Educational — Not Legal AdviceReviewed
Is Oxytocin legal? FDA status and US regulatory standing
Current status
FDA-approved. Oxytocin is an FDA-approved drug (status recorded ).
Primary source: www.accessdata.fda.gov
Federal legal status
FDA approval status
Oxytocin is an FDA-approved drug. FDA-approved oxytocic hormone. Brand: Pitocin (NDA 016992 and generics). Indicated for labor induction and postpartum hemorrhage. As an approved drug it is compounded via the approved-drug / USP-monograph route; its bulk substance appears on the FDA 503B outsourcing-facility list, not the 503A pharmacy bulk-substances list. Prescription only.
Also known as
OT · Pitocin
Status history
- Oxytocin is an FDA-approved drug. [source]
Frequently asked questions
- Is Oxytocin FDA approved?
- Oxytocin is an FDA-approved drug (status recorded 1980-07-09). Primary source linked on this page.
- Can doctors prescribe Oxytocin?
- Oxytocin is listed as prescription-availability in the PeptideBase library. Prescribing rules vary by state and prescriber licensure — consult a licensed clinician.
PeptideBase provides educational research tools and provider discovery. It does not provide medical advice, diagnosis, treatment, prescribing guidance, or dosing instructions. Consult a qualified healthcare professional before making health decisions.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .