Which GLP-1s Can Be Compounded? The FDA Shortage and Bulks-List Rules

Almost none of them, lawfully. Both federal routes that let a pharmacy compound semaglutide or tirzepatide depended on those drugs sitting on FDA's shortage list, and both shortages are over — tirzepatide since December 2024, semaglutide since early 2025. In April 2026 the agency went further still, moving to strike all three molecules — semaglutide, tirzepatide, liraglutide — off the bulks list that outsourcing facilities draw from, on the finding that nothing clinical justified keeping them there.

The two routes, and what each one requires

Federal law exempts compounded drugs from ordinary approval requirements through two sections of the Food, Drug, and Cosmetic Act. Neither is a general license to copy an approved drug.

Section 503A — a state-licensed pharmacy or physician

Under 503A the drug has to be compounded for one identified patient against a prescription written for them. There is a second condition, and it is the one that bites: not regularly, and not in inordinate amounts, may a compounder make what the statute calls “essentially a copy of a commercially available drug”.^[1] FDA sets a specific threshold for that phrase: a compounder is not doing it "regularly or in inordinate amounts" if it fills four or fewer prescriptions of that compounded product in a calendar month.^[1]

Read that number against how compounded GLP-1s are actually sold. A telehealth program shipping monthly refills to thousands of subscribers is not filling four prescriptions a month.

Section 503B — a registered outsourcing facility

Outsourcing facilities may compound at larger scale, but they cannot use a bulk drug substance unless that substance appears on FDA's 503B bulks list, or the drug is on FDA's shortage list at the time it is compounded, distributed and dispensed.^[1] Semaglutide and tirzepatide are on neither.

Both shortages are closed

The tirzepatide date took three steps to settle. FDA called that shortage over on October 2, 2024; litigation sent the decision back to the agency for reevaluation three weeks later; and on December 19, 2024 a fresh determination landed in the same place. Compounders who read only the first announcement, or only the remand, got the timeline wrong in opposite directions.^[2] The semaglutide shortage was resolved in the same period, and FDA set explicit end dates for its enforcement discretion rather than leaving compounders to guess.^[1]

The litigation named in both rows is Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.) — the compounding industry's challenge to the shortage determination.^[1] FDA was explicit that these dates cover only violations that depend on shortage-list status. It reserved the right to act on anything else, including "findings that a product may be of substandard quality or otherwise unsafe."^[1]

April 2026: FDA moves to close the bulks-list route

On April 30, 2026 FDA proposed striking all three molecules from the bulks list that outsourcing facilities compound from. It had worked through the nominations and concluded there was no clinical reason for a 503B facility to be building these drugs out of raw substance at all.^[3]

When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound copies of them from bulk drug substances.

— FDA press announcement, April 30, 2026

FDA invited comments through June 29, 2026 and said it would consider them before a final determination.^[3] That window has closed; the determination is pending. If it is finalized as proposed, the bulks-list route shuts for these three molecules regardless of any future shortage argument.

So what can still be compounded

• A documented individual clinical need. 503A still permits compounding for a specific patient whose need cannot be met by the approved product — a documented reaction to something in the approved formulation, or a strength the commercial pens are simply not made in. The exemption is patient-specific and prescription-driven, not a product line.^[1]
• Anything genuinely in shortage at the time. The shortage condition is assessed when the drug is compounded, distributed and dispensed, not when the program launched.^[1]
• Not semaglutide or tirzepatide at scale. Neither is in shortage, neither is on the 503B bulks list, and FDA has proposed keeping them off it.^[1][3]

What to ask a seller

1. Which section are you compounding under, 503A or 503B? A seller that cannot answer this is not thinking about the rule it has to satisfy.
2. Name the pharmacy. 503A compounding happens at a state-licensed pharmacy; 503B at a facility registered with FDA, and that register is public. A program that will not name the pharmacy behind the vial cannot be checked at all.
3. On what basis is my prescription not a copy of an approved drug? If the answer is a standard formulation offered to every customer, that is the question FDA's "essentially a copy" language is about.