Wisconsin Administrative Code
Pharmacy Examining Board
Chapter Phar 15 - Compounding Pharmaceuticals
Subchapter I - General
Section Phar 15.16 - Component Selection

Universal Citation: WI Admin Code ยง Phar 15.16

Current through August 26, 2024

(1) Active pharmaceutical ingredients or added substances used in compounding shall be manufactured by an FDA registered facility or accompanied by a certificate of analysis.

(2) APIs and added substances shall meet USP or NF monograph specifications when monographs are available. A pharmacist shall use professional judgement in selection of APIs if USP or NF grade is not available.

(3) All components shall be stored and handled consistent with the manufacturer's labeling or USP or NF monographs and in a manner that prevents contamination and deterioration.

(4) A pharmacist compounding for human use may not use components that have been withdrawn or removed from the market for safety or efficacy reasons by the FDA. A pharmacist compounding for food producing animal use may not use components prohibited for use in food producing animals.

Disclaimer: These regulations may not be the most recent version. Wisconsin may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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