Is BPC-157 Legal in Michigan? How to Access It Through Legal Channels

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BPC-157 has no FDA approval and no approved pharmacy route yet

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From the public record

FDA product listings naming BPC-157

The FDA NDC Directory holds 20 listings naming BPC-157 from 16 firms: 20 bulk ingredient listings and 0 finished product listings, 0 under an FDA-approved application. A listing is a registration by a firm, not an FDA approval.

FDA product listings naming BPC-157: the figures
MeasureValueNote
Listings naming BPC-15720
Bulk ingredient listings20raw material registrations, not finished medicines
Of those, bulk ingredient for human prescription compounding8
Finished product listings0
Listings under an FDA-approved application0
Firms with a listing16

Source: FDA, National Drug Code Directory via openFDA, data as of Nov 11, 2026

How this was calculated

Searched ingredient and product names in the NDC Directory download for the exact name variants, then counted listings by FDA marketing category and by listing firm.

Scope: Current NDC Directory listings whose ingredient or product name contains BPC 157 or BPC-157

Firms submit listings themselves. A listing does not mean FDA has reviewed the substance for safety or effectiveness, or that it may lawfully be compounded.

Download the data (CSV)

From the public record

FDA drug recalls naming BPC-157

FDA enforcement reports list 6 drug recall entries naming BPC-157 from 2019 to 2025-10-15. 6 of them are for compounded or other unlisted products and 0 for products FDA lists under a label. The most common stated reason was lack of sterility assurance (6 of 6).

FDA drug recalls naming BPC-157: the figures
MeasureValueNote
Recall entries on record6
For products FDA lists under an approved or registered label0
For compounded or other unlisted products6matched by the name in the product description
Class I (most serious)0
Class II6
Class III0
Most recent recall reported2025-10-15
Most common stated reasonlack of sterility assurance6 of 6 entries

Source: FDA, Enforcement Reports (drug recalls) via openFDA, data as of Nov 10, 2026

How this was calculated

Counted enforcement report entries matched by FDA's listed active substance, or by the name in the product description where FDA lists none. Reasons were grouped by keywords in FDA's stated reason.

Scope: Recalls whose product description names BPC-157, including compounded and multi-ingredient products

Each recall covers specific lots from one firm and is not a statement about every product with this ingredient. One event can appear as several entries, one per product.

Download the data (CSV)

From the public record

Registered clinical studies of BPC-157

ClinicalTrials.gov lists 4 registered studies that name BPC-157 as an intervention as of 2026-11-11. Of these, 1 are recruiting, 1 are completed and 0 are phase 3 studies.

Registered clinical studies of BPC-157: the figures
MeasureValue
Registered studies4
Recruiting now1
Not yet recruiting1
Completed1
Terminated, withdrawn or suspended0
Phase 3 (including phase 2/3)0
Phase 2 (including phase 1/2)1
Phase 12

Source: NIH National Library of Medicine, ClinicalTrials.gov, data as of Nov 11, 2026

How this was calculated

Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.

Scope: Studies whose intervention field matches BPC 157 or BPC-157, any condition, any country, all statuses

A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.

Download the data (CSV)

At a glance

  • FDA approval / None; no approved drug contains BPC-157 in any country FDA searched [1]
  • Pharmacy bulks list / In none of the three categories, including category 1 [2]
  • Category 2 table / Removed April 22, 2026 after nominators withdrew [7][6]
  • Advisory committee / July 23, 2026 vote favored listing; advice only [8]
  • HHS draft policy / Conditional enforcement discretion only [5][6]
  • Outsourcing facilities / Not on FDA's list for them [3]
  • Sport / WADA class S0, prohibited at all times [9]

What is BPC-157's federal status?

BPC-157 is a synthetic peptide of 15 amino acids, described as a fragment of a protein first isolated from human gastric juice [1]. No FDA-approved drug contains it, no US Pharmacopeia or National Formulary monograph exists for it, and FDA's July 2026 review found no approved product containing it in any country it searched [1]. Websites sell it as capsules, injections, oral sprays and nasal sprays, some labeled 'for research purposes only and not for human or veterinary use'; those products are not FDA-approved drugs [1].

Can a pharmacy compound it?

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), including category 1, the group FDA says it generally will not act against compounders for if the conditions are met [2]. It is also not on FDA's list for outsourcing facilities, the larger registered compounders [3].

It sat in category 2, FDA's table of substances that may present significant safety risks, from September 2023 until April 22, 2026, and came off because the groups that nominated it withdrew, not because FDA cleared it [7][6]. FDA's stated concerns remain on that page: compounded BPC-157 'may pose risk for immunogenicity for certain routes of administration', plus peptide-related impurities and characterization of the active ingredient, and the agency said it 'lacks sufficient information to know whether the drug would cause harm when administered to humans' [7].

What does the October 2026 draft HHS policy say?

HHS filed a notice on October 28, 2026 announcing a draft enforcement-discretion policy covering six peptides including BPC-157, scheduled for Federal Register publication on October 30, 2026, with public comments open for two weeks after publication [5][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 policy's conditions are met [5].

The conditions for BPC-157 are: the acetate form only, in subcutaneous, intramuscular, oral or topical forms (nasal, rectal and intravenous are not listed); a single active ingredient; bulk substance from an FDA-registered manufacturer with a valid certificate of analysis meeting a peptide testing standard; a label reading 'This is a compounded drug product. Not for resale.'; a patient-specific prescription; serious adverse events and quality problems reported to FDA MedWatch; an FDA 510(k)-cleared syringe as the only co-packaged device; and documentation of adequate bioavailability for oral forms [6].

The notice says it 'does not establish any rights for any person and is not binding on HHS or the public', and HHS may revisit it, for example if a safety signal or product quality issue appears [6].

Separately, FDA's Pharmacy Compounding Advisory Committee voted on July 23, 2026 in favor of adding BPC-157 to the pharmacy bulks list, against FDA staff's recommendation. The vote is advice only, and adding BPC-157 would need formal rulemaking [8][6].

Questions worth asking

Choose the questions you want to keep

Is BPC-157 safe, and is it allowed in sport?

FDA concluded there is 'insufficient clinical safety information to characterize the safety profile' of BPC-157, and its search of the adverse-event database through December 4, 2025 found three reports, all involving injectable BPC-157, which FDA said it cannot tell were caused by the drug [1]. A 2026 systematic review of human evidence found three studies covering 30 patients, all of poor methodological quality, with certainty of evidence rated very low [10]. WADA names BPC-157 in class S0 (non-approved substances), prohibited at all times, in a 2026 List in force since January 1, 2026 [9].

Check what you know

Think you have it? Try 4 quick questions and see what the article says.

1. According to the article, when is BPC-157 prohibited in sport under WADA's list?

Question 1 of 4

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Frequently asked questions

Is BPC-157 legal in Michigan?
It is not FDA-approved and appears in none of the three categories on FDA's bulk-substance list for state-licensed pharmacies; it is also absent from FDA's list for outsourcing facilities [1][2][3]. A draft October 2026 HHS policy describes conditional enforcement discretion for certain compounders, but it is non-binding and is not an approval [5][6].
Can a pharmacy fill a BPC-157 prescription?
A patient-specific prescription is one condition the October 2026 draft HHS policy lists for state-licensed compounders using BPC-157 acetate, alongside an FDA-registered bulk supplier, a certificate of analysis meeting a peptide testing standard, MedWatch reporting and a specified label [6][5].
Did the July 2026 advisory committee vote make BPC-157 legal?
No. The committee's vote was advisory, and adding BPC-157 to the pharmacy bulks list would require formal rulemaking with a proposed rule, public comment and a final rule [8][6].
Is BPC-157 known to be safe in humans?
FDA concluded there is insufficient clinical safety information to characterize its safety profile, and it identified no human studies of BPC-157 given by mouth, subcutaneous injection, nasal spray or skin [1]. A 2026 systematic review found three studies and 30 patients, with certainty of evidence rated very low [10].

Reader questions

What people actually ask

Short answers drawn from the sources this article cites.

Are there human trials on BPC-157?

Yes, but very few. A 2026 systematic review of human evidence found three studies covering 30 patients, all of poor methodological quality, with certainty of evidence rated very low. FDA also concluded there is insufficient clinical safety information to characterize BPC-157's safety profile.

Is BPC-157 FDA-approved?

No. BPC-157 is not an FDA-approved drug, and FDA's July 2026 review found no approved product containing it in any country it searched. No US Pharmacopeia or National Formulary monograph exists for it either.

References

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Evidence overview for Is BPC-157 Legal in Michigan? How to Access It Through Legal Channels