As the popularity of GLP-1 medications like Ozempic, Wegovy, Mounjaro, and Zepbound continues to grow, Nevada compounding pharmacies are now facing significant regulatory changes. The Nevada State Board of Pharmacy has issued a directive that prohibits the compounding, dispensing, and distribution of semaglutide and tirzepatide injection products by both 503A (traditional compounding pharmacies) and 503B (outsourcing facilities regulated by the FDA).
This follows the FDA’s recent removal of both medications from its official drug shortage list and signals a broader national effort toward tighter enforcement of compounded GLP-1 medications. Here’s what Nevada pharmacies and healthcare providers need to know.
What started this change?
On December 19, 2024, and February 21, 2025, the FDA issued declaratory orders removing tirzepatide and semaglutide, respectively, from the federal drug shortage lists. Because they are no longer on the FDA’s shortage list, pharmacies can no longer use the shortage exception to legally compound them.
The FDA also emphasized that compounded versions of these drugs—especially those using salt forms like semaglutide sodium or semaglutide acetate—are not the same as the approved drugs used in Ozempic and Mounjaro. These compounded versions haven’t been reviewed for safety or effectiveness, and because they’re considered near-duplicates of existing drugs, federal law now restricts their use.
Who must comply?
The Nevada directive applies to both:
- 503A pharmacies – traditional compounding pharmacies that prepare medications for individual patients based on a prescription; and
- 503B outsourcing facilities – FDA-registered entities that compound medications in bulk for healthcare providers.
Under the Board’s directive:
- 503A and 503B pharmacies must immediately stop compounding tirzepatide injection products.
- 503A pharmacies must immediately stop compounding semaglutide injection products.
- 503B pharmacies must cease compounding, distributing, and dispensing semaglutide injection products after May 22, 2025.
Are there any exceptions?
In the directive, Nevada pharmacies are instructed to consult the FDA’s January 2018 guidance on “essentially copies” of commercially available drugs, which outlines very limited exceptions under federal law. However, these exceptions are narrow and do not generally apply to salt forms or compounded GLP-1 medications.
Additionally, the Board reminded pharmacies that:
- 503A pharmacies may not sell compounded medications to practitioners, and
- All pharmacies must comply with updated Nevada Administrative Code (NAC) 639.757, as recently amended by LCB File NO. R053-24 (effective Nov. 15, 2024).
What are the penalties for noncompliance?
Facilities that continue to compound, dispense, or distribute tirzepatide or semaglutide injection products after the effective dates will be in violation of Nevada law including: NRS 639.100, NRS 639.233, NRS 639.288, NRS 639.310, and NAC 639.593.
What should compounding pharmacies do now?
To ensure compliance and reduce risk, Nevada compounding facilities should:
- Immediately review and update compounding protocols and inventory to ensure no further compounding, dispensing, distribution of semaglutide or tirzeparide injection products.
- Educate staff on the current legal status of these medications, and
- Confirm compliance with Nevada’s recently updated compounding regulation (NAC 639.757) and consult the FDA’s 2018 guidance for extremely limited exceptions.