DEA Form 222

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. EO-DEA117, DEA-DC-070, February 26, 2023

Question: In light of the elimination of the DATA-Waiver identifier (i.e., X-waiver number) from my DEA registration certificate, am I still able to use my existing DEA-Form 222s to order controlled substances or should I return them to DEA?

Answer: Yes, you can still use the existing forms. They DO NOT need to be returned to DEA. On December 29, 2022, with the signing of the CAA of 2023, Congress eliminated the DATA-Waiver requirement. Section 1262 of the CAA of 2023 removed the federal requirement for practitioners to apply for a special waiver prior to prescribing buprenorphine for the treatment of Opioid Use Disorder (OUD). It also removed the requirement for the assignment of an identification number (i.e., X-waiver number) associated with being a DATA-waived provider, for inclusion with the registration issued to the practitioner. 21 U.S.C. 823(g)(2)(D)(ii). DEA-registered practitioners, allowed to handle schedule I and II controlled substances, are issued DEA-Form 222s. These forms are printed by DEA with the practitioner's DEA registration number and registered location; however, no forms were printed with a practitioner"s X-waiver number. As the X-waiver numbers were not used previously to order controlled substances on DEA-Form 222s, no change is necessary. Orders for controlled substances are still placed using your DEA number only. DEA-registered practitioners who are allowed to handle schedule I and II controlled substances, may obtain and use DEA-Form 222s. 21 CFR 1305.04(a). EO-DEA265, DEA-DC-069, April 2, 2023

Question: What should we do if a DEA Form 222 is lost or stolen?

Answer: If a DEA Form 222 is lost or stolen, the registrant must execute another DEA Form 222 and attach a statement to the new form containing the order form number and date of the lost or stolen form. The statement must indicate that the goods covered by the first DEA Form 222 were not received due to the loss or stolen form. 21 CFR 1305.16(a). A copy of the second form and a copy of the statement must be retained with a copy of the initial form. 21 CFR 1305.16(a). The copy of the statement must be attached to the copy of the second form sent to the supplier. 21 CFR 1305.16(a). If the first DEA Form 222 is subsequently located by the supplier, the supplier must mark "Not Accepted" on the face of the form and return the original form to the registrant attached to the statement. 21 CFR 1305.16(a). A registrant, upon discovery of the loss or theft of used or unused order forms, must immediately report the loss or theft to the local DEA Diversion Field Office and provide the serial numbers of each lost or stolen order form. 21 CFR 1305.16(b). If an unused order form is later recovered or found, the registrant must immediately notify the local DEA Diversion Field Office. 21 CFR 1305.16(e). EO-DEA187, October 5, 2020

Question: How do I cancel a DEA Form 222 after it has been submitted to a supplier?

Answer: A purchaser may cancel part or all of an order on a DEA Form 222 by notifying the supplier in writing of the cancellation. 21 CFR 1305.19(a). The supplier must indicate the cancellation on the original DEA Form 222 sent by the purchaser by drawing a line through the canceled items and printing "canceled" in the space provided for the number of items shipped. 21 CFR 1305.19(a). For information regarding canceled electronic orders, see below, Controlled Substance Ordering System (CSOS) – Electronic Order Forms. EO-DEA189, October 5, 2020

Question: Who can sign executed DEA 222 Order Forms?

Answer: Registrants, and individuals given power of attorney by registrants, can sign DEA 222 order forms. Any registrant may authorize one or more individuals to obtain and execute DEA Forms 222 by granting a power of attorney to each such individual. 21 CFR 1305.05(a).

In order to grant a valid power of attorney, pursuant to 21 CFR 1305.05(d), the power of attorney must be signed by:

• The registrant, if an individual; a partner of the registrant, if a partnership; or an officer of the registrant, if a corporation, corporate division, association, trust or other entity;
• The person to whom the power of attorney is being granted; and
• Two witnesses.

In addition to the signature requirement, valid power of attorneys are subject to the following provisions under this section. A power of attorney executed under this section may be signed electronically, by any or all of the persons required to sign. 21 CFR 1305.05(f). The power of attorney may be revoked at any time by the person who signed the most recent application for DEA registration or reregistration and two witnesses. 21 CFR 1305.05(e). The power of attorney should be filed with executed DEA Forms 222 if applicable, and must be available for inspection. 21 CFR 1305.05(a). The power of attorney is not submitted to DEA, but, it must be readily retrievable for inspection. In sum, individuals granted a valid power of attorney under this section may sign DEA 222 order forms. EO-DEA194, October 5, 2020

Question: What should be done with unused DEA 222 Order Forms if a business closes?

Answer: When a registered purchaser discontinues business activities involving schedule I and II controlled substances for any reason (i.e. discontinues business or professional practice altogether, ceases legal existence, or if the registered purchaser dies), all unexecuted DEA 222 order forms must be promptly returned to DEA Headquarters Registration Section. See 21 CFR 1301.52, 1305.18 and 1305.20(h). Similarly, a purchaser must immediately return all unused 222 forms if its registration for schedule I and II controlled substances is suspended or revoked under 21 CFR 1301.36. EO-DEA190, October 5, 2020

Disclaimer: Guidance documents, like this document, are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance document that is not accessible through the Department's guidance portal, or similar guidance portals for other Executive Branch departments and agencies, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department's complete discretion, consistent with applicable laws.