Is BPC-157 Legal in Maryland? The Federal Picture

Is BPC-157 an approved drug?

No. BPC-157 is a synthetic peptide of 15 amino acids, described as a fragment of a protein first isolated from human gastric juice, and it is made as a free base or an acetate salt, which FDA treats as two different bulk substances [1]. No FDA-approved drug contains it, there is no US Pharmacopeia or National Formulary monograph for it, and FDA's July 2026 review found no approved product containing it in any country it searched [1].

Where does it stand on FDA's compounding lists?

BPC-157 is in none of the three categories on FDA's list of nominated bulk substances for state-licensed pharmacies and physicians (updated May 14, 2026) [2]. Category 1 is the group FDA says it generally will not act against compounders for, if conditions are met, so that policy does not cover BPC-157 [2].

BPC-157 sat in category 2, the significant-safety-risk group, from September 2023 until April 22, 2026, and now appears in a separate 'nominated but withdrawn' table after the nominating groups withdrew their nominations [8]. Removal was not a finding of safety, and FDA's concerns remain on the page: compounded BPC-157 'may pose risk for immunogenicity for certain routes of administration' and FDA 'has identified no, or only limited, safety-related information for the proposed routes of administration' [8]. It is also absent from FDA's bulk substances list for outsourcing facilities, the large registered compounders (list updated March 21, 2025) [4].

At the July 23, 2026 Pharmacy Compounding Advisory Committee meeting, members voted in favor of adding BPC-157 to the pharmacy bulks list against FDA reviewers' recommendation [1][5]. The vote was non-binding and BPC-157 is not on the list [5][6].

What does the October 2026 HHS draft policy say?

On October 28, 2026 HHS filed a notice announcing a draft enforcement-discretion policy covering six peptides, BPC-157 among them, scheduled for Federal Register publication on October 30, 2026 [3][6]. HHS says it 'does not intend to take enforcement action' against a state-licensed pharmacy, federal facility or licensed physician compounding with a listed peptide while FDA's list is developed through rulemaking, if the conditions are met [3].

For BPC-157 the conditions include BPC-157 acetate only, given subcutaneously, intramuscularly, orally or topically (nasal, rectal and intravenous are not listed), a single active ingredient, bulk substance from an FDA-registered manufacturer with a valid certificate of analysis, a patient-specific prescription, and reporting of serious adverse events to FDA MedWatch [6].

The notice says the policy 'does not establish any rights for any person and is not binding on HHS or the public'; it is not an approval and does not put BPC-157 on any list [3].

What about Maryland?

This page covers the federal picture only and does not set out Maryland statutes or board rules. Federally, BPC-157 remains unapproved and absent from FDA's pharmacy and outsourcing-facility bulk-substance lists, and HHS's draft policy does not add it to an FDA list [2][3][4].