BPC-157
Routine U.S. dispensing route: not verified
- Route considered
- Compounding from the bulk substance under section 503A, or enrollment in a registered clinical study
- What this covers
- Covers BPC-157 free base and BPC-157 acetate, the two forms FDA evaluated.Source 1
What the records establish
- No FDA-approved BPC-157 drug: FDA staff state that neither form is a component of an approved drug and that no applicable USP or NF monograph exists.Source 1
- BPC-157 is not on FDA’s final list of bulk substances that 503A pharmacies may use, in the version displayed as up to date as of October 8, 2026.Source 2
- FDA lists BPC-157 among nominations that were withdrawn and describes possible risks, including immunogenicity for certain routes of administration and peptide-related impurities.Source 3
- FDA’s compounding advisory committee discussed BPC-157 on July 23, 2026. Its recommendations are non-binding; the meeting is not an approval or a listing decision.Source 4
What they do not establish
- Whether a particular pharmacy or clinic may supply BPC-157 to you. FDA describes an interim policy for certain nominated substances; how it applies after a withdrawn nomination is a regulatory interpretation we have not had reviewed, so we state no conclusion.Source 5
- Whether BPC-157 is effective or safe for anyone. We do not assess either.
- The status of products marketed as dietary supplements or for research use. This summary covers prescription compounding only.
Study registry records
- Still unresolved
- Interim-policy status after the withdrawn nomination is unresolved pending competent regulatory review.
- We will revise this after
- A final FDA action after the July 2026 meeting, an amendment to 21 CFR 216.23, a change to FDA’s safety-risk page, or a registry update.
Requirement-by-requirement Access Check: BPC-1576 requirements
Requirement: An applicable USP or NF monograph exists
ContradictedFDA staff state that no applicable monograph exists for either form.Source 1
Requirement: BPC-157 is a component of an FDA-approved drug
ContradictedFDA staff state that neither form is a component of an FDA-approved drug.Source 1
Requirement: BPC-157 appears on the 503A bulks list (21 CFR 216.23)
ContradictedBPC-157 is not on the list.Source 2
Requirement: FDA’s interim policy covers compounding with BPC-157
UnresolvedFDA lists BPC-157 among withdrawn nominations that were previously in category 2.Source 3 What that means under the interim policy requires regulatory review we have not obtained, so we state no conclusion.Source 5
Requirement: The July 2026 advisory meeting provides an access basis
Not applicableAdvisory committees make non-binding recommendations. A meeting or vote is not an approval or a listing.Source 4
Requirement: A registered clinical study is enrolling U.S. participants
UnresolvedThe U.S. record we reviewed was not yet recruiting, and its summary (20 patients) conflicts with its enrollment field (30, estimated).Source 6 The recruiting record we reviewed lists only a site in China.Source 7