DEA Amends Regulations Applicable to Registrants Ordering Certain Controlled Substances

Last month, the Drug Enforcement Administration (DEA) published a notice in the Federal Register that it is amending its regulations and issuing a final rule to implement a new single-sheet format for the DEA Form 222, as well as to improve the recordkeeping requirements for DEA registrants.

DEA Form 222 is similar to a prescription pad or order form that allows DEA registrants to order and transfer Schedule I and Schedule II controlled substances. The registrant is responsible for obtaining the form and retaining the executed and unexecuted forms to comply with record-keeping requirements. The DEA has been working with industry stakeholders to finalize a rule on the DEA Form 222 for over a decade.

NPRM Comments

The notice of proposed rulemaking received twelve comments from individuals, pharmaceutical distributors, retail pharmacies, pharmaceutical companies, and associates representing retail pharmacies and pharmacists. Of the comments, two were just general statements of support for the rule, void of any discussion of the proposed regulatory changes. Another comment supported the rule but noted that adopting the “single-sheet form would make sense only if security measures are in place,” further saying “all-important concerns have been addressed.” Most of the remaining statements sought clarification of certain proposed rule provisions or recommended additional changes. Only one of the twelve comments explicitly opposed the rule. 

Final Rule Changes

This final rule changes the DEA Form 222 from a triplicate form with carbon paper to a single sheet of paper. Controlled substance purchasers are now explicitly allowed to retain electronic copies of the Form at the registered location. This change also eliminates the requirement that suppliers mail executed their Form 222s to the local DEA field offices, which is expected to reduce, and possibly eliminate entirely, the cost burden typically associated with the activity.

Other changes include a provision that allows Powers of Attorney signed under Section 1305.05 to be signed electronically (provided they are still signed by two witnesses), a provision that notes that DEA registrants are not required to sign or date Form 222 requisition requests, and clarifying language that ARCOS-reporting suppliers are not required to make a copy of the original Form 222.

The final rule became effective on October 30, 2019 and includes a two-year transition period for registrants to adjust to the new format and process. During the two year period, the existing triplicate forms may continue to be used.