For clinicians
hCG for prescribers: status, evidence and what FDA has said
A neutral reference. It reports hCG's regulatory status, the quality of its human evidence and what FDA has said about it. It does not suggest a dose, a protocol or a source.
Status reviewed 2026-10-01 · By the Grey Peptides Editorial Board · Regulatory fields generated from our tracker
| Also known as | — |
| FDA approval | Approved (Pregnyl, Ovidrel) |
| Compounding (503A) | Rx (FDA-approved) |
| Outsourcing (503B) | No 503B status recorded |
| WADA 2026 List | Prohibited (S2.2.1) |
| WADA 2027 List | Prohibited (S2.2.1) |
| Evidence grade | High |
| Status reviewed | 2026-10-01 |
What FDA has said
hCG is FDA-approved. The prescribing information is the authority on its dosing, monitoring and contraindications; below is what each label carries in its boxed warning and how its Warnings and Precautions section is organised, read from DailyMed on 2026-10-01.
Novarel label version 41, effective 2025-08-27
No boxed warning.
This is an older-format label whose Warnings section has no numbered subsections; read it in full at the source.
Read the full Novarel prescribing information on DailyMed
Pregnyl label version 11, effective 2025-12-02
No boxed warning.
This is an older-format label whose Warnings section has no numbered subsections; read it in full at the source.
Read the full Pregnyl prescribing information on DailyMed
Monitoring: what the literature does and does not say
For an approved drug, the prescribing information is where monitoring is set out — in its Warnings and Precautions section, whose headings are listed above for each label, and in its dosing and specific-populations sections. This page lists those headings so a prescriber can see what the label covers; it does not restate the label, and the label, not this page, is the authority.
Compounding: where it stands
Today's position for hCG: Rx (FDA-approved). An FDA advisory committee's vote is a non-binding recommendation; until FDA acts, a vote does not change what may be compounded. Our explainer on the 503A and 503B categories sets out what each status means, and the regulatory tracker is updated as FDA acts.
The evidence
A 237-amino-acid heterodimeric glycoprotein hormone with an alpha subunit shared with LH/FSH/TSH and a unique beta subunit that allows LH-receptor-mediated stimulation of testicular Leydig cells or ovarian corpus luteum.
The encyclopedia entry lists the human and animal studies we hold, each with its PMID.
What this page leaves out
Doses, regimens and titration. For an approved drug those belong to the prescribing information, linked above; restating them here would create a second, unmaintained copy.
Sources
- Novarel prescribing information, DailyMed SPL version 41; read 2026-10-01. DailyMed
- Pregnyl prescribing information, DailyMed SPL version 11; read 2026-10-01. DailyMed
- Grey Peptides regulatory tracker, row for hCG, reviewed 2026-10-01. Tracker · dataset
- World Anti-Doping Agency. Prohibited List 2027, dated August 26, 2026, in force January 1, 2027. WADA
This page is a reference for qualified professionals. It is not medical advice, it does not recommend any treatment, and it is not a substitute for the prescriber's own judgement and their state and federal obligations.
Others in this group: Bremelanotide (PT-141) · Dulaglutide · Exenatide · IGF-1 (mecasermin) · Leuprolide · Liraglutide · Octreotide · Orforglipron · Semaglutide · Somatropin · SS-31 (elamipretide) · Teriparatide · Tesamorelin · Tirzepatide