What is the Current Status of the GLP-1 Drug Shortage?
Over the past two years, GLP-1 medications such as tirzepatide, dulaglutide, and semaglutide have been in high demand due to their proven effectiveness in managing Type 2 diabetes and weight loss. As demand surged, the pharmaceutical supply chain struggled to keep up, causing widespread shortages that affected patients across the U.S. Fortunately, the FDA recently announced that the shortage of tirzepatide injection has been resolved. The manufacturer now confirms that they are able to meet both current and projected national demand. However, other GLP-1 drugs, such as dulaglutide and semaglutide, remain in short supply as manufacturers continue to ramp up production.
While this is great news for tirzepatide users, it’s important to note that local supply disruptions may still occur. Pharmacies may take time to restock their shelves, and patients could experience short-term gaps in availability until supply chain logistics stabilize. Stay informed by checking the FDA’s Drug Shortages Database for the most current information on GLP-1 availability.
Can Compounders Provide GLP-1 Medications During a Shortage?
If you’ve been relying on compounded versions of GLP-1 medications, you may wonder whether compounders can continue offering these drugs, especially when the shortage seems to be resolving. The FDA has clarified its policies regarding compounders and the production of GLP-1 medications. Under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, compounders are limited in how they can reproduce FDA-approved medications.
For example, under Section 503A, pharmacies are prohibited from compounding drugs that are “essentially copies” of commercially available products unless they meet certain legal exemptions. Now that tirzepatide is no longer on the FDA’s shortage list, the ability for compounders to legally produce compounded versions of this medication is restricted.
In contrast, outsourcing facilities operating under Section 503B face even stricter rules. They cannot produce drugs that are nearly identical to FDA-approved products unless those drugs remain on the shortage list. Currently, dulaglutide, semaglutide, and liraglutide injections are still considered to be in shortage, so compounded versions of these medications may still be legally produced, but only under specific guidelines.
FAQs About GLP-1 Availability & Compounding Regulations
What You Should Know:
The shortage of tirzepatide has been resolved, meaning it’s now commercially available in most areas. However, other GLP-1 drugs are still experiencing supply issues.
If you’ve been using a compounded version of tirzepatide, you will likely need to switch to the commercially available product.
Compounded versions of dulaglutide and semaglutide are still legal while those medications remain on the FDA’s shortage list.
As always, consult with your healthcare provider if you have any questions about switching medications or need help finding alternatives during these supply disruptions.
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