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503A compounded peptide: pharmacy and FDA status verification sheet
Record the exact substance on the prescription and the pharmacy filling it, then check each FDA page and write down what it said and the date you looked. Bring the questions to the prescriber or pharmacist. It is a verification record, not a recommendation to use any peptide.
The prescription and the pharmacy
Substance exactly as writteninclude the salt form: free base, acetate, mesylate
Prescriber name and licence state
Pharmacy name, state and licence number
Pharmacy type503A pharmacy or 503B outsourcing facility
FDA pages checked
Write what each page said about this exact substance and the date you looked.
| Date checked | FDA page | What it says about this substance |
|---|---|---|
| 503A bulks list and interim categories | ||
| Category 2 and nominated-but-withdrawn table | ||
| Pharmacy Compounding Advisory Committee records | ||
FDA statements to check against
- Bulk substances used under 503A must come with a valid certificate of analysis and be made by an establishment registered with FDA under section 510.[1]
- Category 1 means FDA does not intend to take action if the guidance conditions are met; it is not approval.[1]
- Ibutamoren mesylate has been in category 2 since December 29, 2022 (503B) and September 29, 2023 (503A).[2]
- Ipamorelin acetate has been in 503B category 2 since September 29, 2023.[2]
- FDA's July 2026 briefing concluded against adding BPC-157 to the 503A bulks list.[3]
- Advisory committee recommendations are non-binding; only FDA's own listing decides.[4]
Questions for the pharmacist or prescriber
- Which 503A route covers this substance: monograph, approved-drug component, the bulks list, or a category 1 nomination?
- Can I see the certificate of analysis for the bulk substance and for my batch?
- Is this pharmacy licensed in my state, and when was its last inspection?
- What happens to my prescription if FDA changes this substance's status?
Sources for the facts on this sheet
- U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Accessed 2026-10-18. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
- U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Accessed 2026-10-18. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- U.S. Food and Drug Administration. FDA Briefing Document for BPC-157-Related Bulk Drug Substances, Pharmacy Compounding Advisory Committee meeting of July 23-24, 2026. Accessed 2026-10-18. https://www.fda.gov/media/193343/download
- U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Accessed 2026-10-18. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
This sheet records information for a conversation with your prescriber or pharmacist. It does not replace their instructions or the medication's prescribing information.