02-392-3 Me. Code R. § 13-7

Current through 2024-51, December 18, 2024

Section 392-3-13-7 - Compounding

1. Scope

This section applies to non-sterile compounding pharmacies, for which no separate license or endorsement is required other than the general retail pharmacy license or closed-shop pharmacy license. A sterile compounding pharmacy must be separately licensed pursuant to Chapter 37 of the board's rules.

2. Operational Requirements

A. USP Chapter 795 - A non-sterile compounding pharmacy shall comply in all respects with United States Pharmacopeia USP 36-NF 31, General Chapter <795>, Pharmaceutical Compounding - Nonsterile Preparations, 2013-14 edition, Vol. 1, p. 355. ("Chapter 795"). The board incorporates Chapter 795 into this chapter by reference. Chapter 795 may be obtained from:

National Technical Information Service

5285 Port Royal Road

Springfield, VA 22161

(703) 605-6400

-or-

U.S. Pharmacopeial Convention

www.usp.org

3. Activity Records

At the request of the board, a non-sterile compounding pharmacy shall generate within 3 business days a report showing the number and type of prescriptions dispensed during the period of time specified by the board. The contents and format of the report shall be determined by the board. The reporting period is subject to the record retention requirements contained in Chapter 24 of the board's rules.

02-392 C.M.R. ch. 3, § 13-7