The United States Drug Enforcement Administration (“DEA”) elevated Hydrocodone combination medications, including Vicodin, from a Schedule III to a Schedule II Controlled Substance. The reclassification was published the Final Rule for the Controlled Substances Act (“CSA”) in the Federal Register1 on August 22, 2014. The new rule will take effect on October 6, 2014.

While Schedule II Controlled Substances are classified as having an accepted medical use, they also carry a heightened risk of abuse. The DEA has long sought the change of Hydrocodone combination medications from a Schedule III to a Schedule II Controlled Substance based on its research and analysis finding that Hydrocodone combination medications are over-prescribed, prevalent on the black market, and highly addictive. According to DEA Administrator Michele Leonhart, “Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents.”2This change has a number of significant implications for the health care industry:

  • When combination painkillers, such as Vicodin, were classified as Schedule III Controlled Substances, an authorized prescriber could write a 30-day prescription with up to 5 refills. Under the new rule, as a Schedule II, no refills will be permitted.
  • Patients will need to see their health care provider at least every 90 days for a new prescription. An estimated 25 million Americans are on automatic refills of Hydrocodone.3 With the reclassification, these patients likely have to schedule more appointments with their health care providers at potentially increased costs.
  • Hydrocodone combination prescriptions, like other Schedule II Controlled Substances, will not be able to be called in to a pharmacy absent an emergency.
  • Manufacturers, distributors, and pharmacies will be required to maintain heightened security and increased record keeping.
  • Providers can expect to face greater scrutiny from regulatory agencies concerning the utilization of Hydrocodone combination medications due to this change in schedule.
  • Prescribers, Pharmacies, Pharmacists, Wholesale and Terminal Distributors, as well as medical practices that maintain controlled substances for in-office dispensing, will need to review any specific state law regulatory requirements that accompany this change in federal law.4

While seemingly a small change, the reclassification of Hydrocodone combination medications is consistent with the changing prescription-drug environment and will undoubtedly have considerable effects for health care providers and their patients.