DEA Further Restricts Hydrocodone Combination Products

Deborah Brauser

August 21, 2014

The US Drug Enforcement Administration (DEA) voted today to move forward with rescheduling hydrocodone combination products (HCPs) from schedule III to schedule II drugs. Schedule II medications are considered to be the most potentially harmful and open to abuse.

According to the final rule, which will be released in the Federal Register tomorrow, the rescheduling of these painkillers will take effect in 45 days.

As reported at the time by Medscape Medical News, the DEA published a formal proposal for this rescheduling back in February following similar recommendations from the US Food and Drug Administration (FDA) and from the Assistant Secretary for Health and Human Services (HHS).

In addition to containing hydrocodone, HCPs also contain nonnarcotic substances such as aspirin or acetaminophen. Although hydrocodone by itself is classified as a schedule II drug, HCPs have been in the schedule III classification ever since the Controlled Substances Act (CSA) was first passed by Congress back in 1971.

"Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS,...the DEA finds that these facts and all other relevant data constitute evidence of potential for abuse of HCPs," write the DEA in their final rule.

"As such, the DEA is rescheduling HCPs as a schedule II controlled substance under the CSA," they add.

Substantial Feedback

HCPs are currently approved for marketing for the treatment of pain and for cough suppression.

The DEA published its formal proposal in February and asked for feedback, which could be given until April 28. The organization received 573 comments, of which 52% supported the recommended rescheduling, 41% opposed, and 7% did not voice a definitive opinion.

Of those who supported the rule, 62% were members of the general public. In fact, 74% of all general public comments were in support of the rescheduling proposal.

A total of 14% of the supportive comments were from clinicians; 56% of all physician comments supported, or supported with qualification, the rescheduling.

"The majority of those opposed to rescheduling HCPs were pharmacists, pharmacy students, and ultimate users," write the DEA in their final rule.

A total of 60% of all comments from pharmacists and pharmacy students opposed the proposal. Also, 32 of the 35 comments from ultimate users were in opposition.

Patrick Morrisey, the attorney general from West Virginia, the state with the highest per capita rate of prescription drug overdoses in 2013, was among those who wrote in support of the rescheduling.

"This reclassification is not only justified given the high abuse and addiction potential of hydrocodone prescription painkillers, it is necessary to combat the drug abuse epidemic that is destroying so many...communities," wrote Morrisey.

"Rescheduling hydrocodone is one way to help prevent this drug from falling into the wrong hands and will ensure that these drugs are handled with the same precautions as other pain medications, such as oxycodone, hydromorphone, and fentanyl," he added in a release.

Also falling under the schedule II classification are illegal substances, such as methamphetamine and heroin, and prescribed medications, such as dextroamphetamine sulphate (Adderal, Teva Pharmaceuticals).

Zohydro Not Affected

The DEA notes that Zohydro ER (Zogeniz, Inc), a single-entity-formulation hydrocodone product approved recently by the FDA, is already currently a schedule II controlled substance and will not be affected by the new actions.

However, all other pharmaceuticals "containing hydrocodone currently on the market in the United States are HCPs and are subject to this rulemaking."

"The DEA finds that the scientific, medical, and epidemiological data are robust and support rescheduling HCPs into Schedule II of the CSA," writes the organization.

Once the final rule goes into effect, anybody who handles HCPs will be subject to the CSA's schedule II regulatory controls. This will include "administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, engaging in research, conducting instructional activities, and conducting chemical analysis" of these substances.

In addition, any individual who handles or desires to handle HCPs will need to register with the DEA.

The final rule will be published in the Federal Register on August 22, 2014.


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