S05158 Summary:
| BILL NO | S05158 |
| SAME AS | SAME AS A01923 |
| SPONSOR | LANZA |
| COSPNSR | |
| MLTSPNSR | |
| Rpld §206 sub 1 ¶(o), add §280-d, Pub Health L; amd §§6810 & 6816-a, Ed L | |
| Requires the commissioner of health to establish and publish a list of generic drug products. | |
S05158 Actions:
| BILL NO | S05158 | |||||||||||||||||||||||||||||||||||||||||||||||||
| 02/25/2021 | REFERRED TO HEALTH | |||||||||||||||||||||||||||||||||||||||||||||||||
| 01/05/2022 | REFERRED TO HEALTH | |||||||||||||||||||||||||||||||||||||||||||||||||
S05158 Memo:
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S05158 Text:
Go to topSTATE OF NEW YORK ________________________________________________________________________ 5158 2021-2022 Regular Sessions IN SENATE February 25, 2021 ___________ Introduced by Sen. LANZA -- read twice and ordered printed, and when printed to be committed to the Committee on Health 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 Paragraph (o) of subdivision 1 of section 206 of the public 2 health law is REPEALED. 3 § 2.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-d to 4 read as follows: 5 § 280-d. 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: (i) 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- 20 istration has identified as having an actual or potential bioequivalence 21 problem or (ii) as an interchangeable biological product and has listed 22 such product on the list of approved drug products with interchangeabil- 23 ity. EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD01823-01-1S. 5158 2 1 2. The manufacturer of a generic drug product shall make available to 2 the department the studies and summaries, including bioequivalence data, 3 therapeutic equivalence data, and incidence of adverse events, and asso- 4 ciated analytical methods, including dissolution data and test methods 5 provided to the Federal Food and Drug Administration as part of the 6 application for such generic drug product. The department shall make 7 such information freely and publicly available on its website. 8 § 3. Paragraphs (a) and (e) of subdivision 6 of section 6810 of the 9 education law, paragraph (a) as amended by chapter 590 of the laws of 10 2011 and paragraph (e) as amended by chapter 357 of the laws of 2017, 11 are amended to read as follows: 12 (a) Every prescription written in this state by a person authorized to 13 issue such prescription shall be on prescription forms containing one 14 line for the prescriber's signature. The prescriber's signature shall 15 validate the prescription. Every electronic prescription shall provide 16 for the prescriber's electronic signature, which shall validate the 17 electronic prescription. Imprinted conspicuously on every prescription 18 written in this state in eight point upper case type immediately below 19 the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED 20 GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless 21 the prescriber writes d a w in such box in the prescriber's own hand- 22 writing or, in the case of electronic prescriptions, inserts an elec- 23 tronic direction to dispense the drug as written, the prescriber's 24 signature or electronic signature shall designate approval of substi- 25 tution by a pharmacist of a generic drug product pursuant to [paragraph26(o) of subdivision one of] section [two hundred six] two hundred eight- 27 y-d of the public health law. No other letters or marks in such box 28 shall prohibit substitution. No prescription forms used or intended to 29 be used by a person authorized to issue a prescription shall have 'd a 30 w' preprinted in such box. Such box shall be placed directly under the 31 signature line and shall be three-quarters inch in length and one-half 32 inch in height, or in comparable form for an electronic prescription as 33 may be specified by regulation of the commissioner. Immediately below 34 such box shall be imprinted in six point type the words "Dispense As 35 Written". Notwithstanding any other provision of law, no state offi- 36 cial, agency, board or other entity shall promulgate any regulation or 37 guideline modifying those elements of the prescription form's contents 38 specified in this subdivision. To the extent otherwise permitted by law, 39 a prescriber may modify only those elements of the prescription form's 40 contents not specified in this subdivision. Notwithstanding any other 41 provision of this section or any other law, when a generic drug is not 42 available and the brand name drug originally prescribed is available and 43 the pharmacist agrees to dispense the brand name product for a price 44 that will not exceed the price that would have been charged for the 45 generic substitute had it been available, substitution of a generic drug 46 product will not be required. If the generic drug product is not avail- 47 able and a medical emergency situation, which for purposes of this 48 section is defined as any condition requiring alleviation of severe pain 49 or which threatens to cause disability or take life if not promptly 50 treated, exists, then the pharmacist may dispense the brand name product 51 at his regular price. In such instances the pharmacist must record the 52 date, hour and nature of the medical emergency on the back of the 53 prescription and keep a copy of all such prescriptions. 54 (e) No prescriber shall be subjected to civil liability arising solely 55 from authorizing, in accordance with this subdivision, the substitution 56 by a pharmacist of a generic drug product pursuant to [paragraph (o) ofS. 5158 3 1subdivision one of] section two hundred [six] eighty-d of the public 2 health law. 3 § 4. Paragraph (d) of subdivision 6 of section 6810 of the education 4 law, as added by chapter 913 of the laws of 1986, is amended to read as 5 follows: 6 (d) No prescriber shall be subjected to civil liability arising solely 7 from authorizing, in accordance with this subdivision, the substitution 8 by a pharmacist of a generic drug product pursuant to [paragraph (o) of9subdivision one of] section two hundred [six] eighty-d of the public 10 health law. 11 § 5. Paragraph (b) of subdivision 1 of section 6816-a of the education 12 law, as added by chapter 776 of the laws of 1977, is amended to read as 13 follows: 14 (b) The substituted drug product is contained in the list of generic 15 drug products established pursuant to [paragraph (o) of subdivision one16of] section [two hundred six] two hundred eighty-d of the public health 17 law; and 18 § 6. This act shall take effect on the ninetieth day after it shall 19 have become a law; provided that the amendments to paragraph (e) of 20 subdivision 6 of section 6810 of the education law, made by section 21 three of this act, shall not affect the expiration of such paragraph, 22 when upon such date the provisions of section four of this act shall 23 take effect. Effective immediately, the addition, amendment and/or 24 repeal of any rule or regulation necessary for the implementation of 25 this act on its effective date are authorized to be made and completed 26 on or before such effective date.