Hydrocodone Products Reclassified as Schedule II

Over TMA's objections, the Drug Enforcement Administration (DEA) last month published a final rule in the Federal Register reclassifying drugs that contain hydrocodone combinations from Schedule III to Schedule II. The change will take effect Oct. 6.

[Read TMA's Q&A for Physicians on the Hydrocodone Reclassification]

The move is designed to help curb the abuse of hydrocodone-containing medications. It would: 

  • Prohibit physicians from delegating advanced practice nurses and physician assistants authority to prescribe these drugs outside of a hospital or hospice setting;
  • Prevent physicians from calling in prescriptions for these medications to pharmacies; and
  • Prohibit refills of prescriptions for these drugs.

Additionally, moving hydrocodone combination products from Schedule III to Schedule II will have an impact on Texas physicians' prescribing practices. According to the Federal Register, after Oct. 6, drugs such as Vicodin will only be prescribed for a 90-day period. The current federal rule allows patients to receive a 180-day supply of this Schedule III drug.

Please note the rule change affects only hydrocodone combination products. Pure hydrocodone already is classified as a Schedule II drug.

At TexMed 2014 in May, physicians voiced their opposition to the reclassification in testimony before the Reference Committee on Science and Public Health. In its review of TMA's current policy on hydrocodone, the Council on Science and Public Health also noted the complexity of the issue, agreeing on the need to study it further to develop a TMA position. In the end, TMA's House of Delegates reaffirmed TMA's policy, which states the association "supports the classification of hydrocodone as a Schedule III, not a Schedule II, drug." 

The Council on Science and Public Health's review of the policy regarding hydrocodone classification and management noted that while recognizing the public health problems caused by the misuse, abuse, and diversion of prescription narcotics that result in death and addiction, hydrocodone is associated with more drug abuse and diversion than any other licit or illicit opioid. TMA's opposition to reclassifying the drug hinges, in part, on members' perception that this would place unnecessary requirements on physicians and additional burdens on patients.

The council agrees that addressing the public health problems of misuse, abuse, and diversion of hydrocodone requires comprehensive and integrated strategies in education, monitoring, and enforcement.

TMA continues to express opposition to the change in classification and to support a focus on physician education. Find more information, or access a free course on how to achieve safe use of opioids.

For information on prescribing Schedule II drugs, see the Texas Medical Board's online FAQs.

Action, Sept. 2, 2014