U.S. Food and Drug Administration (FDA)
Is Dulaglutide legal in United States?
ApprovedFDA-approved as Trulicity for type 2 diabetes since 2014; as a biologic it cannot be compounded
The regulator has approved it as a medicine.
Dulaglutide is FDA-approved (Biologics License Application, first approved 18 September 2014) as an adjunct to diet and exercise for glycaemic control in adults and children aged 10 and over with type 2 diabetes, and to reduce major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease or multiple risk factors. It is not approved for weight loss. FDA states that biological products are not eligible for the compounding exemptions in sections 503A and 503B, so there is no compounding pathway for dulaglutide.
Last verified 2026-09-29 · how we verify
Dulaglutide elsewhere
Sources (2)
- 01TRULICITY (dulaglutide) injection prescribing informationU.S. Food and Drug Administration · 2026-03 · accessed 2026-09-29
- 02Compounding and the FDA: Questions and AnswersU.S. Food and Drug Administration · 2025-09-16 · accessed 2026-09-29