A pregnancy hormone used in fertility care. It is a licensed biologic that cannot be compounded under 503A.
Key takeaway
hCG is a glycoprotein hormone made by the placenta. It acts like LH and is used in fertility treatment and some forms of hypogonadism.
At a glance
| FDA status | In an FDA-approved drug |
|---|---|
| 503A compounding | No 503A pathway: regulated as a licensed biological product |
| Body areas | Sexual & reproductive health, Hormones & pituitary |
| Through ScriptMates | Information only |
| Open questions | 1 noted below |
What is hCG (human chorionic gonadotropin)?
hCG is a glycoprotein hormone made by the placenta. It acts like LH and is used in fertility treatment and some forms of hypogonadism.
Since March 23, 2020, FDA regulates hCG as a licensed biological product. FDA says such products are not eligible for the 503A and 503B compounding exemptions.
Dosage forms
FDA-approved Pregnyl and Novarel are powders for solution for intramuscular injection.
Is hCG (human chorionic gonadotropin) FDA-approved?
Approved as Pregnyl and other chorionic gonadotropin products, now under biologics licenses (e.g., BLA 017692).
Can it be prescribed through ScriptMates?
No 503A pathway: regulated as a licensed biological product. A partner pharmacy lists it, but it has no lawful 503A pathway today (regulated as a licensed biological product).
What we could not confirm
- One partner lists “HCG Pregnyl”, which may be the licensed product rather than a compound. That is a dispensing question, not a compounding one, so it is not shown here as prescribable.
Sources
- Drugs@FDA: Pregnyl (chorionic gonadotropin)
- FDA: Notice to compounders on the March 23, 2020 biologics transition
Checked October 27, 2026. FDA updates these pages, so confirm before relying on them.