BPC-157: where it stands with the FDA, and what it costs
The compound at the center of the FDA's compounding review of peptides. No FDA-approved drug contains it.
Prices by form:injections (82)capsules (16)
Go to clinicLowest per monthBPC-157 injection
Enhanced · from $109/mo
Go to clinicLowest at a clinic we link toBPC-157 injection
Live Vital · $144.50/mo (supply not stated, counted as 4 weeks: ≈ $155 per 30 days)
Where BPC-157 stands today
No FDA-approved drug contains BPC-157, and it is not on the 503A bulks list. FDA had it in 503A Category 2 (significant safety risks) from September 2023 until April 22, 2026, when FDA removed it because the nominations were withdrawn. On July 23, 2026 FDA's advisory committee voted 8-6 (1 abstention, per law-firm reports) to recommend listing it, against FDA staff's proposal. On October 30, 2026 HHS published (as a draft, comments closed mid-November) an interim enforcement discretion policy: HHS does not intend to take enforcement action against 503A pharmacies compounding BPC-157 acetate for subcutaneous, intramuscular, oral or topical use, single-ingredient only, from a certificate-of-analysis-backed API from an FDA-registered manufacturer, with adverse-event reporting and the other listed conditions. The policy does not cover 503B outsourcing facilities.
For pharmacies compounding one patient's prescription (section 503A)
Not on the 503A bulks list and in no FDA category (removed from Category 2 on April 22, 2026 after its nominations were withdrawn). Since Oct 30, 2026 it is one of six peptides in HHS's interim enforcement discretion policy for 503A compounding, limited to the form and routes below and ten conditions.
“Bulk drug substances nominated but withdrawn ... BPC-157 Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization.”
““BPC-157” has been removed from category 2 because the nominations were withdrawn by the nominators.”
HHS interim enforcement discretion policy (Office of the Secretary, not FDA)
“HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a bulk drug substance in Appendix A.”
Form and routes HHS covers
“Based on the identified updated information, enforcement discretion for BPC-157 acetate is appropriate for subcutaneous, intramuscular, oral, and topical dosage forms that are compounded from API accompanied by a certificate of analysis (CoA) meeting the conditions of this policy.”
“BPC-157 (free base) and BPC-157 acetate were in Category 2 from September 2023 until April 22, 2026, and neither the placement nor the removal changed their status under section 503A; Center for Drug Evaluation and Research (CDER) recommended against listing either form, and the Pharmacy Compounding Advisory Committee (PCAC) voted in favor of inclusion.”
One of the ten conditions: single-ingredient products only (no blends)
“The compounded drug product contains only a single Active Pharmaceutical Ingredient (API) listed in Appendix A.”
The Federal Register notice calls the policy a draft; written comments closed two weeks after publication
“HHS is announcing the availability of a draft”
21 CFR 216.23(a), the 503A bulks list itself: six substances (Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester, thymol iodide); none of the compounds in this file
“The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act.”
For outsourcing facilities (section 503B)
Not on the 503B bulks list and not in any 503B category (FDA's 503B nominations list, updated March 21, 2025, does not name it)
“Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or”
The 503B bulks list holds five substances (diphenylcyclopropenone, glycolic acid, quinacrine HCl oral, squaric acid dibutyl ester, trichloroacetic acid); none of the compounds in this file
“FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:”
The HHS policy names 503A compounders only; it does not cover 503B outsourcing facilities
“HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician”
The FDA's compounding advisory committee
23 July 2026: Should BPC-157 (free base) and BPC-157 acetate be placed on the 503A bulks list? (use FDA reviewed: ulcerative colitis). Vote: 8 yes, 6 no, 1 abstention (both forms), per law-firm reports. Committee recommended inclusion, against FDA staff's proposal; no FDA rule yet; HHS cited the vote in its Oct 30, 2026 interim policy
“VOTE: Should BPC-157 (free base) be placed on the list? ... VOTE: Should BPC-157 acetate be placed on the list?”
FDA warnings, recalls and letters
12 June 2023: Warning letter treating BPC-157 and TB-500 sold online as unapproved new drugs. (Warrior Labz SARMS (online seller)).
““BPC-157,” “TB-500,” ... products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).”
14 September 2023: Untitled letter: compounding with BPC-157 acetate is outside section 503A. (Barclay, Luke, and Pillai Specialty Pharmacy dba Meta Pharmacy Services, Las Vegas, NV (503A pharmacy)).
“Your firm compounded drug products using ibutamoren mesylate, BPC-157 acetate and theanine, that are not eligible for the exemptions provided by section 503A(a), because the bulk drug substances are not the subject of applicable USP or NF monographs, not components of FDA-approved human drugs, and do not appear on the 503A bulks list.”
21 October 2025: Recall of BPC-157 for injection, part of a recall of the facility's sterile products. Class II; recall initiated 2025-07-30, classified 2025-10-21, distributed nationwide. (GenoGenix LLC, Boca Raton, FL (registered 503B outsourcing facility)).
“BPC-157 for Injection, 15mg/10mL vial, all presentations ... Lack of Assurance of Sterility”
21 October 2025: Recall of a BPC-157/thymosin beta-4 combination injection. Class II; recall initiated 2025-07-30, classified 2025-10-21, distributed nationwide. (GenoGenix LLC, Boca Raton, FL (registered 503B outsourcing facility)).
“BPC-157/Thymosin Beta-4 for Injection ... Lack of Assurance of Sterility”
For athletes who are tested
Prohibited at all times (in and out of competition) (World Anti-Doping Agency, 2026 Prohibited List (in force 1 Jan 2026; WADA approved a 2027 list in Sept 2026, effective 1 Jan 2027, not read here)).
“This class covers many different substances including but not limited to BPC-157”
Our reading
Since Oct 30, 2026 a 503A pharmacy can compound BPC-157 acetate for a patient-specific prescription with federal enforcement risk low if it meets all ten HHS conditions (no blends such as BPC-157 with TB-500; no other salt forms such as 'BPC-157 arginate'; routes as listed). This is enforcement discretion, not legal status: the statute's bulk-substance condition is still unmet, HHS can revisit it, the notice calls the policy a draft, and state boards of pharmacy may still restrict it. A 503B facility has no such policy. Claims that BPC-157 is 'FDA approved' or 'legal' are wrong.
Every source above was checked again on 14 November 2026.
What 91 clinics charge
- EnhancedBPC-157 injectionfrom $109/mo
- BelleBPC-157 injectionfrom $116for 30 days
- ChiaBPC-157from $115/mosupply not stated, counted as 4 weeks: ≈ $123 per 30 days
- ArgoBPC-157 injection$125/mo
- PepScribeBPC-157 injectionfrom $129/mo
What BPC-157 is
- What it is
- Synthetic peptide (15 amino acids, from a gastric protein sequence)
- How it works
- A 15-amino-acid fragment of a protein found in gastric juice, studied mostly in animals for tissue healing.
- How it is given
- Subcutaneous injection; also sold as capsules and nasal sprays
- Also called
- body protection compound 157, pentadecapeptide BPC 157
BPC-157 side by side
About BPC-157
Is BPC-157 FDA-approved?
No. No FDA-approved drug contains BPC-157. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is BPC-157 legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug contains BPC-157, and it is not on the 503A bulks list. FDA had it in 503A Category 2 (significant safety risks) from September 2023 until April 22, 2026, when FDA removed it because the nominations were withdrawn. On July 23, 2026 FDA's advisory committee voted 8-6 (1 abstention, per law-firm reports) to recommend listing it, against FDA staff's proposal. On October 30, 2026 HHS published (as a draft, comments closed mid-November) an interim enforcement discretion policy: HHS does not intend to take enforcement action against 503A pharmacies compounding BPC-157 acetate for subcutaneous, intramuscular, oral or topical use, single-ingredient only, from a certificate-of-analysis-backed API from an FDA-registered manufacturer, with adverse-event reporting and the other listed conditions. The policy does not cover 503B outsourcing facilities.
How much does BPC-157 cost?
91 clinics publish a price. The lowest that compares per month is from $109/mo at Enhanced, and the middle of 71 clinics' lowest monthly prices is about $189. What a month buys differs by clinic, so each price lists what it includes. every BPC-157 price
What forms does BPC-157 come in?
Clinics sell it as injection (82 prices), capsules (16 prices), other (10 prices), nasal spray (1 price), tablets (1 price).