Compounded GLP-1s in 2026: What Prescribers Can Still Do

The tirzepatide shortage was declared resolved on December 19, 2024, and the semaglutide shortage on February 21, 2025. FDA’s enforcement grace periods for compounded copies ended March 5, 2025 (tirzepatide, 503A pharmacies and physicians), March 19, 2025 (tirzepatide, 503B outsourcing facilities), April 24, 2025 (semaglutide, 503A), and May 22, 2025 (semaglutide, 503B). Since then, a compounded semaglutide or tirzepatide product qualifies for the compounding exemptions only if it is not “essentially a copy” of the approved drug. The one cushion is an FDA enforcement policy, not a legal exemption: no action against a compounder that fills four or fewer prescriptions of a copy per calendar month.

Most of what ranks for this question is written by telehealth sellers or for pharmacists. This guide is written for the prescriber (MD, DO, NP, PA) and separates what the compounder is exposed to from what your chart and your prescription have to show. It works from 21 U.S.C. 353a, FDA’s January 2018 essentially-a-copy guidance, FDA’s December 2016 prescription-requirement guidance, FDA’s April 1, 2026 compounder notice, and state board orders. Current as of October 2026.

Can I still prescribe compounded semaglutide in 2026?

Yes, but only for a patient whose documented medical need the approved product cannot meet. FDA states that compounded drugs “should only be used in patients whose medical needs cannot be met by an FDA-approved drug” (content current as of September 16, 2025). Section 503A exempts a compounded drug from approval requirements only if it is compounded “for an identified individual patient based on the receipt of a valid prescription order” and the compounder does not regularly or in inordinate amounts compound products that are essentially copies of a commercially available drug.

Two things the shortage ending changed: the shortage-based basis for copies is gone, and what remains is the “significant difference” exception, which belongs to the prescriber. The statute says a product is not essentially a copy when there is a change, made for an identified individual patient, that produces a significant difference “as determined by the prescribing practitioner.” The determination is yours. The documentation burden follows it.

GLP-1 receptor agonists are also not controlled substances: semaglutide, tirzepatide, and liraglutide do not appear on DEA’s alphabetical list of controlled substances (checked October 1, 2026). EPCS, the Ryan Haight in-person exam rule, and the DEA telemedicine rule therefore do not apply to the GLP-1 prescription itself. They do apply to phentermine or testosterone prescribed by the same clinic. A separate guide on the DEA telemedicine rule for TRT and weight loss clinics is forthcoming.

When did the shortage grace periods end?

Source: FDA’s compounder updates page. FDA set the 503A periods at 60 calendar days from each announcement or the date of the district court’s ruling on a preliminary injunction in Outsourcing Facilities Association v. FDA, whichever came later. The court denied the tirzepatide motion on March 5, 2025 and the semaglutide motion on April 24, 2025, and FDA’s March 10 and April 28, 2025 updates state that 503A enforcement discretion ended with those rulings. The 503B dates were fixed. The Ohio Board of Pharmacy’s GLP-1 guidance (issued July 17, 2025) tabulates the nominal February 18 and April 22 dates for 503A. Ohio’s position, not a federal safe harbor, is that a clinic that bought compounded product before those dates may continue to dispense what it already purchased, but may not compound GLP-1s past the dates.

503A vs 503B: who can compound what

503A covers compounding by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician. It is patient-specific. A physician who compounds in their own office is a 503A compounder and is subject to the same conditions, and FDA’s prescription guidance treats a “valid order or notation by a physician who compounds a drug for his or her own patient documented in that patient’s health record” as the prescription. Your chart order is the prescription.

503B covers outsourcing facilities, a category established in 2013 by the Drug Quality and Security Act, inspected by FDA and subject to current good manufacturing practice requirements. FDA’s prescription guidance says clinics and practitioners can obtain non-patient-specific compounded drugs for office use from outsourcing facilities, and only from them. But 21 U.S.C. 353b lets an outsourcing facility compound from bulk drug substance only if the substance is on the 503B bulks list or the drug is on the shortage list. FDA’s April 1, 2026 notice states that tirzepatide and semaglutide appear on neither.

That closes the office-stock route. Since March 19, 2025 (tirzepatide) and May 22, 2025 (semaglutide), outsourcing facilities have had no shortage-based or bulks-list basis to compound these drugs from bulk API, and a 503A pharmacy is limited to patient-specific prescriptions plus limited anticipatory quantities, so it is not an office-stock source. The same statute also requires that an outsourcing facility’s drug not be essentially a copy of an approved drug.

What the April 2026 bulks-list proposal does

On April 30, 2026, FDA proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk drug substances. The Federal Register notice was published May 1, 2026, and comments closed July 30, 2026. As of October 1, 2026, no final determination had been published. The proposal would formalize a position that already holds in practice, because the shortage-based basis ended in 2025.

What did the April 1, 2026 FDA notice change?

Nothing in law. The notice restated existing 503A and 503B conditions and the January 2018 guidance, and it added an example: FDA may consider a compounded product combining semaglutide API with vitamin B12 to be essentially a copy when the route is the same and the amounts are within 10 percent of the approved strengths. It created no new rule.

What the four-per-month policy does and does not permit

FDA’s policy, stated “at this time,” is that it does not intend to take action against a compounder for compounding an essentially-a-copy product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug product during a calendar month. Read it carefully:

• The count is the compounder’s. As FDA words it, the unit is the compounder, the compounded drug product, and the calendar month, with no prescriber-level carve-out. On that reading the pharmacy’s count runs across every prescriber it serves, and your prescription can be the fifth without you knowing it. The policy addresses enforcement against the compounder; it says nothing about the prescriber.
• It is enforcement policy, not a statutory safe harbor. The “at this time” language means FDA can change it.
• Prescriptions documenting a significant difference are not counted. FDA’s guidance says such a prescription “would not be counted towards the four prescriptions.”
• It does not permit salt forms or research-grade API. FDA says semaglutide sodium and semaglutide acetate “are different active ingredients than are used in the approved drugs” (current as of October 1, 2026). Ohio states that “research use only” products “may not be used for compounding in any circumstance”.
• It does not permit 503B bulk compounding, and it does not create office stock.
• It is not a routine channel. FDA’s own guidance defines the underlying limit as compounding copies no more often than needed “to address unanticipated, emergency circumstances.”

FDA lists red flags that look like a routine channel: a compounder that routinely substitutes compounded copies on receipt of prescriptions, offers pre-printed prescription pads for a copy without a significant-difference determination, or compounds on a routine or pre-set schedule rather than as needed.

What the chart has to show for a non-copy formulation

The 2018 guidance says the determination should be documented on the prescription, in any format, provided it makes clear that the prescriber identified the relevant change and the significant difference it produces for the patient. A notation added after a pharmacy call-back should be as specific and carry the date of the conversation.

What counts is a change in formulation that produces a documented, patient-specific difference: an allergy to an excipient in the approved product, a dosage form the patient genuinely cannot use, or a needed strength that is not available or easily substitutable. FDA also warns that Congress did not intend a patient allergy to justify compounding without the ingredient for patients who lack the allergy.

What does not count: adding vitamin B12 or another substance (Oregon’s board states that adding substances to an otherwise essentially-copy product is not among the circumstances meeting section 503A(b)(2)), a “custom” strength within 10 percent of an approved strength, price, convenience, or patient preference. FDA says the benefit “must be produced by the change the compounder will make,” and that other factors such as a lower price are not sufficient.

FDA “generally does not intend to question prescriber determinations that are documented in a prescription or notation,” but it will consider whether the prescription “documents that the determination was made.” The guidance also quotes the 1997 House conference report: where a claimed significant difference is “a mere pretext,” such as minor strength changes not known to be significant or a prescriber “receiving financial remuneration or other financial incentives to write prescriptions for compounded products,” the compounding is treated as copying. Keep the patient-specific reasoning in the chart as well as on the prescription, since the guidance also expects compounders to keep records of these notations and of how many copy prescriptions they have filled.

Informed consent for a compounded, unapproved product

This is not consent language, and state law may require specific consent content. These are the elements a consent should cover, drawn in part from FDA’s published statements and in part from the documentation rules above:

1. The product is not FDA-approved, and FDA does not review compounded drugs for safety, effectiveness, or quality.
2. The specific documented reason the approved product is not being used for this patient.
3. Who the compounder is, and that the clinic is not the manufacturer.
4. Known risks, including dosing errors with vials (FDA describes patients measuring incorrect doses and clinicians miscalculating doses) and the adverse event counts: as of May 31, 2026, FDA had received 990 reports for compounded semaglutide and more than 730 for compounded tirzepatide.
5. Alternatives, including the approved injectables and the oral semaglutide product (the Wegovy pill), which FDA approved on December 22, 2025.
6. How adverse events get reported, through FDA’s MedWatch program.
7. Whatever additional content your state requires.

Inventory and dispensing records when vials are in the office

A clinic that holds patient-specific vials should expect them to be read the way the Ohio Board of Pharmacy’s order in Ree’s Bar of Beauty LLC (Case A-2025-0299) read one. The board found compounded semaglutide and tirzepatide vials bought from an unlicensed source, multiple punctured multi-dose vials without a date opened or beyond-use date, no documented orders for administration, and a contracted medical director who never met the clinic’s patients. The board issued a summary suspension on September 30, 2025, later resolved by settlement with a $25,000 penalty and a written reprimand. Ohio’s GLP-1 guidance also requires pharmacies and prescriber clinics that compound to comply with USP 797 and the board’s compounding rules.

The administration-record and disposal rows are practice recommendations; the rest map to the sources shown.

When to use the FDA-approved product instead

A workable rule: use the approved product unless you can state, in one specific sentence, the patient-specific attribute of the approved product that makes it unsuitable and the change the compounded product makes to address it. If the reason is price, convenience, preference, a B12 add-on, or a strength within 10 percent of an approved one, the approved product is the only defensible choice. The prescriber’s test is the 503A significant-difference determination described above. FDA’s proposed standard for outsourcing facilities mirrors the same logic: the bulks-list notice says that “unless an attribute of the FDA-approved drug makes it medically unsuitable for certain patients” and the compounded product is intended to address that attribute, there is no clinical need to compound from bulk. If the reason is difficulty with injections, the approved oral option should be part of that conversation.

What the warning letters mean for a prescriber

FDA announced a crackdown on deceptive drug advertising on September 9, 2025. On March 3, 2026, it issued 30 warning letters to telehealth companies over claims implying sameness with approved products and over branding that obscured the compounder. A third set was posted in June 2026; the NativeMed letter cites the claim “the same active ingredient in Ozempic and Wegovy” and states that such claims represent compounded products as FDA-approved or evaluated when they are not. Marketing rules are covered in a forthcoming guide on FDA and FTC rules for GLP-1 marketing.

This is a compliance guide, not legal advice. Your state board’s rules and your counsel govern.

Documenting a significant-difference determination, tracking vials by lot and expiry, and keeping consent and progress notes in one place are record-keeping problems, and PrismEHR is built for them in wellness practices: GLP-1 management and progress-visit documentation templates, inventory management for injectables with lot and expiry tracking, labs and orders, a patient portal, built-in messaging, and video telehealth. eRx with EPCS covers the controlled substances a weight loss clinic may also prescribe. For the cash-pay side of the same practice, see our guide to membership and auto-renewal rules.