CHAPTER 20:67:04
RECORD KEEPING
Section
20:67:04:01 Record keeping.
20:67:04:02 Retention and inspection of records.
20:67:04:03 Retrieval of records.
20:67:04:04 Financial records treated as confidential materials.
20:67:04.01. Record keeping. Wholesale drug distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs, including outdated drugs. These records shall include the following information:
(1) The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;
(2) The identity and quantity of the drugs received and distributed or disposed of;
(3) The dates of receipt and distribution or other disposition of the drugs; and
(4) Documentation of storage conditions as required in § 20:67:03:02.
Source: 18 SDR 95, effective November 25, 1991; 45 SDR 86, effective December 24, 2018.
General Authority: SDCL 36-11A-14(8).
Law Implemented: SDCL 36-11A-1.4, 36-11A-7, 36-11A-34, 36-11A-41.
20:67:04.02. Retention and inspection of records. Inventories and records required by this chapter may be maintained by manual or electronic means in a form that allows inspection and photocopying of requested records during inspections. All records shall be retained for six years following disposition of the drugs.
Source: 18 SDR 95, effective November 25, 1991; 45 SDR 86, effective December 24, 2018.
General Authority: SDCL 36-11A-14(8),(14).
Law Implemented: SDCL 36-11A-16, 36-11A-17, 36-11A-44.
20:67:04.03. Retrieval of records. Records described in this chapter that are kept at the inspection site at a central location apart from the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.
Source: 18 SDR 95, effective November 25, 1991.
General Authority:SDCL 36-11A-14(8),(14).
Law Implemented:SDCL 36-11A-7, 36-11A-17.
20:67:04.04. Financial records treated as confidential materials. Any financial records inspected or photocopied by the board shall be treated as confidential materials and not open to public inspection.
Source: 18 SDR 95, effective November 25, 1991.
General Authority:SDCL 36-11A-14(2),(13).
Law Implemented:SDCL 36-11A-16.
