S.D. Admin. R. 20:67:03:01

Current through Register Vol. 50, page 162, June 24, 2024

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(3) Have a separate quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, recalled, misbranded, or adulterated or that are in immediate or sealed secondary containers that have been opened;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

S.D. Admin. R. 20:67:03:01

18 SDR 95, effective 11/25/1991; 45 SDR 086, effective 12/24/2018

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

Law Implemented: SDCL 36-11A-7.