South Dakota § 36-11A-1 - Definitions.

§ 36-11A-1. Definitions.

Terms used in this chapter mean:

(1)    Repealed by SL 2017, ch 174, § 1;

(2)    "Board," the Board of Pharmacy;

(3)    "Chain pharmacy warehouse," a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales or transfers of such drugs to a group of chain pharmacies that have the same common ownership and control;

(4)    Co-licensed partner," a party that, with another party or parties, has the right to engage in the manufacturing or marketing, or both, of a co-licensed product;

(5)    "Co-licensed product," a prescription drug in which two or more parties have the right to engage in the manufacturing or marketing, or both, of a drug consistent with the United States Food and Drug Administration's implementation of the Prescription Drug Marketing Act (21 C.F.R. Parts 203 and 205);

(6)    "DSCSA," the Drug Supply Chain Security Act as included as Part II of the Federal Drug Quality and Security Act of 2013;

(7)    "Drug," "prescription drug," any drug, including any biological product, except for blood and blood components intended for transfusion or biological products that are also medical devices required by federal law or federal regulation to be dispensed only by a prescription, including finished dosage forms and bulk drug substances subject to § 503(b) of the Federal Food, Drug and Cosmetic Act;

(8)    "Drug coupon," a form which may be redeemed at no cost or at reduced cost for a prescription drug;

(9)    "Drug Enforcement Administration," the Drug Enforcement Administration of the United States Department of Justice;

(10)    "Drug sample," a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug;

(11)    "Facility," a facility of a wholesale distributor where prescription drugs are stored, handled, repackaged, or offered for sale;

(12)    "Licensee," any wholesale drug distributor licensed pursuant to the provisions of this chapter;

(13)    "Manufacturer," as defined by the DSCSA;

(14)    "Out-of-state wholesale drug distributor," a wholesale drug distributor with no physical facilities located in this state;

(15)    "Outsourcing facility," a facility that is engaged in compounding of nonpatient specific sterile and nonsterile drugs that complies with § 503(b) of the Federal Food, Drug and Cosmetic Act as of January 1, 2017, and is registered and inspected by the United States Food and Drug Administration;

(16)    "Pharmacy," a place licensed by the board under chapter 36-11 in which prescription drugs are sold;

(17)    "Repackage," repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of a prescription drug excluding that completed by the pharmacist responsible for dispensing the drug to the patient;

(18)    "Repackager," a person who repackages;

(19)    "Sterile pharmaceutical," any dosage form of a drug, including parenterals, such as injectables, surgical irrigants, and ophthalmics, devoid of viable microorganisms;

(20)    "Third-party logistics provider," an entity that provides or coordinates warehousing, distribution, or other services on behalf of a manufacturer, wholesale distributor, or dispenser as defined in the DSCSA, but does not take title to the prescription drug or have general responsibility to direct the prescription drug's sale or disposition;

(21)    "Transaction history," a statement, in paper or electronic form, that includes the transaction information of each prior transaction going back to the manufacturer of the product.

Source: SL 1991, ch 307, § 1; SL 2007, ch 215, § 1; SL 2017, ch 174, § 1.