Enrolled SB 32: Relating to biological products; relating to the practice of pharmacy; relating to the Board of Pharmacy; and providing for an effective date.

00Enrolled SB 32 01 Relating to biological products; relating to the practice of pharmacy; relating to the Board of 02 Pharmacy; and providing for an effective date. 03 _______________ 04 * Section 1. AS 08.80.030 is amended by adding a new subsection to read: 05 (c) The board shall post and maintain a link to the United States Food and 06 Drug Administration's list of all currently approved interchangeable biological 07 products on the board's Internet website. 08 * Sec. 2. AS 08.80.294 is amended to read: 09 Sec. 08.80.294. Information about equivalent generic drugs and 10 interchangeable biological products. (a) In addition to other information that may be 11 required under state or federal laws or regulations, a pharmacist, when dispensing a 12 brand-name prescription drug order that is 13 (1) not a biological product, shall include the generic drug name that 14 is an equivalent drug product for the drug dispensed;

01 (2) a biological product, shall include the dispensed product's 02 (A) proprietary name, if available; or 03 (B) proper name. 04 (b) The generic drug name or proprietary or proper biological product 05 name required under (a) of this section shall be placed directly on the container's label 06 near the brand name. 07 * Sec. 3. AS 08.80.294 is amended by adding a new subsection to read: 08 (c) In this section, 09 (1) "proper name" means a name that reflects scientific characteristics 10 of the product such as chemical structure and pharmacological properties; 11 (2) "proprietary name" means a name that is trademarked and 12 registered for private use. 13 * Sec. 4. AS 08.80.295 is amended to read: 14 Sec. 08.80.295. Substitution of equivalent drug products or 15 interchangeable biological products. (a) Unless the prescription indicates that it is to 16 be dispensed only as written, the pharmacist may, with the consent of the patient, 17 substitute an equivalent drug product or interchangeable biological product. 18 (b) A pharmacist who substitutes an equivalent drug product or 19 interchangeable biological product in compliance with this section and applicable 20 regulations incurs no greater liability in filling the prescription than would be incurred 21 in filling the prescription by dispensing the prescribed name brand product. 22 * Sec. 5. AS 08.80.295 is amended by adding new subsections to read: 23 (c) Except as provided in (d) of this section, if an interchangeable biological 24 product exists for a biological product prescribed to a patient, the dispensing 25 pharmacist or the pharmacist's designee shall communicate to the prescribing 26 practitioner information regarding the biological product provided to the patient, 27 including the name and manufacturer of the biological product. The communication 28 must be provided within three business days after dispensing the biological product as 29 follows: 30 (1) by making an entry that is electronically accessible to the 31 prescribing practitioner through

01 (A) an interoperable electronic medical records system; 02 (B) an electronic prescribing technology; 03 (C) a pharmacy benefit management system; or 04 (D) a pharmacy record; or 05 (2) if the pharmacist or the pharmacist's designee is unable to make an 06 entry through one of the means provided under (1) of this subsection, by facsimile 07 transmission, telephone communication, electronic mail transmission, or transmission 08 by other prevailing means, to the prescribing practitioner. 09 (d) The dispensing pharmacist or the pharmacist's designee is not required to 10 communicate information under (c) of this section if the dispensed biological product 11 is a refill of a prescription and is the same as the biological product that was dispensed 12 on the previous filling of the prescription. 13 (e) Entry into an electronic records system as described under (c)(1) of this 14 section is presumed to provide notice to the prescribing practitioner. 15 (f) A pharmacist shall maintain a record of a dispensed biological product for 16 a minimum of two years after the date of the dispensing. 17 (g) In this section, "designee" means an agent or employee of the dispensing 18 pharmacist whom the dispensing pharmacist has authorized to communicate the 19 information required under (c) of this section. 20 * Sec. 6. AS 08.80.480(34) is amended to read: 21 (34) "substitute" ["SUBSTITUTION"] means to dispense, without 22 the prescriber's expressed authorization, 23 (A) an equivalent drug product in place of the prescribed drug; 24 or 25 (B) an interchangeable biological product in place of the 26 prescribed biological product; 27 * Sec. 7. AS 08.80.480 is amended by adding new paragraphs to read: 28 (37) "biological product" means a product that is applicable to the 29 prevention, treatment, or cure of a disease or condition of human beings, and is a 30 virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or 31 derivative, allergenic product, protein other than a chemically synthesized

01 polypeptide, or analogous product, or arsphenamine or derivative of arsphenamine or 02 any other trivalent organic arsenic compound; 03 (38) "interchangeable biological product" means a biological product 04 that the United States Food and Drug Administration has determined 05 (A) meets the standards for interchangeability under 42 U.S.C. 06 262(k)(4); or 07 (B) is therapeutically equivalent to another biological product 08 under the most recent edition or supplement of the United States Food and 09 Drug Administration's Approved Drug Products with Therapeutic Equivalence 10 Evaluations. 11 * Sec. 8. The uncodified law of the State of Alaska is amended by adding a new section to 12 read: 13 TRANSITION: REGULATIONS. The Board of Pharmacy may adopt regulations 14 necessary to implement the changes made by this Act. The regulations take effect under 15 AS 44.62 (Administrative Procedure Act), but not before the effective date of the relevant 16 provision of this Act implemented by the regulation. 17 * Sec. 9. Section 8 of this Act takes effect July 1, 2018. 18 * Sec. 10. Except as provided in sec. 9 of this Act, this Act takes effect January 1, 2019.