Minn. R. agency 164, ch. 6800, OPERATION OF PHARMACIES, pt. 6800.3300

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

Part 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 [Repealed, 31 SR 1673]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 [Repealed, 31 SR 1673]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 [Repealed, 31 SR 1673]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.

Minn. R. agency 164, ch. 6800, OPERATION OF PHARMACIES, pt. 6800.3300

18 SR 1145; 31 SR 1673; 36 SR 237

Statutory Authority: MS s 151.06; 152.02