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Regulatory Compliance Standards

Meaning

Regulatory Compliance Standards are the mandated rules, guidelines, and specifications established by governmental and international bodies, such as the FDA, EMA, or compounding pharmacy boards, that govern the development, manufacturing, quality control, and distribution of pharmaceuticals, medical devices, and health supplements. Adherence to these standards is legally required to ensure product safety, efficacy, and consistent quality, providing a critical framework for protecting public health. In the domain of hormonal health, these standards are particularly rigorous for compounded bioidentical hormones and novel delivery systems.