BPC-157: legal status and evidence

Short answer: BPC-157 is not FDA-approved. Since October 30, 2026, a state-licensed pharmacy may compound BPC-157 acetate for one patient with a prescription under an interim HHS policy, in these forms only: subcutaneous or intramuscular injection, oral, or topical [1], [2]. FDA’s own staff reviewed the evidence and recommended against it [2], [3].

At a glance

Legal status	HHS interim policy: compounding with a patient-specific prescription [1]
Form covered	BPC-157 acetate [2]
Routes allowed	Subcutaneous or intramuscular injection, oral, or topical [2]
FDA Category 2	September 2023 to April 22, 2026 [2]
FDA staff view	Recommended against adding it to the 503A bulks list [2], [3]
Advisory committee	Voted in favor [2]
Human evidence (FDA review)	Not enough human data. FDA found no studies of BPC-157 given by injection, by mouth, through the nose or on the skin. [3]
Last checked	November 5, 2026

What FDA’s staff found

FDA’s drug center (CDER) reviewed BPC-157 for the uses it was nominated for: ulcerative colitis and other uses [3].

• FDA found no studies that gave BPC-157 to people by mouth, by injection under the skin, through the nose or through the skin. [3]
• It found one small trial in ulcerative colitis, with too few details to judge, and two studies that gave BPC-157 as a rectal enema for up to two weeks. Those studies reported no serious adverse events, but gave little safety information. [3]
• There is no information on how the human body absorbs or clears BPC-157. [3]
• No country has approved a drug containing BPC-157. [3]
• FDA also raised a concern that injected BPC-157 could trigger an immune reaction, because of possible clumping (aggregation) and impurities. [3]

Why HHS allowed it anyway

HHS gave three reasons in Appendix B to its policy [2]:

1. Use of BPC-157 is now documented and counted, including several human studies;
2. A lot-specific certificate from an FDA-registered facility now reports the identity, impurity, endotoxin, microbial and residual solvent results FDA’s review found missing;
3. The policy’s conditions (lot testing, single-ingredient products, MedWatch reporting) address the risks.

HHS may revisit the policy if a safety signal or a product quality problem appears, and the policy lasts until FDA decides in a final rule whether to add the peptide to the 503A bulks list [1].

How to get it legally

1. A licensed clinician decides it is right for you and writes a prescription in your name.
2. A state-licensed compounding pharmacy (503A) prepares it from an ingredient made at an FDA-registered facility, with a valid certificate of analysis [1].
3. The label says: “This is a compounded drug product. Not for resale.” It contains only one active ingredient [1].

See how to check a compounding pharmacy and how to read a peptide COA.

What is not known

FDA’s review found too little human data to describe how well BPC-157 works or how safe it is over time [3]. Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed [1]. Talk to a licensed clinician before you use any compounded peptide.

Change log

• November 5, 2026: page created from the HHS policy, Appendix B and FDA’s July 2026 briefing document.