In just shy of three months following receipt of the Department of Health and Human Services (“HHS”)’s rescheduling recommendation, see prior post here, DEA announced the issuance of a Notice of Proposed Rulemaking (“NPRM”) Thursday to reschedule all hydrocodone combination products (“HCPs”) from schedule III to schedule II. For prior discussions on this issue, see our prior posts here, here, and here.
DEA’s NPRM includes a summary of its findings regarding the eight factors it is required to consider to transfer HCPs to schedule II. 21 U.S.C. § 811(a), (c). Following a brief background on the history of the current placement of HCPs in schedule III, DEA explained that it reviewed the scientific and medical evaluation sent by HHS and completed its own eight-factor analysis pursuant to 21 U.S.C. § 811(c). DEA concluded that based on the eight-factor analysis, it finds “these facts and all other relevant data constitute substantial evidence of high potential for abuse of HCPs.” For a discussion of the utility of dual oversight of drug scheduling by FDA and DEA, see here and here.
Rescheduling HCPs from schedule III to schedule II will impact every legitimate controlled substance handler including patients. Rescheduling will impose more stringent regulatory requirements upon manufacturers, distributors, dispensers such as pharmacies and physicians, importers and exporters. For example registrants can only transfer schedule II substances between themselves via a triplicate, sequentially-numbered DEA Form 222 Official Order Form or its electronic equivalent while registrants may transfer schedule III drugs with invoices, packing slips or other records. Prescriptions for schedule II substances, with limited exceptions, must be written, may only be written for a 30-day supply, and pharmacies must receive original prescriptions before dispensing. Prescriptions for schedule III may be written, oral or faxed. Pharmacists cannot refill schedule II prescriptions; but if authorized to do so, can refill schedule III prescriptions up to five times within a six month period. Manufacturers and distributors must secure schedule II substances in a safe, steel cabinet or vault while schedule III substances may be stored in a less secure controlled substance cage or other enclosure. (Notably, DEA also states in the NPRM that “[m]any manufacturers and exporters are likely to have sufficient space in their existing vaults to accommodate HCPs,” though DEA “understands that some manufacturers, exporters, and distributors will need to build new vaults or expand existing vaults to store HCPs.”)
DEA’s NPRM is also interesting in light of recent changes in the availability of hydrocodone products. When DEA first proposed to reschedule HCPs, there were no single-entity hydrocodone products approved for use in the United States. However, on October 25, 2013, FDA approved Zohydro, making it the first, and only, single-entity hydrocodone product approved in the United States. Zohydro is a schedule II controlled substance because single-entity hydrocodone products have been placed in schedule II since Congress first enacted the Controlled Substances Act. Some groups have expressed concerns about the approval of Zohydro, noting its lack 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 deterrent technology to all hydrocodone schedule 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 launch this month. DEA’s NPRM to move HCPs to schedule II leaves open the question of whether the request to add abuse-deterrent technology will be expanded to apply to these products as well.
Interested persons may file comments on the NPRM on or before April 28, 2014. Interested persons “adversely affected or aggrieved” by the proposed rule may file a request for hearing on or before March 31, 2014.