Extemporaneous Compounding

Abstract

Extemporaneous compounding of medications has been an integral component of the practice of pharmacy and medicine since the practices began. A staple of early medical and pharmacy practice, even today many patients benefit from compounding at some point in their care. Unfortunately, the regulation of the practice has not been so consistent. With a recent decision by the US Supreme Court, compounding regulation is again uncertain. This commentary reviews compounding practice, the history of compounding regulation, and discusses the current regulatory status of the practice.

Key Words:

• Compounding
• extemporaneous
• law
• regulation
• Supreme Court
• FDA
• FDCA
• FDAMA

Additional information

Notes on contributors

Susan C. Winckler

Cherokee Layson-Wolf, PharmD, is Assistant Professor at the University of Maryland School of Pharmacy. At the time that this review was conducted, she was a Community Care Pharmacy Practice Resident at Virginia Commonwealth University.

Perry G. Fine, MD, is Professor of Anesthesiology, School of Medicine and Associate Medical Director, Pain Management Center at the University of Utah Health Sciences Center, Salt Lake City; and National Medical Director, VistaCare, based in Scottsdale, AZ. This commentary is based on an article in Dr. Fine's VistaCare Palliative Medicine Monitor.

Jonathan R. Gavrin, MD, is the Internet editor for the Journal. He is Associate Professor of Anesthesiology and Adjunct Associate Professor of Medicine at the University of Washington School of Medicine; Associate Member, Fred Hutchinson Cancer Research Center; and Associate Director for Clinical Anesthesia Services, Harborview Medical Center.

Perry G. Fine, MD, is Professor of Anesthesiology, School of Medicine and Associate Medical Director, Pain Management Center at the University of Utah Health Sciences Center, Salt Lake City; and National Medical Director, VistaCare, based in Scottsdale, AZ. This commentary is based on an article in Dr. Fine's VistaCare Palliative Medicine Monitor.

Philip J. Wiffen, is the Regional Pharmaceutical and Prescribing Adviser, Anglia & Oxford Region of the National Health Service Executive, a member of the Oxford Regional Pain Relief Unit and Coordinating Editor of the Cochrane Collaboration Pain Palliative and Supportive Care Collaborative Review Group.

Perry G. Fine, MD, is Professor of Anesthesiology, School of Medicine; Associate Medical Director, Pain Management Center at the University of Utah Health Sciences Center, Salt Lake City; and National Medical Director, VistaCare, based in Scottsdale, AZ. This commentary is based on an article in Dr. Fine's VistaCare Palliative Medicine Monitor.