Posted: 14 Mar 2019 07:06 PM PDT After years of talk about replacing the antiquated, carbon-leaved triplicate Official Order Form (“DEA Form 222” or “DEA-222s”) required for schedule I and II controlled substance transfers, the Drug Enforcement Administration (“DEA”) is proposing to implement a single-sheet order form. New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222), 84 Fed. Reg. 5395 (Feb. 21, 2019). In addition, DEA is proposing to expand who can issue powers of attorney (“POAs”) authorizing employees to execute DEA-222s. The Federal Controlled Substances Act (“CSA”) requires written orders made by a purchaser to be documented on a DEA Form 222 or its electronic equivalent through DEA’s Controlled Substance Ordering System (“CSOS”) for the transfer of schedule I and II controlled substances. DEA currently issues serially numbered DEA-222s with the registrant’s name, address, and registration number, their authorized activity, and the drug schedules they are authorized to handle. Current DEA-222s are triplicate forms with carbon sheets sandwiched in-between. The DEA-222s allow DEA to track schedule I and II transactions. Registrants fill out the DEA-222, adding the name and address of the DEA-registered supplier, the date, the number of controlled substance packages ordered, package size, and the controlled substances they wish to order. The purchaser retains Copy 3 of the form and sends Copy 1 and Copy 2 to the supplier. The supplier documents the number of controlled substance packages shipped and the date shipped. The supplier retains Copy 1 of the form and sends Copy 2 to the DEA Special Agent in Charge where the supplier is located. The purchaser documents the quantity of packages received and the date on Copy 3. The purchaser and the supplier must maintain their DEA-222 copies for two years. DEA is proposing to preprint the new forms on security paper, with each bearing a unique number and enhanced security features “to ensure the identity of the original while making it difficult to copy for counterfeit purposes.” DEA believes the single-sheet form will be more convenient for registrants, noting that technology now exists with laser printers, scanners, and photocopiers that were not available when the triplicate form was initiated. DEA also observed that a single vendor produces the triplicate forms and that process has become costly. Registrants ordering schedule I and II substances with the new DEA-222s would complete and retain a copy of the form and send the original to the supplier. The supplier would record information related to filling the order on the original form and retain it. Suppliers, such as pharmacies and practitioners, who are not required to report transactions to DEA’s Automation of Reports and Consolidated Orders System (“ARCOS”) would submit a copy of the original DEA-222 to the DEA Registration Section/DRR by mail or email. The purchaser will record information related to the items received on its copy of the form. Purchasers and suppliers would continue to preserve order forms for two years. DEA will permit registrants to exhaust their supply of triplicate DEA-222s for up to two years after the rule becomes effective. DEA would issue the new forms to registrants when they deplete their supply of triplicate forms. DEA is also proposing to expand who may issue POAs to execute the new DEA-222s. Registrants may authorize individuals to order schedule I and II substances by executing a POA for each such individual. The POA must be retained with executed DEA-222s for the same period as any order form bearing the signature of the employee authorized by the POA, and must be available for inspection by DEA investigators. Currently, only the person who signed the most recent DEA application can execute POAs for authorizing persons to execute DEA-222s on behalf of the registrant. DEA is proposing to expand the number of individuals who can issue a POA similar to who can sign an application for a DEA registration. DEA is proposing that a POA for executing the new DEA-222s be issued by the registrant if an individual, by a partner if the registrant is a partnership, or by an officer if the registrant is a corporation, corporate division, association, trust, or other entity, any corporate officer may sign the POA. Replacing triplicate DEA-222s is overdue. Sophisticated technology is available that allows registrants to order schedule I and II substances with enhanced security that minimizes the risk of diversion through ordering. DEA could have required all registrants to order schedule I and II substances electronically through the CSOS system, which would have created a burden on those registrants who lack access to the Internet or required technology. And why not relieve ARCOS-reporting suppliers from having to file copies of order forms when they already submit the sales data to DEA? The new flexibility for who may issue a POA to execute the new DEA-222s will help resolve the current conundrum faced by registrants when the individual who signed the prior DEA registration is not available or has left the company. Electronic comments must be submitted, and written comments must be postmarked, on or before April 22, 2019. |
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