Compounded semaglutide and tirzepatide are not FDA-approved. The FDA declared both national shortages resolved by early 2025, so compounding is now limited mainly to patient-specific prescriptions under section 503A, and in 2026 the FDA proposed keeping both off the 503B bulks list.
Compounded semaglutide and tirzepatide are not FDA-approved, and the FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed. During the national shortages of the brand-name products, the FDA allowed broader compounding, but it declared the tirzepatide shortage resolved in late 2024 and the semaglutide shortage resolved in February 2025, and the grace periods that followed have ended. Today, compounding of these medications is limited mainly to state-licensed pharmacies filling individual prescriptions under section 503A, within limits on copying approved drugs. In April 2026 the FDA also proposed keeping semaglutide, tirzepatide and liraglutide off the list of substances that larger outsourcing facilities may compound from bulk ingredients.
Federal law sets up two main compounding pathways, which the FDA describes on its Compounding Laws and Policies page:
| Section 503A | Section 503B | |
|---|---|---|
| Who | Compounders such as state-licensed pharmacies that are not outsourcing facilities | Outsourcing facilities, a voluntary category created by the Drug Quality and Security Act |
| Prescription requirement | Drugs must be compounded based on valid patient-specific prescriptions | May compound under a patient-specific prescription or in response to a provider's order, such as office stock |
| Manufacturing standards | Exempt from current good manufacturing practice (CGMP) requirements | Subject to CGMP requirements |
| FDA oversight | Not FDA-approved; exempt from premarket approval | Not FDA-approved; inspected by FDA on a risk-based schedule and required to report adverse events |
Neither pathway involves FDA approval of the final product. That is the key distinction between a compounded medication and a brand-name product such as Wegovy or Zepbound.
When a drug is on the FDA's shortage list, compounders have more room to make versions of it. Once the shortages of these medications were resolved, the FDA gave compounders time to wind down before resuming normal enforcement. According to the FDA's policy page:
| Date | Event |
|---|---|
| October 2, 2024 | FDA determines the tirzepatide injection shortage is resolved |
| December 19, 2024 | After re-evaluation, FDA issues a new decision that the tirzepatide shortage is resolved |
| February 21, 2025 | FDA determines the semaglutide injection shortage is resolved |
| March 2025 | Enforcement discretion for tirzepatide ends for 503A pharmacies (after a court denied an injunction on March 5) and for 503B outsourcing facilities (March 19) |
| Late April to May 2025 | Enforcement discretion for semaglutide ends for 503A pharmacies (after a court denied an injunction on April 24) and for 503B outsourcing facilities (May 22) |
| April 1, 2026 | FDA updates its guidance, reminding compounders of the conditions they must meet |
| April 30, 2026 | FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list |
The FDA explains that a 503A compounder must compound for an individual patient based on a prescription, and must not compound, regularly or in inordinate amounts, drugs that are essentially copies of commercially available drugs.
The FDA intends to treat a compounded product as essentially a copy if it has the same active ingredient as a commercially available product, unless a prescriber determines and documents that the compounded version contains a change that produces a significant difference for an identified individual patient. The FDA gives a specific example: a product that combines semaglutide with another ingredient, such as vitamin B12, may still be considered essentially a copy if it is given the same way as the approved products and the amounts are within 10 percent of the strengths of the respective commercially available products.
In its April 2026 update, the FDA also stated that, at this time, it does not intend to take action against a compounder for essentially-copy compounding if the compounder fills four or fewer prescriptions of that compounded product during a calendar month.
The FDA explains that outsourcing facilities cannot compound from bulk drug substances unless the substance appears on the 503B bulks list or the drug is on the FDA's shortage list. Tirzepatide and semaglutide currently appear on neither.
On April 30, 2026, the FDA proposed formally excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, saying it found no clinical need for outsourcing facilities to compound them from bulk substances. The notice was published in the Federal Register on May 1, 2026, with a public comment period that ran through the end of June 2026. The FDA said it would consider comments before making a final determination, so check the FDA's website for the current status.
The FDA's page on unapproved GLP-1 drugs, most recently updated in October 2026, lists several concerns:
The FDA's practical advice to patients includes getting a prescription from a licensed clinician and filling it at a state-licensed pharmacy, using a new sterile needle and syringe for each injection, discarding multiple-dose vials 28 days after first use, and not using any injectable GLP-1 product that arrives warm or without adequate refrigeration.
ACOG's 2026 practice advisory notes that unapproved compounded GLP-1 formulations are widely available online, including in low "microdose" amounts. Low-dose GLP-1 regimens are an off-label use: they are not an FDA-approved way to use these medications, and the compounded products involved are not FDA-approved. Discuss the evidence and regulatory status with a licensed provider; dosing is set by the prescriber.
Compounded semaglutide and tirzepatide available through NewDay Wellness are prescribed by licensed providers through an independent clinical partner and dispensed by licensed US pharmacies, and they are not FDA-approved.
No. The FDA states that compounded drugs are not approved by FDA and that it does not review them for safety, effectiveness or quality before they are marketed. The brand-name products went through FDA review; compounded versions did not.
In limited ways. State-licensed 503A pharmacies may compound for individual patients based on a prescription, but may not make essentially copies of approved drugs regularly or in inordinate amounts. 503B outsourcing facilities currently may not compound them from bulk ingredients, because neither drug is on the 503B bulks list or the shortage list.
503A compounders fill patient-specific prescriptions and are exempt from federal manufacturing (CGMP) requirements. 503B outsourcing facilities can also supply providers' offices, must follow CGMP requirements and are inspected by the FDA on a risk-based schedule. Products from neither pathway are FDA-approved.
On April 30, 2026, the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, which would bar outsourcing facilities from compounding them from bulk substances. The FDA said it would consider public comments before a final decision.
A licensed provider can explain the difference between FDA-approved and compounded options, whether an approved product fits your needs, and how to use any prescribed medication safely. Ask about the pharmacy, the ingredient form and how doses are measured before you start. This article is educational and does not determine eligibility for any treatment.
Written by the NewDay Wellness editorial team from the sources above and checked against them before publication, and medically reviewed by Dr. Sean Arora and Dr. Shannon Arora of Arora Health & Aesthetics; see our editorial standards. This article is educational and does not diagnose conditions, establish eligibility for any medication, or replace care from a licensed provider. Compounded medications are not FDA-approved.
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