Since the DEA has changed its regulations on reporting theft or significant loss of controlled substances, numerous pharmacies have been making reporting errors, subjecting themselves to unnecessary penalties. For example, I am currently representing a pharmacy that was cited for not following the required reporting procedure. And this is not the first case in my practice. Sometimes, pharmacies only file an online Form 106 through the DEA’s website within one day of theft discovery. The updated regulations, however, require a different procedure.
21 CFR 1301.74(c) specifically requires a notice to the local DEA Field Division Office, in writing, of any theft or significant loss of any controlled substances within one business day of discovery. This means that a notice should be provided by email, fax, or any other means to a local DEA office. In an ongoing case, a Diversion Investigator in Northern California represented that even a call would suffice. But note that the regulation requires a notice in writing, so if you do make a call, make sure to follow up by a written notice as well.
The regulation further provides that “the registrant must also file a complete and accurate DEA Form 106 with the Administration through the DEA Diversion Control Division secure network application within 45 calendar days after discovery of the theft or loss. Thefts and significant losses must be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action taken against them. When determining whether a loss is significant, a registrant should consider, among others, the following factors:
(1) The actual quantity of controlled substances lost in relation to the type of business;
(2) The specific controlled substances lost;
(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
(5) Whether the specific controlled substances are likely candidates for diversion;
(6) Local trends and other indicators of the diversion potential of the missing controlled substance.”
The main point to remember is the requirement to submit a written notice (not the actual Form-106) within one business day of the discovery to your local DEA Filed Division Office and to follow up by submitting an online 106 form through the DEA Diversion website.