A 4732: Requires that pharmacists get express written consent before substituting a drug product for a less expensive drug product, including biological products.

  
  STATE OF NEW YORK ________________________________________________________________________ 4732 2025-2026 Regular Sessions  IN ASSEMBLY February 6, 2025 ___________ Introduced by M. of A. RAMOS -- read once and referred to the Committee on Higher Education AN ACT to amend the education law, in relation to requiring patient consent when substituting medication The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Subdivisions 1, 2 and 3 of section 6816-a of the education 2 law, subdivisions 1 and 2 as added by chapter 776 of the laws of 1977, 3 paragraph (a) of subdivision 1 as amended by chapter 913 of the laws of 4 1986, and subdivision 3 as added by chapter 357 of the laws of 2017, are 5 amended to read as follows: 6 1. A pharmacist shall substitute a less expensive drug product 7 containing the same active ingredients, dosage form and strength as the 8 drug product prescribed, ordered or demanded, provided that the follow- 9 ing conditions are met: 10 (a) The prescription is written on a form which meets the requirements 11 of subdivision six of section sixty-eight hundred ten of this article 12 and the prescriber does not prohibit substitution, or in the case of 13 oral prescriptions, the prescriber must expressly state whether substi- 14 tution is to be permitted or prohibited. Any oral prescription that does 15 not include such an express statement shall not be filled; and 16 (b) The substituted drug product is contained in the list of drug 17 products established pursuant to paragraph (o) of subdivision one of 18 section two hundred six of the public health law; and 19 (c) The pharmacist shall indicate on the label affixed to the immedi- 20 ate container in which the drug is sold or dispensed the name and 21 strength of the drug product and its manufacturer unless the prescriber 22 specifically states otherwise. The pharmacist shall record on the 23 prescription form the brand name or the name of the manufacturer of the 24 drug product dispensed; and EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD05242-01-5 
 A. 4732 2 1 (d) The patient who shall receive the drug product gives express writ- 2 ten consent that the pharmacist may substitute such drug product for a 3 less expensive drug product. 4 2. In the event a patient chooses to have a prescription filled by an 5 out of state dispenser, [the laws of that state shall prevail] such 6 out-of-state dispenser shall receive express written consent from the 7 patient who shall receive the drug product that such drug product may be 8 substituted for a less expensive drug product. 9 3. A pharmacist shall substitute a less expensive biological product 10 for a prescribed biological product provided that all of the following 11 conditions are met: 12 (a) the substituted biological product is either an interchangeable 13 biological product for the prescribed product or the substituted biolog- 14 ical product is one for which the prescribed product is an interchangea- 15 ble biological product; 16 (b) the prescriber does not designate that a substitution is prohibit- 17 ed as described in subdivision six of section sixty-eight hundred ten of 18 this article; [and] 19 (c) the pharmacist indicates on the label affixed to the immediate 20 container in which the biological product is sold or distributed the 21 name and strength of the product and its manufacturer unless the pres- 22 criber specifically states otherwise; and 23 (d) the patient who shall receive the biological product gives express 24 written consent that the pharmacist may substitute such biological prod- 25 uct for a less expensive biological product. 26 § 2. This act shall take effect on the ninetieth day after it shall 27 have become a law. Effective immediately, the addition, amendment and/or 28 repeal of any rule or regulation necessary for the implementation of 29 this act on its effective date are authorized to be made and completed 30 on or before such effective date.