Compounding has been traditionally defined as a process where a pharmacist or a physician combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Traditionally compounded drugs (CDs) are made in response to an individual prescription from a licensed health provider in the context of a pharmacist’s and health care professional’s relationship with a specific patient. This book provides background information on CDs and non-traditional compounding pharmacies relevant to policy discussions. This book will also examine the FDA’s regulation of drug compounding and will discuss relevant legal authorities. Specifically, the status of FDA’s authority to oversee drug compounding, and the gaps, if any, between state and federal authority will be discussed, as well as how FDA has used its data and authority to oversee drug compounding, and the actions taken or planned by states or national pharmacy organizations to improve oversight of drug compounding.
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