Last week, DEA proposed two new rules regarding (1) reporting theft or significant loss of controlled substances and (2) registration fees.

1.     15-day requirement for reporting drug loss or theft.

This proposed rule would amend DEA regulations regarding Form-106, used by the registrants to report thefts or significant losses of controlled substances, to clarify that all such forms must be submitted electronically. In addition, the proposed rule would add new requirements for the form to be submitted accurately and within a 15-day time period. This proposed rule will not change the requirement that registrants notify the DEA Field Division Office in their area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The comment period is now open. If you would like to address this proposed rule, submit your comments by following these instructions.

    2.       Increased registration fee

A new registration fee will take effect for all new applications and all renewal applications submitted on or after October 1, 2020. Current registration fee for a pharmacist is $731, which will increase to $888 (for a three-year cycle).

In addition to raising fees, DEA also made a comment regarding its refund policy.  Currently, DEA’s policy is that it will not issue a refund of registration fees, including if the payment was made in error based on guidance provided by DEA personnel. The Notice of Proposed Rulemaking now includes provisions that “will give DEA’s Administrator discretionary authority to refund registration fees.” The circumstances warranting consideration of a refund include: “applicant error, such as duplicate payments, payment for incorrect business activities, or payments made by persons who are exempt under this section from application or renewal fees; DEA error; and death of a registrant within the first year of the three-year registration cycle.”