An active pharmaceutical ingredient (API) used as a starting material in compounding. The FDA maintains lists of bulk drug substances that may or may not be used by 503A and 503B compounding entities.
"Bulk Drug Substance" is filed under Regulatory in the PeptideAtlas glossary, alongside 17 other terms in that group.
2 other glossary entries refer to this term in their own definition, which is usually the fastest way to see how it is used in practice.
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.
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.
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.
Terms that reference this one: FDA Category 1, PCAC (Pharmacy Compounding Advisory Committee).
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), Off-Label Use, Orphan Drug, EMA (European Medicines Agency), TGA (Therapeutic Goods Administration), MHRA (Medicines and Healthcare products Regulatory Agency).