Minn. R. agency 164, ch. 6800, LICENSING PHARMACIES, pt. 6800.1050

Current through Register Vol. 49, No. 24, December 9, 2024

Part 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:

(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

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.

Minn. R. agency 164, ch. 6800, LICENSING PHARMACIES, pt. 6800.1050

9 SR 1656; 18 SR 1145; L 2001 1Sp4 art 6 s 1; 31 SR 1673; 36 SR 237

Statutory Authority: MS s 151.06; 152.02