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

Narcotic Treatment Programs Best Practice Guideline

PART 7

SECURITY

Federal regulations address basic security requirements for NTPs. DEA is responsible for evaluating whether NTP security systems are in compliance with DEA regulations.

The following sections outline some of the factors that DEA considers in determining whether security systems are in compliance with security regulations and summarize specific requirements that pertain to the security of controlled substances in an NTP. Before making expenditures for a new or modified security system, existing and proposed NTPs are encouraged to contact their local DEA field diversion office to determine whether the proposed system is in compliance with the regulations. (Local DEA diversion field offices are listed in Appendix D).


DEA Security Regulations

DEA may exercise discretion regarding the degree of security required in NTPs based on such factors as the location of the program and the number of patients, security guards, physicians, and staff members connected with the program. [21 CFR 1301.74(l)].

In determining whether an NTP's security system complies with federal regulation, DEA considers several factors, including but not limited to the following [21 CFR 1301.71(b) and 1301.74(l)]:

  • Type (e.g., methadone, LAAM) and form (e.g., bulk powder, liquid, tablets) of controlled substances handled;
  • Quantity of controlled substances handled;
  • Location of the facility (e.g., high or low crime area);
  • Type of building construction (e.g., brick or frame);
  • Physical layout of the program interior (e.g., degree of separation of patient areas from medication dispensing and storage areas);
  • Type of safe or vault used;
  • Adequacy of electronic detection and alarm systems;
  • Number of patients enrolled in the program;
  • Availability of local police protection or private security; and
  • Adequacy of key control systems and/or combination lock control systems.

Security of Controlled Substance Stocks

The following sections summarize specific requirements related to NTP security.

Safes, Steel Cabinets, or Vaults

Requirements for safes, steel cabinets, or vaults include, but are not limited to, the following specifications or their equivalent. [21 CFR 1301.72(a)].

  • Safes, steel cabinets, or vaults must be constructed to withstand the following:
    • 30 man-minutes against surreptitious entry,
    • 10 man-minutes against forced entry,
    • 20 man-hours against lock manipulation, and
    • 20 man-hours against radiological techniques.
  • Safes and steel cabinets that weigh less than 750 lbs, must be bolted or cemented to the floor or wall in such a way that they cannot be readily removed.
  • Safes and steel cabinets, if necessary, depending on the quantities and type of controlled substance medications stored, must be equipped with an alarm system, which upon unauthorized entry will transmit a signal directly to a central station protection company, a police department, or a 24-hour control station operated by the NTP. It is recommended that each NTP contact their local DEA Diversion Field Office (see Appendix D) to determine if their program’s safe/steel cabinet requires an alarm system.
  • Vaults must be equipped with an alarm system, which upon unauthorized entry will transmit a signal directly to a central station protection company, a police department, or a 24-hour control station operated by the NTP.
  • A vault must be constructed of 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with 1/2-inch steel rods tied 6 inches on center, or the structural equivalent.
  • A vault must be equipped with a self-closing and self-locking "day-gate", or its equivalent, if the vault remains open for frequent access.

    NTPs are advised to change security codes and dispensing area locks/keys and lock combinations when dispensing personnel resign or are terminated from employment.

Alarm Systems

Components of the alarm system must include [21 CFR 1301.72(a)]:

  • Contact switches on the door of the vault;
  • A device designed to detect illegal entry into the vault (i.e., electrical lacing of walls, floors, and ceilings; sensitive ultra sonic equipment within the vault; or sound accumulator system); and
  • Safes and steel cabinets, if necessary, depending on the quantities and type of controlled substance medications stored, must be equipped with an alarm system, which upon unauthorized entry will transmit a signal directly to a central station protection company, a police department, or a 24-hour control station operated by the NTP. It is recommended that each NTP contact their local DEA Diversion Field Office (see Appendix D) to determine if their program’s safe/steel cabinet requires an alarm system.
  • Vaults must be equipped with an alarm system, which upon unauthorized entry will transmit a signal directly to a central station protection company, a police department, or a 24-hour control station operated by the NTP.

For additional security of staff, patients, and medication, it is recommended that components of the alarms system also include:

  • A perimeter alarm system covering doors and windows of the program; and
  • Holdup alarms in strategic areas (i.e., the reception and dispensing areas).

Accessibility of Controlled Substances

Requirements pertaining to accessibility include the following:

  • The delivery of narcotic substances must only be accepted by a licensed practitioner employed at the facility or by other authorized individuals designated in writing (excluding persons currently or previously dependent on drugs), who must sign for the narcotics. [21 CFR 1301.74(h)]
  • Patients must be required to wait in an area physically separated from the narcotic storage and dispensing area. [21 CFR 1301.74(j)].The term "dispensing area" refers to the actual physical location where the dispensing occurs. It does not include any waiting or common areas.
  • Narcotics dispensed or administered at an NTP must be dispensed or administered only by the following individuals [21 CFR 1301.74(i)]:
    • A licensed practitioner;
    • A registered nurse under the direction of a licensed practitioner;
    • A licensed practical nurse under the direction of a licensed practitioner; or
    • A pharmacist under the direction of a licensed practitioner.
  • The controlled substance storage areas must be accessible only to an absolute minimum of specifically authorized employees. [21 CFR 1301.72(d)]
  • When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through controlled substance storage areas or manufacturing areas during production of controlled substances (e.g., the compounding area), the registrant must provide adequate observation of the area by an employee specifically authorized in writing. [21 CFR 1301.72(d) and 1301.73(c)].

It is recommended that the required documentation of those individuals authorized to have access to the dispensing area be easily retrievable and maintained in a central location.

The NTP should check with the State Methadone Authority, or its equivalent, to determine if there are any additional restrictions to access.

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