All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall meet the following conditions:

1. (1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
2. (2) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;
3. (3) Have a separate quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, recalled, misbranded, or adulterated or that are in immediate or sealed secondary containers that have been opened;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. (4) Be maintained in a clean and orderly condition;
5. (5) Be free from infestation by insects, rodents, birds, or vermin of any kind;

6. (6) Be secured from unauthorized entry by:

   1. (a) A well-lighted outside perimeter of the premises;
   2. (b) An alarm system to detect entry after hours; and
   3. (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.

Prior versions effective: 1991-11-25.