S T A T E   O F   N E W   Y O R K
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                                 5903--A
    Cal. No. 783

                       2015-2016 Regular Sessions

                            I N  S E N A T E

                              June 10, 2015
                               ___________

Introduced  by  Sen.  HANNON -- read twice and ordered printed, and when
  printed to be committed to the Committee on Rules  --  recommitted  to
  the  Committee  on  Health in accordance with Senate Rule 6, sec. 8 --
  reported favorably from said committee, ordered to  first  and  second
  report,  ordered to a third reading, passed by Senate and delivered to
  the Assembly, recalled, vote reconsidered, restored to third  reading,
  amended  and  ordered  reprinted,  retaining its place in the order of
  third reading

AN  ACT  to  amend  the  public  health  law,  in  relation  to   unused
  prescription drug donation and redispensing

  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-b to read as follows:
  S  280-B.  UNUSED PRESCRIPTION DRUG DONATION AND REDISPENSING PROGRAM.
1. AS USED IN THIS SECTION:
  (A) "DONOR ENTITY" MEANS A MANUFACTURER, WHOLESALER, OR DISTRIBUTOR OF
PRESCRIPTION DRUGS; A PHARMACY; OR A HOSPITAL AUTHORIZED  UNDER  ARTICLE
TWENTY-EIGHT OF THIS CHAPTER.
  (B)  "RECIPIENT ENTITY" MEANS A MANUFACTURER, WHOLESALER, OR DISTRIBU-
TOR OF PRESCRIPTION DRUGS; A PHARMACY; OR A  HOSPITAL  AUTHORIZED  UNDER
ARTICLE TWENTY-EIGHT OF THIS CHAPTER.
  (C)"THIRD PARTY INTERMEDIARY" MEANS A NOT-FOR-PROFIT ORGANIZATION THAT
FACILITATES  THE  DONATION  OR TRANSFER OF PRESCRIPTION DRUGS UNDER THIS
SECTION BUT DOES NOT TAKE POSSESSION OR OWNERSHIP  OF  THE  PRESCRIPTION
DRUGS.
  (D)  "REDISPENSE"  MEANS  TO  DISPENSE  A  PRESCRIPTION  DRUG THAT WAS
DONATED AND RECEIVED UNDER THIS SECTION.
  2. THE COMMISSIONER SHALL MAKE REGULATIONS GOVERNING THE DONATION  AND
REDISPENSING OF UNUSED PRESCRIPTION DRUGS UNDER THIS SECTION.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD11582-09-6
              

S. 5903--A                          2

  3.  A DONOR ENTITY MAY DONATE UNUSED PRESCRIPTION DRUGS TO A RECIPIENT
ENTITY, DIRECTLY OR THROUGH A  THIRD-PARTY  INTERMEDIARY,  IN  A  SECURE
MANNER,   ENSURING   THE   PRIVACY  OF  ANY  INDIVIDUALS  FOR  WHOM  THE
PRESCRIPTION DRUGS WERE INITIALLY DISPENSED OR INTENDED TO BE DISPENSED.
PRESCRIPTION  DRUGS REDISPENSED UNDER THIS SECTION SHALL BE INSPECTED BY
A PHARMACIST OR OTHER LICENSED HEALTH CARE PROVIDER AS PROVIDED BY REGU-
LATIONS.  THE PARTICIPATION OF ANY DONOR OR RECIPIENT ENTITY  IN  REDIS-
PENSING SHALL BE VOLUNTARY.
  4.  ONLY  PRESCRIPTION  DRUGS  RECEIVED  BY  THE  RECIPIENT  ENTITY IN
TAMPER-EVIDENT PACKAGING AS DEFINED BY UNITED STATES PHARMACOPOEIA (USP)
GENERAL CHAPTER 659, OR IN UNIT-DOSE OR MULTIPLE-DOSE PACKAGING, MAY  BE
REDISPENSED. NO PRESCRIPTION DRUGS MAY BE REDISPENSED THAT:
  (A) SHOW EVIDENCE OF BEING ADULTERATED OR MISBRANDED;
  (B) SHOW EVIDENCE OF PACKAGING HAVING BEEN TAMPERED WITH;
  (C) WILL EXPIRE BEFORE THE USE BY THE PATIENT BASED ON THE PRESCRIBING
PRACTITIONER'S DIRECTIONS FOR USE;
  (D)  OR  HAVE  BEEN EXCLUDED FROM THE PROGRAM UNDER REGULATIONS OF THE
COMMISSIONER.
  5. A PRESCRIPTION DRUG SHALL NOT BE REDISPENSED IF IT IS RESTRICTED TO
A PATIENT REGISTERED WITH THE DRUG'S MANUFACTURER UNDER FEDERAL FOOD AND
DRUG ADMINISTRATION REQUIREMENTS INCLUDING, BUT NOT  LIMITED  TO,  THOSE
RELATING TO RISK EVALUATION AND MITIGATION STRATEGIES (REMS), UNLESS THE
REDISPENSING  IS  EFFECTIVELY RESTRICTED TO ENSURE THAT THE PRESCRIPTION
DRUG IS ONLY DISPENSED IN ACCORDANCE WITH THOSE REQUIREMENTS AS APPLICA-
BLE.
  6. A RECIPIENT ENTITY MAY ALSO BE A DONOR ENTITY.
  7. PRESCRIPTION DRUGS HAVING PASSED INSPECTION UNDER SUBDIVISION THREE
OF THIS SECTION MAY BE REPACKAGED OR PREPACKAGED BY THE RECIPIENT ENTITY
PRIOR TO FURTHER REDISPENSING.
  8. RECIPIENT ENTITIES SHALL GIVE PRIORITY FOR REDISPENSING TO PATIENTS
WHO ARE INDIGENT, UNINSURED, OR UNDER-INSURED.
  9. A REDISPENSED PRESCRIPTION DRUG SHALL NOT BE RESOLD BY  ANY  PERSON
OR ENTITY. HOWEVER, THIS SUBDIVISION DOES NOT BAR THE PAYMENT OF REASON-
ABLE PROCESSING FEES.
  10.  NO PERSON OR ENTITY SHALL BE SUBJECT TO CRIMINAL OR CIVIL LIABIL-
ITY, OR PROFESSIONAL DISCIPLINE FOR ANY ACTION TAKEN IN REASONABLE  GOOD
FAITH  COMPLIANCE  WITH  THIS SECTION, EXCEPT UNDER OTHERWISE APPLICABLE
GROUNDS FOR LIABILITY.
  11. THE DEPARTMENT SHALL WORK  WITH  PROSPECTIVE  AND  APPROVED  DONOR
ENTITIES,  RECIPIENT  ENTITIES AND THIRD-PARTY INTERMEDIARIES TO EDUCATE
THEM ABOUT REDISPENSING AND PROMOTE PARTICIPATION IN  REDISPENSING.  THE
DEPARTMENT  SHALL MAINTAIN A LIST OF RECIPIENT ENTITIES, AND THIRD-PARTY
INTERMEDIARIES AND PUBLISH IT ON THE DEPARTMENT'S WEBSITE.
  S 2. This act shall take effect immediately.