STATE OF NEW YORK ________________________________________________________________________ 371 2025-2026 Regular Sessions IN SENATE (Prefiled) January 8, 2025 ___________ Introduced by Sen. SKOUFIS -- 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 creating a wholesale prescription drug importation program The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. The public health law is amended by adding a new section 2 280-d to read as follows: 3 § 280-d. Wholesale prescription drug importation program. 1. As used 4 in this section, the following terms shall have the following meanings: 5 (a) "Wholesale prescription drug importation program" or "program" 6 means the wholesale prescription drug importation program created under 7 this section. 8 (b) "Prescription drug wholesaler" means an entity authorized to 9 acquire prescription drugs and sell or distribute them wholesale in the 10 state. 11 (c) "Approved wholesaler" means a prescription drug wholesaler author- 12 ized to participate in the importation program under this section pursu- 13 ant to approval by the state education department under section sixty- 14 eight hundred eight of the education law. 15 2. The commissioner, in consultation with the commissioner of educa- 16 tion and other appropriate federal and state agencies, shall design a 17 wholesale prescription drug importation program for the wholesale impor- 18 tation of prescription drugs from Canada. The program design shall 19 comply with applicable federal requirements, including 21 U.S.C. § 384, 20 and requirements regarding safety and cost savings. Under the program 21 design: 22 (a) prescription drugs shall only be acquired from Canadian 23 prescription drug suppliers regulated and authorized under the laws of 24 Canada or one or more Canadian provinces, or both; EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD00949-01-5
S. 371 2 1 (b) only prescription drugs meeting the federal Food and Drug Adminis- 2 tration's safety, effectiveness, misbranding, adulteration and other 3 standards shall be imported under the program; 4 (c) only prescription drugs expected to generate substantial savings 5 for consumers in the state shall be imported; 6 (d) the prescription drug is not: 7 (i) a controlled substance as defined in 21 U.S.C. § 802; 8 (ii) a biological product as defined in 42 U.S.C. § 262; 9 (iii) an infused drug, including a peritoneal dialysis solution; 10 (iv) an intravenously injected drug; 11 (v) a drug that is inhaled during surgery; 12 (vi) a drug which is a parenteral drug, the importation of which is 13 determined by the United States Secretary of Health and Human Services 14 to pose a threat to public health; 15 (e) any approved wholesaler shall at all times comply with the track- 16 ing and tracing requirements of 21 U.S.C. §§ 360eee and 360eee-1 to the 17 extent practicable prior to imported prescription drugs coming into the 18 possession of the approved wholesaler, and fully comply with those 19 requirements after imported prescription drugs are in the possession of 20 the approved wholesaler; 21 (f) an approved wholesaler shall not sell, distribute or dispense 22 prescription drugs imported under the program outside of the state; 23 (g) the commissioner may impose an annual fee on approved wholesalers, 24 which may be based in whole or in part on the value of prescription 25 drugs imported by the approved wholesaler under the program, to support 26 the operation of the program; 27 (h) every approved wholesaler shall provide the commissioner and the 28 commissioner of education with information on its participation in the 29 program as required by such commissioners including but not limited to: 30 (i) the name and quantity of the active ingredient of the drug; 31 (ii) a description of the dosage form of the drug; 32 (iii) the date on which the drug is received; 33 (iv) the quantity of the drug that is received; 34 (v) the point of origin and destination of the drug; and 35 (vi) the price paid by the approved wholesaler for the drug 36 (i) the commissioner shall provide for auditing of the program, 37 including making sure that prescription drugs are made available at 38 substantial savings to consumers as a result of the program, ensuring 39 that the prescription drugs are approved for marketing in the United 40 States, meet all labeling requirements under state and federal laws and 41 regulations, and is not adulterated or misbranded, and ensuring that 42 prescription drugs are authentic and in compliance with the federal Food 43 and Drug Administration's approved drug specifications and standards. 44 3. The department, in consultation with the state education depart- 45 ment, shall promulgate rules and regulations to design the program in 46 accordance with subdivision two of this section. 47 4. (a) The commissioner, in consultation with the commissioner of 48 education, shall seek all necessary approvals and certification by the 49 secretary of the U.S. Department of Health and Human Services and/or 50 other appropriate federal officials or agencies for the wholesale 51 prescription drug importation program designed under this section. 52 (b) The commissioner shall seek the appropriate federal approvals, 53 waivers, exemptions, or agreements, or a combination thereof, as needed 54 to enable all covered entities enrolled in or eligible for the drug 55 discount program authorized by section 340B of the federal public health 56 service act (42 U.S.C. § 256b) to participate in the wholesale
S. 371 3 1 prescription drug importation program to the fullest extent possible 2 without jeopardizing their eligibility for such drug discount program. 3 5. Upon receipt of federal approval and certification under paragraph 4 (a) of subdivision four of this section, the commissioner shall imple- 5 ment the program pursuant to this section. 6 6. The commissioner shall immediately suspend the importation of a 7 specific prescription drug or the importation of prescription drugs by 8 an approved wholesaler if the commissioner discovers that any drug or 9 activity is in violation of this section or any federal or state law or 10 regulation, and shall immediately notify the commissioner of education 11 of such suspension. Furthermore, the commissioner shall inform the 12 commissioner of education of all facts and circumstances leading to such 13 suspension as soon as practicable, and shall cooperate with the commis- 14 sioner of education in any disciplinary investigation or action pursuant 15 to title eight of the education law related to such wholesaler. 16 7. Nothing in this section shall be construed as affecting or in any 17 way interfering with the commissioner of education's oversight of whole- 18 salers. 19 8. The commissioner shall annually report to the governor, the tempo- 20 rary president of the senate, and the speaker of the assembly regarding 21 the implementation of a federally approved wholesale prescription drug 22 importation program. The report shall include, at a minimum: 23 (a) a list of the prescription drugs imported under the program; 24 (b) a list of all participating Canadian prescription drug suppliers, 25 approved wholesalers, and other participating entities; 26 (c) estimated cost savings during the previous fiscal year; 27 (d) information regarding audit findings; and 28 (e) any other relevant information. 29 § 2. Section 6808 of the education law is amended by adding a new 30 subdivision 10 to read as follows: 31 10. Prescription drug importation program wholesalers. a. A wholesaler 32 shall not participate in the wholesale prescription drug importation 33 program under section two hundred eighty-d of the public health law 34 without prior application and approval by the department. 35 b. Such application shall be made on a form prescribed by the depart- 36 ment. 37 c. Such application shall be accompanied by a fee determined by the 38 department. 39 d. All approvals shall be renewed on dates set by the department. 40 e. All approvals shall meet applicable federal laws and regulations 41 including under 21 U.S.C. § 384, as amended, and any regulations promul- 42 gated thereunder. 43 § 3. This act shall take effect eighteen months after it shall have 44 become a law. Effective immediately, the addition, amendment and/or 45 repeal of any rule or regulation necessary for the implementation of 46 this act on its effective date are authorized to be made and completed 47 on or before such effective date.