Regulatory notice
Compounded hormone and GLP-1 preparations. Compounded hormone and GLP-1 preparations are not FDA-approved and are not interchangeable with FDA-approved products; where an approved product exists, any difference from it is the prescriber’s determination for an individual patient. Each preparation is compounded and dispensed by our 503A pharmacy partner on a patient-specific prescription. ExaVeyra makes no claim that any preparation is safe or effective for any condition. Availability depends on the pharmacy’s license in the destination state, on whether the substance may be compounded under federal and state law, and on current FDA policy for the agent prescribed. ExaVeyra Sciences is a supplier: it does not provide medical care, does not consult with patients and takes no part in clinical decisions.
The GLP-1 Compounding Landscape in 2026
The commercially available GLP-1 and dual-incretin receptor agonists are FDA-approved drugs. When FDA listed them in shortage beginning in 2022, the FD&C Act allowed 503A pharmacies and 503B outsourcing facilities to compound them while the shortage lasted.
FDA declared the shortage of GLP-1 receptor agonist products resolved in February 2025, and of dual GIP and GLP-1 receptor agonist products in late 2024. The deadlines that followed differ by agent. For the dual-incretin products, enforcement discretion ended for 503A pharmacies on 18 February 2025 and for 503B outsourcing facilities on 19 March 2025. For the GLP-1 products it ended on 22 April 2025 and 22 May 2025 respectively. A 503A pharmacy may still compound these agents for an individual patient when the prescriber identifies a need the commercially available product does not meet.
Practitioner note: This page is an educational resource. ExaVeyra Sciences does not make clinical efficacy claims. All supply is intended for licensed practitioners operating within applicable federal and state regulatory frameworks. Sourcing decisions should be guided by current FDA guidance and legal counsel.
503A vs. 503B: Side-by-Side
| 503A: State-Licensed Pharmacy | 503B: FDA Outsourcing Facility | |
|---|---|---|
| Regulatory basis | Section 503A of FD&C Act | Section 503B of FD&C Act |
| Batch production | Individual prescriptions only | Large-scale batches permitted |
| FDA oversight | State pharmacy boards primary | Direct FDA registration + inspection |
| GMP requirements | State standards apply | Federal cGMP standards required |
| Batch testing | Variable by state | Required: sterility, potency, impurities |
| Current GLP-1 status | Limited, patient-specific need only | Ceased (post-shortage resolution) |
| Distribution scope | To specific patient per Rx | To practitioners & healthcare facilities |
The ExaVeyra Supply Standard
Verified Source Integrity
Compounded preparations are prepared by a 503A pharmacy licensed by its state Board of Pharmacy, against a valid prescription for an individual patient. ExaVeyra does not work with a 503B outsourcing facility. Batch documentation and certificates are available upon request.
NPI-Verified Access
The pharmacy's formulary and pricing are released after NPI verification. Every practitioner account is checked against the NPPES registry first.
Regulatory Navigation
With the FDA enforcement landscape evolving rapidly, ExaVeyra publishes ongoing compliance updates for practitioners navigating the post-shortage 503A/503B framework.
Cold-Chain Logistics
The dispensing pharmacy ships each prescription in temperature-controlled packaging, with the storage conditions printed on the label.
Common Questions
The research citations and scientific content on this page are provided for educational and informational purposes only. This content does not constitute medical advice, diagnosis, or treatment recommendations. ExaVeyra Sciences does not make clinical efficacy claims for any products. All cited publications are independently authored peer-reviewed studies available through PubMed, PMC, or DOI. Nothing in these citations is a claim about any product. Practitioners decide, within their own scope of practice, whether and how any material is used.