This is a complex and evolving topic, generating a ton of calls and interest to us. There are multiple moving parts to this, and here is a brief summary as of the date of this post:
1) What is a compounded drug?
a drug made locally at a 'compounding pharmacy' -- in essence the chemical structure is published by the pharmaceutical company that developed the drug or it has come off patent and is now 'generic' and the local pharmacy makes the drug themselves in house locally
often, the underlying chemical 'active ingredient' drug is 'compounded' with another substance, such as vitamin b12 and that 'combination' is sold as a 'new drug'
2) Is compounding of prescription medications legal?
every state varies in how compounded drugs are allowed / regulated
the FDA does not regulate / oversee the quality / production / safety of compounded drugs
If the underlying chemical ingredient is still on patent, the stance of the US Federal Government is that usage of that chemical as a 'compounded drug' violates federal intellectual property law:
3) Compounded GLP-1 drugs in TX
TX allows for compounding of drugs (many states do not, per above)
FDA makes an exception / does not prosecute pharmacies and doctors for compounding drugs that are declared by FDA as 'on shortage' even if they are not yet generic
Since their inception, the demand for semaglutide and tirzaperitide have been more than the companies that own them have been able to produce, so until now they have been under FDA 'shortage' status until now...
4) Semaglutide (Wegovy, Ozempic) and Tirzaperitide (Zep Bound, Monjuro)
see my other posts on the evolution of this landscape
The chemical semaglutide is patented by a Novo Nordisk and sold as the brand name drug Ozempic when used for diabetes and Wegovy when used for weight loss
Semaglutide has been removed from the FDA 'shortage' list and therefore is no longer legally allowed to be sold as a compounded drug as of May 22 (https://www.ziatsmedical.com/post/fda-declares-shortage-of-semaglutide-over)
The FDA has been sued by compounding pharmacies, so perhaps this will get delayed while in court: https://www.ziatsmedical.com/post/in-fort-worth-drug-compounders-sue-us-fda-over-removal-of-wegovy-ozempic-from-shortage-list
The chemical tirzaperitide is patented by Eli Lily and sold as the brand name drug ZepBound when for weight loss and Monjuro when for diabetes
Tirzaperitide has been removed from FDA 'shortage' list and is no longer legally allowed to be sold as a compounded drug as of March 19
5) What to do if you are on these medications?
as of this writing Medicare is not covering these medications for weight loss; they will sometimes cover for diabetes, chronic kidney disease, and congestive heart failure
some commercial insurers are covering for obesity, but generally only if BMI is > 35 and sometimes also requiring a co-morbidity such as sleep apnea, hypertension, etc
the process to get insurance approval is slow and time consuming, requiring prior authorization from our office which if appropriate we are happy to do but can take weeks to months for insurance to approve
6) Alternatives if not covered by insurance
Eli Lilly has begun selling direct to consumer versions of tirzaperitide for $300-$500 per month (depending on price)
Novo Nordisk has recently announced a simliar program (see below) for semaglutide, with similar pricing
7) What if my pharmacy says they can still compounding 'with a doctors order'?
I have recently become aware of some pharmacies in Fort Worth telling patients that if their physician states there is a 'medical need' to be on a comopunded version of a GLP-1 they will continue to make it / sell it
I find this very disappointing, misleading to the patients, and a frank attempt for these pharmacies to shift legal liability to the physicians in order to continue to sell product that is not legal
We are happy to discuss with you about you case and how we can move forward if GLP-1 is the right mediation for you, but we are not willing to compromise our integrity nor the patent laws of the United States of America, even if local compounding pharmacies tell you otherwise, and we will not honor nor work with the pharmacies that are recommending this tactic
Federal Judge Denies Appeal by Compounding Pharmacies: https://www.reuters.com/business/healthcare-pharmaceuticals/us-judge-denies-injunction-stop-bar-copies-lilly-weight-loss-drug-2025-03-06/
Danish drugmaker Novo Nordisk said Wednesday that it will drop prices 23% for all doses of Wegovy. https://search.app/uZZ8QYxdG3sRP1vg6
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