Enclomiphene: A Regulatory Update

Over the past 6 to 8 years, we have received various inquires from practitioners and patients alike related to the prescribing of enclomiphene. As we have researched this issue several times, we would like to share with you our findings.

First, the FDA compounding subcommittee (PCAC) voted to block the use of enclomiphene for compounding and its inclusion on the 503A/503B allowed compounding list.. As you know, enclomiphene is one of two isomer components of Clomid (clomiphene citrate), but has itself as a standalone product never been in an FDA-approved product inspite of various attempts. The last attempt was made by Therapeutics, Inc. with a drug called Androxal (enclomiphene), but failed due to concerns of "adequate data".

Additionally, the new United States Pharmacopeia <795> guidelines from November 2023 requires that the active materials used for compounding be of USP or National Formulary grade. The enclomiphene available on the market for purchase from Darmerica is of "in-house" grade; meaning the guidelines for its manufacturer are provided by the manufacturer themselves, as it has no description in the USP, British Pharmacopeia, Japonese Pharmacopeia, European Pharmacopeia, or Brazilian Pharmacopeia. As a nationally accredited pharmacist practice, we would be cited and could lose accreditation and have issues with State or Federal regulatories if they were to discover that we are using enclomiphene for compounding. Additionally, FDA inspections of compounding pharmacies can lead to them requesting list of prescribers of products which can lead to prescribers encountering issues as well.

Next, the cost: 25 gm of the raw material is >$800 and that is the smallest size available and is ONLY available from one supplier. Therefore, the patient would need to be pay the initial fee to cover the cost of the raw material + shipping and then we would have to add on a labor/formulation fee of $65 for the initial dispense.

For those individuals absolutely determined to prescribe the enclomiphene, we would direct you to CareFirst Specialty Pharmacy: https://www.cfspharmacy.pharmacy/enclomiphene-capsules

And lastly, the head to head studies of clomiphene citrate vs enclomiphene tend to demonstrate similar efficacy, but with enclomiphene demonstrating a cleaner side effect profile. MP47-02 ENCLOMIPHENE VS. CLOMIPHENE: SAFETY AND TESTOSTERONE LEVELS IN HYPOGONADAL MEN | Journal of Urology

Based on this, and the risk vs benefit ratio, it would seem not worth the professional liability to prescribe the enclomiphene, with such scrutiny and little therapeutic difference between the two.

We hope you find this information useful and helpful for your decision making around the use of enclomiphene for you or the patients you care for.