What is the Origin of Compounding Regulation?

The practice of compounding is ancient, but formal regulation emerged largely from drug safety crises in the mid-20th century, leading to the establishment of bodies like the FDA. The modern regulatory structure, particularly in the United States, was significantly clarified by the Drug Quality and Security Act (DQSA) of 2013. This legislation differentiated between traditional compounding pharmacies (503A) and outsourcing facilities (503B), each with distinct operational requirements.

What is the Mechanism of Compounding Regulation?

The regulatory mechanism functions through mandates for Good Manufacturing Practices (GMP) or Good Compounding Practices (GCP), rigorous facility inspections, and mandatory reporting requirements. These procedures ensure that compounded products meet standards for potency, sterility, and purity before reaching the patient. Regulations dictate the types of ingredients that can be used and the circumstances under which a medication may be compounded, typically based on a specific patient prescription.

Compounding Regulation ∞ Area

Compounding Regulation

Meaning

Compounding Regulation encompasses the set of federal and state laws, standards, and guidelines that govern the practice of pharmacy compounding, which is the preparation of customized medications for individual patients. These regulations are designed to ensure the safety, quality, and efficacy of non-commercially available drug preparations. Adherence to these strict rules is paramount for pharmacies preparing personalized hormonal therapies. This regulatory oversight is critical for protecting public health when utilizing tailored pharmaceutical interventions.