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Drug Compounding Regulations

Meaning

Drug Compounding Regulations encompass the specific legal and administrative rules governing the practice of preparing custom-made medications to meet the unique needs of an individual patient. These rules establish strict quality control, facility standards, and professional guidelines for pharmacists and physicians who create drug formulations that are not commercially available. In the hormonal health space, these regulations are particularly relevant for personalized hormone replacement therapies, ensuring the safety, purity, and potency of tailored bio-identical hormone preparations. Adherence to these standards is critical for maintaining patient trust and therapeutic efficacy.