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November 08 - 09 2014, 12:00 AM - 12:00 AM

ASA Quality Meeting 2014

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FDA to Recommend Reclassification of Hydrocodone Products to Schedule II

Friday, October 25, 2013

On October 24, 2013, the Food and Drug Administration (FDA) announced that it plans  to recommend to the Department of Health and Human Services (HHS) the reclassification of hydrocodone combination products from Schedule III to Schedule II.  The FDA recommendation now requires the approval of HHS and the Drug Enforcement Administration.  A rescheduling of these drug products to Schedule II means that prescriptions may not be refilled and these drugs will be subject to tighter prescribing requirements.

In issuing the statement, Janet Woodcock, M.D., the FDA's Director of the Center for Drug Evaluation and Research stated:

 "However, in recent years, the FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States. While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse."

FDA Statement.

DEA Drug Scheduling Practitioner's Manual.  

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