For several years, high demand strained the supply of certain GLP-1 medicines, and during official shortages compounding pharmacies sometimes prepared versions of them under specific federal rules. As the manufacturers' supply stabilized, the FDA updated its shortage determinations and clarified the limits on compounding “copies” of drugs that are commercially available again.
The high-level timeline (injection products)
- Tirzepatide injection: in late 2024 the FDA determined the national shortage was resolved and removed those products from the shortage list (around December 19, 2024).
- Semaglutide injection: in early 2025 the FDA similarly determined the shortage was resolved (around February 21, 2025).
- After a shortage ends, the legal room to compound essentially-copies of the approved drug generally narrows. The exact enforcement windows are time-limited and best read on FDA's own pages — this is not a compliance calendar.
What “compounding a copy” means
Compounding is allowed in defined circumstances. Two pathways people hear about: Section 503A (state-licensed pharmacies compounding for an individual patient on a valid prescription) and Section 503B (FDA-registered outsourcing facilities under different requirements). In both, compounding a product that is essentially a copy of a commercially available FDA-approved drug is restricted unless a recognized legal exception applies. When supply of the approved product is adequate, the appropriate choice is generally the FDA-approved brand — not a compounded look-alike.
Compounded is not the same as FDA-approved
- The FDA has not reviewed a specific compounded preparation the way it reviews an approved drug for safety, effectiveness, and manufacturing quality.
- Labels, concentrations, inactive ingredients, and beyond-use dates can differ from brand pens and vials.
- The FDA has raised concerns about unapproved GLP-1 products — including certain salt forms and products of uncertain purity that were never intended for sterile human injection. “It looks similar on social media” is not a quality standard.
How New Start MD approaches it
New Start MD is physician-guided care that uses licensed providers and state-licensed pharmacies, and will not prescribe outside the law. We educate patients about FDA-approved options first; we do not promise compounded copies of commercially available GLP-1 drugs when shortage-based authority no longer applies. If a medicine you hoped for isn't legally available to compound, that's often the law catching up to improved brand supply — and your provider can discuss approved alternatives and lifestyle care.
Education only — not legal or medical advice, and not a guarantee of product availability. Regulatory status changes; FDA primary sources and counsel control interpretation. Compounded medicines are not FDA-approved. Prescriptions are issued only if appropriate after a clinician evaluation. Adults 18+.
Sources
The primary sources behind this article — so you can read them yourself.
- FDA — Clarifies policies for compounders as national GLP-1 supply stabilizes — U.S. Food and Drug Administration
- FDA — Concerns with unapproved GLP-1 drugs used for weight loss — U.S. Food and Drug Administration
- FDA — Intends to take action against non-FDA-approved GLP-1 drugs — U.S. Food and Drug Administration
- FDA — Human drug compounding — U.S. Food and Drug Administration
Products are available only by prescription after a consultation with a licensed provider, who decides whether treatment is appropriate. Many compounds described here are not FDA-approved medicines and have not been tested in people for the uses described; information on this site is educational and is not medical advice.