New DEA Guidance on 222 Forms Used in Pharmacy Sales/Closures
The DEA has published a new guidance document related to use of 222 forms when selling or closing a pharmacy. The text of the document is copied below.
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Drug Enforcement Administration
Diversion Control Division
Guidance Document
Title: Requirement to Use Multiple Single-Sheet DEA Form 222s (Order Forms) When Transferring Schedule I or II Controlled Substances Upon Termination or Transfer of a DEA Registration, or Discontinuing Business Altogether
Summary: This guidance document clarifies the requirement for Drug Enforcement Administration (DEA) registrant-transferors to use multiple single-sheet DEA Form 222s (order forms) when transferring schedule I or II controlled substances to a DEA registrant-transferee when the number of items being transferred exceeds the number of lines available on the order form.
Activity: Completing Multiple Single-Sheet DEA Form 222s
To Whom It Applies: DEA Registrants
Question: Can a DEA registrant-transferor attach an itemized list or an inventory of schedule I or II controlled substances to a single-sheet DEA Form 222 in lieu of completing multiple DEA Form 222s when the number of items to be transferred to a DEA registrant-transferee exceeds the number of lines on the form?
Answer: No. When transferring inventory from a registrant-transferor to a registrant-transferee upon the termination of registration, transfer of registration, or discontinuance of business, transfers of schedule I or II controlled substances require the use of order forms in accordance with 21 CFR 1305. See 21 CFR 1301.52(e)(1). Under 21 CFR 1305.03, the completion of DEA Form 222 is required for each distribution of a schedule I or II controlled substance.
Neither the Controlled Substances Act nor its implementing regulations authorize adding attachments or itemized lists to DEA Form 222s. Rather, DEA regulations state, in relevant part: “Only one item may be entered on each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance. The number of lines completed must be noted on that form at the bottom of the form, in the space provided.” 21 CFR 1305.12(b). In addition, Part 1 of the Instructions for the DEA Form 222 states: “The purchaser fills out no more than twenty line items in this section. If more items are needed, use another form.” When the registrant-transferor adheres to the requirements of 21 CFR 1301 and 1305, and follows the instructions set forth on the DEA Form 222, there is no discrepancy between the number of items ordered, the number of lines completed, and the controlled substances transferred.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or Department of Justice policies.
EO-DEA117, DEA-DC-070, February 26, 2023
