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Administrative Rules

    20:51:31:01.  Definitions. Terms used in this chapter mean:

    (1)  "Compounding," the constitution, reconstitution, combination, dilution, or another process causing a change in the form, composition, or strength of any ingredient or any other attribute of a product;

    (2)  "Hazardous drug," a pharmaceutical that is antineoplastic, carcinogenic, mutagenic, or teratogenic;

    (3)  “Nonsterile compounding," the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer's labeling, or otherwise altering a drug or bulk drug substance to create a non-sterile preparation; and

    (4)  "Sterile compounding," the aseptic processing of any pharmaceutical preparation that is required to be sterile when administered to patients.

    Source: 36 SDR 100, effective December 14, 2009; 50 SDR 138, effective June 2, 2024.

    General Authority: SDCL 36-11-11(1)(3).

    Law Implemented: SDCL 36-11-2.2(3).

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