In a move that could shake up the medical spa industry, the FDA has officially resolved the shortages of Ozempic and Wegovy, signaling a potential crackdown on compounded semaglutide.
This decision directly impacts medspas offering weight loss services, as many have relied on compounding pharmacies to provide semaglutide-based treatments.
What Does Resolving The Semaglutide Shortage Actually Mean?
The FDA’s announcement means that because the shortages are no longer recognized, compounding pharmacies may no longer legally produce semaglutide versions that were previously permitted under emergency supply shortages. The FDA has been clear that compounded drugs are only allowed when the commercially available drug is in shortage. We saw this when they resolved the shortage with Tirzepatide in early 2025 and what that meant for medspas.
Now that Ozempic and Wegovy are readily available, medspas sourcing semaglutide from compounders may find themselves in regulatory hot water. But, you do not need to empty your fridge’s yet.
You can read the FDA’s official stance on compounding and drug shortages here.
What Does This Mean?
Basically, it all starts with the compounding pharmacies where medical spas get their semaglutide.
According to the FDA’s guidelines, state-licensed pharmacies compounding under section 503A of the FD&C Act are permitted to continue compounding, distributing, or dispensing semaglutide injection products until April 22, 2025.
For outsourcing facilities under section 503B of the FD&C Act: Compounding, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug until May 22, 2025.
What Is The Difference Between A 503A and 503B Compounding Pharmacy?
The difference between 503A and 503B compounding pharmacies comes down to regulations, oversight, and the scope of their operations.
- 503A pharmacies are often used when a medspa orders compounded medications for a specific patient.
- 503B pharmacies are necessary if a medspa wants to stock semaglutide or other injectables in bulk for in-office administration.
Since the FDA is tightening regulations around compounded semaglutide, understanding whether your pharmacy is 503A or 503B is critical for compliance.
What’s Next?
Medspa owners should stay vigilant about FDA guidance and ensure their weight loss programs align with federal regulations.
Yes, there will be pushback and as we discussed in the article below, compounding pharmacies may find ways around the regulations.
However, as Dave Knapp from On The Pen discusses below, it may be a tough case for compounding pharmacies to explain why thousands of patients who received traditional compounded semaglutide previously ALL now need an adjusted version of the peptide.
What Medspa’s Should Do Now?
If you are currently offering semaglutide from a compounding pharmacy you should receive some kind of update from your pharmacy regarding how they plan to address this FDA announcement.
Expect offerings of updated compounds (e.g. adding B12) and a few more hoops to jump through such as questionnaires as to why your patient needs the B12 infused version.
We will keep you updated on the latest as we get closer to the imposed stoppage dates – and hopefully there will be legal options for medspas to continue to purchase and provide the GLP-1 peptides to their clients in the future.
