FDA Moves to Keep GLP-1s Off the 503B Bulks List

On April 30, 2026, the FDA announced that it proposes not to include semaglutide, tirzepatide and liraglutide on the 503B bulks list. Coverage at the time, including STAT, described it as a move that would end large-scale compounding of the popular GLP-1 drugs. That is broadly the direction, but the details matter for clinics, telehealth companies and anyone who works with compounding pharmacies.

This guide explains what the FDA actually proposed, how it differs from the drug shortage list, where the shortages stand, and what remains unsettled. It is a summary of public documents, not a view on any particular business model.

Two different lists, often confused

A lot of coverage blurs two separate FDA tools. They work differently.

The drug shortage list. When the FDA lists a drug as in shortage, federal law gives compounders more room to make copies of it. For 503B outsourcing facilities, a drug on the shortage list can be compounded from bulk ingredients even if the substance is not on the bulks list. For 503A pharmacies, the shortage status affects whether a compounded drug counts as "essentially a copy" of an approved product.

The 503B bulks list. This is a list of bulk drug substances that outsourcing facilities may use because the FDA has found a "clinical need" for them. The FDA's view is that clinical need is about patient safety and medical necessity, not supply problems or price. Outside of a shortage, an outsourcing facility generally may compound from a bulk substance only if that substance is on this list.

So when a shortage ends, the bulks list becomes the remaining route for 503B facilities to compound from bulk ingredients. That is why the 2026 notice drew so much attention.

What the FDA proposed in 2026

The notice was published in the Federal Register on May 1, 2026 (91 FR 23431, docket FDA-2018-N-3240). A few points that are easy to get wrong:

• It is a notice, not a final rule. The FDA proposes not to add the three substances to the list and asked for public comment before making a final decision.
• The drugs were never on the bulks list. The FDA is not removing them. It reviewed nominations to add them and tentatively found no clinical need for outsourcing facilities to compound them from bulk.
• It covers 503B outsourcing facilities. The bulks list decision does not change the rules for 503A pharmacies, according to law firm summaries of the notice.
• The comment period was extended. The original 60-day window was extended by 30 days in a June 26, 2026 notice, and comments closed on July 30, 2026.

According to Frier Levitt's summary, the FDA considered and rejected several arguments for clinical need, including alternative routes of administration, different strengths, excipient sensitivities, multi-ingredient combinations and device preferences.

As of late October 2026, we found no final FDA decision on the notice. Outside reporting after the comment period closed said the FDA was reviewing comments and had not announced a timeline. Check the docket on regulations.gov for the current status before relying on this.

Where the shortages stand

The 2026 notice did not end the shortages. The FDA had already declared the semaglutide and tirzepatide shortages resolved more than a year earlier. Per the FDA's compounding policy page:

The "enforcement period" dates were grace periods during which the FDA said it did not intend to take action against compounders for making copies while patients transitioned.

Outsourcing facility groups challenged both shortage decisions in court. District courts denied preliminary injunctions in 2025, and a September 2026 Clark Hill client alert reports that the Fifth Circuit upheld the FDA's decisions in two unpublished rulings.

Liraglutide is different. At the time of the 2026 notice, liraglutide injection was still listed as in shortage, so law firm summaries noted that outsourcing facilities could still compound it on that basis while it stays listed. If the bulks list decision is finalized, that route would close once the shortage ends.

What it means for 503A pharmacies

The bulks list notice does not change the 503A framework, but that does not mean 503A compounding of these drugs is open-ended. The main limits come from other rules:

• Patient-specific prescriptions. 503A pharmacies compound based on a valid prescription for an identified individual patient.
• The "essentially a copy" limit. The FDA's policy treats a compounded drug as essentially a copy if it has the same active ingredient, a similar or easily substitutable strength, and the same route of administration as an approved product that is commercially available. Such copies cannot be compounded regularly or in inordinate amounts.
• Prescriber determinations. An exception applies when the prescriber documents that a change produces a significant difference for that specific patient.
• Combination products. The FDA has said, for example, that semaglutide combined with vitamin B12 may still be treated as a copy when each ingredient is close to a commercial strength.
• Low-volume tolerance. The FDA has said it does not currently intend to act on copies when a compounder fills four or fewer prescriptions of that product per calendar month.

How these rules apply to any given program is a legal question, and the answer can change with FDA guidance and court decisions.

Marketing is a separate risk

Separate from the compounding rules, the FDA has focused on how compounded GLP-1s are advertised. In September 2025, as part of a broader action on drug advertising, the FDA sent warning letters to telehealth companies over GLP-1 marketing. Holland & Knight's summary lists the kinds of claims flagged, such as describing a compounded product as "generic" for a brand-name drug, or as having the same ingredient as a named brand. The FDA treated those products as misbranded because of misleading advertising.

For telehealth and clinic owners, this means website copy, ads and patient emails are part of the compliance picture, not just the pharmacy arrangement.

Questions to raise with counsel

Businesses that touch compounded GLP-1s often work through questions like these with healthcare counsel:

1. Which of our products, if any, rely on a shortage listing, and what happens if that listing changes?
2. Is each partner pharmacy operating under 503A or 503B, and what is it relying on to compound each product?
3. How are prescriber significant-difference determinations documented, and who reviews them?
4. Does our marketing describe compounded products accurately, without implying FDA approval or equivalence to a brand?
5. Who monitors the 503B bulks docket, the shortage list and FDA warning letters, and how fast can we change course?

Where NutriCove fits

NutriCove's compounding service connects clinics with 503A and 503B compounding pharmacy partners. What any partner can lawfully supply depends on rules like the ones above, so it is a conversation to have with your own healthcare counsel and the pharmacy before anything is offered to patients. If you want to understand how partner introductions work, see the compounding partners page.

Sources

• FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide from 503B Bulks List, FDA
• List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B, Federal Register
• Notice extending the comment period to July 30, 2026, Federal Register via GovInfo
• FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, FDA
• Report on the FDA proposal to end GLP-1 compounding by outsourcing facilities (April 30, 2026), STAT
• FDA Proposal Would Leave Semaglutide, Tirzepatide, and Liraglutide Off 503B Bulks List, Epstein Becker Green
• FDA Proposes to Exclude GLP-1 Receptor Agonists from the 503B Bulks List, Frier Levitt
• Fifth Circuit Upholds FDA GLP-1 Shortage Decisions, Clark Hill
• FDA, HHS Taking Action Against Telehealth's Compounded Drug Advertising, Holland & Knight

This article is general information, not legal or medical advice. Talk to a qualified attorney or licensed professional about your situation.