The Drug Enforcement Administration (“DEA” or the “Administration”) recently published a notice in the Federal Register (volume 84, number 189, pages 51368–51377) that the Administration is amending its regulations and issuing a final rule to implement not only a new single-sheet format for its DEA Form 222, but to improve the corresponding recordkeeping requirements for DEA registrants as well. This final rule will become effective October 30, 2019, and will provide a two-year transition period for registrants to acclimate to the new format and process.
The Administrator of the DEA gets its authority to amend such regulations as a delegation from the Attorney General, and the Attorney General gets this authority from the Controlled Substances Act (“CSA”). Under the CSA, the DEA, via the authority granted to it from the Attorney General, may promulgate rules and regulations relating to, among other things, the registration and control of the manufacture, distribution, and dispensing of controlled substances, as well as the control of importers and exporters of controlled substances.
DEA has been working with industry stakeholders to finalize a rule on the DEA Form 222 and related matters since 2007. The Form 222 is akin to a prescription pad or order form that allows DEA registrants to order and transfer Schedule I and Schedule II controlled substances. In fact, it is the only document that authorizes the distribution of such scheduled substances. It is the registrant’s responsibility to secure the DEA Form 222 and retain both the executed and unexecuted forms and comply with certain record-keeping requirements. In its current state, Form 222 is a triplicate form with interleaved carbon paper.
However, starting October 30, 2019, Form 222 will be a single sheet of paper, which DEA expects will both improve ease of use by registrants and reduce labor burden costs. Notably, among the many amendments to the regulations made in response to stakeholder comments, DEA will now explicitly allow controlled substance purchasers to retain electronic copies of Forms 222 at the registered location. Since the final rule eliminates the requirement that suppliers hand-mail executed Forms 222 to local DEA field offices, the associated cost burden of this activity is also expected to be eliminated.
Other amendments include: a provision that allows Powers of Attorney executed under Section 1305.05 to be signed electronically (but retains the requirement that such documents be signed by two witnesses); clarifying language that ARCOS-reporting suppliers are not required to make a copy of the original Form 222; and revisions to reflect that DEA registrants are not required to sign or date Form 222 requisition requests.
At present, it is unclear how these new Administration regulations and expectations may impact record-keeping requirements that are not being amended. Therefore, we encourage industry stakeholders to remain apprised of DEA’s ongoing evaluation of its regulations and the amendments made to the same. The Administration’s notice in the Federal Register is further indication that DEA is actively engaged in the regulation and control of the manufacture, distribution, and dispensing of controlled substances.
Should you have any questions regarding the notice or any of the issues raised in this alert, please do not hesitate to reach out to Rachael Pontikes, John Kendzior, or Kelly Kearney for further discussion.