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The Dea Proposes To Reschedule Hydrocodone Products From Schedule Iii To Schedule Ii


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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.


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.”



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.”)


just how many people are the DEA saying abuse hydrocodone products?

are you punishing 100,000 abusers out of 10million legitamate patients?

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