Six peptides now have an interim compounding pathway: Here’s what it means
HHS has released a draft interim enforcement discretion policy for six peptides. Here’s what it covers, what it doesn’t, and what healthcare organizations need to do now.
Note: This content is for general informational purposes only and does not constitute legal advice. Please consult a licensed attorney for legal guidance.
Last updated: October 30, 2027
At a glance
- HHS has released a draft, nonbinding interim policy covering six peptides: BPC-157, TB-500, Epitalon, Semax, KPV, and MOTS-c.
- HHS does not intend to take enforcement action against state-licensed 503A pharmacies, federal facilities, and licensed physicians that compound these peptides for individual patients with a valid prescription, as long as every policy condition is met. Coverage applies only to the specific form and route listed for each peptide.
- Each product may contain only one covered peptide. Blends and combinations fall outside the policy.
- The peptides are not on the 503A Bulk Drug Substances List and are not Category 1.
- This is not FDA approval, and HHS can narrow or withdraw the policy. It is not a safe harbor and does not create a right to compound or ship.
- State requirements still apply on top of federal ones.
HHS has released a draft, nonbinding interim enforcement discretion policy for six peptides. Under it, HHS does not intend to take enforcement action against state-licensed 503A pharmacies, federal facilities, and licensed physicians that compound these peptides for individual patients with a valid prescription, when specific conditions are met. The peptides have not been added to the 503A Bulk Drug Substances List, and they are not in Category 1 of FDA’s interim bulks policy.
This is the moment many in the industry have been waiting for since the FDA moved more than a dozen peptides to Category 2 in 2023. Here is what the policy means, what it still does not mean, and what your organization should be doing right now.
How did we get here?
The path to today’s interim enforcement discretion policy started three years ago in September 2023. Here’s a high-level timeline noting key events from then until now.
September 2023 — FDA moves 19 peptides to Category 2. Licensed compounding pharmacies can no longer prepare them.
February 27, 2026 — HHS Secretary announces intent to reclassify 14 peptides, describing the 2023 restrictions as having pushed demand toward an unregulated black market rather than reducing access.
April 15, 2026 — FDA formally removes 12 peptides from Category 2 and announces the PCAC review schedule. Removals take effect April 22.
July 23-24, 2026 — PCAC convenes at FDA’s White Oak Campus to review seven peptides and recommends six—BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax—for inclusion on the 503A Bulks List, subject to FDA’s final determination.
October 14, 2026 — HHS and FDA send an “Interim Access Policy for Compounding Using Certain Peptides” to OMB for regulatory review.
October 28, 2026 — HHS releases its draft interim enforcement discretion policy for 503A compounding, covering the six peptides.
Before the end of February 2027 — A second PCAC meeting is expected to review five additional peptides
Peptides covered by the HHS interim policy
Under HHS’s interim enforcement discretion policy, the following peptides are covered for 503A compounding, each only in the form and route listed. A listed peptide in a different salt form or route is outside the policy:
BPC-157
- Covered form: acetate
- Covered routes: subcutaneous injection, intramuscular injection, oral, and topical; requires documentation that the specific formulation achieves adequate human oral biovailability
TB-500 (the fragment, Ac-LKKTETQ)
- Covered form: acetate
- Covered routes: subcutaneous or intramuscular injection
Epitalon
- Covered form: acetate
- Covered routes: subcutaneous or intramuscular injection, dispensed in intermittent courses
Semax
- Covered form: free base
- Covered route: intranasal only
- Open issue: the policy allows only an FDA 510(k)-cleared syringe as a device co-packaged with or containing the drug. How an intranasal product and its nasal device fit that condition is unresolved.
KPV
- Covered form: acetate
- Covered routes: topical and oral; oral requires documentation that the specific formulation achieves adequate human oral bioavailability.
MOTS-c
- Covered form: acetate
- Covered routes: subcutaneous or intramuscular injection
What does the interim access policy actually mean?
It’s important to note: the policy means HHS does not intend to take enforcement action when every condition is met. It is not FDA approval, and it does not add the peptides to the 503A Bulks List. It is a draft interim enforcement position while formal rulemaking continues, and HHS can narrow or withdraw it, for example, if a safety signal or product quality issue arises. It is not a safe harbor, and state boards of pharmacy are not bound by it.
Is this the same as FDA approval?
No. This is an important distinction for any organization building a peptide program — and for patient communication.
Even with this policy in place, many of these substances have not completed clinical trials, received a formal New Drug Application, or been validated as finished drug products. Compounded medications are not evaluated by the FDA for safety, efficacy, or quality.
Enforcement discretion is not FDA approval. Informed consent and patient communication must reflect that.
What changes now that there’s an interim compounding policy in place?
Licensed 503A pharmacies and physicians can compound these substances for individual patients with a valid prescription and HHS does not intend to take enforcement action, as long as the policy’s conditions are met. The policy does not remove other requirements:
1. Sourcing requirements still apply. Bulk drug substances must be manufactured by an FDA-registered establishment and accompanied by a valid certificate of analysis. Research-grade peptides labeled “for research use only” cannot be used in human compounding under any circumstances.
2. Compounding remains tied to patient-specific prescribing. Interim compounding status does not create a wholesale or manufacturing pathway. Every patient needs a valid, patient-specific prescription from a licensed provider.
3. The FDA evaluation continues. The FDA will continue its evaluation of these peptides for addition to the 503A Bulk list, and may update determinations based on new safety information.
What happens next?
These 6 peptides are still being reviewed by the FDA for addition to the 503A Bulk Compounding Category 1 list. The current policy update is a temporary enforcement policy while we wait for that update.
For reference, the FDA uses a three-category system to evaluate nominated bulk drug substances, the active pharmaceutical ingredients that compounding pharmacies use to prepare customized medications:
| Category | What It Means | Can It Be Compounded? |
| Category 1 | Sufficient safety information; within scope of FDA’s interim enforcement policy for 503A compounding | Yes, with a valid patient-specific prescription |
| Category 2 | Significant safety risks identified; not within scope of interim enforcement policy | No |
| Category 3 | Insufficient data to evaluate | No |
Review state specific regulations and laws
Federal enforcement discretion does not automatically satisfy state-level requirements. State pharmacy boards have independent authority to add requirements on top of the federal baseline, and they use it.
Requirements for third-party testing, additional licensing, and prescriber supervision vary significantly by state. Some states restrict what a nurse practitioner can independently prescribe. Others limit which compounding pharmacies can ship into the state.
State pharmacy boards don’t just set rules. They enforce them. Compounders operating outside state-specific requirements have faced action even when federal requirements were fully met.
For organizations building multi-state programs, this is not a hypothetical risk. It is an operational reality that needs to be built into your compliance framework from day one.
What does this mean for your business?
Patient interest in peptides has already been growing. In fact, estimated U.S. Google search volume for “peptides” increased 398% year over year, reflecting a significant rise in public interest.
The market is growing alongside that interest. The global peptide therapeutics market was estimated at $140.86 billion in 2025 and is projected to reach $294.58 billion by 2033. To put that into perspective, the global consumer AI market was projected at $12 billion in 2025.
Your patients were already asking about these therapies. This interim enforcement policy may make it possible for you to offer it to them, when the right standards are met along with applicable state laws. Patients are researching providers, comparing options, and deciding where to go right now.
The organizations with compliant peptide pathways, and infrastructure already in place can capture that now. Those still building risk patients looking elsewhere for support.
Partnering with a digital health infrastructure provider like OpenLoop can help you meet demand for clinically prescribed peptide pathways sooner, without having to build the clinical, technical, and compliance infrastructure from scratch.
What should you consider next?
The interim policy is a nonbinding position HHS can revisit. The compliance work still applies either way. Here is where to start:
- Audit your pharmacy partnerships. Not all compounding pharmacies operate at the same standard. Confirm third-party testing, FDA-registered API sourcing, state licensing coverage, and USP 797 compliance before patient volume accelerates.
- Build your clinical protocols. Compounded peptide programs require documented clinical rationale, patient-specific prescriptions, and informed consent that clearly communicates these are not FDA-approved products. Build these workflows now, not after launch.
- Map your state compliance gaps. State pharmacy board requirements, prescriber supervision rules, and shipping restrictions vary and change. Know where your gaps are before you scale.
- Align your patient communication. Marketing language, consent forms, and patient education materials must not imply FDA approval or guaranteed availability. Get this right before you launch.
- Move. The regulatory pathway is open. The organizations that act on it compliantly and quickly will be the ones patients choose.
Work on adding a compliant peptide program faster with OpenLoop
If you’re looking to offer peptides to your patients, without the clinical build, think about working with a white-label infrastructure provider like OpenLoop.
Launching a compliant peptide pathway requires the right pharmacy partners, clinical protocols, prescriber oversight, and state-by-state compliance infrastructure. With OpenLoop, you get:
- Access to compounded medications through vetted 503A pharmacy partners, with rigorous sourcing and quality standards (where permitted by law)
- Medically reviewed, repeatable clinical protocols ready for peptide programs
- Licensed clinician network with credentialing and oversight across all 50 states
- Compliance-aligned infrastructure that adapts as federal and state regulations evolve
- 24/7/365 patient support
Contact our team to learn more about building a peptide-ready program.
