S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                    133
 
                        2021-2022 Regular Sessions
 
                           I N  A S S E M B L Y
 
                                (PREFILED)
 
                              January 6, 2021
                                ___________
 
 Introduced by M. of A. GOTTFRIED, BARRON, CAHILL, COOK, DINOWITZ, ENGLE-
   BRIGHT,  GALEF, GUNTHER, HUNTER, LAVINE, MAGNARELLI, MONTESANO, RAMOS,
   J. RIVERA,  L. ROSENTHAL,  SEAWRIGHT,  SIMON,   ZEBROWSKI,   JACOBSON,
   STIRPE,  HEVESI,  CARROLL,  MIKULIN,  REYES, BENEDETTO, CRUZ, EPSTEIN,
   COLTON, NIOU -- Multi-Sponsored by -- M. of A.  BUTTENSCHON,  LUPARDO,
   THIELE -- read once and referred to the Committee on Higher Education
 
 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:
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
              

                       [ ] is old law to be omitted.
                                                            LBD00370-01-1

 A. 133                              2
 
   (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;
   (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.