Section Phar 15.16 - Component Selection(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contamination and deterioration.(4) A pharmacist compounding for human use may not use components that have been withdrawn or removed from the market for safety or efficacy reasons by the FDA.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.Wis. Admin. Code Pharmacy Examining Board Phar 15.16
Adopted by, CR 16-085: cr. Register April 2018 No. 748, eff. 11/1/2018