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Alaska Statutes.

Title 8. Business and Professions

Chapter 80. Pharmacists and Pharmacies

Section 480. Definitions.

AS 08.80.480. Definitions.

In this chapter, unless the context otherwise requires,

(1) "administer" means the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or other means;

(2) "biological product" means a product that is applicable to the prevention, treatment, or cure of a disease or condition of human beings, and is a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or derivative of arsphenamine or any other trivalent organic arsenic compound;

(3) "board" means the Board of Pharmacy;

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

(5) "controlled substance" has the meaning given in AS 11.71.900 ;

(6) "deliver" or "delivery" means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for consideration;

(7) "device" means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including a component part or accessory, that is required under federal law to bear the label "Caution: Federal or state law requires dispensing by or on the order of a physician";

(8) "dispense" or "dispensing" means the preparation and delivery of a drug or device to a patient or patient's agent under a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by, a patient;

(9) "distribute" means the delivery of a drug or device other than by administering or dispensing;

(10) "drug" means an article recognized as a drug in an official compendium, or supplement to an official compendium; an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal; an article other than food, intended to affect the structure or function of the body of man or animal; and an article intended for use as a component of an article specified in this paragraph but does not include devices or their components, parts, or accessories;

(11) "drug regimen review" includes evaluation of the prescription drug order and patient record for

(A) known allergies;

(B) rational therapy-contraindications;

(C) reasonable dose and route of administration;

(D) reasonable directions for use;

(E) duplication of therapy;

(F) drug-drug, drug-food, and drug-disease interactions;

(G) adverse drug reactions; and

(H) proper utilization, including over- or under-utilization, and optimum therapeutic outcomes;

(12) "equivalent drug product" means a drug product that has the same established name, active ingredients, strength or concentration, and route of administration and that is formulated to contain the same amount of active ingredients in the same dosage form and to meet the same compendia or other applicable standards for strength, quality, purity, and identity, but that may differ in characteristics such as shape, scoring configuration, packaging, excipients including colors, flavors, preservatives, and expiration time;

(13) "interchangeable biological product" means a biological product that the United States Food and Drug Administration has determined

(A) meets the standards for interchangeability under 42 U.S.C. 262(k)(4); or

(B) is therapeutically equivalent to another biological product under the most recent edition or supplement of the United States Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations;

(14) "intern" means an individual who is

(A) currently licensed by this state to engage in the practice of pharmacy while under the personal supervision of a pharmacist and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist; or

(B) a graduate from a college of pharmacy who is currently licensed by the board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist;

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

(16) "legend drug" means a prescription drug;

(17) "manufacturing" means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from a substance of natural origin or independently by means of chemical or biological synthesis, and includes packaging or repackaging of a substance or labeling or relabeling of its container, and the promotion and marketing of drugs or devices; "manufacturing" also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons;

(18) "nonprescription drug" means a nonnarcotic medicine or drug that may be sold without a prescription and that is prepackaged for use by the consumer and labeled in accordance with the requirements of the statutes and regulations of the state and the federal government;

(19) "outpatient dispensing" means dispensing drugs for administration outside of the hospital pharmacy's control;

(20) “outsourcing facility” means a facility at one geographic location or address that is engaged in the compounding of sterile drugs for a facility at another geographic location;

(21) "owner" means the owner of a place of business for wholesaling, retailing, compounding, or dispensing drugs, medicines, or poisons;

(22) "patient counseling" means the communication by the pharmacist of information, as defined in the regulations of the board, to the patient or care giver in order to improve therapy by ensuring proper use of drugs and devices;

(23) "person" has the meaning given in AS 01.10.060 and also includes a governmental agency;

(24) "pharmaceutical care" is the provision of drug therapy and other pharmaceutical patient care services intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process as defined in regulations of the board;

(25) "pharmacist" means an individual currently licensed by this state to engage in the practice of pharmacy;

(26) "pharmacist-in-charge" means a pharmacist who accepts responsibility for operation of a pharmacy in a manner that complies with laws and regulations applicable to the practice of pharmacy and the distribution of drugs and who is personally in charge of the pharmacy and the pharmacy's personnel;

(27) "pharmacy" means a place in this state where drugs are dispensed and pharmaceutical care is provided and a place outside of this state that is subject to licensure or registration under AS 08.80.157(b);

(28) "pharmacy located outside of the state" means a pharmacy that prepares or mixes prescription drugs outside of the state, regardless of the location at which those drugs may be shipped, mailed, or delivered to the consumer;

(29) "pharmacy technician" means a supportive staff member who works under the immediate supervision of a pharmacist;

(30) “practice of pharmacy” means the interpretation, evaluation, and dispensing of prescription drug orders in the patient's best interest; participation in drug and device selection, drug administration, drug regimen reviews, and drug or drug-related research; provision of patient counseling and the provision of those acts or services necessary to provide pharmaceutical care; the independent prescribing, dispensing, and administration of drugs in accordance with AS 08.80.168; the responsibility for compounding and labeling of drugs and devices except labeling by a manufacturer, repackager, or distributor of nonprescription drugs and commercially packaged legend drugs and devices; proper and safe storage of drugs and devices; and maintenance of proper records for them;

(31) "practitioner" means an individual currently licensed, registered, or otherwise authorized by the jurisdiction in which the individual practices to prescribe and administer drugs in the course of professional practice;

(32) "preceptor" means an individual who is currently licensed by the board, meets the qualifications as a preceptor under the regulations of the board, and participates in the instructional training of pharmacy interns;

(33) "prescription drug" means a drug that, under federal law, before being dispensed or delivered, is required to be labeled with either of the following statements: (A) "Caution: Federal law prohibits dispensing without prescription"; (B) "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian"; or a drug that is required by an applicable federal or state law or regulation to be dispensed only under a prescription drug order or is restricted to use by practitioners only;

(34) "prescription drug order" means a lawful order of a practitioner for a drug or device for a specific patient;

(35) "significant adverse drug reaction" means a drug-related incident that may result in serious harm, injury, or death to the patient;

(36) "substitute" means to dispense without the prescriber's expressed authorization,

(A) an equivalent drug product in place of the prescribed drug; or

(B) an interchangeable biological product in place of the prescribed biological product;

(37) "third-party logistics provider" means an entity that provides or coordinates warehousing or other logistics services for a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of the product, and that does not take ownership of the product or have responsibility to direct the sale or disposition of the product;

(38) "wholesale" means sale by a manufacturer, wholesale dealer, distributor, or jobber to a person who sells, or intends to sell, directly to the user;

(39) "wholesale drug distributor" means anyone engaged in wholesale distribution of drugs, including manufacturers; repackagers; own-label distributors; private label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses; chain drug warehouses; wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.