The Drug Enforcement Administration (DEA) has published a new final rule regarding reporting of theft or significant loss of controlled substances. Through the final rule, the DEA amended the existing regulations governing the form and timing used to formally report these thefts or losses.
The rule, which goes into effect on July 24, 2023, adds a follow-up requirement to the initial requirement of all registrants to report the theft or loss in writing to the DEA field office within one business day of discovery. Under the new rule, the formal follow-up notice must be electronically filed with DEA within 45 calendar days of the discovery.
New Two-Step Process
Under the new rule, registrants must now follow a two-step method of reporting theft or significant loss of controlled substances. As was the case before the final rule, registrants must alert the DEA field office in writing of the theft or loss within one business day of discovering the theft or loss.
Now, as a second follow-up step, registrants must also submit a new DEA Form 106 within 45 calendar days of the discovery. The form must be uploaded through the online portal. There is also a new Form 106 for registrants to use in this process. According to the DEA, after the rule goes into effect, the old paper Form 106 submissions will no longer be accepted.
The DEA settled on a 45 day timeframe for this formal notification process after comments to its proposed rule that urged a longer timeframe to allow for complete and accurate, thorough investigation to occur. Additionally, because the new rule now requires the Form 106 to be uploaded through the online portal, if a registrant encounters a problem submitting the form, then the submitter must also document the failures and attempted submissions.
The DEA has also published guidance for filling out the Form 106 in Appendix I of its Pharmacist Manual. The DEA has acknowledged that the meaning of a “discovery” that triggers the application of this rule can be ambiguous, but it will be addressed this ambiguity in future rulemakings.
As part of the rule, the DEA responded to many of the 22 comments that it received in connection with its notice of proposed rulemaking about these changes. One pattern of comments received by the DEA was regarding the discovery of a theft or significant loss where there are multiple registrants in a single practice. Commenters questioned whose responsibility it is to report when it’s not clear whose stock was affected by the theft or significant loss, the DEA said the following:
DEA regulations require each registrant to provide effective controls and procedures to guard against theft and diversion of controlled substances and to maintain complete and accurate records of controlled substances. Individual registrants in a multiple registrant clinic setting should be responsible for their own records and controlled substance storage. Records and controlled substances for each individual DEA registrant should be kept separate from all other registrants to aide in distinguishing which controlled substances belong to which DEA registrant. Therefore, each registered practitioner whose stock was affected by the theft or loss, is responsible for providing the one-day notification to DEA’s Field Division Office and for filing DEA Form 106. Each practitioner is responsible for designating who files a report of theft or loss within their clinic or pharmacy, therefore, DEA leaves this decision solely for the practitioner.
Through this comment, the DEA reinforced that each registrant is responsible for keeping records of their own stock of controlled substances, and that any theft or loss that it is the responsibility of the particular registrant or their designee to report substantial losses and thefts from their particular stock of controlled substances.
Reed Smith will continue to follow developments with this rule and with other regulations governing the use of controlled substances. If you have any questions about this or any related regulations, please reach out to the health care lawyers at Reed Smith.