On October 28, 2026, HHS announced the availability of “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,” covering HHS’s enforcement policy regarding the use of certain peptide bulk drug substances in compounding pursuant to section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Usually, substances not yet on the Food and Drug Administration’s (FDA’s) approved 503A bulk drug substances list cannot legally be compounded. This policy, done via enforcement discretion, allows state-licensed pharmacies and physicians to compound these peptides, with restrictions.
This announcement is one of several recent actions to advance the Make America Healthy Again (MAHA) agenda via enforcement discretion, rather than rulemaking. While some may hail this and similar exercises of enforcement discretion as positive developments, policies enacted through enforcement discretion should be approached cautiously, particularly in light of the recent court decision, Franco v. Chobani, LLC (184 F.4th 599 (7th Cir. 2026)).
HHS’s Enforcement Discretion Policy Regarding 503A Compounding of Certain Peptides
- What is a Peptide and How are they Used?
Peptides are short chains of amino acids (protein building blocks) that can have a range of effects on the body (i.e. help orchestrate hormone activity, immune defense, tissue repair and growth, control of inflammation, and digestion). GLP-1s and insulin are examples of FDA-approved peptides. The perceived benefits of peptides for general wellness and treatment of specific diseases – often accompanied by aggressive marketing – has led to explosive demand. These products may contain claims that relate to anti-aging, athletic performance, muscle injury recovery, or reducing inflammation. Compounded peptides that are marketed online or by wellness clinics are not FDA-approved. HHS Secretary Kennedy prioritized increasing practitioner and patient access to these products, and this policy is reflective of that stance.
2. Which Peptides Can be Compounded Under HHS’s Policy
HHS’s Policy, in Appendix A and Appendix B, states which peptides may be compounded under this policy, lists each specific identity and routes of administration. The peptides that may be compounded under this policy are:
- BPC-157
- Epitalon
- KPV
- MOTS-c
- Semax
- TB-500
Under the HHS policy, the compounded peptides may only contain a single active pharmaceutical ingredient, or one peptide, from the list above.
3. Restrictions to Qualify for Enforcement Discretion under HHS’s Policy
HHS’s Policy includes the following, additional requirements for the above-listed peptides to qualify for enforcement discretion:
a. Strict Chemical Identity: Peptides must strictly match specified identities (amino acid sequence, structure, molecular weight, formula) and adhere to approved routes of administration.
b. Drug Delivery Device: The only drug delivery device co-packaged or containing the compounded drug is an FDA 510(k)-cleared syringe.
c. Verified Characterization & Certificate of Analysis (CoA): Bulk substances must come from an FDA-registered facility and be accompanied by a valid CoA testing for identity, purity, potency, endotoxins, heavy metals, and contaminants.
d. Registered & Compliant Manufacturers: The primary manufacturer must be FDA-registered and CGMP-compliant. Any third-party resellers or repackers must thoroughly validate the original manufacturer and its CoA.
e. Mandatory Reporting & Patient Clear Labeling: Compounders must report product information, serious adverse events, and quality issues to FDA’s MedWatch program and state authorities, while providing clear reporting instructions on patient labeling.
A compounder that makes a peptide dosage form complying with these requirements, and a downstream practitioner who dispenses it to a patient, would not be prioritized for enforcement, even though the compounded peptide would otherwise be adulterated and misbranded under the FD&C Act. While the HHS Policy is seemingly good news for those seeking to make, administer, and use these products, there are important limitations to consider.
Enforcement Discretion and the Bigger Picture
1. What is Enforcement Discretion?
Enforcement discretion is a policy determination by an agency, here HHS, to choose to not enforce certain regulatory requirements that a product would normally be subject to under Federal law. FDA or HHS exercising enforcement discretion does not change any of the applicable laws or regulations but rather marks an agency’s decision to temporarily not pursue enforcement action against a product that would otherwise be considered as violating FD&C Act (or other) requirements.
2. The Limits of Enforcement Discretion
Enforcement discretion does not change the applicable law. Accordingly, when an agency decides to exercise enforcement discretion, products subject to federal regulation are still subject to state laws and state product liability lawsuits. A prime example of this can be found in the Franco v. Chobani, LLC decision, which has roiled the food industry and is an important cautionary tale for the drug and compounding industry.
The dispute in this case centered on whether Chobani’s “Zero Sugar” labeling was deceptive because the product contained allulose—a rare sugar that is chemically a monosaccharide but metabolizes differently than conventional sugars. Chobani marketed a line of yogurt as “sugar free” or “zero sugar”, but each serving contained about four grams of allulose. Chobani did this based on FDA’s stance in its Allulose Guidance, where FDA said it would exercise enforcement discretion to allow manufacturers to omit allulose from “Total Sugars” and “Added Sugars” on Nutrition Facts panels due to its low caloric impact. The Francos sued Chobani, alleging the labeling deceived them and violated various state consumer protection laws.
The Seventh Circuit held that the Franco’s case could proceed, the enforcement discretion policy on allulose notwithstanding. FDA filed an amicus brief, explaining the limits of its non-binding enforcement discretion policy and asserting that the policy did not amend or even interpret its “Total Sugars” regulation.
This case provides an object lesson in the limits of enforcement discretion. An agency may decide not to enforce a particular regulation, but statements providing for enforcement discretion do not change the legal enforceability of a provision or provide for broad immunity from actions brought under state laws, including product liability cases, class actions, and enforcement by state regulators.
3. Other Recent Examples of Agency Enforcement Discretion
Despite its legal limitations, FDA has used enforcement discretion to advance its policy goals in various instances. On October 8, 2026, the FDA issued the “Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants: Guidance for Industry,” announcing that FDA does not intend to enforce the food traceability final rule’s requirements for certain retail food establishments and restaurants that did not qualify for the small business exemption set out in the final rule.
On February 5, 2026, FDA announced its intent to exercise enforcement discretion regarding how firms voluntarily label food products that do not contain FD&C Act certified, artificial colors.
4. Takeaways and Future Considerations
The position of the Seventh Circuit in Chobani is not new – we have long cautioned our food and drug clients that reliance upon enforcement discretion still leaves entities open to legal action under state law. Enforcement discretion can help avoid the resource-intensive rulemaking process to amend an existing regulation and can appear to swiftly advance particular policy goals, such as increased access to peptides. However, taking a lesson from Chobani, a peptide supplier, compounder, or administering practitioner should keep the following in mind
a. State Rules Still Apply: Compounders are still bound by state Boards of Pharmacy who can still enforce their own rules; state requirements still apply to practitioners and facilities who administer the products.
b. Guidance is Not a Legal Shield: The HHS Policy does not give regulated entities an absolute legal defense or preemption safe harbor. Decisions by a federal agency to not enforce legal standards do not insulate them from litigation concerns under state consumer protection laws.
c. Policies Can Shift: Enforcement discretion can shift at any time, so regulated entities should understand the underlying, controlling regulations and what enforcement of those regulations would mean for their products.
d. HHS v FDA Origins: A unique wrinkle for the HHS Peptide Policy is that it came from HHS, not FDA. As compounders move forward, they should consider how enduring this policy may be and what changes could come about once an FDA Commissioner is confirmed.
Please contact Rachael Vieder Linowes ([email protected]) if you have any questions.
