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News RE: DEA rules to reschedule Hydrocodone

The following information was received from APhA:

DEA will be publishing the Final Rule on hydrocodone rescheduling on Friday, August 22, 2014. Despite strong opposition from APhA and a number of other pharmacy stakeholders, DEA finalized the Rule in substantially the same form as it was proposed, meaning that hydrocodone combination products (HCPs) will be classified as Schedule II drugs. The Final Rule will go into effect in 45 days from the date of its publication in the Federal Register. In its announcement of the Final Rule, DEA noted that it received over 600 comments on the rule and that a “small majority” of commenters endorsed the change. DEA issued a full news release today

When the Final Rule takes effect, it will apply to “all pharmaceuticals containing hydrocodone currently on the market in the United States.” At that time, all Schedule II requirements will become applicable to HCPs, including, but not limited to, the requirements related to DEA registration, security protocols, labeling and packaging, inventory, and recordkeeping and reporting. It is unclear how pharmacists are supposed to treat patients with pending refills for HCPs, but DEA does state that a practitioner may issue multiple Schedule II prescriptions to provide up to a 90-day supply of medication. However, the DEA cautions that practitioners must make their own determinations, “based on sound medical judgment and in accordance with established medical standards,” regarding whether multiple prescriptions are appropriate for a patient.

We continue to review the text of the Final Rule. A more detailed analysis is available August 22 on

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