An FDA advisory committee that evaluates substances nominated for inclusion on the bulk drug substance lists used in compounding. PCAC reviews safety, efficacy, and historical use data to recommend whether substances should be permitted for compounding under sections 503A and 503B.
"PCAC (Pharmacy Compounding Advisory Committee)" is filed under Regulatory in the PeptideAtlas glossary, alongside 17 other terms in that group.
A compounding pharmacy that prepares medications based on individual prescriptions. Subject to state board of pharmacy oversight.
A compounding facility registered with the FDA that can produce compounded medications in larger quantities without individual prescriptions, subject to FDA inspection.
A medication prepared by a licensed compounding pharmacy to meet an individual patient's specific needs. Subject to different regulations than manufactured drugs.
More Regulatory terms: 503A Pharmacy, 503B Outsourcing Facility, Compounded Medication, Research Use Only (RUO), WADA (World Anti-Doping Agency), FDA Category 2, FDA Category 1, Class II Recall, Drug Shortage Declaration, USP (United States Pharmacopeia), IND (Investigational New Drug), Bulk Drug Substance, Off-Label Use, Orphan Drug, EMA (European Medicines Agency), TGA (Therapeutic Goods Administration), MHRA (Medicines and Healthcare products Regulatory Agency).