FDA Advances Peptide Compounding Review: Category 2 Removals Announced and PCAC Hearing Confirmed

What 503A Pharmacies and 503B Outsourcing Facilities Need to Know Now

April 15, 2026 | Prepared by Courtney M. Sullivan, Attorney | [email protected]; 602-900-8562

BREAKING — APRIL 15, 2026: FDA REMOVES PEPTIDES FROM CATEGORY 2 AND CONFIRMS PCAC HEARING DATES

On April 15, 2026, the FDA updated its official 503A Bulk Drug Substances list to announce the removal of 11 peptides from Category 2 — the category that has prohibited their use in compounding since 2023–2024. The removals take effect seven calendar days from the date of notice. This action occurred simultaneously with the announcement of a July 23 and 24, 2026 PCAC hearing for seven of those substances, and announces a separate PCAC review for four additional peptides before the end of February 2027. Federal Register notice (Docket No. FDA-2025-N-6895) formalizes the July hearing.

This is a significant and concrete regulatory development — but it is not a green light to compound. The pathway from Category 2 removal to lawful compounding runs through PCAC review, rulemaking, and formal 503A Bulks List placement. Facilities must understand exactly where each substance stands before acting.

Background: The Road to This Hearing

The Category 2 Restrictions and Their Consequences

Between September 2023 and December 2024, the prior administration moved 19 widely prescribed compounded peptides to Category 2 status — effectively prohibiting their use in compounding. These were therapies that millions of Americans had been receiving under physician supervision through licensed pharmacies for tissue repair, immune modulation, metabolic health, cognitive support, and regenerative medicine.

The restrictions did not eliminate patient demand. They redirected it — directly into unregulated black-market channels. Patients who lost access to pharmacy-compounded peptides turned to “research use only” vendors operating without pharmaceutical-grade quality controls, sterility testing, or regulatory accountability. Studies have estimated that over 40% of peptide products sourced from unregulated vendors contain inaccurate dosing, contamination, or degraded compounds. Patients were not simply going without. Many were accessing products far more dangerous than anything produced in a licensed compounding facility.

This outcome was predictable. It is the same dynamic observed with GLP-1 medications and other restricted compounded substances: regulatory restrictions that close the licensed pharmacy pathway do not resolve patient demand — they push it toward less visible, less safe, and entirely unaccountable alternatives.

The Change in Administration and Secretary Kennedy’s February Announcement

On February 27, 2026, HHS Secretary Robert F. Kennedy Jr. publicly announced the Administration’s intent to reverse the prior administration’s Category 2 restrictions and restore the compounding pathway for peptide therapies. That announcement signaled a meaningful shift in regulatory posture, but it was not itself a formal FDA action. The legal pathway for compounding restricted peptides requires the FDA to follow its established administrative process, which includes PCAC review, public comment, and ultimately rulemaking or formal guidance.

The April 15, 2026 update to the FDA’s 503A Bulk Drug Substances list is the formal administrative mechanism through which that policy intent is now being executed. By removing 11 substances from Category 2 and confirming the PCAC consultation schedule, FDA has taken the first concrete regulatory step toward restoring lawful compounding access for these peptides.

The removal of a substance from Category 2 does not place those substances on the 503A Bulks List. They remain unlawful for compounding until their formal addition to the Bulks List.  The PCAC hearing is the next step in the process that will determine whether formal list placement follows.

The Category System: How Peptide Compounding Eligibility Is Determined

For a substance to be lawfully used in compounding under Section 503A, it must either comply with an applicable USP/NF monograph, be a component of an FDA-approved drug, or appear on the 503A Bulks List with Category 1 status. Removal from Category 2 alone does not satisfy this requirement. The July PCAC hearing is the formal evaluation step that precedes a final determination on list placement for the substances under review.

The April 15, 2026 Update: What the FDA Actually Did

Substances Removed from Category 2 — With Confirmed July 2026 PCAC Dates

The following seven substances are being removed from Category 2 within seven calendar days of April 15, 2026. The FDA has simultaneously confirmed their review at the July 23–24, 2026 PCAC meeting. These are the substances for which the path toward formal compounding eligibility is most immediately active:

Substances Removed from Category 2 — PCAC Review Before February 2027

A Special Case: GHK-Cu

What Does “Removed from Category 2” Actually Mean?

These substances are being removed from Category 2 because their original nominations were withdrawn by the nominators — not because the FDA has affirmatively found them safe or eligible for compounding. Removal from Category 2 means they enter a transitional status: no longer prohibited under the Category 2 framework, but not yet formally eligible for compounding.

The FDA’s interim enforcement policy governs compounding from nominated substances not yet on the final bulks list. Facilities should consult compliance counsel before resuming or initiating compounding of any substance removed from Category 2, and should not treat removal from Category 2 as equivalent to Category 1 placement.

The July 23–24, 2026 PCAC Meeting

What the Committee Will Evaluate

The PCAC will spend July 23 and July 24, 2026 evaluating seven peptide substances (in both free base and acetate forms) that have been nominated for inclusion on the Section 503A Bulk Drug Substances List. The hearing will be held at the FDA White Oak Campus in Silver Spring, Maryland, with a virtual participation option available.

July 23, 2026

July 24, 2026

Why These Substances Matter

Several of the peptides on the July agenda — including BPC-157, TB-500, KPV, MOTS-C, Semax, and Epitalon — were among those moved to Category 2 status between 2023 and 2024, removing them from the lawful compounding market. As of April 15, 2026, all seven substances on the July agenda have been removed from Category 2, with their PCAC review dates now confirmed. Their appearance on the PCAC agenda reflects the Administration’s stated commitment to reevaluating those restrictions on the merits.
Of particular note is MOTS-C, which is being evaluated for obesity and osteoporosis. Given the trajectory of GLP-1 medications and the demonstrated patient demand for metabolic therapies, MOTS-C warrants close attention from facilities operating in the weight management and metabolic health space.

Emideltide / DSIP, nominated for opioid withdrawal, chronic insomnia, and narcolepsy, addresses conditions with significant unmet clinical need and limited approved treatment options. Its evaluation reflects the broader policy conversation about compounding’s role in addressing gaps in the commercial drug supply.

What the PCAC Process Involves

The PCAC is a federal advisory committee that provides recommendations to the FDA on compounding-related regulatory questions. At this meeting, the Committee will review the clinical and safety evidence submitted in support of each nominated substance, hear presentations from the nominators, and receive public comment. The Committee’s recommendations are advisory — they do not themselves change the legal status of any substance — but they carry significant practical weight in FDA’s subsequent determinations.
A favorable PCAC recommendation initiates the rulemaking process toward formal placement on the 503A Bulks List. An unfavorable recommendation, or a finding that the clinical evidence is insufficient to evaluate safety, can effectively close the door on compounding eligibility for that substance — even for substances that were recently in active clinical use.

Important Distinction: Neither the April 15 Category 2 Removals Nor the PCAC Hearing Authorize Compounding

Removal from Category 2 lifts the formal prohibition on compounding a substance, but does not place it on the 503A Bulks List. Until the FDA completes its formal rulemaking process following the PCAC hearing and formally adds a substance to the 503A Bulks List, the clear legal pathway for compounding these substances does not yet exist. The April 15 update and the PCAC hearing are important and encouraging developments — but neither is itself a restoration of compounding authority. Facilities should not begin or resume compounding any substance removed from Category 2 based solely on the April 15 update or the scheduling of this hearing. Consult compliance counsel before acting.

How to Participate: Critical Deadlines

This hearing represents a genuine opportunity for pharmacies, outsourcing facilities, prescribers, and patient advocates to put clinical evidence and real-world access data directly in front of the committee evaluating these substances. FDA has allotted approximately one hour per substance for public hearing presentations, distributed across session time slots on both days.

Public hearing sessions on July 23 begin at approximately 10:15 a.m., 11:50 a.m., 2:15 p.m., and 4:00 p.m. ET. Sessions on July 24 begin at approximately 10:20 a.m., 12:30 p.m., and 3:20 p.m. ET. If the number of registrants exceeds available time, FDA may conduct a lottery to determine speakers. The contact person will notify registered speakers of their allotted time by July 1, 2026.

For in-person attendance inquiries: Takyiah Stevenson, Center for Drug Evaluation and Research, 240-402-2507, [email protected]. Advisory committee information line: 301-796-8220.

What Happens After the Hearing: Anticipated Next Steps

The PCAC’s recommendations following the July hearing will shape FDA’s path forward for each substance under review. The most likely outcomes and their implications:

Favorable recommendation: Where the Committee finds sufficient safety and clinical evidence, FDA will proceed toward formal rulemaking to add the substance to the 503A Bulks List. This process involves publication of a proposed rule, a public comment period, and ultimately a final rule — a timeline that typically spans many additional months. Facilities should not interpret a favorable PCAC recommendation as immediate authorization to compound.

Recommendation with conditions: The Committee may find that evidence is promising but incomplete, recommending that additional safety data or clinical evidence be developed before a final determination. This outcome would likely extend the timeline for rulemaking while signaling a constructive path toward eligibility.

Unfavorable recommendation: A finding that the clinical evidence is insufficient or that safety concerns are unresolved could result in the substance not being added to the 503A Bulks List and being deferred for further review. Facilities that currently compound these substances — or have been anticipating restored access — should monitor the Committee’s findings closely.

Regardless of the PCAC’s recommendations, facilities should expect that the regulatory environment for peptide compounding will continue to evolve. Key areas to monitor include the FDA’s formal rulemaking timeline following the hearing, any updated enforcement guidance, state board of pharmacy responses in jurisdictions that maintain independent substance restrictions, and the outcome of pending federal litigation challenging the FDA’s categorization authority.

Compliance Action Items: Preparing Your Facility Now

Whether you currently compound any of the substances under review, or are preparing to do so in anticipation of a favorable outcome, now is the time to ensure your facility is operationally and legally ready. Boesen & Snow Law recommends the following priority steps:

• Understand the April 15 update before acting: Removal from Category 2 is not the same as placement on Category 1. Review the FDA’s interim enforcement policy and consult compliance counsel before initiating or resuming compounding of any substance affected by the April 15 update. Confirm the effective removal date (seven calendar days from April 15) through the FDA’s official published list, not secondary sources.
• Monitor the FDA’s official communications: Track the FDA’s published bulk drug substances list and any Federal Register notices or guidance documents following the PCAC hearing. Do not resume compounding of any restricted substance based on advisory committee proceedings alone.
• Submit public comments: Facilities with clinical experience, patient outcome data, or operational insights regarding the substances under review should submit written comments to Docket No. FDA-2025-N-6895 by July 9, 2026. Well-documented comments can meaningfully influence the Committee’s recommendations.
• Consider requesting a speaking slot: Nominators and interested parties may present oral testimony before the Committee. Requests must be submitted by June 30, 2026. Boesen & Snow Law can assist with preparation and submission.
• Assess your USP compliance posture: Confirm that sterile compounding operations comply with USP <797> and non-sterile operations with USP <795>, including environmental monitoring, personnel qualification, beyond-use dating, and documentation.
• Qualify your API suppliers: Source all active pharmaceutical ingredients from FDA-registered manufacturers. Obtain and maintain current Certificates of Analysis. Establish documented supply chain integrity before resuming or initiating peptide compounding.
• Review quality assurance protocols: Update testing protocols including potency verification, sterility testing, endotoxin (LAL) testing, and stability programs specific to peptide formulations.
• Verify state board alignment: Confirm that your state board of pharmacy permits compounding of the specific substances in question. Some states maintain independent restricted-substance lists or impose requirements beyond the federal framework.
• Update documentation and recordkeeping systems: Ensure complete records of prescriptions, compounding logs, batch records, and test results sufficient to demonstrate compliance with both federal and state requirements.
• 503B-specific obligations: Outsourcing facilities must confirm cGMP standards compliance, current FDA registration, adverse event reporting procedures (MedWatch), and inspection readiness in addition to substance-level eligibility.
• Train compounding personnel: Ensure personnel are trained on peptide-specific handling, reconstitution, storage, and stability requirements before resuming or initiating production.

The Patient Safety Imperative

The stakes of this regulatory proceeding extend well beyond the pharmacy industry. When the prior administration moved these peptides to Category 2, it did not make patients safer — it made their sourcing less visible and less accountable. Patients who had been receiving compounded peptide therapies under physician supervision through licensed pharmacies found themselves without a regulated option. Many did not stop seeking treatment. They turned to black-market suppliers: online vendors operating outside any regulatory framework, selling products of unknown purity, potency, and sterility to patients who had no way to assess the risk.

Studies have estimated that a substantial portion of peptide products from unregulated vendors — some analyses place the figure above 40% — contain inaccurate dosing, contamination, or degraded active compounds. These adverse outcomes go entirely unreported because black-market suppliers have no reporting mechanisms, no adverse event surveillance, and no accountability to any regulatory body. The harms are invisible to regulators — but they are real.

A favorable outcome from the July PCAC hearing — and the eventual restoration of the lawful compounding pathway for these substances — would bring patient care back into the licensed pharmacy system, where USP standards, state board oversight, physician supervision, and federal requirements work together to ensure product quality and patient safety. That outcome is not a loosening of regulation. It is smarter, more effective regulation: one that actually reaches the patients it is designed to protect.

How Boesen & Snow Law Can Help

Boesen & Snow Law has advised 503A pharmacies, 503B outsourcing facilities, prescribers, and pharmaceutical companies throughout the peptide categorization saga — from the initial Category 2 restrictions through the current Administration’s policy shift. Our team is available to assist with:

• Drafting and submitting public comments to the July PCAC docket
• Analyzing the April 15, 2026 update and advising on operational implications for your specific products
• Creation of master formulation records and SOPs
• Preparing and presenting oral testimony before the Committee
• Regulatory readiness assessments and compliance program development
• State board of pharmacy alignment across multiple jurisdictions
• API supplier due diligence and documentation review
• Strategic guidance as this regulatory landscape continues to evolve