S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                    604
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                              January 5, 2023
                                ___________
 
 Introduced  by  Sens.  SKOUFIS,  FELDER,  HOYLMAN,  JACKSON, MAY, MYRIE,
   SERRANO, THOMAS -- read twice and ordered printed, and when printed to
   be committed to the Committee on Health
 
 AN ACT to amend the public health law, in relation to creating a  whole-
   sale prescription drug importation program

   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Title 2 of article 2-A of 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. (A)
 THERE IS HEREBY CREATED IN THE DEPARTMENT A WHOLESALE PRESCRIPTION  DRUG
 IMPORTATION PROGRAM.
   (B)  AS  USED  IN  THIS  SECTION,  UNLESS THE CONTEXT CLEARLY REQUIRES
 OTHERWISE, THE FOLLOWING TERMS SHALL HAVE THE FOLLOWING MEANINGS:
   (I) "WHOLESALE PRESCRIPTION DRUG  IMPORTATION  PROGRAM"  OR  "PROGRAM"
 MEANS  THE WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM CREATED UNDER
 THIS SECTION.
   (II) "PRESCRIPTION DRUG WHOLESALER"  MEANS  AN  ENTITY  AUTHORIZED  TO
 ACQUIRE  PRESCRIPTION DRUGS AND SELL OR DISTRIBUTE THEM WHOLESALE IN THE
 STATE.
   (III) "APPROVED  WHOLESALER"  MEANS  A  PRESCRIPTION  DRUG  WHOLESALER
 APPROVED UNDER THIS SECTION TO PARTICIPATE IN THE PROGRAM.
   (C)  THE  COMMISSIONER  SHALL  DEVELOP  AND  IMPLEMENT  THE PROGRAM IN
 CONSULTATION WITH INTERESTED STAKEHOLDERS AND APPROPRIATE FEDERAL  OFFI-
 CIALS.  THE  PROGRAM  SHALL COMPLY WITH APPLICABLE FEDERAL REQUIREMENTS,
 INCLUDING 21 U.S.C. § 384, AND REQUIREMENTS REGARDING  SAFETY  AND  COST
 SAVINGS. UNDER THE PROGRAM:
   (I)  THE  COMMISSIONER  SHALL  APPROVE  ONE  OR MORE PRESCRIPTION DRUG
 WHOLESALERS  TO  SEEK  FEDERAL  CERTIFICATION  AND  APPROVAL  TO  IMPORT
 PRESCRIPTION  DRUGS  FROM  ONE  OR  MORE  OTHER COUNTRIES, TO BE SOLD OR
 DISTRIBUTED WHOLESALE IN THE STATE;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD03404-01-3
              

 S. 604                              2
 
   (II) PRESCRIPTION DRUGS SHALL ONLY BE ACQUIRED  FROM  SUPPLIERS  REGU-
 LATED  AND AUTHORIZED UNDER THE LAWS OF THE OTHER COUNTRY OR A JURISDIC-
 TION THEREOF;
   (III)  ONLY PRESCRIPTION DRUGS MEETING THE U.S. FOOD AND DRUG ADMINIS-
 TRATION'S SAFETY, EFFECTIVENESS, AND OTHER STANDARDS SHALL  BE  IMPORTED
 UNDER THE PROGRAM;
   (IV)  ONLY PRESCRIPTION DRUGS EXPECTED TO GENERATE SUBSTANTIAL SAVINGS
 FOR CONSUMERS SHALL BE IMPORTED;
   (V) THE 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 FEASIBLE AND PRACTICAL, INCLUDING PRIOR TO IMPORTED  PRESCRIPTION
 DRUGS COMING INTO ITS POSSESSION;
   (VI)  AN APPROVED WHOLESALER SHALL NOT SELL OR DISTRIBUTE PRESCRIPTION
 DRUGS IMPORTED UNDER THE PROGRAM OUTSIDE THE STATE;
   (VII) THE COMMISSIONER MAY IMPOSE AN ANNUAL  FEE  ON  APPROVED  WHOLE-
 SALERS,  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;
   (VIII)  EVERY  APPROVED WHOLESALER SHALL PROVIDE THE COMMISSIONER WITH
 INFORMATION ON ITS PARTICIPATION IN THE PROGRAM AS  REASONABLY  REQUIRED
 BY  THE  COMMISSIONER;  THE COMMISSIONER MAY PROVIDE FOR KEEPING CERTAIN
 INFORMATION CONFIDENTIAL WITHIN THE DEPARTMENT WHERE  REASONABLY  NECES-
 SARY FOR SUCCESSFUL OPERATION OF THE PROGRAM; AND
   (IX)  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.
   (D)  THE  COMMISSIONER  SHALL  MAKE REGULATIONS AND TAKE OTHER ACTIONS
 REASONABLY NECESSARY TO IMPLEMENT THE PROGRAM.
   2. THE COMMISSIONER SHALL CONSULT WITH THE ATTORNEY GENERAL TO IDENTI-
 FY THE POTENTIAL FOR, AND TO MONITOR, ANTICOMPETITIVE BEHAVIOR UNDER  OR
 IN RELATION TO THE PROGRAM.
   3. (A) THE COMMISSIONER SHALL SEEK ALL NECESSARY APPROVALS AND CERTIF-
 ICATION  BY  THE  SECRETARY  OF  THE U.S. DEPARTMENT OF HEALTH AND HUMAN
 SERVICES OR OTHER APPROPRIATE FEDERAL  OFFICIALS  OR  AGENCIES  FOR  THE
 WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM.
   (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 FEDERAL
 340B DRUG PRICING PROGRAM TO PARTICIPATE IN THE  WHOLESALE  PRESCRIPTION
 DRUG IMPORTATION PROGRAM TO THE FULLEST EXTENT POSSIBLE WITHOUT JEOPARD-
 IZING THEIR ELIGIBILITY FOR THE 340B PROGRAM.
   4.  THE  COMMISSIONER SHALL ESTABLISH PROCEDURES FOR PRESCRIPTION DRUG
 WHOLESALERS TO APPLY AND BE  APPROVED  TO  BE  AN  APPROVED  WHOLESALER,
 INCLUDING  REQUIREMENTS  FOR  PERIODIC  RENEWAL  OF  THAT  APPROVAL. THE
 COMMISSIONER SHALL PROVIDE REASONABLE GROUNDS FOR SUSPENDING OR REVOKING
 APPROVAL OF AN APPROVED WHOLESALER UNDER THIS SECTION, INCLUDING REASON-
 ABLE PROVISION FOR NOTICE, OPPORTUNITY TO BE HEARD, AND APPEAL.
   5. THE COMMISSIONER SHALL ANNUALLY REPORT TO THE  ASSEMBLY  COMMITTEES
 ON  HEALTH AND ON WAYS AND MEANS AND THE SENATE COMMITTEES ON HEALTH AND
 ON FINANCE REGARDING THE OPERATION OF THE  WHOLESALE  PRESCRIPTION  DRUG
 IMPORTATION PROGRAM.
   § 2. This act shall take effect immediately.