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Description
National Law Review (Polsinelli PC) was explicit on April 22, 2026: removing a Category 2 bulk drug substance does not, on its own, authorize use of that substance in compounding or bring it within FDAs interim enforcement discretion policy for substances in Category 1. Even Category 1 substances are only under enforcement discretion, which is short of full authorization

Titterington JS, Sukhanov S, Higashi Y, Vaughn C, Bowers C, Delafontaine P

He states that there are a range of unpleasant side effects, and that is not needed if a person is already taking estrogen and/or testosterone via hormone replacement therapy (HRT)

Nature , 432 (7016), 466472
Siddique MM, Seraj MMB, Adnan MN, Galib SM

HorvathRCzerminBGulatiSDemuthSHougeGPyleAet al
