CHAPTER 20:67:03
DRUG STORAGE AND HANDLING REQUIREMENTS
Section
20:67:03:01 Facilities.
20:67:03:02 Storage conditions.
20:67:03:03 Examination upon receipt required.
20:67:03:04 Outgoing shipments to be inspected.
20:67:03:05 Quarantine required.
20:67:03:06 Opened containers to be identified.
20:67:03:07 Standards for returned drugs to be met.
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(3) Have a separate quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, recalled, misbranded, or adulterated or that are in immediate or sealed secondary containers that have been opened;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.
20:67:03:02. Storage conditions. All prescription drugs shall be stored as required by the labeling of the drugs. If no storage requirements are established for a prescription drug, the drug may be held at controlled room temperature to help ensure that its identity, strength, quality, and purity are not adversely affected. Manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs shall be utilized, as applicable, to document proper storage of prescription drugs.
Source: 18 SDR 95, effective November 25, 1991.
General Authority:SDCL 36-11A-14(7).
Law Implemented:SDCL 36-11A-7.
20:67:03:03. Examination upon receipt required. Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination must be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.
Source: 18 SDR 95, effective November 25, 1991.
General Authority:SDCL 36-11A-14(7),(13).
Law Implemented:SDCL 36-11A-7.
20:67:03:04. Outgoing shipments to be inspected. Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.
Source: 18 SDR 95, effective November 25, 1991.
General Authority:SDCL 36-11A-14(7),(13).
Law Implemented:SDCL 36-11A-7.
20:67:03:05. Quarantine required. Prescription drugs that are outdated, damaged, deteriorated, recalled, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier.
Source: 18 SDR 95, effective November 25, 1991; 45 SDR 86, effective December 24, 2018.
General Authority: SDCL 36-11A-14(7).
Law Implemented: SDCL 36-11A-7, 36-11A-34.
20:67:03:06. Opened containers to be identified. Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such and shall be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.
Source: 18 SDR 95, effective November 25, 1991.
General Authority:SDCL 36-11A-14(7),(13).
Law Implemented:SDCL 36-11A-7.
20:67:03:07. Standards for returned drugs to be met. If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the drug shall be destroyed or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling as a result of storage or shipping.
Source: 18 SDR 95, effective November 25, 1991.
General Authority:SDCL 36-11A-14(7),(13).
Law Implemented:SDCL 36-11A-7.
