FDA Urges Tighter Restrictions on Hydrocodone Combination Products

Published Online: Friday, November 8, 2013
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The FDA has announced that it will recommend that pain-killers containing hydrocodone in combination with other drugs such as acetaminophen and aspirin be subjected to tighter restrictions. The recommendation, which must be approved by the Department of Health and Human Services (HHS) and the Drug Enforcement Administration, would reclassify hydrocodone combination painkillers such as Vicodin and Lortab as Schedule II drugs from their current status as Schedule III drugs.

The change would reduce the length of time that patients can get refills of the medications without a new prescription to 90 days from the current limit of 180 days. Patients would also have to take prescriptions for the drugs to their pharmacy rather than having their doctor call them in. The classification change would add new storage and record-keeping requirements for the drugs for pharmacists. And, in some states, nurse practitioners and other health care providers who can currently prescribe the drugs would no longer be able to do so.

Schedule II drugs are considered to have the highest potential for abuse of drugs that can legally be prescribed. Other drugs classified as Schedule II include the painkillers oxycodone, methadone, and fentanyl. The FDA plans to submit a formal recommendation to HHS regarding the reclassification by early December. An FDA expert advisory panel voted 19 to 10 in January 2013 in favor of the reclassification.

To read more on the FDA's recommendation, click here.

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