Minnesota Administrative Rules

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[Repealed, 31 SR 1673]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[Repealed, 31 SR 1673]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[Repealed, 31 SR 1673]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

Statutory Authority:

MS s 151.06; 152.02

History:

18 SR 1145; 31 SR 1673; 36 SR 237

Published Electronically:

October 2, 2012