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Recordkeeping

DEA Accountability Investigations

A DEA accountability investigation is an unannounced investigation conducted by DEA personnel of an NTP's records and security measures of all controlled substances on hand.

Upon entering the premises, DEA personnel must (1) present their credentials, (2) state the purpose of their visit, and (3) present a written notice of their inspection authority (DEA Form 82 – Notice of Inspection of Controlled Premises) to the owner, operator, or agent in charge of the NTP. [21 CFR 1316.05].

Wherever possible, informed consent must consist of a written statement signed by the owner, operator, or agent in charge of the NTP, and witnessed by two persons. The written consent includes the following information [21 CFR 1316.08]:

That the owner, operator, or agent of the NTP:

Has been informed of his/her constitutional right not to have an administrative inspection without an Administrative Inspection Warrant (AIW),

Has the right to refuse consent to such an inspection,

Has been presented with a Notice of Inspection,

Has given his/her consent voluntarily, without threats of any kind,

May withdraw his/her consent at any time during the course of the inspection, and

Has been informed that if anything of an incriminating nature is found, it may be seized and used against him/her in a criminal prosecution.

In those cases in which informed consent is not given, or where consent is withdrawn, DEA personnel must obtain an AIW. [21 CFR 1316.08(a)]. If the owner, operator, or agent of an NTP refuses to permit the execution of an AIW, or impedes DEA personnel in the execution of an AIW, he/she is to be advised that such refusal or action constitutes a violation of the Controlled Substances Act of 1970. [21 CFR 1316.12].

Once DEA personnel have begun an accountability investigation, the owner, operator, or agent of the NTP must provide them with the following information [21 CFR 1301.74(c), 1304.11(b) and (c), 1305.09, 1305.13, and 1307.21]:

The initial inventory (if the NTP has been open for business less than two years, or upon request of DEA Investigators);

The latest biennial inventory conducted (if the NTP has be in operation more than two years);

Receipts (DEA Form-222s) of the medication received since the inventory was conducted; and

Documentation of the amount of medication dispensed, spilled, returned to manufacturer, transferred to another NTP, missing due to theft or unexplained loss, destroyed since the inventory was conducted, or awaiting destruction.

It is also recommended that the NTP provide investigators with the most recent physical inventory. For a list of the documents required during a DEA investigation, see Appendix C.

Also during an accountability investigation, a "closing inventory" will be conducted. A closing inventory is a physical count of all the program’s controlled substance medications on hand as of that date. The closing inventory will be verified by an official of the program, and should be done prior to or after the day’s dispensing hours. In addition, it should be noted on the paperwork whether the closing inventory was taken at the opening or close of business hours.

DEA maintains a strict accountability policy regarding the reconciliation of all narcotic inventory medications. All registered NTPs must provide an accurate and complete accounting of all narcotic medication that has been received, dispensed, returned, destroyed, reported lost/stolen, or otherwise disposed of. [21 CFR 1304.21].

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