In February 2025, the U.S. Food and Drug Administration (FDA) announced that the national shortage of semaglutide injections, the active ingredient in popular GLP-1 medications like Ozempic® and Wegovy® was officially resolved.
During the shortage, many compounding pharmacies were permitted to prepare individualized semaglutide formulations for patients.
Now that supply is normalized, those temporary exceptions are changing. Both patients and prescribers must understand what’s allowed, what’s not, and how to stay safe.
For a quick primer, see What Is a Compounding Pharmacy? and our safety overview Are Compounding Pharmacies Safe?.
503A vs 503B, Who Can Compound GLP-1 Medications?
- 503A pharmacies (like AllMedRx) compound patient-specific prescriptions under state boards of pharmacy and follow USP <795> and USP <797> standards.
- 503B outsourcing facilities are FDA-registered and follow Current Good Manufacturing Practice (CGMP), allowing them to compound certain medications in bulk for office use.
USP Standards, The Foundation of Patient Safety
The U.S. Pharmacopeia (USP) establishes national quality standards:
- USP <795> non-sterile compounding (capsules, creams, suspensions)
- USP <797> sterile compounding (injectables, ophthalmics)
- Both chapters became official on November 1, 2023, strengthening environmental controls, technician training, and beyond-use dating.
For injectables like semaglutide, USP <797> compliance ensures sterility, potency, and stability critical for safety and efficacy.
Safety Watch-Outs with Compounded GLP-1s
While compounding remains vital for patient specific therapy, compounded GLP-1s require careful oversight:
- Ingredient accuracy: Some products have contained unapproved semaglutide salt forms. Always confirm your pharmacy uses semaglutide base from an authorized supplier.
- Testing & quality: Legitimate pharmacies perform identity, potency, sterility, and purity testing on every batch.
- Labeling: Each container must display accurate beyond-use dating (BUD) and storage instructions.
Learn how to evaluate a pharmacy’s practices in Are Compounding Pharmacies Safe?.
What the FDA’s 2025 Decision Means for Patients
The FDA’s February 2025 update means:
- Most 503A pharmacies can no longer compound semaglutide injections unless a valid shortage or medical exception exists.
- 503B outsourcing facilities remain under expanded FDA oversight for GLP-1 products.
- Patients using compounded semaglutide should consult their providers about transitioning back to FDA-approved formulations, now widely available.
If you have allergies or sensitivities, learn how customized, allergen-free medications can help in Allergy Drops vs Shots vs Pills (2025) from our partners at AllergyWorx.
Bottom Line
The end of the semaglutide shortage marks a new chapter for compounded GLP-1 medications.
Only pharmacies that adhere to USP standards, verify their ingredients, and maintain strict sterility controls should be trusted to compound these drugs.
At AllMedRx, we’re committed to providing safe, transparent, and compliant compounding services, helping patients and clinicians make informed decisions in 2025 and beyond.For insights into how compliance and regulatory standards create long-term value in healthcare, explore Capital Worx Investments, our partner site focused on innovation and growth in the compounding and pharmaceutical sectors.