NTP Best Practice Guideline

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Publications > Manuals > NTP Best Practice Guideline > Recordkeeping > Records for Compounding Controlled Substances > Compounding for Off-Site Use

Recordkeeping

Compounding for Off-Site Use

Each NTP that is registered or authorized to compound narcotic drugs for off-site use in an NTP must maintain records which include the following information [21 CFR 1304.25]:

Bulk Form
Finished Form

Bulk Form: Records for each narcotic controlled substance in bulk form to be used in, or capable of use in, or being used in, the compounding of the same or other non-controlled substance in finished form must include the following information:

Name of the substance;
Quantity compounded in bulk form by the NTP, including the date, quantity, and batch or other identifying number of each batch compounded;

Quantity and date received, including the name, address, and DEA number of the registrant from whom the substance was received;

Quantity used to compound the same substance in finished form, including:

Date and batch or other identifying number of each compounding;

Quantity used in the compounding;

Finished form (i.e., 10 mg tablets or 10 mg concentration per fluid ounce);

Number of units of finished form compounded;

Quantity lost during compounding and the causes, if known;

Total quantity of the substance contained in the finished form;

Theoretical and actual yields; and

Any other information necessary to account for all controlled substances used in the compounding process;
Quantity distributed in bulk form to other programs, including the date and quantity of each distribution and the name, address, and registration number of each program to whom a distribution was made; and

Quantity disposed of by destruction, including the reason, date, and manner of destruction.

For further information on procedures related to the destruction of medication, see the section entitled "Destruction of Liquid or Solid Medication."

Finished Form: Records for each narcotic substance in finished form must include the following information:

Name of the substance;

Finished form and the number of units or volume in each commercial container (i.e., 100-tablet bottle or 3 ml bottle);

Number of containers of each such commercial finished form compounded from bulk form;

Number of units of finished forms and/or commercial containers received from other persons, including the date or number of units and/or commercial containers in each receipt and the name, address, and DEA registration number of the person from whom the units were received;

Number of units and/or commercial containers compounded by the NTP registrant from units in finished form received from others, including:

Date and batch or other identifying number of each compounding;

Operation performed (i.e., repackaging or relabeling);

Number of units of finished form used in the compound, the number compounded, and the number lost during compounding, with the causes, if known; and

Any other information necessary to account for all controlled substances used in the compounding process;

Number of containers distributed to other programs, including the date, the number of containers in each distribution, and the name, address, and DEA registration number of the program to which the containers were distributed; and

Number of units of finished forms and/or commercial containers destroyed in any manner by the NTP registrant, including the reason, the date, and manner of destruction.

For further information on procedures related to the destruction of medication, see the section entitled "Disposal of Liquid or Solid Medication."

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