FAQs: Department of Health and Human Services (HHS) Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances

Click here to view the November 10, 2026, letter from the Federation of State Medical Boards regarding HHS’s policy.

November 10, 2026
FAQs: Department of Health and Human Services (HHS) Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances

Background
On October 28, HHS released interim Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances for compounding six specified peptides while the Food and Drug Administration (FDA) considers their inclusion on the Section 503A bulk drug substances list. The policy provides conditional federal non-enforcement, not FDA approval, and does not itself amend federal statutory requirements, state law, or state board authority.

Written comments on this interim policy are due by November 13, 2026.
1. What did HHS do?
HHS released, in draft for public comment, an interim policy stating that it does not intend to take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound certain peptide products when all of the policy’s conditions are met. The policy covers six substances: BPC-157, epitalon, KPV, MOTS-c, Semax, and TB-500.

The policy creates a conditional enforcement approach while FDA considers, through rulemaking, whether to include these substances on the section 503A bulk drug substances list through rulemaking. It does not add these peptides to that regulatory list or approve the resulting compounded products.
To fall within HHS’s non-enforcement policy, compounders must meet specific conditions. To qualify compounders must:

• Use the right ingredient: one of the six listed peptides with the specified identity and route of administration, made by an FDA-registered manufacturer and backed by a certificate of analysis.
• Keep the product simple and safe: one active ingredient only, an FDA-cleared syringe as the only device, proof that oral forms are absorbed and no insanitary conditions.
• Label and report: mark the product as compounded and not for resale. Report about the products made, serious adverse events, and quality problems to FDA and the states.
• Have a valid prescription: compound only for an individual patient with a prescription.

2. What is the duration of the policy?
The policy has no fixed expiration date. For each peptide, it applies until a final rule determines whether the substance will be included on the 503A bulks list. This means that the interim period could end at different times for different substances. HHS also expressly reserves the ability to revisit the policy, in whole or in part, including if a safety signal or product quality issue arises.
3. Are these peptides legal?
The policy does not make these peptides categorically “legal” or “FDA-approved.” It establishes conditions in which HHS does not intend to enforce the federal requirements by their use in compounding. The products remain unapproved compounded drugs. HHS calls the notice a draft that “does not establish any rights,” and it may revisit the policy if safety or quality problems arise.
4. Does this change state law or board authority?
Not by itself. The policy does not amend state medical or pharmacy practice acts, expand scope of practice, or direct state boards to suspend their own enforcement. Nothing in the document expressly displaces state requirements governing prescribing, compounding, dispensing, administration, or professional conduct.
Boards should continue to evaluate their statutory authority and applicable requirements on relevant issues, such as medical necessity, informed consent, documentation, advertising, supervision, and the standard of care. These are also central elements of FSMB’s current prescribing and dispensing guidance.
State medical boards that have issued guidance or statements related to physicians prescribing non-FDA-approved (research grade) peptides include:

• Alabama Board of Medical Examiners: Board Notice Concerning the Prescribing of Non-FDA Approved (Research-Grade) Peptides
• Mississippi Board of Medical Licensure (Jointly with Mississippi Boards of Nursing and Pharmacy): Joint Statement Concerning the Prescribing of Non-FDA Approved (Research-Grade) Peptides
• South Carolina Board of Medical Examiners: Notice Concerning the Prescribing of Non-FDA Approved (Research-Grade) Peptides and FDA-Ineligible Peptides

Any state-specific law limiting board action or incorporating federal compounding requirements must be evaluated separately. The HHS policy alone does not resolve those questions.
5. What happens if state law depends on section 503A compliance?
If state law expressly requires compliance with section 503A, the HHS policy should not automatically be treated as satisfying that requirement. Section 503A specifies the conditions for statutory exemptions, including eligibility of the bulk drug substance; the HHS policy instead describes when the agency does not intend to take enforcement action despite the substance’s current status.

State medical board counsel should examine exactly what the state provision incorporates:

• Section 503A’s statutory requirements;
• The regulatory bulks list;
• FDA or HHS guidance and enforcement policies; and
• A separate state definition of permissible compounding or an express state-law exception.

These different wordings may produce different outcomes. A board should not assume that a state-law requirement for “503A compliance” is met merely because a compounder follows the HHS enforcement policy.
6. Can doctors now compound these peptides? What is the impact?
The policy applies to licensed physicians, but it is not unrestricted permission to compound. A physician would need to meet every policy condition and separately confirm that state law permits the activity and any additional state requirements are met.

Coverage is limited to the six peptide identities and their specified administration routes:

Peptide	Covered form	Covered route or dosage form
BPC-157	Acetate	Subcutaneous, intramuscular, oral, and topical
TB-500	Acetate	Subcutaneous or intramuscular injection
Epitalon	Acetate	Subcutaneous or intramuscular injection, dispensed in intermittent courses
Semax	Free base	Intranasal
KPV	Acetate	Topical and oral
MOTS-c	Acetate	Subcutaneous or intramuscular injection

 

 

 

 

 

*Acetate refers to a common salt form of the peptide. The policy covers only the specific forms listed.

Additional conditions include:

• An FDA-registered original bulk manufacturer that complies with current good manufacturing practice, with appropriate documentation and testing;
• A single Active Pharmaceutical Ingredient (API);
• Documentation of adequate human oral bioavailability for any oral formulation;
• Reporting and labeling safeguards;
• Any drug delivery device co-packaged with or containing the compounded drug must be an FDA 510(k)-cleared syringe; and
• A patient-specific prescription and compliance with other applicable FD&C Act requirements, including the prohibition on insanitary conditions.

Physicians seeking to compound under the policy must meet the same supplier, testing/documentation, and reporting conditions as pharmacies. State law still governs whether physicians may compound in the office. State medical boards may want to coordinate with their state board of pharmacy on oversight of physicians who compound.

7. Will state medical boards receive reports from compounders?
Not necessarily. The policy calls for compounders to report products compounded, serious adverse events, and product quality issues to FDA and to the states where the products are compounded and sent, if different. Serious adverse event and product quality issues are to be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program, regardless of whether the events are considered drug-related. Product reports must include:

• Active ingredient and strength per unit;
• Original active-ingredient manufacturer and the facility’s unique identifier; and
• Dosage form and administration route.

The policy does not say that reports must go directly to the state medical board. It also does not name a state recipient or set reporting deadlines, frequency or a standard state submission process. Boards should not assume they will automatically receive compounder reports or copies of FDA MedWatch submissions.

State medical boards, pharmacy boards, and relevant health departments should coordinate to clarify who will receive reports, how reports involving physician compounders will be handled, and how information will be shared. This would implement the policy’s state-reporting expectation while supporting the cross-board collaboration recommended by FSMB.
8. What could the potential confusion be? How should boards think through this?
The principal risk is that a conditional federal enforcement policy will be interpreted as a broad determination of legality, safety, or clinical appropriateness. Several distinctions should guide board communications:

Potential misunderstanding	Clarification
“HHS approved these peptides.”	The policy is enforcement discretion, not FDA approval.
“These substances are now on the 503A bulks list.”	This policy does not include the peptides on the 503a list.
“Following the policy means full 503A compliance.”	Federal enforcement discretion does not amend the statutory conditions.
“All forms, routes, and peptide combinations are covered.”	Coverage depends on identities, routes, and the single-API condition.
“Federal nonenforcement prevents state board action.”	The policy does not itself amend state law or instruct boards to suspend enforcement.
“Availability establishes medical necessity or standard of care.”	FSMB guidance separately requires individualized clinical justification, informed consent, and appropriate care.
“The state medical board will automatically receive reports.”	The policy identifies states, but not a specific state agency or complete reporting process.

 

 

 

 

 

 

 

 

 

Boards may want to consider three questions:

1. Federal enforcement coverage: Does the exact product and compounding activity meet every HHS condition?
2. State-law permissibility: Does applicable state law permit the prescribing, compounding, dispensing, and administration, including any incorporated federal requirements?
3. Clinical appropriateness: Does the care meet applicable standards for evaluation, medical necessity, consent, monitoring, documentation, and advertising?

Boards should also review existing peptide notices to determine whether clarification is needed, and distinguish their federal, state-law, and clinical foundations.

9. How does this interface with FSMB’s current policy?
HHS’ policy does not change the principles in FSMB’s Guidance on Recent Trends in Prescribing and Dispensing (2026) or White Paper on Compounding of Medications by Physicians (2020). Both emphasize patient-specific medical necessity, appropriate clinical judgment, and compliance with applicable federal and state requirements. Federal non-enforcement does not establish that treatment meets the standard of care.

The white paper recommends that physician compounding be driven by a documented medical need in an individual patient and compliant with U.S. Pharmacopeia (USP) standards for sterile compounding. The prescribing guidance reinforces individualized assessment, informed consent, monitoring, and truthful advertising.

Together, these documents support continued scrutiny of clinical justification and compounding safety, along with coordination between medical and pharmacy boards. Inclusion in the HHS policy does not establish that a physician should prescribe a peptide or is equipped to compound it safely. Boards should distinguish access to a compounded product from the clinical justification for prescribing or administering it.

For informational purposes only: This document is not intended as a comprehensive statement of the law on this topic, nor to be relied upon as authoritative. Non-cited laws, regulations, and/or policy could impact analysis on a case-by-case or state-by-state basis. All information should be verified independently.
Questions, comments, or corrections? Please contact (advocacy@fsmb.org)