Is BPC-157 Legal in Arizona? Federal and State Status Explained
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.
| Measure | Value | Note |
|---|---|---|
| Listings naming BPC-157 | 20 | |
| Bulk ingredient listings | 20 | raw material registrations, not finished medicines |
| Of those, bulk ingredient for human prescription compounding | 8 | |
| Finished product listings | 0 | |
| Listings under an FDA-approved application | 0 | |
| Firms with a listing | 16 |
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.
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.
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).
| Measure | Value | Note |
|---|---|---|
| Recall entries on record | 6 | |
| For products FDA lists under an approved or registered label | 0 | |
| For compounded or other unlisted products | 6 | matched by the name in the product description |
| Class I (most serious) | 0 | |
| Class II | 6 | |
| Class III | 0 | |
| Most recent recall reported | 2025-10-15 | |
| Most common stated reason | lack of sterility assurance | 6 of 6 entries |
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.
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.
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.
| Measure | Value |
|---|---|
| Registered studies | 4 |
| Recruiting now | 1 |
| Not yet recruiting | 1 |
| Completed | 1 |
| Terminated, withdrawn or suspended | 0 |
| Phase 3 (including phase 2/3) | 0 |
| Phase 2 (including phase 1/2) | 1 |
| Phase 1 | 2 |
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.
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.
At a glance
- FDA approval / None; no approved product found in any country FDA searched [1]
- Pharmacy list / Not listed; category 1 does not cover it [3]
- Outsourcing list / Not listed [6]
- Safety-risk page / Category 2 from September 2023 to April 22, 2026; now in the withdrawn table [2]
- Advisory vote / July 23, 2026; advice only [4]
- HHS draft policy / October 28, 2026; not an approval, not binding [5]
Is BPC-157 an approved drug?
No. No FDA-approved drug contains BPC-157, 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]. It is a synthetic peptide of 15 amino acids, made as a free base or an acetate salt [1]. Compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before marketing [7].
Where does BPC-157 sit 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), so category 1 does not cover it. It is also not on FDA's outsourcing-facility list (updated March 21, 2025) [3][6].
FDA now lists it in a 'nominated but withdrawn' table, not the active category 2 table. It was in category 2 from September 2023 until April 22, 2026, when the groups that nominated it withdrew their nominations [2][7]. The move was not a finding of safety. FDA's page still states concerns about immunogenicity, impurities and a lack of safety information for the proposed routes [2].
On July 23, 2026 FDA's Pharmacy Compounding Advisory Committee voted in favor of adding BPC-157 to the list, against FDA staff's recommendation. News reports give the vote as 8 to 6 with 1 abstention. The vote is advice only, BPC-157 is not on the list, and adding it needs formal rulemaking [4][7].
What is the October 2026 HHS draft policy?
On October 28, 2026 HHS announced a draft enforcement-discretion policy for six peptides, including BPC-157, scheduled for Federal Register publication on October 30, 2026 [5]. 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][7].
For BPC-157 the draft conditions include:
- the acetate form only, in subcutaneous, intramuscular, oral or topical forms (nasal, rectal and intravenous are not listed);
- a single active ingredient;
- a patient-specific prescription;
- a label reading 'This is a compounded drug product. Not for resale.' [7]
The policy names state-licensed pharmacies, federal facilities and licensed physicians, not outsourcing facilities [7]. It is not an approval or a listing, it is 'not binding on HHS or the public', and HHS may revisit it, for example if a safety signal or product quality issue appears [5][7].
What about Arizona?
Arizona-specific permission is not established by the federal records. The federal picture is that BPC-157 is an unapproved substance, absent from both FDA compounding lists, and covered only by a nonbinding draft policy [1][3][5][6].
Frequently asked questions
Is BPC-157 FDA-approved?
Is BPC-157 on FDA's list for state-licensed pharmacies?
Did the July 2026 advisory committee vote make BPC-157 legal to compound?
Is BPC-157 banned in sport?
References
Show all 9 referencesHide references
- U.S. Food and Drug Administration.
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA.
- U.S. Food and Drug Administration.
- U.S. Food and Drug Administration.
- Official web page.
- U.S. Food and Drug Administration.
- Official web page.
- World Anti-Doping Agency.
- World Anti-Doping Agency.