Compounded Peptides: Regulations, Safety & FDA Risk Lists

Under the Drug Quality and Security Act (DQSA) of 2013, human drug compounding in the United States operates under two distinct statutory sections of the FD&C Act:

• Section 503A (Traditional Compounding): State-licensed community pharmacies preparing individualized formulations based on a valid, patient-specific prescription. Governed primarily by United States Pharmacopeia (USP) standards, including USP <795> for non-sterile and USP <797> for sterile compounding, under state board of pharmacy oversight.
• Section 503B (Outsourcing Facilities): Federally registered facilities authorized to compound large batches of sterile medications for hospital and clinic 'office use' without individual prescriptions. Must comply directly with federal cGMP regulations and undergo routine FDA inspections.

Pharmacies may only compound using bulk chemical powders if the substance has an official USP monograph, is an active ingredient in an approved drug, or appears on an approved FDA 503A/503B bulks list. The FDA evaluates nominated substances into three categories:

• Category 1: Substances under active evaluation that may be compounded during ongoing review.
• Category 2: Substances identified by the FDA Pharmacy Compounding Advisory Committee (PCAC) as presenting significant safety concerns. Compounding is strictly prohibited.
• Category 3: Substances nominated without sufficient scientific evidence to justify review. Compounding is prohibited.

In late 2023, FDA placed many widely circulated peptides in Category 2, including BPC-157, CJC-1295, ipamorelin, kisspeptin-10 and thymosin alpha-1, citing risks such as immunogenicity and peptide-related impurities. On FDA’s current list (content dated 22 April 2026), GHRP-2, GHRP-6, ipamorelin and kisspeptin-10 remain in Category 2, while BPC-157, CJC-1295, AOD-9604, TB-500, thymosin alpha-1 and others appear as “nominated but withdrawn” by their nominators. Withdrawal is not a safety clearance: a substance with no USP monograph that is not part of an approved drug and not on the 503A bulks list generally still cannot be lawfully compounded.

Under Section 503A and 503B, pharmacies are generally prohibited from compounding copies of commercially available drugs. However, a statutory exception applies when an approved drug appears on the official FDA Drug Shortages database, as occurred with semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound).

While legal during active shortages, compounded GLP-1 medications raise critical safety nuances: some compounding pharmacies have used unapproved peptide salt forms (such as semaglutide sodium or semaglutide acetate) instead of the approved base molecule, leading to FDA warning letters regarding altered stability, pharmacokinetics, and dosing accuracy.