20:67:06:01.  Regular inspections required. All drug distributors, including third party logistics providers, located within the state shall be inspected by the board every two years with follow-ups if problems are found. The following areas may be reviewed when inspections are performed:

          (1)  Responsibility for operation;

          (2)  Policies and procedures;

          (3)  Purchases and sales;

          (4)  Record keeping;

          (5)  Recalls;

          (6)  Facilities;

          (7)  Security;

          (8)  Storage conditions; and

          (9)  Returned goods.

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

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

          Law Implemented: SDCL 36-11A-7, 36-11A-16.

          20:67:06:02.  Exemption from inspection. Wholesale and other drug distributors that have received a satisfactory rating as the result of a full inspection of all operations and procedures by the food and drug administration are exempt from further inspection by the board until any subsequent inspection results in a less than satisfactory rating or until two or more years have passed since the last full inspection by the food and drug administration. Less than satisfactory ratings may include documentation of deficiencies in any drug distribution, repackaging, labeling, quality control, or environmental policies. Deficiencies include any statement which is a part of a compliance report recorded by federal inspection with or without sanctions, penalties, fines, or discipline imposed.

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

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

          Law Implemented: SDCL 36-11A-7, 36-11A-16.

          20:67:06:03.  Out-of-state wholesale and other drug distributor exemption. The board may exempt from inspection any out-of-state wholesale drug distributor pursuant to § 20:67:06:02 on demonstration of a satisfactory rating on an equivalent inspection conducted by the licensing agency of the state where the distributor is located or other inspection agency recognized by the board.

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

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

          Law Implemented: SDCL 36-11A-7, 36-11A-11, 36-11A-16, 36-11A-29.