Minn. R. agency 164, ch. 6800, OPERATION OF PHARMACIES, pt. 6800.3300 - COMPOUNDING STANDARDS
All licensed Minnesota pharmacies that compound nonsterile drug preparations must follow United States Pharmacopeia, chapter 795, standards.
Any licensed Minnesota pharmacy compounding a sterile product must follow the United States Pharmacopeia, chapter 797, standards.
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.
Notes
Statutory Authority: MS s 151.06; 152.02
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