6800 PHARMACIES AND PHARMACISTS

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…

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; E. nuclear; F. central service; G. nonsterile preparation compounding; H. sterile preparation compou…

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 a…

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…

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 inform…

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 comm…

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 definition of and the requirements fo…

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. ret…

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 Boa…

6800.1100 [Renumbered 6800.1250] 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…

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 s…

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…

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 allo…

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…

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 relatin…

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 qualit…

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.…

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 pharmaceu…

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, confe…

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 s…

6800.2000 [Renumbered 6800.2150] Published Electronically: September 21, 2011

6800.2100 [Renumbered 6800.1050] Published Electronically: September 21, 2011

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 ex…

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 …

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 pra…

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

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: Se…

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 …

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 Publish…

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.…

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 …

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 wha…

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 o…

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…

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 retriev…

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 a…

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 …

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 …

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…

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…

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,…

6800.3500 [Renumbered 6800.4150] Published Electronically: September 21, 2011