The use of an FDA-approved drug for a purpose, population, or dosage other than what was approved. Many peptides prescribed by physicians are used off-label based on emerging research.
"Off-Label Use" 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, PCAC (Pharmacy Compounding Advisory Committee), USP (United States Pharmacopeia), IND (Investigational New Drug), Bulk Drug Substance, Orphan Drug, EMA (European Medicines Agency), TGA (Therapeutic Goods Administration), MHRA (Medicines and Healthcare products Regulatory Agency).