Hormone Therapy for Postmenopausal Women

To the Editor: In an assessment of therapies to treat the symptoms of menopause, Pinkerton (Jan. 30 issue) 1 dismisses compounded therapies (except for those used in patients with allergies or when there is a medical need for unusual dosing regimens), and she notes safety concerns. This blanket generalization overlooks the substantial Food and Drug Administration (FDA) oversight established by the 2013 Drug Quality and Security Act (DQSA). Contrary to Pinkerton’s assertion of “minimal government regulation and monitoring,” the drug outsourcing facilities supervised under the DQSA must register with the FDA, be subject to regular unannounced inspections, comply with Current Good . . .