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FDA seeks tighter control of prescription opioid combination drugs


The U.S. Food and Drug Administration will seek to reclassify hydrocodone combination drugs, placing tighter controls on distribution of the narcotic painkillers.

Hydrocodone is a semisynthetic opioid often combined with other pharmaceuticals to produce combination prescription drugs such as Vicodin.

On Thursday, the FDA said that it will submit a formal recommendation to the U.S. Department of Health and Human Services by early December seeking to reclassify hydrocodone combination products from Schedule III to Schedule II drugs.

The move comes as part of efforts to address increased concerns about the abuse and misuse of opioid products, the FDA said.

“Schedule II drugs are subject to more stringent requirements on things like storage, record-keeping and prescribing than Schedule III drugs are,” an FDA spokesman said.

For example, prescriptions for Schedule II drugs cannot be telephoned into drug stores except for emergency situations, and the number of times a patient can refill a prescription before revisiting their doctors is limited.