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Compounding Pharmacy Rules

Meaning

Compounding Pharmacy Rules refer to the stringent set of regulations and standards that govern the practice of preparing personalized medications, including Compounded Hormonal Therapy, outside of the conventional drug manufacturing process. These rules are established by national regulatory bodies, such as the FDA in the United States, and state boards of pharmacy, often incorporating guidelines from organizations like the United States Pharmacopeia (USP). The primary purpose of these regulations is to ensure the safety, quality, and purity of compounded preparations, safeguarding public health from potential risks associated with non-standardized drug production. Compliance involves strict adherence to procedures for ingredient sourcing, facility cleanliness, and quality control testing.