NTP Best Practice Guideline

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Recordkeeping

Dispensing Records

Each NTP must maintain a record of medication dispensing which contains the following information [21 CFR 1304.24(a)]:

Name of substance;

Strength of substance;

Dosage form;

Date dispensed;

Adequate identification of patient (consumer);

Amount consumed;

Amount and dosage form taken home by patient; and

Dispenser's initials.

Each NTP must maintain these records in a dispensing log. [21 CFR 1304.24(b)].

However, as an alternative to the maintaining a dispensing log, an NTP may use an automated/computerized data processing system for the storage and retrieval of the program’s dispensing records, if the following conditions are met:

The automated system maintains the information required in 21 CFR 1304.24(a),
The automated system has the capability of producing a hard copy printout of the program’s dispensing records,
That an NTP print a hard copy of each day’s dispensing log, which is then initialed appropriately by each person who dispensed medication to the program’s patients, and
That the automated system is approved by DEA.

Furthermore, if an NTP uses identification numbers or a similar system, rather than patient names and addresses for medication dispensing records, then that NTP has not "adequately identified" their patients as required by 21 CFR 1304.24(a). According to DEA policy, an NTP that uses such a system to identify its patients must maintain an up-to-date cross-index that associates each identification number with the name and address of the person to whom it refers. This list should be readily available for the auditing or verification of program records.

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