For the purpose of this podcast, we're referring to compounded Semaglutide or Tirzepatide as GLP-1s. A compounded drug might be appropriate if a patient’s medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available. However, compounded drugs are not FDA-approved.
Per FDA regulations enacted under the Drug Quality and Security Act (DQSA), Section 503A permits compounding of drug products “as customized therapies for identified individual patients whose medical needs cannot be met by commercially available drug products. GLP-1s may be prescribed to combat injury, age-related decline and other metabolic conditions. These uses are considered off-label and not officially approved.
GLP-1s, peptides including tirzepatide and semaglutide, have blown up in recent months due to their weight loss benefits. But those relying on GLP-1 programs may soon find themselves without treatment options.
There are new policies for compounders as our national GLP-1 supply begins to stabilize. As a result, many compounding pharmacies won’t be able to provide these peptides in upcoming months.
So why the new restrictions, and what does this mean for your weight loss plans?
On this episode of The Dr. Kris Podcast, Dr. Kris and Steve discuss the reasons behind the changes to GLP-1 policies, who will be impacted the most, and what you can do to stay on the path to weight loss.
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