FDA Submits Interim Peptide Compounding Policy for White House Review: What Pharmacies Should Know

Overview of the Regulatory Action

According to a client alert from the law firm Buchanan Ingersoll & Rooney PC, the U.S. Food and Drug Administration has submitted an interim policy addressing the compounding of peptide active pharmaceutical ingredients (APIs) to the White House Office of Management and Budget (OMB) for interagency review. This procedural step, conducted through OMB's Office of Information and Regulatory Affairs (OIRA), is a standard but significant milestone that typically precedes the public release of a federal agency's rule, interim final rule, or significant guidance document.

While the full substance of the interim policy has not yet been made public, its submission signals that FDA is close to finalizing its long-anticipated position on which peptide compounds may continue to be compounded by state-licensed pharmacies under Section 503A and outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). The peptide compounding space, which includes products such as semaglutide, tirzepatide, BPC-157, thymosin alpha-1, and numerous other investigational and off-label peptides, has been a persistent source of regulatory uncertainty since at least 2021, when several peptides were first nominated to FDA's bulk drug substance lists.

Why OIRA Review Matters

Under Executive Order 12866 and its successors, "significant regulatory actions" by federal agencies must be reviewed by OIRA before publication in the Federal Register. This includes rules, interim final rules, and in some cases guidance documents with substantial economic or policy impact. OIRA review can take anywhere from a few weeks to several months, and the content of a submission is generally kept confidential until the review concludes, unless the submitting agency or OIRA discloses details voluntarily. At this stage, pharmacies and industry stakeholders should treat reports of the interim policy's specific contents with caution until FDA or OIRA releases the actual text.

Legal Framework and Authority

FDA's authority over compounded peptides flows primarily from the Drug Quality and Security Act (DQSA) of 2013, which added Sections 503A and 503B to the FDCA (21 U.S.C. §§ 353a, 353b). Section 503A governs traditional compounding pharmacies that prepare patient-specific prescriptions, while Section 503B governs outsourcing facilities that may compound in larger batches without individual prescriptions, subject to registration and current Good Manufacturing Practice (cGMP) requirements.

Both provisions restrict compounding with bulk drug substances to those that either (1) are components of FDA-approved drugs, (2) appear in the United States Pharmacopeia (USP) or National Formulary (NF) monographs, or (3) have been placed on FDA's bulk drug substance lists following nomination and review by the Pharmacy Compounding Advisory Committee (PCAC). Most peptides at issue, including many popular in anti-aging, weight management, and "wellness" contexts, do not meet the first two criteria and have instead languished for years as "Category 2" nominations, meaning FDA has not reached a final determination on whether they may be used in compounding at all.

Separately, FDA has authority to designate substances as presenting "significant safety risks" that would exclude them from any bulk drug substance list, under the statutory factors outlined in Section 503A(b)(2)(A)(i)-(iii) and FDA's 2016 draft guidance on bulk drug substance evaluation criteria. The agency has also relied on its general enforcement discretion policies, articulated in guidance documents such as the 2016 "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A," to manage the gap between nomination and final rulemaking.

Industry Implications

The peptide compounding industry has grown substantially in recent years, driven by demand for GLP-1 receptor agonists during manufacturer shortages of brand-name semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), as well as consumer interest in peptides marketed for recovery, longevity, and performance. When FDA removed tirzepatide and later semaglutide from its drug shortage lists in 2024 and 2025, compounders lost the statutory shortage-based exception that had permitted large-scale compounding of those specific molecules, prompting litigation from outsourcing facility trade groups and renewed scrutiny of the broader peptide category.

An interim policy addressing peptides more broadly would likely affect:

• 503A community and hospital pharmacies compounding patient-specific peptide prescriptions
• 503B outsourcing facilities producing peptides at scale for clinics and telehealth platforms
• Raw material suppliers and API manufacturers serving the compounding channel
• Telehealth and direct-to-consumer platforms that have incorporated compounded peptides into treatment offerings

Industry stakeholders, including the Alliance for Pharmacy Compounding (APC) and various outsourcing facility operators, have previously urged FDA to provide clearer, faster pathways for peptide nominations, arguing that prolonged regulatory ambiguity harms patient access and creates inconsistent enforcement across FDA district offices and state boards of pharmacy. Conversely, patient safety advocates and some physician groups have called for tighter restrictions, citing concerns about impurities, inconsistent dosing, and insufficient clinical data supporting many compounded peptides' safety and efficacy profiles.

Compliance Considerations

Pending release of the finalized interim policy, compounding pharmacies and outsourcing facilities should consider several prudent compliance steps:

• Review current peptide formulary offerings against FDA's existing 503A and 503B bulk drug substance lists, as well as any FDA-issued safety communications regarding specific peptides
• Monitor the Federal Register and FDA's compounding webpage for publication of the interim policy once OIRA review concludes
• Maintain robust documentation of sourcing, testing, and quality assurance practices, as these remain relevant regardless of the final policy's specific contours
• Engage with state boards of pharmacy, which may issue parallel guidance or enforcement positions
• Consult legal counsel before making significant changes to peptide-related service lines, given the fluid regulatory environment

Looking Ahead

The timeline for OIRA review varies, but historically most reviews conclude within 30 to 90 days absent extensions. Once released, the interim policy will likely be published as either an interim final rule with request for comment or as revised guidance, both of which would open a formal public comment period. Stakeholders should anticipate that FDA's position may distinguish between peptides with established safety data and historical compounding use versus newer or higher-risk peptides lacking such a track record.

As this is a developing matter, this analysis will require updating once the substantive policy is released. Pharmacies, outsourcing facilities, and industry counsel should treat the current period as one of heightened regulatory risk and monitor official FDA and Federal Register communications closely, rather than relying solely on secondary reporting, including this analysis, which is based on a client alert summary rather than the underlying policy text itself.

This analysis is based on reporting from Buchanan Ingersoll & Rooney PC regarding FDA's submission of an interim peptide compounding policy for OMB review. The full text of the policy has not yet been publicly released, and details are subject to change pending completion of the interagency review process.