Since 1971, federal regulations have required that practitioners notify the Drug Enforcement Administration "upon discovery" of any "theft or significant loss" of controlled substances. E.g., 21 C.F.R. 1301.76(b). Registrants are also required to complete and file DEA Form 106 concerning such an occurrence.

In July of 2003, the DEA published a Notice of proposed amendments to its regulation in the Federal Register* requiring registrants to notify it of thefts or unexplained significant losses of controlled substances "immediately upon discovery," the DEA stating in the Notice that it has always expected the notification to occur immediately and without delay.

Stressing its expectation of prompt notification, the DEA explains in this publication that it considers the notification part of a good-faith effort by registrants to maintain effective controls against diversion. It also points out that, although not specifically required by DEA law but because such a theft is a criminal act, registrants should also notify, and promptly, local law enforcement and state regulatory agencies.

Form 106 of the DEA must still be filed, but submitting it "is not immediately necessary." Form 106 requires that a registrant, among other things, document specific circumstances surrounding the incident, detail concerning the names and quantities of controlled substances involved, and the like. When those circumstances and details of an occurrence that are required by Form 106 are not immediately known at the time of discovery, however, the DEA wants registrants to provide the initial notice of a theft or loss by faxing a "short statement" advising of the occurrence to the local Field Division Office. It states in the Federal Register publication that it prefers fax of the initial notification over mail, because delays occurring due to the mailing process may hinder its investigative efforts.

After giving the initial notification immediately upon discovery, the registrant should then make efforts to determine the facts. It should do so, the DEA suggests, both by conducting its own internal inventories and investigations and by enlisting the aid of law enforcement resources, if necessary. Once the circumstances surrounding the theft or loss are clear, Form 106 must be submitted.

The DEA explains that it recognizes some time may elapse between the time initial notification is provided and conclusion of an investigation. If an investigation takes more than two months, however, it suggests that a registrant should provide updates to the DEA.

The Federal Register Notice points out that if, after an investigation, it is determined that no theft or significant loss occurred, no DEA Form 106 need be filed. It recommends, however, that in such instances, a registrant advise DEA that Form 106 is not needed or will not be filed regarding the incident.

In summary, there is not any flexibility with regard to giving the DEA initial notice of a theft or unexplained loss – notification must be given immediately upon discovery, the DEA even preferring initial notification be sent by fax rather than mail. Submitting a full/completed Form 106 would not be immediately necessary, however, the language in the July Federal Register proposal suggesting that Form 106 should not be filed with the DEA until the registrant’s investigation is completed and the details (who, what, when, how many, etc.) called for by that reporting form are clear.

The final language of the regulation amendments and the effective date will be published in the Federal Register, which may not occur until January of 2004, or after.

* See, 68 Federal Register 40576, Vol. 130, July 8, 2003.