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23rd Annual Meeting February 7-10, 2007 New Orleans, LA |
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Annual Meeting Highlights Supported by an educational grant from Merck & Co., Inc. ![]() © 2006 American Academy of Pain Medicine |
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| Saturday, February 10, 2007: 11:00 AM-12:00 PM | |||
| A Decade of the FDAMA: Understanding the Compounding Pharmacy and Optimizing Its Use | |||
| This session will provide an overview of an important but often misunderstood resource for physicians seeking to customize optimal drug therapies for their patients. The compounding of pharmaceuticals under the Food and Drug Administration (FDA) Modernization Act of 1997 does not fall under the same regulatory process administered by the FDA. Physicians considering compounded pharmaceuticals must have a firm understanding of a number of critical issues related to their use, including regulatory issues, the importance of selecting an appropriate compounding pharmacy with rigorous preparation standards, and the need for educating the patient. This symposium will review the legislation regulating compounding pharmacies, the types and amounts of medications they can formulate, and characteristics that distinguish them from drug manufacturers. The session will also focus on a clinician’s responsibilities when using a compounded drug outside the bounds of the approved product insert. | |||
| Submitter: | Donna Bloodworth, MD | ||
| 11:00 AM | Introductory Remarks | ||
| 11:05 AM | Compounding Pharmacy: Its History, Its Current Applications in the US, and How Compounded Pharmaceuticals Differ from FDA Approved Medications Loyd V. Allen, PhD, RPh | ||
| 11:30 AM | The FDA Process of Drug Approval and Key Differences Between Compounding Medications Bradley Galer, M.D. | ||
| 11:55 AM | Question and Answer Session | ||
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