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Research library US Regulatory Status

Is BPC-157 Legal to Purchase in the United States?

Article

US Regulatory Status · 3 MIN READ · GUIDE

01 / Overview

Not a controlled substance, not an approved medicine

BPC-157, body protection compound-157, is a synthetic pentadecapeptide with the sequence Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val. It is not a controlled substance, it is not scheduled under the Controlled Substances Act, and purchasing it for research purposes is not prohibited under federal law.

Is it an approved medicine?

No. BPC-157 has not been approved by the FDA as a medicine for any indication. No new drug application has been submitted for it, and no human clinical trials registered in the United States have been completed for it.

What is the compounding status?

BPC-157 is on the FDA's Category 2 list of bulk drug substances that may present significant safety risks in compounding [1]. This list applies to compounding pharmacies that prepare custom formulations; it does not make the substance illegal to possess or purchase for research.

What does research use only mean?

Materials sold for research use only (RUO) are intended for laboratory research and are not intended for use in humans. The label restriction reflects the regulatory status of the product, not a legal prohibition on its sale. A separate article in this library discusses the RUO designation in detail.

Frequently asked questions

Can BPC-157 be sold as a dietary supplement?

No. It does not meet the definition of a dietary ingredient under the Dietary Supplement Health and Education Act (DSHEA) of 1994 because it was not marketed as a supplement before that date and has not been submitted as a new dietary ingredient.

Is the legal status the same in all countries?

No. Regulatory frameworks vary by country. This article addresses only United States federal law.

Key facts

  • Controlled substance No. BPC-157 is not scheduled under the Controlled Substances Act
  • Approved medicine No. BPC-157 has not been approved by the FDA
  • Compounding status BPC-157 is on the FDA Category 2 list of bulk drug substances that may present safety risks
  • Research use Sold as a research material, labeled for research use only

Footnotes & references

Source list

References

  1. U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of April 22, 2026.

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