Is Enclomiphene Legal in the United States?
Enclomiphene is legal in the US as a compounded medication prescribed by a licensed practitioner. Here's the regulatory picture.
The short answer
Yes. Enclomiphene is legal in the US when compounded by a state-licensed pharmacy and prescribed by a licensed practitioner for an individual patient. It is not currently FDA-approved as a finished branded drug, but compounding pathways are explicit and legal.
What 'compounded' actually means
Compounded medications are prepared by state-licensed pharmacies based on a prescription written for a specific patient by a licensed practitioner. The FDA does not approve compounded medications because they are individualized, there is no mass-manufactured product to approve. The pharmacy itself is regulated by both the state board and, for larger 503B facilities, by the FDA.
Who Selvara works with
Selvara partners with 503A and 503B state-licensed compounding pharmacies. Every prescription is reviewed and written by a licensed practitioner. Coverage is 48 states.
Frequently asked questions
Is compounded enclomiphene the same as Androxal?
Same active molecule. Androxal was the branded development name; the brand version is not currently marketed.
Is it safe?
Compounded enclomiphene from a state-licensed pharmacy is held to USP standards for sterility and potency.
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