The short answer. BPC-157 is not FDA-approved and, as of September 25, 2026, has no lawful compounding pathway. It left FDA’s Category 2 in April 2026 because the nominators withdrew their nominations. That removed the restriction label without adding BPC-157 to any list a pharmacy may compound from.
| FDA approved | No. No USP monograph, and not a component of any approved drug. |
|---|---|
| 503A pharmacy | No pathway. Not on 21 CFR 216.23 and in no category, so outside FDA’s interim policy. |
| 503B outsourcing facility | No pathway. |
| Latest FDA action | Pharmacy Compounding Advisory Committee, Jul 23, 2026. FDA’s briefing recommended against listing. |
| Sport and military | WADA prohibited (S0). DoD prohibited dietary supplement ingredient. |
| MDside position | Our providers do not prescribe it. |
| Last verified | 2026-09-25 |
What changed in 2026, in order
| Date | What happened |
|---|---|
| Sep 29, 2023 | FDA added BPC-157 to 503A Category 2, substances that may present significant safety risks. |
| Apr 14, 2026 | Both nominators’ withdrawal letters posted to the docket. |
| Apr 15, 2026 | FDA gave seven days’ notice that BPC-157 would leave Category 2 because the nominations were withdrawn. |
| Apr 22, 2026 | Removed from Category 2. It now sits in no category. |
| Jul 23, 2026 | The advisory committee discussed BPC-157 for ulcerative colitis. FDA proposed that neither form be listed. |
Leaving Category 2 is not the same as permission
FDA’s interim policy lets a 503A pharmacy compound from a nominated bulk substance only if that substance sits in Category 1. A substance in no category gets no enforcement discretion at all. FDA’s guidance also says a withdrawn nomination does not reflect any determination by FDA. So the April removal changed the label on BPC-157 and left its legal position where it was: no monograph, no approved-drug component, no listing.
What the July advisory committee did and did not do
The committee took separate votes on BPC-157 free base and BPC-157 acetate. FDA’s own briefing recommended that neither be added to the 503A bulks list. As of September 25, 2026, FDA has not posted minutes, and no proposed rule has appeared in the Federal Register. A committee vote is advice to FDA. Only notice-and-comment rulemaking adds a substance to 21 CFR 216.23, and none has started.
The enforcement record
FDA has treated BPC-157 as an unapproved new drug in warning letters since at least 2019, including PD Labs (2019), Tailor Made Compounding (2020) and Warrior Labz (2023). The Department of Defense lists it as a prohibited ingredient and calls it an unapproved drug. WADA prohibits it at all times.
What this means for you
Take BPC-157 off the menu until a rule places it on the 503A list, and check this page before you put it back. If a pharmacy says the April change made it legal, ask for the specific authority in writing. A “research use only” label on the vial makes the position worse: see why that label is no shield.
Read next
Frequently asked questions
Is BPC-157 legal to compound in 2026?
No. As of September 25, 2026 it is not on the 503A bulks list, is in no FDA category, has no USP monograph and is not part of any approved drug. Its April 2026 removal from Category 2 followed the nominators’ withdrawal and did not create a compounding pathway.
Did the FDA advisory committee approve BPC-157?
No. An advisory committee cannot approve or list anything. It discussed BPC-157 on July 23, 2026 and voted separately on two forms, while FDA’s own briefing recommended against listing. FDA had not posted minutes or started rulemaking as of September 2026.
Why did FDA remove BPC-157 from Category 2?
Because both nominators withdrew their nominations in April 2026. FDA removed it on that basis, and its guidance says a withdrawn nomination does not reflect any FDA determination about the substance. The removal says nothing about safety, and it created no route for a pharmacy to compound it.
Is BPC-157 banned in sports?
Yes. The 2026 WADA Prohibited List names it under S0, non-approved substances, prohibited at all times. The Department of Defense also lists it as a prohibited dietary supplement ingredient and describes it as an unapproved drug. Products marketed to athletes or service members carry that exposure.
Primary sources. Last verified September 25, 2026. Corrections are welcome: contact us.
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA, Certain bulk drug substances that may present significant safety risks (updated Apr 22, 2026)
- FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (Jan 2025)
- 21 CFR 216.23, the 503A bulks list
- FDA, Pharmacy Compounding Advisory Committee, July 23-24, 2026
- FDA briefing document, BPC-157 (July 2026 PCAC)
- FDA, voting questions, July 2026 PCAC
- FDA warning letter, PD Labs (Jul 30, 2019)
- FDA warning letter, Tailor Made Compounding (Apr 1, 2020)
- FDA warning letter, Warrior Labz (Jun 12, 2023)
- DoD Operation Supplement Safety, BPC-157: prohibited peptide and unapproved drug (Apr 29, 2025)
- WADA 2026 Prohibited List
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.