S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   4604
 
                        2025-2026 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             February 4, 2025
                                ___________
 
 Introduced by M. of A. SIMON, COOK, DINOWITZ, HUNTER, MAGNARELLI, RAMOS,
   RIVERA,  ROSENTHAL, REYES, CRUZ, EPSTEIN, COLTON, PAULIN, GONZALEZ-RO-
   JAS, SMITH, FORREST, JACKSON,  SIMONE,  HEVESI,  LUNSFORD,  LEVENBERG,
   SANTABARBARA,  LUPARDO,  DeSTEFANO,  DAVILA,  CLARK,  BURDICK,  STECK,
   SHRESTHA, SEAWRIGHT, K. BROWN, SHIMSKY,  PHEFFER AMATO,  BORES,  McDO-
   NOUGH  --  Multi-Sponsored by -- M. of A. BUTTENSCHON -- read once and
   referred to the Committee on Ways and Means
 
 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:
 
   Section  1.  The  public health law is amended by adding a new section
 280-d to read as follows:
   § 280-D. WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM.  1. AS  USED
 IN THIS SECTION,  THE FOLLOWING TERMS SHALL HAVE THE FOLLOWING MEANINGS:
   (A)  "WHOLESALE  PRESCRIPTION  DRUG  IMPORTATION PROGRAM" OR "PROGRAM"
 MEANS THE WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM CREATED  UNDER
 THIS SECTION.
   (B)  "PRESCRIPTION  DRUG  WHOLESALER"  MEANS  AN  ENTITY AUTHORIZED TO
 ACQUIRE PRESCRIPTION DRUGS AND SELL OR DISTRIBUTE THEM WHOLESALE IN  THE
 STATE.
   (C) "APPROVED WHOLESALER" MEANS A PRESCRIPTION DRUG WHOLESALER AUTHOR-
 IZED TO PARTICIPATE IN THE IMPORTATION PROGRAM UNDER THIS SECTION PURSU-
 ANT  TO  APPROVAL BY THE STATE EDUCATION DEPARTMENT UNDER SECTION SIXTY-
 EIGHT HUNDRED EIGHT OF THE EDUCATION LAW.
   2. THE COMMISSIONER, IN CONSULTATION WITH THE COMMISSIONER  OF  EDUCA-
 TION  AND  OTHER  APPROPRIATE FEDERAL AND STATE AGENCIES, SHALL DESIGN A
 WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM FOR THE WHOLESALE IMPOR-
 TATION OF PRESCRIPTION DRUGS  FROM  CANADA.  THE  PROGRAM  DESIGN  SHALL
 COMPLY  WITH APPLICABLE FEDERAL REQUIREMENTS, INCLUDING 21 U.S.C. § 384,
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00949-01-5
 A. 4604                             2
              

 
 AND REQUIREMENTS REGARDING SAFETY AND COST SAVINGS.  UNDER  THE  PROGRAM
 DESIGN:
   (A)   PRESCRIPTION   DRUGS   SHALL  ONLY  BE  ACQUIRED  FROM  CANADIAN
 PRESCRIPTION DRUG SUPPLIERS REGULATED AND AUTHORIZED UNDER THE  LAWS  OF
 CANADA OR ONE OR MORE CANADIAN PROVINCES, OR BOTH;
   (B) ONLY PRESCRIPTION DRUGS MEETING THE FEDERAL FOOD AND DRUG ADMINIS-
 TRATION'S  SAFETY,  EFFECTIVENESS,  MISBRANDING,  ADULTERATION AND OTHER
 STANDARDS SHALL BE IMPORTED UNDER THE PROGRAM;
   (C) ONLY PRESCRIPTION DRUGS EXPECTED TO GENERATE  SUBSTANTIAL  SAVINGS
 FOR CONSUMERS IN THE STATE SHALL BE IMPORTED;
   (D) THE PRESCRIPTION DRUG IS NOT:
   (I) A CONTROLLED SUBSTANCE AS DEFINED IN 21 U.S.C. § 802;
   (II) A BIOLOGICAL PRODUCT AS DEFINED IN 42 U.S.C. § 262;
   (III) AN INFUSED DRUG, INCLUDING A PERITONEAL DIALYSIS SOLUTION;
   (IV) AN INTRAVENOUSLY INJECTED DRUG;
   (V) A DRUG THAT IS INHALED DURING SURGERY;
   (VI)  A  DRUG  WHICH IS A PARENTERAL DRUG, THE IMPORTATION OF WHICH IS
 DETERMINED BY THE UNITED STATES SECRETARY OF HEALTH AND  HUMAN  SERVICES
 TO POSE A THREAT TO PUBLIC HEALTH;
   (E)  ANY APPROVED WHOLESALER SHALL AT ALL TIMES COMPLY WITH THE TRACK-
 ING AND TRACING REQUIREMENTS OF 21 U.S.C. §§ 360EEE AND 360EEE-1 TO  THE
 EXTENT  PRACTICABLE PRIOR TO IMPORTED PRESCRIPTION DRUGS COMING INTO THE
 POSSESSION OF THE APPROVED  WHOLESALER,  AND  FULLY  COMPLY  WITH  THOSE
 REQUIREMENTS  AFTER IMPORTED PRESCRIPTION DRUGS ARE IN THE POSSESSION OF
 THE APPROVED WHOLESALER;
   (F) AN APPROVED WHOLESALER SHALL  NOT  SELL,  DISTRIBUTE  OR  DISPENSE
 PRESCRIPTION DRUGS IMPORTED UNDER THE PROGRAM OUTSIDE OF THE STATE;
   (G) THE COMMISSIONER MAY IMPOSE AN ANNUAL FEE ON APPROVED WHOLESALERS,
 WHICH  MAY  BE  BASED  IN  WHOLE OR IN PART ON THE VALUE OF PRESCRIPTION
 DRUGS IMPORTED BY THE APPROVED WHOLESALER UNDER THE PROGRAM, TO  SUPPORT
 THE OPERATION OF THE PROGRAM;
   (H)  EVERY  APPROVED WHOLESALER SHALL PROVIDE THE COMMISSIONER AND THE
 COMMISSIONER OF EDUCATION WITH INFORMATION ON ITS PARTICIPATION  IN  THE
 PROGRAM AS REQUIRED BY SUCH COMMISSIONERS INCLUDING BUT NOT LIMITED TO:
   (I) THE NAME AND QUANTITY OF THE ACTIVE INGREDIENT OF THE DRUG;
   (II) A DESCRIPTION OF THE DOSAGE FORM OF THE DRUG;
   (III) THE DATE ON WHICH THE DRUG IS RECEIVED;
   (IV) THE QUANTITY OF THE DRUG THAT IS RECEIVED;
   (V) THE POINT OF ORIGIN AND DESTINATION OF THE DRUG; AND
   (VI) THE PRICE PAID BY THE APPROVED WHOLESALER FOR THE DRUG
   (I)  THE  COMMISSIONER  SHALL  PROVIDE  FOR  AUDITING  OF THE PROGRAM,
 INCLUDING MAKING SURE THAT PRESCRIPTION  DRUGS  ARE  MADE  AVAILABLE  AT
 SUBSTANTIAL  SAVINGS  TO  CONSUMERS AS A RESULT OF THE PROGRAM, ENSURING
 THAT THE PRESCRIPTION DRUGS ARE APPROVED FOR  MARKETING  IN  THE  UNITED
 STATES,  MEET ALL LABELING REQUIREMENTS UNDER STATE AND FEDERAL LAWS AND
 REGULATIONS, AND IS NOT ADULTERATED OR  MISBRANDED,  AND  ENSURING  THAT
 PRESCRIPTION DRUGS ARE AUTHENTIC AND IN COMPLIANCE WITH THE FEDERAL FOOD
 AND DRUG ADMINISTRATION'S APPROVED DRUG SPECIFICATIONS AND STANDARDS.
   3.  THE  DEPARTMENT,  IN CONSULTATION WITH THE STATE EDUCATION DEPART-
 MENT, SHALL PROMULGATE RULES AND REGULATIONS TO DESIGN  THE  PROGRAM  IN
 ACCORDANCE WITH SUBDIVISION TWO OF THIS SECTION.
   4.  (A)  THE  COMMISSIONER,  IN  CONSULTATION WITH THE COMMISSIONER OF
 EDUCATION, SHALL SEEK ALL NECESSARY APPROVALS AND CERTIFICATION  BY  THE
 SECRETARY  OF  THE  U.S.  DEPARTMENT OF HEALTH AND HUMAN SERVICES AND/OR
 OTHER APPROPRIATE  FEDERAL  OFFICIALS  OR  AGENCIES  FOR  THE  WHOLESALE
 PRESCRIPTION DRUG IMPORTATION PROGRAM DESIGNED UNDER THIS SECTION.
 A. 4604                             3
 
   (B)  THE  COMMISSIONER  SHALL  SEEK THE APPROPRIATE FEDERAL APPROVALS,
 WAIVERS, EXEMPTIONS, OR AGREEMENTS, OR A COMBINATION THEREOF, AS  NEEDED
 TO  ENABLE  ALL  COVERED  ENTITIES  ENROLLED IN OR ELIGIBLE FOR THE DRUG
 DISCOUNT PROGRAM AUTHORIZED BY SECTION 340B OF THE FEDERAL PUBLIC HEALTH
 SERVICE  ACT  (42  U.S.C.  §  256B)  TO  PARTICIPATE  IN  THE  WHOLESALE
 PRESCRIPTION DRUG IMPORTATION PROGRAM TO  THE  FULLEST  EXTENT  POSSIBLE
 WITHOUT JEOPARDIZING THEIR ELIGIBILITY FOR SUCH DRUG DISCOUNT PROGRAM.
   5.  UPON RECEIPT OF FEDERAL APPROVAL AND CERTIFICATION UNDER PARAGRAPH
 (A) OF SUBDIVISION FOUR OF THIS SECTION, THE COMMISSIONER  SHALL  IMPLE-
 MENT THE PROGRAM PURSUANT TO THIS SECTION.
   6.  THE  COMMISSIONER  SHALL  IMMEDIATELY SUSPEND THE IMPORTATION OF A
 SPECIFIC PRESCRIPTION DRUG OR THE IMPORTATION OF PRESCRIPTION  DRUGS  BY
 AN  APPROVED  WHOLESALER  IF THE COMMISSIONER DISCOVERS THAT ANY DRUG OR
 ACTIVITY IS IN VIOLATION OF THIS SECTION OR ANY FEDERAL OR STATE LAW  OR
 REGULATION,  AND  SHALL IMMEDIATELY NOTIFY THE COMMISSIONER OF EDUCATION
 OF SUCH SUSPENSION.   FURTHERMORE, THE  COMMISSIONER  SHALL  INFORM  THE
 COMMISSIONER OF EDUCATION OF ALL FACTS AND CIRCUMSTANCES LEADING TO SUCH
 SUSPENSION  AS SOON AS PRACTICABLE, AND SHALL COOPERATE WITH THE COMMIS-
 SIONER OF EDUCATION IN ANY DISCIPLINARY INVESTIGATION OR ACTION PURSUANT
 TO TITLE EIGHT OF THE EDUCATION LAW RELATED TO SUCH WHOLESALER.
   7. NOTHING IN THIS SECTION SHALL BE CONSTRUED AS AFFECTING OR  IN  ANY
 WAY INTERFERING WITH THE COMMISSIONER OF EDUCATION'S OVERSIGHT OF WHOLE-
 SALERS.
   8.  THE COMMISSIONER SHALL ANNUALLY REPORT TO THE GOVERNOR, THE TEMPO-
 RARY PRESIDENT OF THE SENATE, AND THE SPEAKER OF THE ASSEMBLY  REGARDING
 THE  IMPLEMENTATION  OF A FEDERALLY APPROVED WHOLESALE PRESCRIPTION DRUG
 IMPORTATION PROGRAM.  THE REPORT SHALL INCLUDE, AT A MINIMUM:
   (A) A LIST OF THE PRESCRIPTION DRUGS IMPORTED UNDER THE PROGRAM;
   (B) A LIST OF ALL PARTICIPATING CANADIAN PRESCRIPTION DRUG  SUPPLIERS,
 APPROVED WHOLESALERS, AND OTHER PARTICIPATING ENTITIES;
   (C) ESTIMATED COST SAVINGS DURING THE PREVIOUS FISCAL YEAR;
   (D) INFORMATION REGARDING AUDIT FINDINGS; AND
   (E) ANY OTHER RELEVANT INFORMATION.
   §  2.  Section  6808  of  the education law is amended by adding a new
 subdivision 10 to read as follows:
   10. PRESCRIPTION DRUG IMPORTATION PROGRAM WHOLESALERS. A. A WHOLESALER
 SHALL NOT PARTICIPATE IN THE  WHOLESALE  PRESCRIPTION  DRUG  IMPORTATION
 PROGRAM  UNDER  SECTION  TWO  HUNDRED  EIGHTY-D OF THE PUBLIC HEALTH LAW
 WITHOUT PRIOR APPLICATION AND APPROVAL BY THE DEPARTMENT.
   B. SUCH APPLICATION SHALL BE MADE ON A FORM PRESCRIBED BY THE  DEPART-
 MENT.
   C.  SUCH  APPLICATION  SHALL BE ACCOMPANIED BY A FEE DETERMINED BY THE
 DEPARTMENT.
   D. ALL APPROVALS SHALL BE RENEWED ON DATES SET BY THE DEPARTMENT.
   E. ALL APPROVALS SHALL MEET APPLICABLE FEDERAL  LAWS  AND  REGULATIONS
 INCLUDING UNDER 21 U.S.C. § 384, AS AMENDED, AND ANY REGULATIONS PROMUL-
 GATED THEREUNDER.
   §  3.  This  act shall take effect eighteen months after it shall have
 become a law. Effective  immediately,  the  addition,  amendment  and/or
 repeal  of  any  rule  or regulation necessary for the implementation of
 this act on its effective date are authorized to be made  and  completed
 on or before such effective date.