NTP Best Practice Guideline

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Recordkeeping

Requirements for an Inventory

DEA requires that NTPs must conduct an initial inventory of all stocks of controlled substance medications on hand on the date that the NTP begins operations. In the event that no controlled substance medications are on hand at this time, this fact must then be noted in the NTP’s initial inventory. [21 CFR 1304.11(b)].

DEA also requires that after the initial inventory is taken, NTPs must conduct a new physical inventory of all stocks of controlled substance medications on hand at least once every two years, which is identified as the official DEA biennial inventory. The biennial inventory may be conducted on any date within two years of the previous biennial inventory date. [21 CFR 1304.11(c)].

It is recommended, however, that NTPs conduct inventories at more frequent intervals in order to maintain adequate control over their needs and requirements.

The initial and biennial inventory must include the following information:
[21 CFR 1304.11]:

Date the inventory is conducted,

Time of day inventory is conducted, i.e., at the open or close of business, and

Name, dosage form, strength, and quantity of each medication on hand at the time of the opening or closing inventory.

It also is recommended that the initials of the individual who conducted the inventory be included in the written record of each inventory.

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