The short answer
Yes, with conditions that matter. Compounding personalized tirzepatide for an individual patient on a valid prescription remains lawful under the federal compounding law, section 503A of the Food, Drug, and Cosmetic Act, and under state pharmacy law. What ended in 2025 was the shortage period during which the FDA said it would not act against pharmacies and outsourcing facilities compounding copies of the branded products in volume. Since then, the ordinary rules apply, and they are stricter.
What changed and when
| Date | Event |
|---|---|
| December 19, 2024 | FDA confirmed that the tirzepatide shortage was resolved, after reconsidering an earlier October 2024 decision |
| February 18, 2025 | End of the FDA’s enforcement discretion for state licensed pharmacies, 503A, compounding tirzepatide |
| March 19, 2025 | End of the same discretion for outsourcing facilities, 503B |
| February 21, 2025 | FDA declared the semaglutide shortage resolved, with 503A discretion ending April 22 and 503B on May 22, 2025 |
During a declared shortage, the law lets compounders prepare a drug that is essentially a copy of the approved product. Once a shortage is over, a 503A pharmacy may not compound essentially copies of a commercially available product regularly or in inordinate amounts. A compounded product is not an essentially copy when the prescriber determines, and documents on the prescription, that a change from the approved product produces a significant difference for that patient. That is the legal basis on which personalized compounded tirzepatide continues to be prescribed.
What a lawful program looks like
- A licensed provider in your state evaluates you and decides whether treatment is appropriate. The prescription is written for you, not pulled from a menu.
- The pharmacy is licensed by its state board of pharmacy, follows United States Pharmacopeia standards for sterile compounding, and is licensed to ship into your state.
- The product is labeled as compounded, with the ingredients and strength on the label, and it is not marketed as the branded product or as equivalent to it.
- The program is clear that compounded medication is not FDA-approved and that the FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed.
Bodi Envi is a LegitScript certified telehealth platform. Its clinical organization is Wasef Health, PC, under medical director Michael Wasef, MD, and its GLP-1 pharmacy partner is VialsRx. Bodi Envi is not a pharmacy, a medical practice or a manufacturer. The LegitScript listing is public and can be checked by anyone.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.
Warning signs
The FDA’s page on unapproved GLP-1 products lists what it has seen: products sold without a prescription, products shipped from unlicensed sources or from outside the United States, dosing errors from vials and syringes the patient was not taught to use, and salt forms of the active ingredient that are not the same substance as the approved drug. A seller that does not require a provider visit, will not name its pharmacy, or describes its product as the same as Zepbound® is one to walk away from.
This is general information and not legal or medical advice. Laws and FDA policy can change, and state rules differ. Personalized compounded tirzepatide, which Bodi Envi’s programs may include, is not FDA-approved and is not equivalent to Zepbound® or Mounjaro®.
Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.
At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.