What is the Origin of FDA Compounding Pharmacy Rules?

These regulations are rooted in the Federal Food, Drug, and Cosmetic Act, with significant modern updates mandated by the Drug Quality and Security Act of 2013. The latter was passed in response to serious public health concerns regarding the safety and quality control of large-volume compounding operations. FDA is the acronym for the U.S. Food and Drug Administration.

What is the Mechanism of FDA Compounding Pharmacy Rules?

The primary function of these rules is to enforce standards, such as Current Good Manufacturing Practices (CGMP) for outsourcing facilities, and to restrict the compounding of drugs from bulk substances unless they are on an FDA-approved list. This mechanism ensures that customized preparations, particularly bioidentical hormone replacement therapies (BHRT) where consistency and purity are essential, meet rigorous quality and sterility standards, thereby protecting the patient from potentially inconsistent or contaminated products.

FDA Compounding Pharmacy Rules ∞ Area

FDA Compounding Pharmacy Rules

Meaning

FDA Compounding Pharmacy Rules are the specific regulatory guidelines and legal statutes established by the U.S. Food and Drug Administration that strictly govern the preparation of customized medications by compounding pharmacies. These rules draw a crucial distinction between the traditional practice of compounding for individual patient needs and large-scale drug manufacturing. They impose stringent requirements on facility standards, quality control testing, and the preparation of medications that are essentially copies of commercially available, FDA-approved drugs. Adherence to these rules is paramount for patient safety.