FDA compounding status
BPC-157
Also listed as Body Protection Compound-157.
BPC-157 is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 in April 2026 after the nominations were withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee recommended it on July 23, 2026. A recommendation is not a listing: nothing changes unless FDA publishes a final rule.
Checked against the primary sources on .
The record
- FDA status
- No compounding pathway today. An FDA advisory committee recommendation is not a listing.
- Compounding basis
- No compounding pathwayNo facility type may compound this substance today.
- FDA advisory committee
- Recommended, not added, Jul 23, 2026
- Sport (WADA 2026)
- Prohibited at all times under WADA class S0 (non-approved substances).
- Offered by PEPLUX
- Yes, as BPC-157 Injection
- Checked on
Offered by PEPLUX
BPC-157 Injection
PEPLUX offers BPC-157 as BPC-157 Injection. The product page covers what it is, its risks, and how prescribing and pricing work.
Status as offered
No compounding pathway today. An FDA advisory committee recommendation is not a listing.
Basis
What this status traces to.
FDA's 503A categories document of April 15, 2026 announced the removal of BPC-157 from Category 2, effective seven days later, because its nominations were withdrawn. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page says compounded BPC-157 may pose a risk of immunogenicity and that FDA has identified no, or only limited, safety-related information for the proposed routes of administration.
Primary sources
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
- FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
- FDA503B Bulk Drug Substances ListDocument dated . Checked .
- eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated April 15, 2026Document dated . Checked .
- FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksDocument dated . Checked .
- Federal RegisterFR Doc 2026-07361: Pharmacy Compounding Advisory Committee; notice of meetingDocument dated . Checked .
- FDA advisory committeeJuly 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeDocument dated . Checked .
- FDA advisory committeePharmacy Compounding Advisory Committee, July 23-24, 2026: voting questionsDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA's Pharmacy Compounding Advisory Committee recommended it at its meeting of July 23, 2026. It was recommended, not added: a committee recommendation is not a listing, and nothing changes unless FDA publishes a final rule. FDA has not posted minutes for that meeting.
If you are subject to anti-doping rules
Prohibited at all times under WADA class S0 (non-approved substances).
Pending or unconfirmed
No proposed or final rule had been published in the Federal Register as of October 13, 2026. FDA had posted no minutes or outcome for the July 2026 committee meeting as of October 13, 2026. The committee outcome stated here rests on LegitScript's report of July 27, 2026, not on an FDA document.
Common questions
BPC-157, answered plainly.
- What is the FDA compounding status of BPC-157?
- BPC-157 is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 in April 2026 after the nominations were withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee recommended it on July 23, 2026. A recommendation is not a listing: nothing changes unless FDA publishes a final rule.
- What does the status of BPC-157 trace to?
- FDA's 503A categories document of April 15, 2026 announced the removal of BPC-157 from Category 2, effective seven days later, because its nominations were withdrawn. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page says compounded BPC-157 may pose a risk of immunogenicity and that FDA has identified no, or only limited, safety-related information for the proposed routes of administration. Checked against the primary sources on October 13, 2026.
- Does a Category 2 removal or an advisory committee recommendation change the status of BPC-157?
- Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
- Does PEPLUX offer BPC-157?
- PEPLUX offers BPC-157 as BPC-157 Injection. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. BPC-157 is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- Is BPC-157 prohibited in sport?
- Prohibited at all times under WADA class S0 (non-approved substances).
- Is anything about the status of BPC-157 pending or unconfirmed?
- No proposed or final rule had been published in the Federal Register as of October 13, 2026. FDA had posted no minutes or outcome for the July 2026 committee meeting as of October 13, 2026. The committee outcome stated here rests on LegitScript's report of July 27, 2026, not on an FDA document.