20:67:03:01.  Facilities. All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall meet the following conditions:

 

          (1)  Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

 

          (2)  Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

 

          (3)  Have a separate quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, recalled, misbranded, or adulterated or that are in immediate or sealed secondary containers that have been opened;

 

          (4)  Be maintained in a clean and orderly condition;

 

          (5)  Be free from infestation by insects, rodents, birds, or vermin of any kind;

 

          (6)  Be secured from unauthorized entry by:

 

               (a)  A well-lighted outside perimeter of the premises;

               (b)  An alarm system to detect entry after hours; and

               (c)  A security system that provides protection against theft and diversion, including, if applicable, theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

 

          Source: 18 SDR 95, effective November 25, 1991; 45 SDR 86, effective December 24, 2018.

          General Authority: SDCL 36-11A-14(7),(10).

          Law Implemented: SDCL 36-11A-7.