FDA Category 1
Definition
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.
Related Terms in Regulatory
503A Pharmacy
A compounding pharmacy that prepares medications based on individual prescriptions. Subject to state board of pharmacy oversight.
503B Outsourcing Facility
A compounding facility registered with the FDA that can produce compounded medications in larger quantities without individual prescriptions, subject to FDA inspection.
Compounded Medication
A medication prepared by a licensed compounding pharmacy to meet an individual patient's specific needs. Subject to different regulations than manufactured drugs.
Research Use Only (RUO)
A regulatory designation indicating a product is intended solely for laboratory research and is not approved for human consumption or therapeutic use.
WADA (World Anti-Doping Agency)
The international organization responsible for promoting, coordinating, and monitoring anti-doping in sports. Many research peptides are on the WADA prohibited list.
FDA Category 2
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.
Class II Recall
An FDA product recall classification indicating a situation where use of or exposure to the product may cause temporary or medically reversible adverse health consequences. All peptide-related FDA recalls to date have been Class II.
Drug Shortage Declaration
An FDA designation that a drug is in shortage, which temporarily allows compounding pharmacies to produce compounded versions. FDA declared semaglutide shortage resolved in February 2025 and tirzepatide in October 2024, restricting further compounding.