Under FDA compounding rules, a substance placed on the Category 2 list is nominated for evaluation but has not yet been approved for use in compounding by 503A or 503B pharmacies. BPC-157 has been placed on this list.
"FDA Category 2" 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 1, 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).