An Act to revise provisions related to pharmacy.

Be it enacted by the Legislature of the State of South Dakota:

Section 1. That   13-33A-4 be AMENDED:

13-33A-4. Any school may acquire and maintain a stock of epinephrine auto-injectors pursuant to a prescription issued by an authorized health care provider for use in an emergency situation of a severe allergic reaction causing anaphylaxis. The provisions of this section are not subject to the prescription requirements in subdivision 36-11-2(21) chapter 36-11.

Section 2. That   36-11-2 be AMENDED:

36-11-2. Terms used in this chapter mean:

(1) "Association," the South Dakota Pharmacists Association;

(2) "Biological product," as defined in 42 U.S.C.   262(i), as of (January 1, 2018);

(3)(2) "Board," or "board of pharmacy," the State Board of Pharmacy in South Dakota;

(4)(3) "Brand name," the proprietary or registered trademark name given to a drug product by its manufacturer, labeler, or distributor and placed on the drug or on its container, label, or wrapping at the time of packaging;

(5) "Chemicals," the chemical materials or medicine;

(6)(4) "Compounding," the preparation, mixing, assembling, packaging, or labeling of a drug or drug device as the result of a practitioner's prescription drug order or an initiative based on the pharmacist/patient/practitioner relationship in the course of professional practice or for the purpose of or as an incident to research, teaching, or chemical analysis and not for sale or dispensing. The term also includes the preparation of drug or drug devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns;

(7)(5) "Delivery," the actual, constructive, or attempted transfer of a drug or drug device from one person to another, whether or not for a consideration;

(8)(6) "Dispense" or "Dispensing," the preparation and delivery of a drug to a patient or a patient's agent pursuant to a prescription drug order in a suitable container with appropriate labeling for subsequent administration to or use by a patient. The term includes preparation of labels for drug devices if the labeling is related to the dosage and administration of drugs;

(9)(7) "Distributing," the delivery of a drug or drug device other than by administration or dispensing;

(10)(8) "Drug administration," the direct application of a drug or drug device by injection, inhalation, ingestion, or any other means to the body of a patient or research subject;

(11)(9) "Drug device," equipment, process, biotechnological entity, diagnostic agent, or other product used in combination with a drug to provide effective management of medication regimens;

(12) "Drug utilization review program," any program operated solely or partially as a professional standards review organization whose purpose is to educate pharmacists and practitioners on severe adverse reactions to drugs, therapeutic appropriateness, overutilization and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions and clinical abuse or misuse, as well as to identify and reduce the frequency of patterns of potential and actual fraud, abuse, gross overuse, inappropriate care or medically unnecessary care associated with specific drugs or groups of drugs among practitioners, pharmacists and patients;

(13)(10) "Equivalent drug product," a drug product, other than a biological product, that is considered to be therapeutically equivalent to other pharmaceutically equivalent products as determined by the latest edition of Approved Drug Products with Therapeutic Equivalence Evaluations, as adopted by the board through rules promulgated pursuant to chapter 1-26;

(14)(11) "Interchangeable biological product," a biological product that the U.S. United States Food and Drug Administration either has licensed and determined meets the standards for interchangeability pursuant to 42 U.S.C.   262(k)(4), as of (January 1, 2018), or has determined is therapeutically equivalent, as set forth in the latest edition of, or any supplement to, the Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations publication as adopted by the board through rules promulgated pursuant to chapter 1-26;

(15)(12) "Labeling," the process of preparing and affixing a label to any drug or drug device container exclusive of the labeling by the manufacturer, packer, or distributor of a nonprescription drug or commercially packaged legend drug or drug device;

(16) "Medical device," an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, that is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease in man or other animals or is intended to affect the structure or any function of the body of man or other animals, that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and that is not dependent upon being metabolized for achievement of any of its principal intended purposes;

(17)(13) "Medicines," drugs or chemicals, or their preparations, in suitable form for the prevention, relief, or cure of diseases when used either internally or externally by man or for animals;

(18)(14) "Nonprescription drugs," drugs that are labeled for use by the general public in accordance with   502 of the Federal Food, Drug and Cosmetic Act as amended through January 1, 1997, 21 U.S.C.   352 (January 1, 2025),