Peptide Rulebook

BPC-157

Also known as: Body Protection Compound-157, Bepecin, PL-14736

BPC-157 is currently not an approved drug for fda-approved drug product.

Not legal or medical advice.

This page is for informational purposes only. Always verify the current official source or consult a qualified professional before making compliance, prescribing, purchasing, or clinical decisions. Read full disclaimer.

A synthetic 15-amino-acid peptide. It has no USAN, no USP/NF monograph, and is not a component of an FDA-approved drug. Commercial products may be sold as BPC-157 acetate or BPC-157 free base, which are distinct active pharmaceutical ingredients.

Current status

FDA-approved drug product: Not an approved drug; 503A pharmacy compounding: Category 2 — significant safety risk; 503B outsourcing-facility compounding: Not on 503B bulk list / not an approved component; Sport (WADA): Prohibited at all times — S0

Status assertions by activity, jurisdiction, date, qualification, and sources
ActivityStatusAs ofJurisdictionQualificationSources
FDA-approved drug productNot an approved drugSep 27, 2024United States federalNo FDA-approved new drug application is in effect for BPC-157.
503A pharmacy compoundingCategory 2 — significant safety riskSep 27, 2024United States federalFDA placed BPC-157 in Category 2 of the 503A bulk list. It is not on the list of bulk substances that can be used in 503A compounding.
503B outsourcing-facility compoundingNot on 503B bulk list / not an approved componentMar 21, 2025United States federalBPC-157 is not a component of an FDA-approved drug and is not on the 503B bulk list. It does not qualify for the 503B bulk-drug-substance exemption.
Sport (WADA)Prohibited at all times — S0Jan 1, 2025United States federalWADA lists BPC-157 as an example of a non-approved substance in class S0. This is a sport-rule prohibition, not a general FDA determination.

What this means

  • ✓ FDA-approved drug product: Not an approved drug. No FDA-approved new drug application is in effect for BPC-157.
  • ✓ 503A pharmacy compounding: Category 2 — significant safety risk. FDA placed BPC-157 in Category 2 of the 503A bulk list. It is not on the list of bulk substances that can be used in 503A compounding.
  • ✓ 503B outsourcing-facility compounding: Not on 503B bulk list / not an approved component. BPC-157 is not a component of an FDA-approved drug and is not on the 503B bulk list. It does not qualify for the 503B bulk-drug-substance exemption.
  • ✓ Sport (WADA): Prohibited at all times — S0. WADA lists BPC-157 as an example of a non-approved substance in class S0. This is a sport-rule prohibition, not a general FDA determination.

What this does not mean

  • ✗ Status in one jurisdiction does not automatically apply elsewhere.
  • ✗ An approved active ingredient is not the same as an approved finished product.
  • ✗ “Research use” labeling does not make an unapproved drug lawful for human use.

Timeline

  1. PCAC scheduled to discuss BPC-157

    advisory

    FDA's Pharmacy Compounding Advisory Committee is scheduled to discuss BPC-157-related bulk substances. Any recommendation is advisory and does not change status immediately.

  2. FDA places BPC-157 in 503A Category 2

    final

    FDA updated the 503A bulk list, placing BPC-157 in Category 2 (significant safety risks).

  3. FDA warning letter cites BPC-157

    enforcement action recorded

    FDA warned Warrior Labz SARMS that its BPC-157 products were unapproved new drugs.

  4. WADA adds BPC-157 to Prohibited List

    effective

    BPC-157 appears as an example in S0 (non-approved substances).

Controlling sources

Frequently asked questions

Is BPC-157 FDA approved?
No. No FDA-approved application is in effect for BPC-157 for any use or route.
Can a pharmacy compound BPC-157?
Under current FDA guidance, BPC-157 is in Category 2 (significant safety risks) for 503A compounding and is not on the 503B bulk list.
Last verified: 2025-03-01
Reviewer: External Regulatory Reviewer
Next review: 2025-06-01

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