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Drug Compounding: Background, Issues & FDA Oversight

Editat de Martti Bram
en Limba Engleză Hardback – 14 mai 2014
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.
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Specificații

ISBN-13: 9781631173608
ISBN-10: 163117360X
Pagini: 123
Dimensiuni: 155 x 230 x 15 mm
Greutate: 0.38 kg
Editura: Nova Science Publishers Inc
Colecția Nova Science Publishers, Inc (US)
Locul publicării:United States

Cuprins

Preface; Compounded Drugs; Federal Authority to Regulate the Compounding of Human Drugs; Drug Compounding: Clear Authority & More Reliable Data Needed to Strengthen FDA Oversight; Statement of Janet Woodcock, Director, Center for Drug Evaluation & Research, Food & Drug Administration. Hearing on "Examining Drug Compounding"; Testimony of Scott Gottlieb, Resident Fellow, The American Enterprise Institute. Hearing on "Examining Drug Compounding"; Testimony of Joe Harminson, Owner of DFW Prescriptions, on behalf of the National Community Pharmacists Association. Hearing on "Examining Drug Compounding"; Index.