3450.
Subp. 4. Delivery. The pharmacist-in-charge shall ensure the environmental control of all
products shipped as follows:
A. compounded, sterile pharmaceuticals must be shipped or delivered as required in part
6800.3000 and stored appropriately in the patient's home; and
B. chain of possession for the delivery of Schedule II controlled substances via courier
must be documented, and a receipt obtained.
Statutory Authority: MS s 151.06
History: 18 SR 1145; 36 SR 237
Published Electronically: September 21, 2011
6800.8005 CYTOTOXIC AGENTS.
Licensed pharmacies that prepare cytotoxic drugs must comply with the requirements in items
A to F in addition to the requirements in parts 6800.8000 to 6800.8004.
A. Cytotoxic drugs shall be compounded in a vertical flow, Class II, biological safety
cabinet.
B. Protective apparel, such as disposable masks, gloves, and gowns with tight cuffs, shall
be worn by personnel compounding cytotoxic drugs.
C. Appropriate safety and containment techniques for compounding cytotoxic drugs shall
be used in conjunction with the aseptic techniques required for preparing sterile products.
D. Disposal of cytotoxic waste shall comply with all applicable local, state, and federal
requirements.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.8005MINNESOTA RULES113
E. Written procedures for handling both major and minor spills of cytotoxic agents must
be developed and must be included in the policy and procedures manual.
F. Prepared doses of cytotoxic drugs must be dispensed and shipped in a manner that will
minimize the risk of accidental rupture of the primary container.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.8006 DRUG USE REVIEW.
Systematic processes of drug use review must be designed, followed, and documented to assure
that appropriate patient outcomes occur from drug therapy on an ongoing basis.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.8007 PATIENT CARE GUIDELINES.
Subpart 1. Primary provider. The pharmacist who assumes the responsibilities under this
part must ensure that there is a designated practitioner primarily responsible for the patient's medical
care and that there is a clear understanding between the practitioner, licensed home care agency, if
any, the patient, and the pharmacist of the responsibilities of each in the areas of the delivery of
care and the monitoring of the patient. Compliance with this subpart shall be documented in the
patient's profile.
Subp. 2. Patient training. The pharmacy must demonstrate or document the patient's training
and competency in managing this type of therapy in the home environment. A pharmacist must be
involved in the patient training process in any area that relates to drug compounding, labeling,
storage, stability, or incompatibility.
Subp. 3. Patient monitoring. The pharmacist shall request access to clinical and laboratory
data concerning each patient and, if the data is obtained, monitor each patient's response to drug
therapy. Any unexpected or untoward response shall be reported to the prescribing practitioner. If
the data is not obtained and the pharmacist is not doing the monitoring, the identity of the health
care provider who has assumed the responsibility shall be documented in the patient's profile.
Subp. 4. Emergency kit. The pharmacy may provide emergency medications and supplies to
be used by designated, registered nurses, employed in the hospice or home health care setting.
The minimum requirements relating to the establishment of an emergency kit are described in
items A to C.
A. The pharmacy must have ownership of and assume the responsibility for the emergency
supply.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
114MINNESOTA RULES6800.8005
B. Appropriate and agreed-to policies and procedures for the use of the kit must be developed
by hospice and home health agencies in conjunction with the supplying pharmacy. Copies of the
policies and procedures must be kept at the supplying pharmacy and a copy submitted to the board.
The policies and procedures must address the following:
(1) the signed prescriber's protocols stating the drugs to be used, under what medical
circumstances they are to be used, who can administer these drugs, how the prescriber is notified
of the use of drugs from the kit, and how the prescription covering the drugs that were used is
transmitted to the pharmacy;
(2) the storage, temperature, stability, humidity, and proper transportation of the portable
container of drugs;
(3) security and who has access to the drugs. An acceptable method is assigning
responsibility by a numbering system for each separate box, designated to each separate registered
nurse;
(4) replacement of the medications used from the container within 72 hours and the
application of tamperproof seals;
(5) the method by which a pharmacy would be furnished with a copy of each prescriber's
prescription drug order or approved protocol reference which will be used as a hard copy prescription
drug order and will trigger drug replacement; and
(6) a system whereby the supplying pharmacy inspects the contents of the emergency
box at least every 60 days for expiration dates of the medications, the tamperproof seal, and the
correctness of the contents list; and documents and retains records of the inspection.
C. The pharmacy having ownership and responsibility shall ensure that each portable
emergency supply is:
(1) sealed with a tamperproof seal to ascertain entry into the kit;
(2) delivered to and kept under the control of a registered nurse;
(3) labeled on the outside of the container with a list of drugs and quantities contained
in the kit; and
(4) limited to drugs that are not controlled substances.
Statutory Authority: MS s 151.06; 151.102
History: 18 SR 1145; 23 SR 1597; 36 SR 237
Published Electronically: September 21, 2011
6800.8008 QUALITY ASSURANCE.
Subpart 1. Quality control program. There must be a documented, ongoing quality control
program that monitors personnel performance, equipment, and facilities. The end product must be
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.8008MINNESOTA RULES115
examined on a sampling basis as determined by the pharmacist-in-charge to assure that it meets
required specifications.
Subp. 2. Hood certification. All laminar flow hoods must be inspected by a qualified individual
for operational efficiency at least every 12 months. Appropriate records of the inspection must be
maintained.
Subp. 3. Prefilters. Prefilters for the clean air source must be replaced on a regular basis and
documented.
Subp. 4. Bulk compounding. If bulk compounding of parenteral solutions is performed using
nonsterile chemicals, extensive end-product testing must be documented before release of the
product from quarantine. The process must include testing for sterility and pyrogens.
Subp. 5. Expiration dates. If the product is assigned an expiration date that exceeds seven
days from its compounding date, there must be in-house data or data in the literature to assure the
sterility and stability of the product when it is used by the patient.
Subp. 6. Quality control audits. There must be documentation of quality assurance audits at
regular, planned intervals.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
RADIOACTIVE DRUGS
6800.8100 DEFINITIONS.
Subpart 1. Manufacturers of radiopharmaceuticals. Any person, firm, or hospital
compounding, mixing, deriving, repackaging, or otherwise preparing a radioactive drug shall be
licensed as a manufacturer, unless the drug is prepared for use by:
A. the medical facility to which the facility preparing the product is physically attached;
or
B. an individual patient when the drug is being dispensed on the order of a licensed
practitioner.
Subp. 2. Nuclear pharmacy. A nuclear pharmacy is any area, place, or premises described
in a license issued by the board with reference to plans approved by the board where radioactive
drugs are stored, prepared, manufactured, derived, manipulated, compounded, or dispensed.
Subp. 3. Radiopharmaceutical. A radiopharmaceutical is any substance defined as a drug in
section 201 (g) (1) of the Federal Food, Drug, and Cosmetic Act that exhibits spontaneous
disintegration of unstable nuclei with the emission of nuclear particles or protons and includes any
nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
116MINNESOTA RULES6800.8008
such substance, but does not include drugs such as carbon-containing compounds or
potassium-containing salts that contain trace quantities of naturally occurring radionuclides.
Subp. 4. Nuclear pharmacy practice. "Nuclear pharmacy practice" refers to a patient-oriented
pharmacy service that embodies the scientific knowledge and professional judgment required for
the assurance of the safe and effective use of radiopharmaceuticals and other drugs.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.8200 SCOPE.
Parts 6800.8100 to 6800.8700 are applicable to pharmacies and manufacturers dealing with
radiopharmaceuticals; provided, however, that parts 6800.0100 to 6800.5600 shall also be applicable
to such pharmacies, unless specifically exempted by parts 6800.8100 to 6800.8700 or are in direct
conflict with them, in which case parts 6800.8100 to 6800.8700 apply.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.8300 MINIMUM STANDARDS.
Proof of adequate space and equipment for storage, manipulation, manufacture, compounding,
dispensing, safe handling, and disposal of radioactive material must be submitted to and approved
by the board before a pharmacy license is issued by the board.
Compliance with all laws and regulations of the U.S. Nuclear Regulatory Commission and
other applicable federal and state agencies shall be deemed minimal compliance with this part.
Further requirements, as the board in its opinion finds necessary and proper for health and safety
in the production, compounding, dispensing, and use of radiopharmaceuticals, may be imposed as
a condition of licensure. A pharmacy exclusively handling radioactive materials may be exempt
from the building and equipment standards of parts 6800.0700, 6800.0800, 6800.0910, 6800.0950,
6800.1050, and 6800.2150 if the board finds it is in the public interest.
Statutory Authority: MS s 151.06
History: 9 SR 1656; 18 SR 1145
Published Electronically: September 21, 2011
6800.8400 PHARMACISTS HANDLING RADIOPHARMACEUTICALS.
A pharmacist handling radiopharmaceuticals must be competent in the preparation, handling,
storage, receiving, dispensing, disposition, and pharmacology of radiopharmaceuticals. The
pharmacist must have completed a nuclear pharmacy course and/or acquired experience in programs
approved by the board. Education and experience in nonapproved programs may be accepted if, in
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.8400MINNESOTA RULES117
the opinion of the board, the programs provide a level of competence substantially the same as
approved programs.
Statutory Authority: MS s 151.06
History: 17 SR 1279; 18 SR 1145
Published Electronically: September 21, 2011
6800.8500 PHARMACIST-IN-CHARGE.
A pharmacy handling radiopharmaceuticals shall not function without having a pharmacist who
is competent in the preparation, handling, storage, receiving, dispensing, disposition, and
pharmacology of radiopharmaceuticals in charge of the licensed premises. A qualified nuclear
pharmacist shall be a currently licensed pharmacist in Minnesota and either be certified as a nuclear
pharmacist by the Board of Pharmaceutical Specialties or meet the following standards:
A. have received a minimum of 200 contact hours of instruction in nuclear pharmacy and
the safe handling and use of radioactive materials from an accredited college of pharmacy, with
emphasis in the following areas:
(1) radiation physics and instrumentation;
(2) radiation protection;
(3) mathematics of radioactivity;
(4) radiation biology; and
(5) radiopharmaceutical chemistry;
B. attain a minimum of 500 hours of clinical nuclear pharmacy training under the supervision
of a qualified nuclear pharmacist; and
C. submit an affidavit of experience and training to the Board of Pharmacy.
Personnel performing tasks within the pharmacy shall be under the immediate and direct
supervision of the pharmacist competent in handling radiopharmaceuticals.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.8550 LABELING OF RADIOPHARMACEUTICALS.
Subpart 1. Immediate container of bulk radiopharmaceutical product. Each compounded
container must bear a label containing the following information:
A. standard radiation symbol with words "Caution - Radioactive Material";
B. radiopharmaceutical name or its abbreviation; and
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118MINNESOTA RULES6800.8400
C. radiopharmaceutical lot number.
Subp. 2. Outer container of bulk radiopharmaceutical product. Each individual prepared
dose must bear a label containing the following information:
A. standard radiation symbol with words "Caution - Radioactive Material";
B. radiopharmaceutical name or its abbreviation;
C. amount of radioactivity;
D. calibration date and time;
E. expiration date and time;
F. volume - if liquid, weight - if solid, number of vials or ampoules - if gas, number of
capsules - if capsules;
G. added substances, such as stabilizers and preservatives;
H. radiopharmaceutical lot number;
I. name, address, and telephone number of nuclear pharmacy, if it is to be transferred for
commercial distribution; and
J. initials of preparing nuclear pharmacist, if it is to be transferred for commercial
distribution.
Subp. 3. Immediate container of each radiopharmaceutical dispensed. Each individual
prepared dose must bear a label containing the:
A. standard radiation symbol with words "Caution - Radioactive Material";
B. radiopharmaceutical name or its abbreviation;
C. radiopharmaceutical prescription or lot number; and
D. patient name.
Subp. 4. Outer container of each radiopharmaceutical dispensed. Each individual prepared
dose must bear a label containing the:
A. standard radiation symbol with words "Caution - Radioactive Material";
B. radiopharmaceutical name or its abbreviation;
C. amount of radioactivity;
D. calibration date and time;
E. expiration date and time;
F. volume - if liquid, or weight - if solid, and number of vials or ampoules - if gas;
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.8550MINNESOTA RULES119
G. added substances, such as stabilizers and preservatives;
H. radiopharmaceutical prescription or lot number;
I. name, address, and telephone number of nuclear pharmacy;
J. patient name; and
K. initials of dispensing nuclear pharmacist.
Statutory Authority: MS s 151.06
History: 36 SR 237
Published Electronically: September 21, 2011
6800.8600 ACQUISITION, STORAGE, AND DISTRIBUTION.
Only radiopharmaceuticals which are approved by the U.S. Food and Drug Administration or
which are investigational drugs having IND or NDA status may be dispensed by a nuclear pharmacy.
Radioactive materials shall be kept locked and secure from unauthorized personnel.
Radiopharmaceuticals shall not be transferred, distributed, or dispensed to any person or firm
not licensed or authorized to receive or possess the drugs.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.8700 RECORD KEEPING.
A pharmacist handling radiopharmaceuticals shall maintain records of acquisition and disposition
of radiopharmaceuticals for at least two years.
In the case of investigational radiopharmaceuticals, the pharmacy records shall include an
investigators protocol for the preparation of radiopharmaceuticals, a copy of the Human Use
Committee approval, a copy of the approved patient consent form, and a letter from the
"manufacturer-sponsor" indicating that the physician requesting the radiopharmaceutical is a
qualified investigator.
Additional records shall be maintained as required by statute or rule of any other state or federal
agency.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
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120MINNESOTA RULES6800.8550
DISCIPLINARY PROCEEDINGS
6800.9100 DEFINITIONS.
Subpart 1. Board. "Board" means the Minnesota Board of Pharmacy.
Subp. 2. Hearing. "Hearing" includes a joint hearing of the board and any other administrative
agency.
Subp. 3. License. "License" means any license, permit, certificate of registration, or other
grant of authority issued or subject to suspension or revocation by the board.
Subp. 4. Revocation or suspension. "Revocation or suspension" of license includes refusal
to renew the same.
Statutory Authority: MS s 151.06
Published Electronically: September 21, 2011
6800.9200 INITIATING PROCEEDINGS.
Proceedings to revoke or suspend licenses may be initiated in one of two ways, except insofar
as any order of suspension or revocation may be issued pursuant to a statute not requiring hearing:
A. on a verified complaint by an individual or an agency required by law to enforce the
law in question, filed with the Board of Pharmacy; or
B. by the board on its own motion, when its investigation discloses probable grounds for
disciplinary action; the board president or director may act for the board in initiating proceedings
under this part.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.9300 PROCEDURE UPON FILING COMPLAINT.
All complaints received pursuant to the provisions of part 6800.9200 shall be dealt with in
accordance with the requirements of Minnesota Statutes, section 214.10.
Statutory Authority: MS s 151.06
Published Electronically: September 21, 2011
6800.9400 STYLE OF PLEADINGS.
All pleadings, notices, orders, and other papers filed in such proceedings shall be captioned
"BEFORE THE MINNESOTA BOARD OF PHARMACY," and shall be entitled "IN THE MATTER
OF THE SUSPENSION OR REVOCATION OF THE ____________ OF ______________
RESPONDENT." The party whose license is involved shall be known and designated as the
"Respondent."
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6800.9400MINNESOTA RULES121
Statutory Authority: MS s 151.06
Published Electronically: September 21, 2011
6800.9500 FORM OF CHARGES.
If the alleged offense is a continuing one, its general nature and the approximate time covered
shall be stated in the complaint or notice of hearing. If a specific incident is relied on, it shall be
alleged with such particularity as to time, place, and circumstances as may be necessary to enable
the respondent to prepare a defense. In either case, the offense may be alleged in the language of
the statute or rule claimed to have been violated. Separate charges shall be stated in separate
paragraphs and numbered consecutively.
Statutory Authority: MS s 151.06
History: 17 SR 1279
Published Electronically: September 21, 2011
6800.9600 ORDER FOR AND NOTICE OF HEARING.
Notices of hearing shall be addressed to the respondent at the last known post office address.
All hearings shall be conducted pursuant to Minnesota Statutes, chapter 14, and the rules for
contested cases of the Office of Administrative Hearings.
Statutory Authority: MS s 151.06
History: 17 SR 1279
Published Electronically: September 21, 2011
6800.9700 SERVICE AND FILING OF PAPERS.
Unless otherwise provided by law, all orders, notices, and other papers may be served by the
director of the board by first class, certified, or registered mail addressed to the party at the last
known post office address, or to the attorney of record. Papers required to be filed with the board
may be mailed to the following address: 2829 University Avenue SE, No. 530, Minneapolis, MN
55414.
Statutory Authority: MS s 151.06; 152.02
History: 17 SR 1279; 18 SR 1145; 31 SR 1673
Published Electronically: September 21, 2011
VARIANCES
6800.9900 VARIANCES.
Subpart 1. Right to request variance. The pharmacist-in-charge of a pharmacy requesting a
variance, or in the case of manufacturers, wholesalers, or gas distributors, a person responsible for
the operation, may request that the board grant a variance from any rule of the Board of Pharmacy.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
122MINNESOTA RULES6800.9400
Subp. 2. Submission and contents of request. A request for a variance must be submitted to
the board in writing. Each request must contain the following information:
A. the specific rule for which the variance is requested;
B. the reason for the request;
C. the alternative measures that will be taken if a variance is granted;
D. the length of time for which a variance is requested; and
E. any other relevant information necessary to properly evaluate the request for the variance.
Subp. 3. Decision on variance. The board shall grant a variance if it determines that:
A. the variance will not adversely affect directly or indirectly, the health, safety, or
well-being of the public;
B. the alternative measures to be taken, if any, are equivalent or superior to those prescribed
in the part for which the variance is requested; and
C. compliance with the part for which the variance is requested would impose an undue
burden upon the applicant.
The board shall deny, revoke, or refuse to renew a variance if the board determines that item
A, B, or C has not been met.
Subp. 4. Notification. The board shall notify the applicant in writing within 60 days of the
board's decision. If a variance is granted, the notification shall specify the period of time for which
the variance will be effective and the alternative measures or conditions, if any, to be met by the
applicant.
Subp. 5. Renewal of variance. Any request for the renewal of a variance shall be submitted
in writing prior to the expiration date of the existing waiver. Renewal requests shall contain the
information specified in subpart 2. A variance shall be renewed by the board if the applicant
continues to satisfy the criteria contained in subpart 3 and demonstrates compliance with the
alternative measures or conditions imposed at the time the original variance was granted.
Subp. 5a. Successor pharmacist-in-charge duties for active variances. After termination
of the services of a pharmacist-in-charge, the successor pharmacist-in-charge shall submit, on the
approved form, an acknowledgment of an awareness and understanding of any active variances
that the pharmacy has been granted according to this part. The successor pharmacist-in-charge shall
be responsible for ensuring that any conditions imposed by the board on any active variances
continue to be met. Existing active variances shall remain in effect until the successor
pharmacist-in-charge successfully submits the forms required in this subpart, for 90 days from the
naming of a successor pharmacist-in-charge, or until the expiration date of the existing variance,
whichever is sooner.
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.9900MINNESOTA RULES123
Subp. 6. Research projects. Pharmacists desiring to participate in research or studies not
presently allowed by or addressed by rules of the board may apply for approval of the projects
through waivers or variances in accordance with subparts 1 to 4.
Statutory Authority: MS s 151.06; 152.02
History: 10 SR 2007; 18 SR 1145; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
LEGEND MEDICAL GASES
6800.9920 DISPENSING AND DISTRIBUTION OF LEGEND MEDICAL GASES.
Parts 6800.9920 to 6800.9924 apply to the retail sale and distribution of legend medical gases.
Statutory Authority: MS s 151.06; 151.19
History: 14 SR 617
Published Electronically: September 21, 2011
6800.9921 REGISTRATION.
Subpart 1. Annual registration required. Every person or establishment selling or distributing
legend medical gases in Minnesota at retail that is not currently licensed as a pharmacy, pharmacist,
medical gas manufacturer, medical gas wholesaler, or practitioner as defined in Minnesota Statutes,
section 151.01, shall annually apply for registration by the board. Employees of an establishment
need not register if the establishment is registered or has applied for registration.
Subp. 2. Issuance. Upon the filing of an application for registration, and upon the payment
of the applicable fee in Minnesota Statutes, chapter 151, the board shall issue a registration certificate
in a form it prescribes. An application for a medical gas distributor registration which has not been
completed within 12 months of the date on which the board received the application is no longer
valid.
Subp. 3. Renewals. The certificate expires on December 1 of each year, and must be renewed
annually. Renewal applications received after December 1 are subject to a late filing fee of $25 in
addition to the renewal fee.
Subp. 4. Separate registration required. A separate registration is required for each location
and is not transferable. The registration certificate must be displayed at the location for which it
was issued. A change in the location of a registered facility will require reregistration.
Statutory Authority: MS s 151.06; 151.19; 152.02
History: 14 SR 617; 31 SR 1673; 36 SR 237
Published Electronically: September 21, 2011
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
124MINNESOTA RULES6800.9900
6800.9922 RESTRICTED SALES.
No person or establishment shall sell or distribute legend medical gases at retail to anyone other
than:
A. a patient on the basis of a prescription from a practitioner; or
B. a hospital, a practitioner as defined in Minnesota Statutes, section 151.01, subdivision
23, a licensed pharmacy, or other institution or person licensed to possess these drugs for use in
the usual course of practice. The distributor of these items shall determine if the purchaser is licensed
to possess them.
Statutory Authority: MS s 151.06; 151.19
History: 14 SR 617
Published Electronically: September 21, 2011
6800.9923 LABELING.
No person or distributor may sell or distribute any legend medical gas product at retail without
the manufacturer's intact federally required labeling.
Statutory Authority: MS s 151.06; 151.19
History: 14 SR 617; 18 SR 1145
Published Electronically: September 21, 2011
6800.9924 RECORDS.
A sale or distribution of legend medical gases by registered distributors of these items at retail
must be limited to the prescription or order of a licensed practitioner. The orders or prescriptions
must be maintained for at least two years, must be filed by patient name or date, and must be readily
retrievable and available for inspection by the Board of Pharmacy. The prescription must bear at
least the patient's name and address, date, name and quantity of legend medical gas distributed, and
name and address of the prescriber. Refills of legend medical gases must be recorded and the record
must be maintained for at least two years.
Statutory Authority: MS s 151.06; 151.19
History: 14 SR 617; 18 SR 1145
Published Electronically: September 21, 2011
DISPENSING BY PRACTITIONERS
6800.9950 DISPENSING BY PRACTITIONERS.
Parts 6800.9951 to 6800.9954 apply to medical, dental, veterinary, and other licensed
practitioners engaged in dispensing drugs and controlled substances.
Statutory Authority: MS s 151.06
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.9950MINNESOTA RULES125
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.9951 DRUG STORAGE.
Practitioners engaged in dispensing drugs shall have a separate locked drug storage area for the
safe storage of drugs. Access to the drug supply shall be limited to persons who have legal authority
to dispense and to those under their direct supervision.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.9952 DISPENSING.
Subpart 1. Who may dispense. A dispensing practitioner shall personally perform all dispensing
functions described in part 6800.3100 that are required of a pharmacist when the dispensing is
being done in a pharmacy. A practitioner may delegate functions that may be delegated to supportive
personnel in accordance with part 6800.3850.
Subp. 2. Written prescriptions required. A practitioner shall reduce all drug orders to a
written prescription that shall be numbered and filed in an organized manner when dispensed.
Patient chart records do not qualify as a prescription record.
Subp. 3. Tight containers. Drugs dispensed shall be packaged in prescription containers
meeting United States Pharmacopeia requirements for "tight" or "well closed" containers.
Subp. 4. Child-resistant containers. Drugs dispensed shall be packaged in child-resistant
containers as required by the federal Poison Prevention Packaging Act unless the patient specifically
requests the use of non-child-resistant containers. Any such request must be documented.
Subp. 5. Controlled substances. Controlled substance prescriptions shall be filed in accordance
with federal and state laws relating to controlled substances.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
6800.9953 LABELING.
Prescription containers, other than those dispensed in unit dose under part 6800.3750, shall be
labeled in accordance with part 6800.3400.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
126MINNESOTA RULES6800.9950
6800.9954 RECORDS.
A practitioner engaged in dispensing drugs shall keep on file at each location from which
dispensing is taking place a record of drugs received, administered, dispensed, sold, or distributed.
The records shall be readily retrievable, shall be maintained for at least two years, and shall include:
A. a record or invoice of all drugs received for purposes of dispensing to patients;
B. a prescription record of drugs dispensed, filed by prescription number or date, showing
the patient's name and address, date of the prescription, name of the drug, strength of the drug,
quantity dispensed, directions for use, signature of practitioner and, if it is a controlled substance,
practitioner's Drug Enforcement Administration number;
C. a record of refills recorded on the back of the prescriptions showing date of refill, quantity
dispensed, and initials of dispenser; and
D. the patient profile requirements of part 6800.3110, if all data required by that part is not
already included in the patient's chart.
Statutory Authority: MS s 151.06
History: 18 SR 1145
Published Electronically: September 21, 2011
Copyright © 2017 by the Revisor of Statutes, State of Minnesota. All Rights Reserved.
6800.9954MINNESOTA RULES127