US DEA Moves Hydrocodone Combination Products to Schedule II Listing

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-22-2014 13:50

The US Drug Enforcement Administration (DEA) has published in the Federal Register a final rule that moves hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II, as recommended by the Assistant Secretary for Health of the US Department of Health and Human Services (HHS) and as supported by the DEA’s own evaluation of relevant data.

​The final rule imposes the regulatory controls and sanctions applicable to Schedule II substances on those who handle or propose to handle HCPs. It goes into effect on October 6, 2014.

The Controlled Substances Act (CSA) places substances with accepted medical uses into one of four schedules, with the substances with the highest potential for harm and abuse being placed in Schedule II, and substances with progressively less potential for harm and abuse being placed in Schedules III through V. (Schedule I is reserved for those controlled substances with no currently accepted medical use and lack of accepted safety for use.)  HCPs are drugs that contain both hydrocodone, which by itself is a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin. When Congress passed the CSA in 1970, it placed HCPs in Schedule III even though it had placed hydrocodone itself in Schedule II. This final rule changes that by placing HCPs into Schedule II.

The rescheduling of HCPs was initiated by a petition from a physician in 1999. The DEA submitted a request to HHS for a scientific and medical evaluation of HCPs and a scheduling recommendation. In 2013, the US Food and Drug Administration held a public Advisory Committee meeting on the matter, and the committee voted to recommend rescheduling HCPs from Schedule III to Schedule II. In December of 2013, HHS sent such a recommendation to the DEA. Two months later, on February 27, the DEA a Notice of Proposed Rulemaking in the Federal Register, outlining its rationale and the proposed changes for moving HCPs from Schedule III to Schedule II and solicited public comments on the proposal, of which almost 600 were received. A small majority of the commenters supported the proposed change, according to the DEA.

Source: Federal Register and DEA


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