FDA compounding status
Enclomiphene Citrate
Also listed as Enclomiphene.
Enclomiphene citrate is in FDA's 503A Category 1. FDA is still evaluating it and has said it does not intend to take action against a 503A pharmacy that compounds it against a patient-specific prescription while the interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Enclomiphene is not in any 503B category. Compounded enclomiphene is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
Enclomiphene is not clomiphene. FDA lists enclomiphene citrate as its own substance, and clomiphene citrate has a separate regulatory status.
Checked against the primary sources on .
The record
- FDA status
- FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.
- Compounding basis
- 503A pharmacy (Category 1, interim policy)Compounded by a state-licensed 503A pharmacy against a patient-specific prescription. The substance is in FDA's 503A Category 1: FDA has said it does not intend to take action while the substance is under evaluation, if the interim policy's conditions are met. This is enforcement discretion, not the bulks list.
- FDA advisory committee
- Not reviewed
- Sport (WADA 2026)
- Prohibited at all times under WADA class S4.2 (anti-estrogenic substances, including selective estrogen receptor modulators).
- Offered by PEPLUX
- No
- Checked on
Basis
What this status traces to.
FDA's 503A categories documents updated September 27, 2024 and May 14, 2026 both list "Enclomiphene Citrate" in Category 1, bulk drug substances under evaluation. Enclomiphene does not appear in any category of FDA's 503B categories document (updated March 21, 2025). It is not on the 503A bulks list in 21 CFR 216.23. Category 1 is FDA's interim enforcement discretion, not a statutory pathway.
Primary sources
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated September 27, 2024Document dated . Checked .
- FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
- FDABulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActDocument dated . Checked .
- eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
- FDACompounding and the FDA: Questions and AnswersDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA's Pharmacy Compounding Advisory Committee has not reviewed it.
If you are subject to anti-doping rules
Prohibited at all times under WADA class S4.2 (anti-estrogenic substances, including selective estrogen receptor modulators).
Enclomiphene is not named on the 2026 list. Class S4.2 covers selective estrogen receptor modulators and names clomifene. Placing enclomiphene in that class is our reading, not a WADA ruling.
Pending or unconfirmed
FDA's database of approved drugs (Drugs@FDA) has not yet been checked for an approved product containing enclomiphene. Placing enclomiphene in WADA class S4.2 is our own reading of the list, not a WADA ruling.
Common questions
Enclomiphene Citrate, answered plainly.
- What is the FDA compounding status of Enclomiphene Citrate?
- Enclomiphene citrate is in FDA's 503A Category 1. FDA is still evaluating it and has said it does not intend to take action against a 503A pharmacy that compounds it against a patient-specific prescription while the interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Enclomiphene is not in any 503B category. Compounded enclomiphene is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
- What does the status of Enclomiphene Citrate trace to?
- FDA's 503A categories documents updated September 27, 2024 and May 14, 2026 both list "Enclomiphene Citrate" in Category 1, bulk drug substances under evaluation. Enclomiphene does not appear in any category of FDA's 503B categories document (updated March 21, 2025). It is not on the 503A bulks list in 21 CFR 216.23. Category 1 is FDA's interim enforcement discretion, not a statutory pathway. Checked against the primary sources on October 13, 2026.
- Does PEPLUX offer Enclomiphene Citrate?
- PEPLUX does not currently offer Enclomiphene Citrate. This page explains its regulatory status and is not a recommendation to use it.
- Is Enclomiphene Citrate prohibited in sport?
- Prohibited at all times under WADA class S4.2 (anti-estrogenic substances, including selective estrogen receptor modulators). Enclomiphene is not named on the 2026 list. Class S4.2 covers selective estrogen receptor modulators and names clomifene. Placing enclomiphene in that class is our reading, not a WADA ruling.
- Is anything about the status of Enclomiphene Citrate pending or unconfirmed?
- FDA's database of approved drugs (Drugs@FDA) has not yet been checked for an approved product containing enclomiphene. Placing enclomiphene in WADA class S4.2 is our own reading of the list, not a WADA ruling.