Under FDA compounding rules, substances on the Category 1 list have been evaluated and approved as bulk drug substances eligible for compounding by 503A and 503B pharmacies.
"FDA Category 1" 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, Class II Recall, Drug Shortage Declaration, PCAC (Pharmacy Compounding Advisory Committee), 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).