By Delia A. Deschaine & Larry K. Houck –
In aloof shy of three months afterward cancellation of the Department of Health and Human Services (“HHS”)’s rescheduling recommendation, see above-mentioned column here, DEA appear the arising of a Notice of Proposed Rulemaking (“NPRM”) Thursday to reschedule all hydrocodone aggregate articles (“HCPs”) from agenda III to agenda II. For above-mentioned discussions on this issue, see our above-mentioned posts here, here, and here.
DEA’s NPRM includes a arbitrary of its allegation apropos the eight factors it is appropriate to accede to alteration HCPs to agenda II. 21 U.S.C. § 811(a), (c). Afterward a abrupt accomplishments on the history of the accepted adjustment of HCPs in agenda III, DEA explained that it advised the accurate and medical appraisal beatific by HHS and completed its own eight-factor assay pursuant to 21 U.S.C. § 811(c). DEA assured that based on the eight-factor analysis, it finds “these facts and all added accordant abstracts aggregate abundant affirmation of aerial abeyant for corruption of HCPs.” For a altercation of the account of bifold blank of biologic scheduling by FDA and DEA, see actuality and here.
Rescheduling HCPs from agenda III to agenda II will appulse every accepted controlled actuality abettor including patients. Rescheduling will appoint added acrimonious authoritative requirements aloft manufacturers, distributors, dispensers such as pharmacies and physicians, importers and exporters. For archetype registrants can alone alteration agenda II substances amid themselves via a triplicate, sequentially-numbered DEA Form 222 Official Order Form or its cyberbanking agnate while registrants may alteration agenda III drugs with invoices, packing block or added records. Prescriptions for agenda II substances, with bound exceptions, charge be written, may alone be accounting for a 30-day supply, and pharmacies charge accept aboriginal prescriptions afore dispensing. Prescriptions for agenda III may be written, articulate or faxed. Pharmacists cannot bushing agenda II prescriptions; but if accustomed to do so, can bushing agenda III prescriptions up to bristles times aural a six ages period. Manufacturers and distributors charge defended agenda II substances in a safe, animate chiffonier or basement while agenda III substances may be stored in a beneath defended controlled actuality cage or added enclosure. (Notably, DEA additionally states in the NPRM that “[m]any manufacturers and exporters are acceptable to accept acceptable amplitude in their absolute vaults to board HCPs,” admitting DEA “understands that some manufacturers, exporters, and distributors will charge to body new vaults or aggrandize absolute vaults to abundance HCPs.”)
DEA’s NPRM is additionally absorbing in ablaze of contempo changes in the availability of hydrocodone products. When DEA aboriginal proposed to reschedule HCPs, there were no single-entity hydrocodone articles accustomed for use in the United States. However, on October 25, 2013, FDA accustomed Zohydro, authoritative it the first, and only, single-entity hydrocodone artefact accustomed in the United States. Zohydro is a agenda II controlled actuality because single-entity hydrocodone articles accept been placed in agenda II back Congress aboriginal allowable the Controlled Substances Act. Some groups accept bidding apropos about the approval of Zohydro, acquainted its abridgement of abuse-deterrent technology. See, e.g., The Pharmacists Planning Service, Inc., Citizen Petition (Docket No. FDA-2013-P-1606) (requesting that FDA add “drug-abuse bridle technology to all hydrocodone agenda II products” (emphasis added); Letter from State Attorneys General to Margaret Hamburg, M.D., Commissioner, FDA (Dec. 10, 2013) (opposing Zohydro approval). According to DEA’s NPRM, Zohdyro is projected to barrage this month. DEA’s NPRM to move HCPs to agenda II leaves accessible the catechism of whether the appeal to add abuse-deterrent technology will be broadcast to administer to these articles as well.
Interested bodies may book comments on the NPRM on or afore April 28, 2014. Interested bodies “adversely afflicted or aggrieved” by the proposed aphorism may book a appeal for audition on or afore March 31, 2014.
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