The short answer
Generally no. FDA removed semaglutide from the shortage list on 21 February 2025, ending the exemption that let pharmacies compound copies; enforcement dates passed in April and May 2025. Compounding an essentially-a-copy product is now prohibited under sections 503A and 503B, and in April 2026 FDA proposed excluding semaglutide from the 503B bulks list entirely.
What changed, and when?
FDA declared the semaglutide shortage resolved on 21 February 2025. That single act removed the legal foundation for most compounded semaglutide in the United States, because both compounding pathways forbid making a drug that is essentially a copy of a commercially available product — section 503A(b)(1)(D) for pharmacies and section 503B(a)(5) for outsourcing facilities — and the shortage listing had been the exemption everyone relied on.
FDA gave the market a runway rather than an immediate cutoff: 503A pharmacies had until 22 April 2025 and 503B outsourcing facilities until 22 May 2025 to stop. Those dates have long passed.
The door closed further in 2026. On 30 April 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 substances. The comment period ran through the summer of 2026. FDA has continued issuing warning letters to compounders and telehealth sellers marketing compounded GLP-1 products.
Is there any remaining pathway?
| Pathway | Status for semaglutide |
|---|---|
| Shortage-based compounding | Closed — shortage resolved February 2025 |
| 503B bulks list | Not listed; FDA proposed formal exclusion April 2026 |
| Salt forms (semaglutide sodium/acetate) | Not permitted — FDA has stated these are different active moieties, not components of the approved drug |
| "Personalized dosing" | Very narrow; see below |
| Prescribing FDA-approved Ozempic/Wegovy | Fully lawful, subject to prescriber scope |
The personalized-dosing argument deserves a direct answer because it is what most vendors now sell. Section 503A permits compounding a drug that would otherwise be essentially a copy where the prescriber determines there is a change that produces a significant difference for that identified individual patient, and that determination must be documented on the prescription. FDA has been clear that this is a narrow, patient-specific exception, not a business model. Producing a standard-strength product at a non-standard concentration, adding B12 or an amino acid as a differentiator, or offering a house microdosing protocol to every patient does not convert a copy into a compliant compound. Bulk production for a patient population is not patient-specific compounding at all.
Products marketed as "research use only," obtained from unregistered suppliers, or personally imported are outside both pathways entirely and are unapproved new drugs.
What can a med spa lawfully do?
Prescribe and use the FDA-approved products. A prescriber acting within their state scope — physician, and NP or PA within their authority and any collaboration requirement — can perform a good faith exam, establish an indication, and prescribe Ozempic, Wegovy, Mounjaro or Zepbound for dispensing by a pharmacy. Semaglutide and tirzepatide are not controlled substances, so the Ryan Haight Act's in-person examination requirement does not apply; telehealth prescribing is governed by ordinary state telemedicine standards instead.
What a med spa should not do is buy bulk product, hold inventory of compounded GLP-1s, or advertise compounded semaglutide by name. Sourcing and advertising are where enforcement lands first.
What this means for your paperwork
Your GLP-1 file needs to establish medical appropriateness, not just a signature. Document the good faith exam by a lawful prescriber, BMI and comorbidities, relevant history including personal or family medullary thyroid carcinoma and MEN 2 — a contraindication in the approved labeling — pancreatitis history, gallbladder disease, current medications, and the treatment plan with titration schedule and monitoring intervals.
The consent should cover the boxed warning for thyroid C-cell tumors in the approved labeling, common gastrointestinal effects, pancreatitis, gallbladder events, hypoglycaemia risk in combination with other agents, pregnancy considerations and discontinuation planning, plus a realistic statement about weight regain after stopping. Add explicit product identity: name the exact FDA-approved product prescribed.
Purge legacy marketing. Website pages, price lists, intake forms and consent templates written during the shortage frequently still say "compounded semaglutide," and that copy is now both inaccurate and an enforcement flag. Keep a dated regulatory memo in your policy manual recording the February 2025 shortage resolution, the 2025 enforcement dates and the April 2026 proposed 503B exclusion, with a scheduled re-check.
Related questions
This answer is educational and is not legal or medical advice. Requirements vary by state and change over time — verify with your own legal and clinical advisors before applying anything here in practice.