“FDA to Reclassify Hydrocodone to Tighten Prescribing Protocols”

Abuse of Opioids Prompts FDA Scrutiny:

The FDA has been evaluating the appropriate use of opioid products very carefully over the past several years.  Abuse and misuse of opioids has reached epidemic proportions in certain areas of the United States which prompted the FDA scrutiny.  The FDA is challenged with balancing the need to ensure opioids are available to patients who require continuous pain relief while addressing the issues of abuse, misuse and addiction. 

FDA will Recommend Reclassification:

Janet Woodcock, M.D., the FDA director for the Center for Drug Evaluation and Research, issued a statement on October 24, 2013 addressing the proposed reclassification of hydrocodone products.  Hydrocodone products are currently classified as Schedule III and will be changed to Schedule II which will increase controls on the products and place additional restrictions on them.  She stated that “by early December, FDA plans to submit our formal recommendation package to the U.S. Department of Health and Human Services (HHS) to reclassify hydrocodone combination products into Schedule II. 

Concurrence by NIDA Anticipated:

We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation.  This will begin a process that will lead to a final decision by the U.S. Drug Enforcement Administration (DEA) on the appropriate scheduling of these products.” 

Prescriber and Patient Education Tools Emphasized:

Dr. Woodcock further stated that “going forward, the agency will continue working with professional organizations, consumer and patients groups, and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most.”

See the FDA statement at


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