Last week the Drug Enforcement Administration (“DEA”) issued a direct final rule clarifying requirements about who may record the supplier’s DEA registration number on a single-sheet DEA Form 222 (“single-sheet form”). Clarification Regarding the Supplier’s DEA Registration Number on the Single-Sheet DEA Form 222, 86 Fed. Reg. 38230 (July 20, 2021). DEA issued a final rule in September 2019 implementing a new single-sheet form to replace triplicate carbon copy DEA Form 222s (“triplicate forms”). New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222), 84 Fed. Reg. 51368 (Sept. 30, 2019).
DEA requires registrants use DEA-222s to transfer schedule I and II controlled substances. (Registrants may also use DEA’s electronic Controlled Substance Ordering System (“CSOS”)). Both the single-sheet and triplicate forms require information about the supplier, including their name, address and DEA registration number. 21 C.F.R § 1305.12(c). DEA explained, consistent with the triplicate form, that the final rule requires the supplier when filling the order to record their DEA registration number on the DEA-222. DEA notes that the field on the triplicate form for the supplier’s registration number is in the section marked “To Be Filled in By Supplier” while the field on the single-sheet form for the supplier’s registration is in the section titled “To Be Filled In By the Purchaser.” Needless to say, the inconsistency has caused some confusion for DEA registrants.
The final rule clarifies that either the purchaser or, if not entered by the purchaser, the supplier, may record the supplier’s DEA number on a single-sheet form. Allowing the purchaser to omit a supplier’s DEA registration number for the supplier to add later provides flexibility for when a supplier may have to fill an order from a different registered location than the one contemplated by a purchaser.
As a reminder, registrants may only use their triplicate forms until they exhaust their supply, after which they must use single-sheet forms. But in any case, registrants must cease using triplicate forms as of October 30, 2021, after which time they must use single-sheet forms. 21 C.F.R. § 1305.20.
As a direct final rule, the rule becomes effective October 18, 2021, unless DEA receives significant adverse comment. DEA will withdraw the rule by September 20, 2021, if it receives significant adverse comment. Electronic comments must be submitted, and written comments postmarked, on or before August 19, 2021.