The U.S. Food and Drug Administration (FDA) issued a notice of proposed rulemaking stating that semaglutide, tirzepatide, and liraglutide should not be included on the 503B Bulks List, the list of active pharmaceutical ingredients (APIs) that 503B pharmacies, known as “outsourcing facilities,” may use when compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act.[1] If finalized, FDA’s action would foreclose bulk API compounding of these popular GLP‑1 receptor agonists by 503B outsourcing facilities outside of FDA-declared shortages. The FDA is accepting public comments through June 29, 2026.[2]
Section 503B and the Bulks List
GLP‑1 products such as semaglutide (Ozempic®, Wegovy®, Rybelsus®), tirzepatide (Mounjaro®, Zepbound®), and liraglutide (Victoza®, Saxenda®) have experienced extraordinary demand since 2022. Because the manufacturers of these branded drugs were unable to meet demand, the FDA declared many dosage forms in shortage. During periods when these products were on the FDA’s drug shortage list, both 503A pharmacies and 503B outsourcing facilities were allowed to lawfully compound “essentially a copy” of these drugs for patients who could not access them. The FDA has since announced an end to these shortages, thus closing that avenue for “essentially a copy” compounding.[3]
Section 503B establishes a regulatory framework for FDA-registered outsourcing facilities to compound drugs without patient-specific prescriptions, subject to current good manufacturing practice (CGMP) requirements, and other conditions.[4] One key condition is that a 503B facility may not compound a drug product using a bulk drug substance unless (1) the substance appears on the FDA’s 503B Bulks List, reflecting a determination of clinical need, or (2) the drug compounded from that substance is on FDA’s drug shortage list at the time of compounding, distribution, and dispensing.[5]
The FDA’s 2019 guidance explains how the Agency interprets “clinical need” and the factors it considers when determining whether to place a substance on the 503B Bulks List, and it reiterates that “clinical need” is distinct from supply constraints or cost considerations.[6] In parallel, the FDA’s guidance titled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the FD&C Act” (January 7, 2025) explains how the FDA manages nominations and enforcement while substances await evaluation, and notes the Agency’s intent to seek public comment when it proposes to include or exclude a nominated substance.[7] These policies frame the GLP‑1 proposal and the comment process now underway.
Current Status of GLP‑1 Compounding
As of April 1, 2026, the FDA reports that semaglutide and tirzepatide do not appear on the 503B Bulks List and are not on the FDA’s drug shortage list, eliminating the two principal lawful routes for 503B bulk API compounding of those agents.[8] The FDA also ended the prior, time-limited enforcement discretion for semaglutide and tirzepatide compounding tied to shortages.[9] Courts denied preliminary injunction motions brought by the Outsourcing Facilities Association challenging the FDA’s shortage determinations, and the related wind-down deadlines remained in effect.[10]
The Notice of Proposed Rulemaking and FDA’s Stated Rationale
The Notice of Proposed Rulemaking (NPRM) would codify the FDA’s preliminary determination that there is no “clinical need” for 503B outsourcing facilities to compound any of the three GLP‑1 agents from bulk substances, even apart from shortage status. The Agency explains that, after reviewing nominations and public comments, it has not identified sufficient evidence of clinical need for outsourcing facilities to compound these drugs from bulk substances.[11] As former FDA Commissioner Marty Makary stated, “When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need.”[12]
The FDA’s analysis follows its 2019 framework. For substances that are components of approved drugs, the FDA first asks two threshold questions: (1) whether an attribute of the approved product makes it medically unsuitable for certain patients for an identified condition, and (2) whether the proposed compounded product must be produced from bulk API rather than from an approved product. Because the FDA preliminarily answered “no” to both questions for each GLP‑1, it did not proceed to balance the Part 2 factors (physical and chemical characterization, safety concerns, evidence of effectiveness for a compounded product, and current or historical compounded use).[13]
In applying this threshold analysis, the FDA addressed and rejected several arguments premised on higher-strength injections, “microdosing” beyond labeled titration, alternative routes of administration such as buccal or sublingual, excipient sensitivity such as avoiding propylene glycol, multi-ingredient combinations with pyridoxine or antiemetics, and device or dose-adjustment preferences. In each case, the FDA found these rationales did not demonstrate medical unsuitability of the approved options or a need to compound from bulk API.[14] The FDA also reiterated that supply issues and cost are not part of the statutory “clinical need” standard; shortages are handled by a separate provision.[15]
In addition, the FDA’s public docket reflects notable stakeholder activity relevant to this proposal, including comments and a citizen petition from Novo Nordisk concerning semaglutide and liraglutide, a comment from Eli Lilly addressing tirzepatide, and submissions from the Outsourcing Facilities Association responding to those arguments.[16] These materials inform the FDA’s preliminary views and will be considered alongside new comments submitted in this rulemaking.
Practical Implications for 503A and 503B Stakeholders
If finalized, the rule would close the bulks-list pathway for semaglutide, tirzepatide, and liraglutide, eliminating bulk API compounding of these agents by 503B facilities unless they start from FDA-approved finished drugs and otherwise satisfy 503B conditions. Facilities should review product portfolios, sourcing strategies, labeling, and promotional materials to ensure they do not imply an API-based compounding pathway that would be prohibited if the rule is finalized.
The NPRM directly targets 503B bulk compounding and does not itself amend the 503A framework. Importantly, the proposal does not affect the ability of 503A compounding pharmacies to prepare patient-specific formulations pursuant to valid prescriptions, provided they satisfy the conditions of Section 503A, including the requirement that such compounding not occur regularly or in inordinate amounts for drugs that are essentially copies of commercially available products. Compounding of GLP‑1 products by 503A pharmacies, however, remains constrained by longstanding “essentially a copy” rules and the end of shortage listings.[17] Prescribers and state-licensed pharmacies should continue to ensure any compounded preparations comply with 503A requirements (including documented clinical rationale where permitted and compliant variations in strength or formulation) while closely monitoring the FDA’s enforcement posture around GLP‑1s.
Patients who obtained compounded GLP‑1s during the shortage period may experience fewer options through large-scale channels if the proposal is finalized. The FDA’s position reflects its preference for approved products to meet demand and its concern that bulk compounding absent demonstrated clinical need can undermine approval incentives and expose patients to quality risks. During shortages, compounded GLP‑1s often entered the market at lower price points than branded products, influencing patient uptake and competitive dynamics. With shortages resolved and the FDA’s proposed bulks-list exclusion, market competition is more likely to occur among FDA-approved products, including new presentations and oral formulations, and through manufacturer pricing strategies rather than compounded alternatives.
Pharmacy Owner Perspective: Purchasing and Dispensing Compounded GLP‑1 Products
Looking forward, pharmacy owners should take immediate note of the FDA’s April 30, 2026, proposed rulemaking, which proposes to permanently exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List based on a finding of no clinical need. As stated, if this rule is finalized, it would eliminate any future possibility that these drugs could be added to the Bulks List and would permanently foreclose the 503B bulk-API compounding pathway, meaning pharmacy owners would likely no longer be able to purchase such 503B-sourced products unless these drugs return to the FDA’s shortage list.
As former FDA Commissioner Makary stated: “When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need.” As pharmacy owners who rely on compounded GLP‑1 products have a direct stake in this rulemaking, they should consider submitting public comments to the Federal Register docket before the June 29, 2026, deadline.
Effective comments from pharmacy owners should address any documented patient populations for whom FDA-approved formulations are medically unsuitable (for example, patients with specific excipient allergies or those requiring dosage forms not commercially available), and explain why bulk API compounding by a 503B facility is necessary to meet that need. Simultaneously, pharmacy owners should develop contingency plans to transition dispensing operations to FDA-approved products or, where clinically justified, work with 503A compounding pharmacies that prepare patient-specific prescriptions under the separate and more limited 503A framework.
How Stakeholders Should Engage Now
The comment deadline is June 29, 2026, with electronic submissions via the docket.[18] Effective comments should address the threshold “medical unsuitability” questions for specific, identified patient populations and explain why a compounded product must be made from bulk API rather than an approved product. Stakeholders should also inventory products, marketing claims, and contracts that depend on bulk GLP‑1 APIs and develop contingency plans to pivot to approved-product starting materials or discontinue affected offerings if the proposal is finalized. After reviewing comments, the FDA may finalize its position, modify it in light of new evidence, or issue a new proposal consistent with the 2019 guidance and the Agency’s case-by-case approach to the Bulks List.[19]
How Frier Levitt Can Help
Frier Levitt regularly advises pharmacies, outsourcing facilities, healthcare providers, and other healthcare stakeholders on FDA regulatory compliance, compounding laws, pharmacy operations, reimbursement matters, and enforcement risk involving compounded products. Our attorneys assist clients in evaluating the impact of evolving FDA guidance and rulemaking, preparing and submitting regulatory comments, assessing operational and sourcing implications, and developing compliance strategies related to compounded GLP-1 products under both Sections 503A and 503B. If you have questions regarding the FDA’s proposed GLP-1 bulks-list exclusion or its impact on your business, contact Frier Levitt to discuss your options and compliance considerations.
[1] List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act, 91 Fed. Reg. 23,432 (proposed May 1, 2026).
[2] Id.
[3] U.S. Food & Drug Admin., FDA Clarifies Policies for Compounders as National GLP‑1 Supply Begins to Stabilize (updated Apr. 1, 2026), https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize.
[4] 21 U.S.C. § 353b.
[5] See 21 U.S.C. § 353b(a)(2)(A); see also U.S. Food & Drug Admin., Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Jan. 2025), at 4–5.
[6] U.S. Food & Drug Admin., Guidance for Industry, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Mar. 2019).
[7] U.S. Food & Drug Admin., Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Jan. 2025).
[8] See supra note 3.
[9] Id.
[10] See Outsourcing Facilities Ass’n v. FDA, No. 4:25-cv-00174 (N.D. Tex. Apr. 24, 2025) (denying preliminary injunction regarding compounded semaglutide); see also BioSpace, Judge Rules Against Semaglutide Compounders After Shortage Declared Over (Apr. 25, 2025).
[11] 91 Fed. Reg. at 23,434–35.
[12] U.S. Food & Drug Admin., FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List (Apr. 30, 2026), https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list.
[13] 91 Fed. Reg. at 23,434.
[14] Id. at 23,435–44.
[15] Id. at 23,434.
[16] Id. at 23,440, 23,443–44.
[17] U.S. Food & Drug Admin., Guidance for Industry, Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Jan. 2018).
[18] 91 Fed. Reg. at 23,432.
[19] Id. at 23,433.
Senior Associate
Senior Counsel
