Bill Text: NY A00236 | 2017-2018 | General Assembly | Amended
Bill Title: Requires the commissioner of health to establish and publish a list of generic drug products.
Spectrum: Partisan Bill (Democrat 10-0)
Status: (Engrossed - Dead) 2018-03-22 - RECOMMITTED TO HEALTH [A00236 Detail]
Download: New_York-2017-A00236-Amended.html
STATE OF NEW YORK ________________________________________________________________________ 236--A Cal. No. 14 2017-2018 Regular Sessions IN ASSEMBLY January 5, 2017 ___________ Introduced by M. of A. PAULIN, GOTTFRIED, DINOWITZ, GALEF, HOOPER, JAFFEE, M. G. MILLER, RIVERA, WEPRIN, ABINANTI -- read once and referred to the Committee on Health -- ordered to a third reading -- passed by Assembly and delivered to the Senate, recalled from the Senate, vote reconsidered, bill amended, ordered reprinted, retaining its place on the order of third reading AN ACT to amend the public health law and the education law, in relation to generic drug products; and to repeal paragraph (o) of subdivision 1 of section 206 of the public health law relating thereto The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Paragraph (o) of subdivision 1 of section 206 of the public 2 health law is REPEALED. 3 § 2. The public health law is amended by adding a new section 280-c to 4 read as follows: 5 § 280-c. Generic drug products. 1. The commissioner shall establish 6 and publish a list of drug products, referred to in this section as 7 "generic drug" products, each of which shall meet the following condi- 8 tions: 9 (a) The drug product has been certified or approved by the commission- 10 er of the Federal Food and Drug Administration as being safe and effec- 11 tive for its labeled indications for use, and a new-drug application or 12 an abbreviated new-drug application approved pursuant to the Federal 13 Food, Drug, and Cosmetic Act is held for such drug product; and 14 (b) The commissioner of the Federal Food and Drug Administration has 15 evaluated such drug product as pharmaceutically and therapeutically 16 equivalent and has listed such drug product on the list of approved drug 17 products with the therapeutic equivalence evaluations, provided, howev- 18 er, that the list prepared by the commissioner shall not include any 19 drug product which the commissioner of the Federal Food and Drug Admin- EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD01072-04-8A. 236--A 2 1 istration has identified as having an actual or potential bioequivalence 2 problem. 3 2. The manufacturer of a generic drug product shall make available to 4 the department the biopharmaceutic studies and summaries, including 5 bioequivalence data and incidence of adverse events, and associated 6 analytical methods, including dissolution data and test methods provided 7 to the Federal Food and Drug Administration as part of the application 8 for such generic drug product. The department shall make such informa- 9 tion freely and publicly available on its website. 10 § 3. Paragraphs (a) and (e) of subdivision 6 of section 6810 of the 11 education law, paragraph (a) as amended by chapter 590 of the laws of 12 2011 and paragraph (e) as amended by chapter 357 of the laws of 2017, 13 are amended to read as follows: 14 (a) Every prescription written in this state by a person authorized to 15 issue such prescription shall be on prescription forms containing one 16 line for the prescriber's signature. The prescriber's signature shall 17 validate the prescription. Every electronic prescription shall provide 18 for the prescriber's electronic signature, which shall validate the 19 electronic prescription. Imprinted conspicuously on every prescription 20 written in this state in eight point upper case type immediately below 21 the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED 22 GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless 23 the prescriber writes d a w in such box in the prescriber's own hand- 24 writing or, in the case of electronic prescriptions, inserts an elec- 25 tronic direction to dispense the drug as written, the prescriber's 26 signature or electronic signature shall designate approval of substi- 27 tution by a pharmacist of a generic drug product pursuant to [paragraph28(o) of subdivision one of] section [two hundred six] two hundred eight- 29 y-c of the public health law. No other letters or marks in such box 30 shall prohibit substitution. No prescription forms used or intended to 31 be used by a person authorized to issue a prescription shall have 'd a 32 w' preprinted in such box. Such box shall be placed directly under the 33 signature line and shall be three-quarters inch in length and one-half 34 inch in height, or in comparable form for an electronic prescription as 35 may be specified by regulation of the commissioner. Immediately below 36 such box shall be imprinted in six point type the words "Dispense As 37 Written". Notwithstanding any other provision of law, no state offi- 38 cial, agency, board or other entity shall promulgate any regulation or 39 guideline modifying those elements of the prescription form's contents 40 specified in this subdivision. To the extent otherwise permitted by law, 41 a prescriber may modify only those elements of the prescription form's 42 contents not specified in this subdivision. Notwithstanding any other 43 provision of this section or any other law, when a generic drug is not 44 available and the brand name drug originally prescribed is available and 45 the pharmacist agrees to dispense the brand name product for a price 46 that will not exceed the price that would have been charged for the 47 generic substitute had it been available, substitution of a generic drug 48 product will not be required. If the generic drug product is not avail- 49 able and a medical emergency situation, which for purposes of this 50 section is defined as any condition requiring alleviation of severe pain 51 or which threatens to cause disability or take life if not promptly 52 treated, exists, then the pharmacist may dispense the brand name product 53 at his regular price. In such instances the pharmacist must record the 54 date, hour and nature of the medical emergency on the back of the 55 prescription and keep a copy of all such prescriptions.A. 236--A 3 1 (e) No prescriber shall be subjected to civil liability arising solely 2 from authorizing, in accordance with this subdivision, the substitution 3 by a pharmacist of a generic drug product pursuant to [paragraph (o) of4subdivision one of] section two hundred [six] eighty-c of the public 5 health law. 6 § 4. Paragraph (d) of subdivision 6 of section 6810 of the education 7 law, as added by chapter 913 of the laws of 1986, is amended to read as 8 follows: 9 (d) No prescriber shall be subjected to civil liability arising solely 10 from authorizing, in accordance with this subdivision, the substitution 11 by a pharmacist of a generic drug product pursuant to [paragraph (o) of12subdivision one of] section two hundred [six] eighty-c of the public 13 health law. 14 § 5. Paragraph (b) of subdivision 1 of section 6816-a of the education 15 law, as added by chapter 776 of the laws of 1977, is amended to read as 16 follows: 17 (b) The substituted drug product is contained in the list of generic 18 drug products established pursuant to [paragraph (o) of subdivision one19of] section [two hundred six] two hundred eighty-c of the public health 20 law; and 21 § 6. This act shall take effect on the ninetieth day after it shall 22 have become a law; provided that the amendments to paragraph (e) of 23 subdivision 6 of section 6810 of the education law, made by section 24 three of this act, shall not affect the expiration of such paragraph, 25 when upon such date the provisions of section four of this act shall 26 take effect. Effective immediately, the addition, amendment and/or 27 repeal of any rule or regulation necessary for the implementation of 28 this act on its effective date is authorized to be made and completed on 29 or before such effective date.
