Office of Diversion Control, US Department of Justice, Drug Enforcement Administration

Narcotic Treatment Programs Best Practice Guideline

PART 6

RECORDKEEPING

DEA requires that NTPs keep a record of all medication received, dispensed, administered, and destroyed. In addition, DEA requires that NTPs retain all records for two years from the date of execution. However, because some states require that records be retained for longer than two years, NTPs should contact the State Methadone Authority (SMA) for information about state requirements.

DEA requires that NTPs conduct an initial inventory of all stocks of controlled substance medications on hand on the date that the NTP begins operations. It is also required that, at least once every two years, each NTP conduct and document a physical inventory (called a "biennial inventory") of the medication on hand. These inventories must include all forms of medication on hand (i.e., liquid, tablet, diskette, or powder) as well as the quantity and strength of each medication.

During a DEA accountability investigation, the beginning inventory used in the audit must be an actual physical inventory taken by the NTP. The beginning inventory selected could either be the NTP’s initial or biennial inventory.

The following sections summarize DEA recordkeeping and inventory requirements, provide an overview of DEA's accountability investigation, and recommended strategies for maintaining complete and accurate records in accordance with DEA regulations. Appendix C includes a list of all documents and information that an NTP is required to have available at the time of a DEA investigation.


Records for Compounding Controlled Substances

The sections that follow review DEA recordkeeping requirements related to the compounding of controlled substances.

Compounding for On-Site Use

All NTP sites that compound a bulk narcotic solution from bulk narcotic powder to liquid for on-site use must keep a separate batch record of the compounding.[21 CFR 1304.24(c)]

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: 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."


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.


Receipts

See Part 3, "Receiving Medication," for information on recordkeeping procedures related to the receipt of medication from the supplier.


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.


Computer Software Requirements for Maintaining Dispensing Records

When an NTP uses an automated data system to maintain dispensing records, the computerized dispensing records must contain the information outlined in 21 CFR 1304.24(a).

See the previous section regarding "dispensing record" requirements (manual as well as computerized).

It is also recommended that an NTP’s computer software program be capable of producing accurate summary reports for any time frame selected by DEA personnel during an investigation. Further, if these summary reports are maintained in hard copy form, they should be kept in a systematically organized and centrally located file.


Reporting Theft and Loss of Controlled Substance Medication

Immediately upon discovery of a theft or significant loss of a controlled substance medication, the NTP must contact the local DEA diversion field office by telephone, facsimile, or with a brief written message explaining the circumstances. Further, a DEA Form-106, "Report of Theft or Loss of Controlled Substances", must be filed. [21 CFR 1201.74(c)].The NTP should also notify the local police, as this may be required by state law.

The following sections review issues and procedures related to reporting the theft and loss of controlled substance medication.

Issues Related to Reporting Theft and Loss

  • Although the regulations do not define the terms "upon discovery" and "significant loss," it is the responsibility of the NTP to use its best judgement to take appropriate action. What would constitute a significant loss for one program may be viewed as comparatively insignificant for another program.
  • The loss of a small quantity of controlled substance, repeated over a period of time, may indicate a significant problem for a program even though the individual amounts of missing controlled substances are not, in and of themselves, significant.
  • A program should be alert for suspicious or unexplained losses. Any signs of a break in, physical entry, or armed robbery should be reported.
  • The burden of responsibility is on the NTP to identify a significant loss and make the required report to DEA. Some factors to consider for determining significant loss include:
    • The quantity missing (i.e., one tablet vs. one bottle)
    • The name and schedule of the missing medication
    • The abuse potential of the missing substance in your area
    • Is this the first time this loss has occurred? Has a similar loss occurred before?
    • Was this loss reported to local law enforcement authorities?

DEA Form-106 (Report of Theft or Loss of Controlled Substances)

The NTP must complete a DEA Form-106 to formally document the actual circumstances of a theft or significant loss and the quantities of controlled substances involved. [21 CFR 1301.74(c)]. However, in many cases, determining the actual circumstances may require some evaluation, review, and possible investigation. Issues and procedures related to the determination of whether and how to use DEA Form-106 include the following:

  • If, after reviewing all the available information, it is determined that no theft or significant loss occurred, no DEA Form-106 need be filed. However, the NTP should notify DEA of the results of the investigation and maintain a record of the occurrence in its loss and theft file for future reference.
  • If there is a question as to whether a theft or a significant loss has occurred, the NTP should contact the local DEA diversion field office.
  • An NTP should not use a DEA Form-106 to adjust inventory.

An NTP should contact the local DEA diversion field office to obtain a DEA Form-106. A completed theft and loss form should include the following information:

  • Name and address of NTP;
  • DEA registration number;
  • Date of theft;
  • Local police department notified;
  • Type of theft (night break in, armed robbery, etc.);
  • Listing of symbols or other identifying markings (if any) used by NTP to mark containers; and
  • Listing of controlled substances missing from theft or significant loss (name, quantity, and strength).

An NTP is required to prepare the form in triplicate, keep the third copy for its records, and send the first and second copies to the local DEA diversion field office.


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].


Maintaining Complete and Accurate Records

DEA regulation and policy require that NTPs provide complete and accurate records. In an effort to assist programs in their attempt to comply with these requirements, DEA strongly recommends that the following strategies be adopted:

  • Ensure that employees understand how to operate relevant equipment, including computers;
  • Maintain appropriate back-ups for computer and other recordkeeping systems; and
  • Establish appropriate shut-down procedures to be used both at the time of dispenser shift changes and at the end of the work day.

DEA is aware that in dealing with liquid controlled substance medications, absolute accountability is not always attainable. An NTP's overall processes, procedures, and results will be taken into account in the evaluation of the outcomes of an investigation.

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Office of Diversion Control  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539