If your practice offers medical weight loss services, it’s crucial to stay informed about recent changes regarding semaglutide and tirzepatide. The FDA has recently updated the status of most forms of these drugs to "available" on the presentations page of their shortage list. This shift, occurring within the last week, marks a significant change, although some presentations have been toggling on and off the list for months. So, what does this mean for weight loss providers? The impact depends on your current practices. Below, we outline key considerations for your practice.
Understanding “Currently in Shortage” Status
Under section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA permits the compounding of drugs that are not “commercially available drug products.” As of today, August 14, 2024, semaglutide and tirzepatide still hold the “Currently in Shortage” designation on the FDA’s drug shortage list. When a drug is listed as "Currently in Shortage" under section 506E of the FD&C Act, it may be compounded, provided that all the conditions of section 503A are met.
There is often confusion among providers as to why these drugs remain on the shortage list when nearly all presentations of semaglutide and tirzepatide are listed as available on the FDA’s website. The key factor is whether the drug is categorized as “Currently in Shortage” or “Resolved,” which ultimately determines its eligibility for compounding.
Prepare for the Possibility of Discontinuing Use of Compounded Versions
It’s important to understand that the FDA’s decision on whether a drug is in shortage or commercially available is based on various internal factors and is not solely dependent on manufacturer reports. Once the FDA marks the shortage of semaglutide and tirzepatide injections as “Resolved” on the shortage list, providers must stop using compounded forms of these commercially available products, except in a few specific cases.
We are learning more from the FDA and will continue to provide updates on what the timeline and expectations will be for the transition away from compounded versions to manufacturer-sourced products.
Responding to Letters from Eli Lilly or Novo Nordisk
If you’ve received letters from legal representatives of Eli Lilly or Novo Nordisk, it’s essential to remain calm but proactive in ensuring your practice complies with FDA regulations. Remember, the FDA ultimately defines what constitutes a “commercially available drug product.” As of now, semaglutide and tirzepatide injections do not meet this definition, but this status could change.
Please contact a legal professional before responding to communications from legal representatives of these manufacturers. If you are represented by counsel, these legal representatives should not contact you directly but should only communicate with you through your legal counsel – this is your legal right.
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