FDA 2025: What Changed for Pharmacies Compounding Semaglutide and GLP-1 Medications

FDA 2025: What Changed for Pharmacies Compounding Semaglutide and GLP-1 Medications

In early 2025, the U.S. Food and Drug Administration (FDA) issued new guidance clarifying how pharmacies can compound GLP-1 medications such as semaglutide and tirzepatide.
These drugs, best known by their brand names for diabetes and weight management, had been in short supply, leading many 503A and 503B facilities to prepare compounded alternatives.

With supply now stabilized, the FDA has narrowed the conditions under which compounding is permitted. Here’s what the new rules mean for patients and pharmacies.

Why Compounding Rules Changed

The FDA declared the national shortage of semaglutide injections resolved in February 2025. That decision ended the temporary allowance that let 503A pharmacies compound GLP-1 drugs for patient-specific prescriptions during the shortage.

Today:

  • 503A pharmacies may compound semaglutide only when a commercial product in the required strength or form is not available.
  • 503B outsourcing facilities may no longer compound semaglutide for office use unless they follow CGMP rules and report batches to the FDA.

For details about the 503A / 503B difference, see How to Evaluate a Compounding Pharmacy in 2025.

How This Affects Patients

If you currently use a compounded GLP-1 medication, make sure your pharmacy:

  • Uses semaglutide base, not salt forms (sodium or acetate).
  • Is a licensed 503A or FDA-registered 503B facility.
  • Performs testing for identity, potency, and sterility under USP <797>.

Your clinician may transition you to an FDA-approved drug once commercial supplies and insurance access allow.

Read about quality standards in Are Compounding Pharmacies Safe?.

Competitor Context and Market Landscape

Large digital retail services such as Capsule, Alto Pharmacy, TruePill, and Mark Cuban Cost Plus Drugs focus on mass-market distribution of commercial prescriptions.
By contrast, 503A pharmacies serve a different mission, creating custom formulations for individual patients under strict USP and state regulation.
This distinction helps the FDA clarify responsibility between large retail channels and compounding specialists when shortages arise.

Why Oversight Matters

The FDA’s 2025 update protects patients by reinforcing testing and traceability while supporting pharmacies that follow best practice standards.

For investors tracking regulatory impact, see Compliance as Alpha to learn how alignment creates operational value.

Key Takeaways

  • GLP-1 compounding is now restricted to specific medical needs.
  • Only licensed 503A / 503B pharmacies may prepare these drugs.
  • Patients should verify ingredient sources and USP <797> compliance.
  • Documentation and transparency remain the strongest safety signals.

Learn more about personalized medicine in What Is a Compounding Pharmacy?.