FDA officially recommends Health, Human Services reschedule hydrocodone
10/25/2013 - The State Journal
WASHINGTON, DC - Department of Health and Human Services Secretary Kathleen Sebelius informed U.S. Sen. Joe Manchin Oct. 24 that the Food and Drug Administration will reschedule hydrocodone combination drugs from a Schedule III drug to a Schedule II controlled substance.
According to the Drug Enforcement Administration, Schedule III drugs, substances or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule II drugs substances or chemicals are defined as drugs with a high potential for abuse. Schedule II drugs have less abuse potential than Schedule I drugs, but use of them have the potential to lead to severe psychological or physical dependence.
Manchin testified to the FDA's Advisory Committee nearly a year ago about the need to reclassify the highly addictive substance.
Health and Human Services is expected to pass the FDA's recommendation along to the Drug Enforcement Administration, which will immediately begin the reclassification process, according to information from Manchin's office.
The DEA keeps strict regulations on how Schedule II drugs may be prescribed and refills are prohibited. And in most cases, a prescriber can fax a Schedule II prescription to a pharmacy, but the original prescription must still be presented to the pharmacist fore review before the drug is dispensed.
"Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities," Manchin said. "The agency has just saved hundreds of thousands of lives."
West Virginia State Police Col. Jay Smithers said the diversion of prescription pain medication for illegal purposes is one of the biggest problems facing West Virginia, despite a legitimate need for pain medication.
"The reclassification of hydrocodone is a major step toward restoring accountability and oversight between medical providers and patients suffering from acute injuries, chronic pain and terminal illness.
"It is my sincere belief that this measure will decrease the amount of hydrocodone available to those who do not possess a legitimate prescription."