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Drug compounding : background, issues and FDA oversight

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 dr.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 organisations to improve oversight of drug compounding.

Online EBSCO Academic Comprehensive Collection

Drug compounding : clear authority and more reliable data needed to strengthen FDA oversight : report to congressional requesters

Online purl.fdlp.gov

Drug Compounding Pharmacies

In light of the 2012 fungal meningitis outbreak, believed to have been caused by a contaminated compounded steroid injection, the regulation of human drug compounding has received significant attention. Drug compounding in its traditional form is the process of combining, mixing, or altering ingredients in order to create a medication for a particular patient. However, as illustrated by the entity that created the steroid medication linked with the meningitis outbreak, concerns have been raised about compounding pharmacies producing drugs on a larger scale. While drug compounding has historically been the focus of state governments through their regulation of pharmacies, questions have arisen regarding the extent the federal government can regulate the practice of compounding through the Food, Drug, and Cosmetic Act (FDCA). This book examines the FDA's regulation of drug compounding and discusses relevant legal authorities, and the potential limits to the FDA's authority to regulate human drug compounding.

Online EBSCO Academic Comprehensive Collection