In the US, each state has its own set of controlled substance regulations that either emulate the DEA federal standard or actually enhance it. Before we delve deeper into what constitutes a “DEA-compliant” logbook, remember this statement: “Each registrant who maintains an inventory of controlled substances must maintain a complete and accurate record of the controlled substances on hand and the date that the inventory was conducted.” That quote is right out of the Code of Federal Regulations (CFR) and does not mandate that a DEA registrant use one method of recordkeeping over another. The key is that the records must be complete, accurate, and readily available for a regulatory inspection.
The common reoccurring theme surrounding what is required in a logbook is whether or not the book must be bound. It is important to note that a bound logbook has pages that are fixed in an unchangeable order: The pages are not removable, in comparison to a loose-leaf logbook. In several situations, loose-leaf logbooks have led to accusations of tampering because the pages can be easily removed.
Besides the “bound” requirement, the logbook must be maintained by the DEA registrant and include at a minimum all of the following information: drug name, container size, strength of medication, bottle number, date of dispensation, explanation of use, lot number (if available), expiration date, amount added to logbook, amount used, running balance, initials of authorized employee, and witness initials for wasting. At a minimum, your logbook should be maintained in accordance with the recordkeeping requirements of §1304.04 of the CFR. If you are using electronic logbooks, the law does not specify that you must print out paper copies; they just must be current and readily available for inspection.
Similarly, in Canada, there is a province-based system of controlled substance regulations; however, all provinces must collectively adhere to Health Canada’s Controlled Drugs and Substances Act. The AAHA Controlled Substance Logs books adhere to Health Canada’s mandatory regulations as well as the recommended Guidelines on Secure Management and Diversion Prevention. These guidelines state that reconciliation of specific controlled substances should occur when new stock is received, issued to a patient-care area, dispensed, and disposed of. In addition, the guidelines state that “logs should be firmly bound and sorted by consecutively numbered pages.”
Simply put, DEA controlled substance logbooks must contain sufficient information to maintain accurate counts of your controlled substances. If the DEA knocks on your door and you can tell them with the utmost confidence the whereabouts of every drug that enters your doors, goes into your safe, is administered to an animal, or is sent to the reverse distributor, you will never have a problem. The DEA requires you to keep accurate records and account for all of your controlled substances. In our opinion, the use of bound controlled substance logbooks such as the third edition of the AAHA Controlled Substance Logs meet the minimum requirements for use in all 50 US states and Canada.
—Jack Teitelman, retired DEA Supervisory Special Agent and CEO of Titan Group, DEA Compliance Experts