If a specific repackaged drug is recalled, all doses labeled with the lot number of the recalled drug must be removed from the unit dose distribution system. All doses of that drug not labeled with a lot number must be removed from the unit dose distribution system.

For the purpose of this section, “Unit dose distribution system," means a drug distribution system that is in a pharmacy outlet, hospital, or other health care facility and uses unit dose packages, or unit of issue packages, labeled in accordance with § 20:51:21:05 and preserves the identity of the drug until the time of administration.

Source: 9 SDR 14, effective August 8, 1982; 12 SDR 151, 12 SDR 155, effective July 1, 1986; 18 SDR 95, effective November 25, 1991; 29 SDR 37, effective September 26, 2002 ; 50 SDR 138, effective June 2, 2024 .

General Authority: SDCL 36-11-11 (1).

Law Implemented: SDCL 36-11-2.2 .

Prior versions effective: 2002-09-26.