FDA recommends hydrocodone be classified as Schedule II
FDA said Thursday that it will recommend that hydrocodone (Vicodin) and hydrocodone combination products be reclassified to Schedule II. Janet Woodcock, CDER director, who announced the recommendation, stated that 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.”
According to a statement, the FDA will submit its formal recommendation to HHS for this reclassification in early December. The agency anticipates agreement with its recommendation. Hydrocodone, which is currently Schedule III for “drugs with a moderate to low potential for physical and psychological dependence,” would be placed under Schedule II, which is reserved for drugs with a high potential of abuse and would elevate the drugs' risk factor to that of cocaine, methampethatime and oxycodone—among others.
This change would also reduce the number of refills patients could receive before going back to their doctor, and patients would have to take the prescription to the pharmacy themselves, as opposed to having a doctor phone it in. New regulations would also reduce the supply a patient would receive from a 180-day supply to 90-day, as well as change who can prescribe these drugs—which varies by state—and other changes.