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

By Ruth Calder, Enforcement Editor (https://glpwatchdog.org/authors/ruth-calder) | Published: 2026-08-14 | Updated: 2026-10-27

Canonical page: https://glpwatchdog.org/research/which-glp1-can-be-compounded

> Both federal routes for compounding semaglutide and tirzepatide depended on FDA shortage status. Both shortages are closed, and FDA has proposed shutting the remaining route.

## Key points

- Tirzepatide's shortage was declared resolved on December 19, 2024; semaglutide's followed in early 2025.
- FDA's enforcement discretion for compounded semaglutide ended April 22, 2025 (503A) and May 22, 2025 (503B).
- Under 503A, filling more than four prescriptions a month of a copy of an approved drug is "inordinate amounts".
- On April 30, 2026, FDA proposed keeping semaglutide, tirzepatide and liraglutide off the 503B bulks list.

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, proposing that all three molecules (semaglutide, tirzepatide, liraglutide) be kept off the bulks list that outsourcing facilities draw from, on the finding that nothing clinical justified adding them. That proposal is still not final.

> **This is about what is lawful, not about what is for sale.** Compounded semaglutide and tirzepatide are still widely advertised. The rules below are what a seller has to satisfy to be doing it legally, and they are the questions to put to any seller before you pay.

## 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. The second condition is the one that matters here: a compounder may not, regularly or in inordinate amounts, make a drug that is what the statute calls **“essentially a copy”** of one already on the market.[1] FDA puts a number on 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]

Compare that with how compounded GLP-1s are 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]

*FDA enforcement-discretion end dates for compounded semaglutide*

| Compounder type | Discretion ended | Condition |
| --- | --- | --- |
| State-licensed pharmacy or physician (503A) | April 22, 2025 | …or the district court's decision in *OFA v. FDA*, whichever is later |
| Registered outsourcing facility (503B) | May 22, 2025 | …or the district court's decision in *OFA v. FDA*, whichever is later |

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 not to include any of the three molecules on 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][5]

> When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need.
>
> — FDA press announcement, April 30, 2026

The Federal Register notice set a comment deadline of June 30, 2026. FDA then extended it to **July 30, 2026**.[5][4] That window has closed. As of October 17, 2026, FDA has published no final determination, so the proposal is still a proposal. If it is finalized as written, none of the three can be compounded from bulk under 503B on a bulks-list basis. Only a shortage could then open the route, and only while it lasts.

## 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, such as a patient with a documented reaction to something in the approved formulation or one who needs a strength the commercial pens are not made in. The exemption is patient-specific and prescription-driven, not a product line.[1]
- **Anything in shortage at the time.** The shortage condition is assessed when the drug is compounded, distributed and dispensed, not when the program launched.[1] Liraglutide injection is on FDA’s shortage list as of October 2026.[6] Semaglutide injection and tirzepatide are not.[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]

Some sellers already list more than the two best-known molecules. [Lavender Sky Health](https://glpwatchdog.org/reviews/lavender-sky-health) offers compounded liraglutide, a once-daily injection, alongside its tirzepatide and semaglutide plans.

## 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 ([how 503A and 503B pharmacies differ](https://glpwatchdog.org/research/503a-vs-503b-compounding-pharmacies)). 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.

Sellers that still list compounded semaglutide answer those questions very differently in public. [FormidableMD](https://glpwatchdog.org/reviews/formidablemd), which offers both FDA-approved and compounded GLP-1s, says its compounded drugs come from 503A pharmacies. [BetterMe Rx](https://glpwatchdog.org/reviews/betterme-rx) names seven partner pharmacies with addresses and phone numbers, [Go Vida Plena](https://glpwatchdog.org/reviews/go-vida-plena) names six, and [Nolu](https://glpwatchdog.org/reviews/nolu) lists four in its terms. [Idgie Health](https://glpwatchdog.org/reviews/idgie-health) names the Houston compounding pharmacy that fills its orders, and the Seattle physician group that prescribes.

Others answer in general terms or not at all. [WeightRx](https://glpwatchdog.org/reviews/weightrx) says its medication is prepared by licensed 503A pharmacies, and [Liberty](https://glpwatchdog.org/reviews/liberty) says only that it uses accredited 503B pharmacies, without naming one. [Rewinding RX](https://glpwatchdog.org/reviews/rewinding-rx) refers to both sections without naming a partner, while [ARSYNL Rx](https://glpwatchdog.org/reviews/arsynl-rx) and [Science & Co](https://glpwatchdog.org/reviews/science-and-co) do not name the pharmacy on their public pages. With those sellers, the second question above is yours to ask before the first order.

> Compounded does not mean counterfeit, and a compounded drug is not automatically unsafe. It is, however, not FDA-approved: the specific product has not been reviewed for safety, efficacy or manufacturing quality. That is the trade-off, and it should be made knowingly.

## Frequently asked questions

### Is compounded semaglutide illegal now?

Not categorically. Compounding for an individual patient with a documented clinical need that the approved product cannot meet remains lawful under 503A. What ended is the shortage-based route that allowed compounding at scale. For semaglutide, FDA's enforcement discretion ran out on April 22, 2025 at state-licensed pharmacies; outsourcing facilities had until May 22, 2025.

### Why is it still sold everywhere then?

Because a rule ending is not the same as enforcement reaching every seller. FDA said its discretion covered only violations depending on shortage-list status, and that it may still act on other grounds, including product quality. Advertising is not evidence of lawful supply.

### Does the 503B bulks list proposal change anything yet?

Not yet. FDA announced the proposal on April 30, 2026 and took comments until July 30, 2026, after extending the original June 30 deadline. As of October 17, 2026 no final determination has been published in the Federal Register. Semaglutide and tirzepatide are still not on the 503B bulks list, so nothing has changed in practice, though the direction is clear.

### What about liraglutide?

The April 2026 proposal names liraglutide alongside the other two and rests on the same conclusion: nothing clinical justified compounding any of them from raw substance. Liraglutide differs in one respect. Liraglutide injection is listed as currently in shortage on FDA's drug shortage database as of October 2026, and a shortage is a separate basis for 503B compounding that lasts only as long as the listing does.

## References

1. U.S. Food and Drug Administration FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. FDA Drug Alerts and Statements. 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
2. U.S. Food and Drug Administration Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products. FDA. 2024. https://www.fda.gov/media/184606/download
3. U.S. Food and Drug Administration FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List. FDA Press Announcements. 2026. https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
4. U.S. Food and Drug Administration List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period. Federal Register (2026-12937). 2026. https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal
5. U.S. Food and Drug Administration List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Federal Register (2026-08552), 91 FR 23431. 2026. https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal
6. U.S. Food and Drug Administration FDA Drug Shortages: Liraglutide Injection. FDA Drug Shortages database. 2026. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide%20Injection&st=c

---

Cite as: GLP Watchdog, Ruth Calder, "Which GLP-1s Can Be Compounded? The FDA Shortage and Bulks-List Rules", published 2026-08-14, updated 2026-10-27. https://glpwatchdog.org/research/which-glp1-can-be-compounded

Canonical HTML page: https://glpwatchdog.org/research/which-glp1-can-be-compounded

Medical disclaimer: Nothing here is medical advice. We report on this subject; we do not treat anyone. Whether to begin a medication, supplement, or treatment, whether to adjust it, and whether to stop are questions for a clinician licensed to answer them, who knows your history.