The Trump administration is reportedly considering a significant change in the federal government’s approach to peptide compounding. According to recent reports, the administration is exploring an interim enforcement discretion policy that would allow compounding pharmacies to prepare certain peptides that are not currently eligible for compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA).
This development follows recent recommendations by the U.S. Food and Drug Administration’s (FDA) Pharmacy Compounding Advisory Committee (PCAC) in July 2026 to permit compounding with six peptides, including BPC-157, TB-500, KPV, MOTS-c, Epitalon, and Semax. Although the recommendations represent an important development for the peptide industry, the FDA has not yet announced whether it will begin the rulemaking necessary to add these substances to the list of permissible bulk drug substances under Section 503A, or whether it will follow the recommendations of scientists within its Center for Drug Evaluation and Research (CDER), who reportedly opposed adding the six peptides to the list because of insufficient safety data.
What a Proposed FDA Peptide Policy Could Mean for the Industry
For compounding pharmacies, active pharmaceutical ingredient (API) manufacturers, distributors, repackagers, and peptide suppliers, the prospect of enforcement discretion presents potentially significant opportunities. However, it also raises important legal questions regarding the scope of the anticipated policy, the legal status of the peptides themselves, and whether the policy would extend to the manufacturers and suppliers responsible for bringing pharmaceutical-grade peptides into the United States.
If implemented, an enforcement discretion policy could allow qualifying pharmacies to begin compounding certain peptides before the FDA completes the formal rulemaking process, which could take 12 to 18 months or longer. However, the timing and availability of any such relief would depend on the policy’s final scope and conditions..
Additionally, FDA enforcement discretion is not the same as FDA authorization. Understanding that distinction will be critical for businesses considering entering or expanding their operations in the peptide market.
What is FDA Enforcement Discretion?
Under Section 503A of the FDCA, qualifying compounding pharmacies may prepare prescription medications without complying with certain federal requirements that otherwise apply to commercially manufactured drugs, including the FDA’s new drug approval, adequate-directions-for-use labeling, and current good manufacturing practice (CGMP) requirements. However, to qualify for these exemptions, a pharmacy must satisfy several statutory conditions, including restrictions on the bulk drug substances used in compounding. Generally, an eligible bulk drug substance must comply with an applicable United States Pharmacopeia or National Formulary (USP/NF) monograph, be a component of an FDA-approved drug if no applicable monograph exists, or appear on the FDA’s list of bulk drug substances permitted for use in compounding (the 503A Bulks List). Additional statutory requirements, including applicable sourcing and quality standards, must also be satisfied.
A favorable recommendation from PCAC does not automatically place a substance on the 503A Bulks List. The FDA must still determine whether it agrees with the PCAC recommendations or with its own scientists at CDER. If it agrees with the PCAC recommendations and moves forward with either rulemaking or enforcement discretion, it must still complete an applicable regulatory process. Nevertheless, the FDA possesses broad discretion to determine how and when it enforces the FDCA. Through an enforcement discretion policy, the FDA may announce that it generally does not intend to pursue enforcement against certain regulated entities for specified statutory violations, provided those entities satisfy defined conditions.
The Supreme Court recognized the breadth of federal agencies’ enforcement discretion in Heckler v. Chaney, 470 U.S. 821 (1985), holding that agency decisions declining to initiate enforcement proceedings are generally presumed unreviewable under the Administrative Procedure Act. The FDA has exercised this authority in numerous contexts, including through its existing interim policies permitting certain compounding activities while the agency evaluates nominated bulk drug substances.
However, enforcement discretion does not legalize conduct that otherwise violates the FDCA. It reflects the FDA’s current enforcement priorities, rather than an affirmative determination that the activity complies with federal law. Under the FDA’s Good Guidance Practices regulation, 21 C.F.R. § 10.115, agency guidance documents generally do not establish legally enforceable rights or responsibilities and are not binding on the FDA or the public. Accordingly, even where the FDA announces that it does not intend to pursue enforcement against certain compounding activities, the agency generally retains authority to take enforcement action, revise its policy, or withdraw its enforcement discretion.
FDA Has Previously Exercised Similar Discretion for Compounding Pharmacies
The proposed peptide enforcement discretion policy would not be unprecedented. The FDA’s January 2025 guidance, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, establishes a framework under which the FDA generally does not intend to pursue enforcement against qualifying compounders using certain nominated bulk drug substances that have not yet been formally added to the 503A Bulks List. Under that policy, certain substances designated as Category 1 may remain eligible for enforcement discretion while the FDA evaluates their inclusion on the list. The policy is subject to conditions concerning the substances, their manufacturers, certificates of analysis, and compliance with other applicable compounding requirements.
The FDA has also exercised enforcement discretion in connection with compounded semaglutide and tirzepatide following the resolution of their respective drug shortages. In those circumstances, the FDA established temporary transition periods during which it generally did not intend to pursue specified enforcement actions against qualifying compounders.
These precedents demonstrate that the FDA can establish meaningful periods of regulatory forbearance without first changing the underlying statutory requirements. They also highlight the limitations of such policies. For example, the FDA’s enforcement discretion periods for glucagon-like peptide-1 (GLP-1) drugs eventually expired, requiring affected compounders to reassess their operations. For pharmacies contemplating substantial investments in peptide compounding, this is an important consideration: an enforcement discretion policy may create a viable near-term business opportunity but may not provide permanent regulatory certainty.
Does Enforcement Discretion Extend to Peptide API Manufacturers and Distributors?
Perhaps the most consequential unresolved question is whether the anticipated policy would extend beyond compounding pharmacies to the upstream peptide supply chain. Consider a common business model in which a foreign pharmaceutical manufacturer produces a peptide API at an FDA-registered facility, using applicable CGMP controls, and supplies the product with a certificate of analysis (COA). The API is then imported into the United States by a registered importer or repackager and distributed to state-licensed 503A compounding pharmacies.
Under existing federal law, this supply chain is not inherently prohibited simply because the API originates overseas or is distributed through an intermediary. However, FDA establishment registration, CGMP compliance, and possession of a valid COA do not independently establish that a particular peptide may lawfully be imported, distributed, or used in human drug compounding. Importers and repackagers must also consider applicable drug establishment registration, drug listing, labeling, manufacturing, and import requirements.
Of particular significance, Section 801(a) of the FDCA authorizes the FDA to detain or refuse admission of imported products that appear to violate applicable federal requirements. Additionally, 21 C.F.R. § 201.122 establishes conditions under which certain APIs intended for further manufacturing or processing may qualify for an exemption from adequate-directions-for-use labeling requirements. Consequently, even if the FDA announces that it will not pursue enforcement against pharmacies compounding certain peptides, that announcement would not necessarily prevent the FDA from detaining shipments of the underlying APIs or pursuing enforcement against upstream manufacturers and distributors.
Any forthcoming policy will need to be evaluated to determine whether its scope extends to API manufacturers, importers, repackagers, and distributors, or is limited to qualifying compounding pharmacies. These details could prove particularly important for companies seeking to import pharmaceutical-grade peptides in commercial quantities and distribute them to multiple compounding pharmacies.
How Much Legal Protection Would an Enforcement Discretion Policy Provide?
Although enforcement discretion does not create a statutory exemption or binding safe harbor, a formal, written FDA policy can provide meaningful practical protection to regulated businesses. In general, a pharmacy that operates within the conditions of published FDA enforcement discretion guidance may have a stronger basis for relying on the FDA’s announced enforcement priorities than a business operating solely in reliance on public statements by administration officials.
However, such reliance is not absolute. FDA guidance documents generally reserve the agency’s authority to take enforcement action when warranted. Moreover, businesses ordinarily cannot compel the FDA to continue exercising enforcement discretion indefinitely. If the FDA subsequently reverses its position, affected businesses may have arguments concerning fair notice, reasonable reliance, or unexplained departures from established agency policy. Nevertheless, those arguments do not guarantee protection against enforcement, particularly where the underlying conduct remains prohibited by statute.
Enforcement discretion also does not bind state boards of pharmacy, eliminate potential product liability exposure, or insulate businesses from other applicable federal and state requirements. For peptide suppliers, additional considerations may arise concerning whether products marketed as “research use only” are actually intended for human administration. The FDA evaluates intended use based on the totality of the circumstances, including labeling, advertising, promotional claims, and distribution practices. Simply identifying a peptide as a research chemical does not necessarily remove it from the FDA’s drug regulatory framework.
What Should Peptide Industry Stakeholders Do Now?
Until the FDA publishes an operative enforcement discretion policy, pharmacies and suppliers should avoid assuming that the PCAC recommendations or administration announcements have changed the legal status of these peptides. Significant uncertainty remains regarding whether the FDA will issue a formal policy, which entities and substances it would cover, and what conditions businesses would need to satisfy to qualify for enforcement discretion.
In the meantime, businesses evaluating opportunities in the peptide market should prioritize two key areas:
Evaluate Peptide Sourcing and Supply Chain Compliance
First, while the PCAC recommended several products to be included on the 503A Bulks List, the FDA has not yet officially announced whether it will follow those recommendations or instead follow the recommendations of the FDA/CDER and prohibit the six peptides in question from being compounded. If the FDA announces it will follow the PCAC’s recommendations and implement an enforcement discretion policy, the agency will also need to specify from whom those products must be sourced. Therefore, it will be very important to focus on the supply chain for the specific peptides. This will require identifying FDA-registered facilities, adhering to CGMPs, and providing COAs who can supply these products. Pharmacies and repackagers should also focus on quality metrics and other manufacturing standards for these manufacturers, including testing protocols, supplier qualifications, and other safeguards. It is easy to expect that any enforcement discretion would require bulk peptides to meet basic quality standards.
Assess State Pharmacy and Medical Board Requirements
Second, while potential enforcement discretion from the FDA could provide comfort with respect to federal law, it has no bearing or precedence with respect to state laws. It is quite possible that certain state boards of pharmacy (and possibly also state boards of medicine) may take the position that compounding or prescribing peptides remains unlawful or restricted.
How Frier Levitt Can Help
For businesses operating in the peptide space, the critical distinction remains between the FDA’s decision not to enforce certain statutory requirements and an affirmative determination that the underlying activities are lawful. Until the FDA provides further guidance, businesses should approach expansion into the peptide market with careful attention to the applicable regulatory requirements, the precise scope of any announced enforcement discretion, and the risks associated with investing in a potentially temporary regulatory framework.
Frier Levitt continues to monitor developments concerning the FDA’s regulation of peptide compounding, bulk drug substances, and pharmaceutical supply chains. We assist compounding pharmacies, API manufacturers, importers, distributors, and other industry participants in evaluating regulatory compliance, structuring operations, and responding to FDA enforcement matters. If you are contemplating how these evolving rules and regulations may affect your business, contact us today.
