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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