(a) Unless the prescription indicates that it is to be dispensed only as written, the pharmacist may, with the consent of the patient, substitute an equivalent drug product or interchangeable biological product.

Terms Used In Alaska Statutes 08.80.295

  • 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. See Alaska Statutes 08.80.480
  • 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. See Alaska Statutes 08.80.480
  • drug: means an article recognized as a drug in an official compendium, or supplement to an official compendium. See Alaska Statutes 08.80.480
  • 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. See Alaska Statutes 08.80.480
  • 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. See Alaska Statutes 08.80.480
  • pharmacist: means an individual currently licensed by this state to engage in the practice of pharmacy. See Alaska Statutes 08.80.480
  • 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 Alaska Stat. See Alaska Statutes 08.80.480
  • 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. See Alaska Statutes 08.80.480
  • substitute: means to dispense, without the prescriber's expressed authorization,
    (A) an equivalent drug product in place of the prescribed drug. See Alaska Statutes 08.80.480
(b) A pharmacist who substitutes an equivalent drug product or interchangeable biological product in compliance with this section and applicable regulations incurs no greater liability in filling the prescription than would be incurred in filling the prescription by dispensing the prescribed name brand product.
(c) Except as provided in (d) of this section, if an interchangeable biological product exists for a biological product prescribed to a patient, the dispensing pharmacist or the pharmacist’s designee shall communicate to the prescribing practitioner information regarding the biological product provided to the patient, including the name and manufacturer of the biological product. The communication must be provided within three business days after dispensing the biological product as follows:

(1) by making an entry that is electronically accessible to the prescribing practitioner through

(A) an interoperable electronic medical records system;
(B) an electronic prescribing technology;
(C) a pharmacy benefit management system; or
(D) a pharmacy record; or
(2) if the pharmacist or the pharmacist’s designee is unable to make an entry through one of the means provided under (1) of this subsection, by facsimile transmission, telephone communication, electronic mail transmission, or transmission by other prevailing means, to the prescribing practitioner.
(d) The dispensing pharmacist or the pharmacist’s designee is not required to communicate information under (c) of this section if the dispensed biological product is a refill of a prescription and is the same as the biological product that was dispensed on the previous filling of the prescription.
(e) Entry into an electronic records system as described under (c)(1) of this section is presumed to provide notice to the prescribing practitioner.
(f) A pharmacist shall maintain a record of a dispensed biological product for a minimum of two years after the date of the dispensing.
(g) In this section, “designee” means an agent or employee of the dispensing pharmacist whom the dispensing pharmacist has authorized to communicate the information required under (c) of this section.
  Previous section
Next section  
 Article 3 Contents