The Enforcement discretion is a regulator's stated decision not to take action against conduct that does not meet a legal requirement. It usually comes with conditions and leaves the law itself unchanged. FDA used it to wind down GLP-1 compounding after the shortages were resolved. In October 2026 the Department of Health and Human Services (HHS) proposed it for six peptides.
How does enforcement discretion apply to compounded GLP-1 treatment?
The enforcement discretion FDA gave GLP-1 compounders after the shortages has ended. While semaglutide and tirzepatide were on the drug shortage list, the limits on compounding essentially copies of them were not applicable. When FDA determined each shortage resolved, it said it did not intend to take action against compounders for a set period. For state-licensed pharmacies compounding under section 503A, that period ended on March 5, 2025 for tirzepatide and on April 24, 2025 for semaglutide. For outsourcing facilities it ran until March 19, 2025 and May 22, 2025. A compounded GLP-1 prescription now rests on section 503A itself: a valid prescription for an identified individual patient, filled by a state-licensed pharmacy, within the section's limit on drugs that are essentially copies of a commercially available drug. BrightSide's compounded tirzepatide is prescribed for an individual patient and filled by a state-licensed pharmacy.
What does enforcement discretion mean at the pharmacy?
At the pharmacy, enforcement discretion is a written policy with conditions, and it covers a pharmacy only while the conditions are met. FDA's interim policy on bulk drug substances is an example. While FDA decides whether a nominated substance belongs on the 503A bulks list, it does not intend to take action against a pharmacy that compounds with a Category 1 substance, provided the conditions in its guidance are met. These policies do not set aside the rest of the law. Each FDA statement on GLP-1 compounding added that the agency may still act on other violations, such as a product that is substandard or unsafe. HHS says it may revisit its peptide policy if a safety signal or product quality issue arises.
How does enforcement discretion apply to peptides?
The newest policy covers six peptides: BPC-157, TB-500, Epitalon, KPV, MOTS-c and Semax. HHS announced its draft enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances in the Federal Register on October 30, 2026. HHS states that it does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed physician compounding with one of these peptides, while the 503A bulks list is developed through rulemaking. The conditions include a bulk substance from a manufacturer registered with FDA, a valid certificate of analysis and a prescription for a specific patient. The notice opened a two-week comment period, states no effective date, and says the policy is not binding on HHS or the public. BrightSide's peptides will be available by prescription once prescribing opens. You can join the peptide list on our peptide hub, and our pharmacy network page covers how we choose pharmacies.
| Policy | Who it covers | Status |
|---|---|---|
| Tirzepatide injection after the shortage | 503A pharmacies; 503B outsourcing facilities | Ended March 5, 2025; ended March 19, 2025 |
| Semaglutide injection after the shortage | 503A pharmacies; 503B outsourcing facilities | Ended April 24, 2025; ended May 22, 2025 |
| Category 1 bulk drug substances | 503A compounders | In effect, under the conditions in FDA guidance |
| Six peptides | 503A compounders | Draft published October 30, 2026; comment period open |
Common questions
Does enforcement discretion make a compounded drug FDA approved?
No. Enforcement discretion is a statement about what a regulator intends to act on. The HHS peptide notice says its policy does not establish any rights for any person and is not binding on HHS or the public. A drug compounded under such a policy is still not FDA approved.
Is enforcement discretion for compounded semaglutide and tirzepatide still in effect?
No. For pharmacies compounding under section 503A, it ended on March 5, 2025 for tirzepatide and on April 24, 2025 for semaglutide. FDA's April 1, 2026 statement sets out the conditions that apply now, starting with a drug compounded for an individual patient based on a prescription.
Related terms
- Bulks list (503A bulk drug substances): the list FDA is developing while these policies are in place.
- FDA drug shortage list: the list whose resolution started the GLP-1 wind-down periods.
- 503A compounding pharmacy: the kind of pharmacy the peptide policy covers.
- Certificate of analysis (COA): a document the peptide policy requires for every lot.
Sources
- HHS, notice of availability of the peptide enforcement discretion policy, 91 FR 68526, October 30, 2026: https://www.govinfo.gov/content/pkg/FR-2026-10-30/html/2026-22192.htm
- HHS, peptide enforcement discretion policy for 503A compounding (policy document): https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
- FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, content current as of April 1, 2026: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
- FDA, Bulk drug substances used in compounding under section 503A of the FD&C Act, content current as of May 14, 2026: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
Compounded medications are not FDA approved. They are prescribed by a licensed clinician and filled by a licensed 503A pharmacy.
