Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Compounding typically occurs in pharmacies, although it may also occur in other settings. Compounding facilities, including pharmacies, can play an important role in serving patient needs, such as in cases when patients cannot use commercially available drug products for various reasons (e.g., doses for paediatric populations may not be commercially available). To protect patients, compounding facilities must meet federal and state standards that apply to them, including ensuring that compounded drugs are not prepared, packed, or held under insanitary conditions. Section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FDC Act) states that a drug is deemed to be adulterated "if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health." The FDA has investigated numerous adverse events, including deaths, caused by contaminated compounded drugs that were produced under insanitary conditions. During the 2012 fungal meningitis outbreak, contaminated steroid injections killed dozens and caused infections in more than 750 patients in numerous states. The FDA continues to observe insanitary conditions at compounding facilities that could cause drugs they prepare to become contaminated and produce a negative impact to patient health. Some compounding facilities have voluntarily recalled drugs and ceased compounding operations based on the the FDA's observation of egregious insanitary conditions.
展开▼
