What is the Origin of Compounded Hormones Legal?

The legal framework for compounding originates from the practice of traditional pharmacy, where medications were routinely prepared on-site, predating large-scale pharmaceutical manufacturing. Modern regulations, particularly in the United States, were clarified and codified by acts like the Drug Quality and Security Act (DQSA) to distinguish between traditional compounding pharmacies (503A) and outsourcing facilities (503B), establishing the legal boundaries for this specialized practice.

What is the Mechanism of Compounded Hormones Legal?

The legal mechanism functions by balancing patient-specific medical necessity with regulatory oversight to ensure quality and safety. Prescribers must issue a patient-specific prescription, and the compounding pharmacy must comply with quality standards, often based on USP guidelines, for preparing non-sterile and sterile products. The legality hinges on the compound being truly individualized and not an attempt to mass-produce copies of commercially available or withdrawn medications.

Compounded Hormones Legal ∞ Area

Compounded Hormones Legal

Meaning

This term describes the legal status and regulatory landscape governing pharmaceutical preparations of hormones that are custom-made by licensed compounding pharmacies to meet the specific, individualized needs of a patient as prescribed by a physician. The legality centers on adherence to specific federal and state laws, which permit compounding when a commercially available, FDA-approved drug is medically inappropriate for the patient, such as needing a unique dosage form or being allergic to a standard excipient. This practice operates within a defined legal exception to standard drug manufacturing regulations.