HHS’s Peptide Compounding Policy: What Healthcare Businesses Need to Know

Note: These routes remain subject to the policy’s other conditions. For example, oral formulations carry an additional documentation requirement concerning bioavailability.

Who Does The Policy Affect?

The policy applies to qualifying 503A pharmacies and physician compounders. It also matters to businesses that facilitate prescribing, sale, or dispensing through those compounders, including telehealth providers.

503B outsourcing facilities are not covered. The policy does not create a new allowance for those facilities to compound the six peptides referenced.

Businesses must therefore understand both the product being offered and the type of facility preparing it. A peptide’s inclusion in this policy does not establish that every source or formulation is acceptable.

Requirements for Compounding Under the Enforcement Discretion Policy

The policy sets out 10 conditions for eligibility. The following summarizes those conditions; businesses should review the policy itself for the complete requirements.

1. A covered peptide ingredient. The bulk drug substance must be one of the six substances identified in the policy.
2. The specified identity and route of administration. The ingredient must meet the policy’s identity specifications — including the relevant chemical characteristics — and be used through a permitted route.
3. FDA-registered sourcing and a valid certificate of analysis. The bulk drug substance must come from a facility registered under section 510 of the FD&C Act and be characterized and identified in a valid certificate of analysis (COA).
4. Original-manufacturer verification. The original manufacturer must be FDA-registered and comply with applicable current good manufacturing practice and other FD&C Act requirements. Its physical manufacturing location must appear on the COA supplied to the compounder. Where an intermediary supplies the ingredient, the policy also calls for documented manufacturer qualification and COA validation by that intermediary.
5. Reporting. Compounders must meet the policy’s reporting requirements concerning products compounded, serious adverse events, and product quality issues, including reporting to FDA and the relevant states.
6. Required labeling. The product label must include: “This is a compounded drug product. Not for resale.”
7. A single active pharmaceutical ingredient. The policy states that the compounded product must contain “only a single Active Pharmaceutical Ingredient (API) listed in Appendix A.” 
   1. While more clarification may become available in the coming weeks, the release references single-active pharmaceutical ingredient products a number of times, and does not delineate an allowance for exceptions.
   2. LegitScript interprets this as requiring a single-API formulation, excluding combinations with any other active ingredient. This approach supports meaningful safety monitoring by making it easier to attribute adverse events or clinical outcomes to a specific substance. Combining APIs could make it difficult to determine whether an outcome is associated with the covered peptide, another ingredient, or their interaction.
8. Evidence supporting oral bioavailability. For oral preparations, the compounder is expected to maintain documentation confirming that the specific formulation achieves adequate oral bioavailability in humans. An allowed oral route alone does not satisfy this condition.
9. Restrictions on delivery devices. The policy limits a delivery device co-packaged with, or containing, the compounded drug to an FDA 510(k)-cleared syringe. Businesses should not assume that clearance of a different device, such as an injector pen, satisfies this requirement.
10. Compliance with other applicable requirements. The product must meet other applicable FD&C Act requirements, including the patient-specific prescription requirement under section 503A and the prohibition against compounding under insanitary conditions.

What Does This Mean for LegitScript Certification?

LegitScript’s position is that offering one of these peptides should not, by itself, prevent a merchant from achieving certification when the offering meets the enforcement discretion policy’s conditions and all other applicable Certification Standards and laws and regulations governing compounding.

LegitScript’s Certification review will consider the specific ingredient, formulation, route of administration, compounding facility, supply chain compliance, and other relevant requirements. 

Offering other peptides or peptide formulations that fall outside the enforcement discretion policy and are not otherwise eligible for compounding under Section 503A or 503B remains a barrier to certification. 

Applicants and certified businesses should be prepared to provide supporting information about their offerings and pharmacy relationships.

Preparing for Certification and Platform Requirements

Before introducing or expanding a compounded peptide offering impacted by the recent enforcement discretion policy, businesses should:

• Confirm the exact ingredient form, formulation, and route of administration.
• Verify that the compounding arrangement falls within the policy’s 503A scope.
• Gather documentation demonstrating compliance with all applicable conditions.
• Review labels, marketing, and patient communications to avoid suggesting that enforcement discretion means FDA approval.
• Monitor updates to FDA’s enforcement discretion policy and be prepared to adjust product offerings if it is revised or withdrawn, including within any applicable transition periods or deadlines.
• Independently review the current policies of any advertising platforms, payment processors, acquirers, or card brands they intend to work with.

LegitScript is an independent, third-party certification organization that assesses businesses against its Certification Standards and Certification Terms and Conditions. We do not control the policies of advertising platforms, payment processors, acquirers, or card brands. LegitScript updates its review processes to reflect changes in applicable laws, regulations, and regulatory guidance. These updates do not change the independent requirements of advertising platforms or payment providers, and certification does not guarantee access to their services.

Even when a platform intends to update its policies to reflect the enforcement discretion policy, implementation may take time and may not align with LegitScript’s timeline. Businesses should independently confirm each platform’s current requirements and the effective date of any changes. Those requirements may differ from LegitScript’s and may restrict activities that otherwise qualify for certification.

Ongoing Monitoring and Certification Expectations

Ongoing compliance monitoring remains a core part of LegitScript Certification. Businesses whose covered compounded peptide offerings meet the policy’s conditions, applicable laws and regulations, and our Certification Standards will not face certification enforcement action solely for offering those peptides. Monitoring will continue to assess each certified merchant’s broader products, services, and business practices. The policy does not extend to other impermissible offerings or change the requirements governing them. Where violations are identified, LegitScript will take appropriate action under its Certification Standards and Certification Terms and Conditions.

As the regulatory landscape evolves, LegitScript will continue to monitor policy developments and regulatory shifts, assess their implications against our Certification Standards and review practices, and communicate updates to clients and partners. We remain committed to helping businesses navigate these changes with clear guidance and consistent expectations for compliance and transparency.

For quick answers to common questions about the enforcement discretion policy and LegitScript’s certification approach, see the Frequently Asked Questions appendix below. 

Our team is available at [email protected] to help existing clients and prospective applicants understand what these changes mean for their certification review.