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Changes in reporting loss/theft of controlled substances

By Natalia Mazina on August 27, 2023
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DEA regulations require DEA registrants to notify their local Field Division Office, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of such. Registrants must complete and submit to their local DEA Field Division a DEA Form 106 regarding the theft or loss.

Prior to July 24, 2023, registrants were submitting Form 106 within one business day of discovery of the theft or loss. But effective July 24, 2023, registrants have 45 days to submit the form.

An important caveat: registrants must still report the theft or significant loss within one business day of discovering it by notifying their local DEA Division Office (in writing, such as by email or fax). After providing the notice to the local DEA branch, the registrant has 45 days to properly prepare Form 106 and submit it with all supporting documentation through the DEA’s online system (DEA no longer accepts hardcopies of Form 106).

To clarify, this is a two-step process consisting of the preliminary one-day reporting and filing Form 106. For more information, please review Federal Register summarizing the final rule on reporting theft or significant loss of controlled substances.  

In addition, manufacturers and wholesalers need to perform a third step and report theft/loss to ARCOS through ARCOS Online Reporting.

  • Posted in:
    Other
  • Blog:
    Pharmacy & Healthcare Legal Blog
  • Organization:
    Mazina Law
  • Article: View Original Source

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