16-02: REPORTING THEFT OR LOSS OF CONTROLLED SUBSTANCES (CII-CVI) TO THE BOARD
This policy elaborates on the requirements for reporting loss or theft of controlled substances, a concept which was briefly discussed in 247 CMR 6.02(10) and 247 CMR 10.03(q). In Massachusetts, Schedules II-VI are considered controlled substances and any suspected significant reportable loss requires the pharmacy to submit Section A of the Report of Loss of Controlled Substances form within 7 days. After submitting Section A, any other reports such as investigation results or police reports must be submitted to the Board using Section B within 21 days of the original submission or as soon as the investigation is complete.
However, if a loss is confirmed/possible and reportable, licensees have to submit DEA Form 106 to the DEA. A copy of Form 106 and Section A must also be submitted to the Board within 7 business days. If the reason for loss is known initially, Sections A and B as well as Form 106 and any other necessary documents need to be submitted.
If the reason on Form 106 is "Other", then an attestation must be sent indicating the pharmacy has conducted perpetual inventories, cycle counts, biennial inventories, and inventory reports for 3 months prior to the loss. A statement describing the percentage of loss in total number of units, such as tablets, must also be sent.
When reporting the loss of C-II drugs, an attestation must be submitted stating that the C-II inventory has been checked every 10 days by a pharmacist. If the inventory has not been checked every 10 days, an explanation as to why must be submitted. In addition to this, DEA Form 222 and purchase invoices for the 3 months prior to the loss until the present must be submitted.
All types of losses should be submitted using a specific email*: DHPLOPP.ADMIN@MassMail.State.MA.US
* Once the pharmacy's internal investigation is complete or within 21 days of the initial email – whichever is sooner – the pharmacy needs to submit the outcome of their investigation.
For Schedules II-V I, any type of loss due to theft of an employee needs to be reported. However, for all other types of loss or theft, only "significant loss" needs to be reported. The DEA acknowledges "significant loss" can vary depending on the pharmacy or pharmacy department, so they leave the definition vague and thus allow each institution to determine what "significant loss" means to them. However, they do advise that when in doubt, one should err on the side of caution and report. This table from Policy 16-02 summarizes the types of loss that needs to be reported depending on the loss type and Schedule.