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FDA Hormone Regulation

Meaning

FDA Hormone Regulation denotes the comprehensive set of policies, guidelines, and enforcement actions implemented by the U.S. Food and Drug Administration governing the manufacturing, testing, marketing, and clinical use of pharmaceutical-grade hormone products and related drug therapies. This regulatory oversight ensures that approved hormonal medications, including bioidentical and synthetic preparations, meet stringent standards for safety, efficacy, and quality control before they are made available for patient treatment. The scope includes both prescription drugs and certain over-the-counter hormone-related preparations.