Enclomiphene Citrate HSA/FSA Eligibility and Submission: The Complete 2026 Guide

At a glance

• FDA approval / None; no FDA-approved drug contains enclomiphene as an active ingredient [1]
• Compounding status / FDA Category 1, bulk substances under evaluation; enforcement discretion, not approval [3]
• 2022 FDA advisory vote / 4 yes, 8 no on adding enclomiphene citrate to the allowed bulk list [4]
• Tax guidance / IRS Publication 502 covers drugs and medicines as expense categories in general; it does not settle eligibility for compounded enclomiphene [2]
• Clomiphene distinction / Clomiphene is a mixture of enclomiphene and zuclomiphene; FDA-approved only for ovulatory dysfunction in women [1][5]

What enclomiphene is

Enclomiphene is an oral selective estrogen receptor modulator. It blocks estrogen receptors in the pituitary, so the pituitary releases more LH and FSH, which tells the testes to make more testosterone [1]. FDA's own advisory-committee presentation says no FDA-approved drugs contain enclomiphene as an active ingredient [1].

Clomiphene is related but not the same drug. Clomiphene citrate is a mixture of enclomiphene and zuclomiphene, and it is FDA-approved only for ovulatory dysfunction in women who want to become pregnant [1][5]. The Clomid label has no male indication. It says there are no adequate or well-controlled studies showing clomiphene citrate is effective for male infertility [5].

What the tax guidance says

IRS Publication 502 lists drugs and medicines among medical expense categories in general terms [2]. Whether a specific compounded enclomiphene prescription qualifies for HSA or FSA spending is not established here.

What is enclomiphene's compounding status?

Enclomiphene has no FDA-approved product and no USP monograph, and it is not on FDA's final list of bulk substances that can be used in compounding. Pharmacies therefore cannot simply compound it as a routine matter, and FDA is still evaluating it [3]. FDA's list, updated May 14, 2026, places enclomiphene citrate in Category 1, Bulk Drug Substances Under Evaluation. FDA says it does not intend to take action against a compounder using a Category 1 substance if the conditions in its guidance are met. That is enforcement discretion, not approval and not a finding that the product is safe or effective [3].

At the June 8, 2022 meeting of FDA's Pharmacy Compounding Advisory Committee, FDA proposed that enclomiphene citrate not be added to the allowed bulk substances. The committee voted yes 4, no 8, abstain 0 [4]. Enclomiphene is not on FDA's Category 2 list of bulk substances that may present significant safety risks [6]. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness, or quality before they reach patients [7].

Frequently asked questions

›Is enclomiphene FDA-approved?

No. FDA's own advisory-committee presentation says no FDA-approved drugs contain enclomiphene as an active ingredient [1]. The sponsor received a complete response letter in 2015, and no approval has followed [1].

›What is enclomiphene's FDA compounding status?

FDA lists enclomiphene citrate in Category 1, Bulk Drug Substances Under Evaluation [3]. That is enforcement discretion, not approval and not a finding of safety or effectiveness [3].

›Is enclomiphene the same as clomiphene?

No. Clomiphene citrate is a mixture of enclomiphene and zuclomiphene [1]. The Clomid label covers ovulatory dysfunction in women, and it says there are no adequate or well-controlled studies showing effectiveness in male infertility [5].

References

1. U.S. Food and Drug Administration. U.S. Food and Drug Administration
2. Publication 502 (2025), Medical and Dental Expenses | Internal Revenue Service. Publication 502 (2025), Medical and Dental Expenses | Internal Revenue Service
3. U.S. Food and Drug Administration. U.S. Food and Drug Administration
4. U.S. Food and Drug Administration. U.S. Food and Drug Administration
5. U.S. National Library of Medicine, DailyMed. Clomid (clomiphene citrate) tablets, Cosette prescribing information. Clomid (clomiphene citrate) tablets, Cosette label
6. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
7. Human Drug Compounding Laws | FDA. Human Drug Compounding Laws | FDA