Monday, August 25, 2014

August 24, 2014 Get Ready; Get Set…. DEA Publishes Final Rule Rescheduling HCPs: Affected Registrants Must Swallow a 45-Day Compliance Window

By Karla L. Palmer
The U.S. Drug Enforcement Administration (“DEA”) published last Friday a Final Rule rescheduling hydrocodone combination products (“HCPs”) from Schedule III to Schedule II.  We posted about the proposed rescheduling here (NPRM published February 27, 2014).  There was little doubt that DEA would up-schedule HCP’s, especially in light of HHS’s recommendation to do so.  It is disappointing, however, that DEA did not heed the request of industry and provide for more time for the implementation of the heightened security and other requirements.

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