S T A T E   O F   N E W   Y O R K
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                                  3329

                       2013-2014 Regular Sessions

                          I N  A S S E M B L Y

                            January 24, 2013
                               ___________

Introduced  by  M.  of A. MORELLE, LUPARDO, WRIGHT, CUSICK, SCHIMMINGER,
  BENEDETTO, BRONSON, CAHILL, GABRYSZAK, GALEF, GUNTHER, JACOBS, JAFFEE,
  ROBERTS, SIMOTAS, STEVENSON, WEPRIN, PEOPLES-STOKES -- Multi-Sponsored
  by -- M. of A. ABBATE, ABINANTI, BRAUNSTEIN, BRENNAN, GIBSON, HEASTIE,
  MAGEE, RUSSELL, SCHIMEL, THIELE, TITONE -- read once and  referred  to
  the Committee on Higher Education

AN ACT to amend the education law, in relation to establishing under the
  direction  of the state board of pharmacy a drug repository program to
  accept and dispense donated prescription drugs

  THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section  1.  The education law is amended by adding a new section 6831
to read as follows:
  S 6831. REPOSITORY PROGRAM; ACCEPT AND DISPENSE  DONATED  PRESCRIPTION
DRUGS. 1. AS USED IN THIS SECTION: A. "HOSPITAL" HAS THE SAME MEANING AS
IN  SUBDIVISION  ONE  OF  SECTION TWENTY-EIGHT HUNDRED ONE OF THE PUBLIC
HEALTH LAW.
  B. "NONPROFIT CLINIC" MEANS A CORPORATION AS DEFINED  IN  SUBPARAGRAPH
FIVE  OF  PARAGRAPH (A) OF SECTION ONE HUNDRED TWO OF THE NOT-FOR-PROFIT
CORPORATION LAW, OR ANY CHARITABLE ORGANIZATION NOT  ORGANIZED  AND  NOT
OPERATED  FOR PROFIT, THAT PROVIDES HEALTH CARE SERVICES TO INDIGENT AND
UNINSURED PERSONS. "NONPROFIT CLINIC" SHALL NOT INCLUDE A HOSPITAL OR  A
FACILITY  AS  DEFINED IN SUBDIVISION ONE OF SECTION TWENTY-EIGHT HUNDRED
ONE OF THE PUBLIC HEALTH LAW.
  C. "PRESCRIPTION DRUG" MEANS ANY DRUG TO WHICH THE FOLLOWING APPLIES:
  (1) UNDER THE FOOD, DRUG, AND COSMETIC ACT, 52 STAT. 1040  (1938),  21
U.S.C.A.  301, AS AMENDED, THE DRUG IS REQUIRED TO BEAR A LABEL CONTAIN-
ING THE LEGEND,  "CAUTION:  FEDERAL  LAW  PROHIBITS  DISPENSING  WITHOUT
PRESCRIPTION"  OR "CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR
ON THE ORDER OF A LICENSED  VETERINARIAN"  OR  ANY  SIMILAR  RESTRICTIVE
STATEMENT, OR THE DRUG MAY BE DISPENSED ONLY UPON A PRESCRIPTION.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD06626-01-3
              

A. 3329                             2

  (2)  UNDER  THIS  ARTICLE,  THE  DRUG  MAY  BE  DISPENSED  ONLY UPON A
PRESCRIPTION.
  (3)  DRUGS THAT CAN ONLY BE DISPENSED TO A PATIENT REGISTERED WITH THE
DRUG'S MANUFACTURER IN ACCORDANCE WITH FEDERAL FOOD  AND  DRUG  ADMINIS-
TRATION  REQUIREMENTS  MAY  NOT  BE  ACCEPTED  OR  DISTRIBUTED UNDER THE
PROVISIONS OF THIS SECTION.
  2. THE STATE BOARD OF  PHARMACY  SHALL  ESTABLISH  A  DRUG  REPOSITORY
PROGRAM  TO  ACCEPT  AND  DISPENSE  PRESCRIPTION  DRUGS  DONATED FOR THE
PURPOSE OF BEING DISPENSED TO INDIVIDUALS  WHO  ARE  RESIDENTS  OF  THIS
STATE  AND  MEET  ELIGIBILITY  STANDARDS  ESTABLISHED IN RULES AND REGU-
LATIONS ADOPTED BY THE BOARD UNDER SUBDIVISION  FIVE  OF  THIS  SECTION.
ONLY PRESCRIPTION DRUGS IN THEIR ORIGINAL SEALED AND TAMPER-EVIDENT UNIT
DOSE  PACKAGING  SHALL BE ACCEPTED AND DISPENSED. THE PACKAGING SHALL BE
UNOPENED, EXCEPT THAT DRUGS PACKAGED  IN  SINGLE  UNIT  DOSES  SHALL  BE
ACCEPTED  AND  DISPENSED  WHEN  THE  OUTSIDE  PACKAGING IS OPENED IF THE
SINGLE UNIT DOSE PACKAGING IS UNDISTURBED. PRESCRIPTION DRUGS DONATED BY
INDIVIDUALS BEARING AN EXPIRATION DATE THAT IS LESS THAN SIX MONTHS FROM
THE DATE THE DRUG IS DONATED SHALL  NOT  BE  ACCEPTED  OR  DISPENSED.  A
PRESCRIPTION  DRUG SHALL NOT BE ACCEPTED OR DISPENSED IF THERE IS REASON
TO BELIEVE THAT IT IS ADULTERATED AS DESCRIBED  IN  SECTION  SIXTY-EIGHT
HUNDRED  FIFTEEN OF THIS ARTICLE. SUBJECT TO THE LIMITATION SPECIFIED IN
THIS SUBDIVISION, UNUSED PRESCRIPTION DRUGS DISPENSED  FOR  PURPOSES  OF
THE MEDICAID PROGRAM MAY BE ACCEPTED AND DISPENSED UNDER THE DRUG REPOS-
ITORY PROGRAM.
  3.  A.  ANY  PERSON,  INCLUDING A DRUG MANUFACTURER OR ANY HEALTH CARE
FACILITY MAY DONATE PRESCRIPTION DRUGS TO THE DRUG  REPOSITORY  PROGRAM.
THE  DRUGS  SHALL BE DONATED AT A PHARMACY, HOSPITAL OR NONPROFIT CLINIC
THAT ELECTS TO PARTICIPATE IN THE  DRUG  REPOSITORY  PROGRAM  AND  MEETS
CRITERIA FOR PARTICIPATION IN THE PROGRAM ESTABLISHED IN RULES AND REGU-
LATIONS ADOPTED BY THE STATE BOARD OF PHARMACY UNDER SUBDIVISION FIVE OF
THIS  SECTION. PARTICIPATION IN THE PROGRAM BY PHARMACIES, HOSPITALS AND
NONPROFIT CLINICS IS VOLUNTARY. NOTHING IN THIS SECTION REQUIRES A PHAR-
MACY, HOSPITAL OR NONPROFIT CLINIC TO PARTICIPATE IN THE PROGRAM.
  B. A PHARMACY, HOSPITAL OR NONPROFIT CLINIC ELIGIBLE TO PARTICIPATE IN
THE PROGRAM SHALL DISPENSE PRESCRIPTION DRUGS DONATED UNDER THIS SECTION
TO INDIVIDUALS WHO ARE RESIDENTS OF THIS STATE AND MEET THE  ELIGIBILITY
STANDARDS  ESTABLISHED  IN  RULES  AND  REGULATIONS ADOPTED BY THE BOARD
UNDER SUBDIVISION FIVE OF THIS SECTION OR TO OTHER  GOVERNMENT  ENTITIES
AND  NONPROFIT  PRIVATE ENTITIES TO BE DISPENSED TO INDIVIDUALS WHO MEET
THE ELIGIBILITY STANDARDS.  A PRESCRIPTION DRUG SHALL BE DISPENSED  ONLY
PURSUANT  TO  A  PRESCRIPTION  ISSUED  BY A LICENSED HEALTH PROFESSIONAL
AUTHORIZED TO PRESCRIBE DRUGS, AS DEFINED IN SECTION SIXTY-EIGHT HUNDRED
TWO OF THIS ARTICLE. A  PHARMACY,  HOSPITAL  OR  NONPROFIT  CLINIC  THAT
ACCEPTS  DONATED DRUGS SHALL COMPLY WITH ALL APPLICABLE FEDERAL LAWS AND
LAWS OF THIS STATE DEALING WITH STORAGE AND  DISTRIBUTION  OF  DANGEROUS
DRUGS  AND SHALL INSPECT ALL PRESCRIPTION DRUGS PRIOR TO DISPENSING THEM
TO DETERMINE THAT SUCH DRUGS ARE NOT ADULTERATED. THE PHARMACY, HOSPITAL
OR  NONPROFIT  CLINIC  SHALL  CHARGE   INDIVIDUALS   RECEIVING   DONATED
PRESCRIPTION  DRUGS  A HANDLING FEE ESTABLISHED IN ACCORDANCE WITH RULES
AND REGULATIONS ADOPTED BY THE BOARD  UNDER  SUBDIVISION  FIVE  OF  THIS
SECTION.  PRESCRIPTION  DRUGS  DONATED  TO  THE  REPOSITORY SHALL NOT BE
RESOLD.
  4. A. AS USED IN THIS SECTION, "HEALTH CARE PROFESSIONAL" MEANS ANY OF
THE FOLLOWING WHO PROVIDE MEDICAL, DENTAL OR OTHER HEALTH-RELATED  DIAG-
NOSIS, CARE OR TREATMENT:

A. 3329                             3

  (1)  INDIVIDUALS  AUTHORIZED UNDER THIS TITLE TO PRACTICE MEDICINE AND
SURGERY OR PODIATRIC MEDICINE AND SURGERY;
  (2)  REGISTERED  PROFESSIONAL  NURSES  AND  LICENSED  PRACTICAL NURSES
LICENSED UNDER ARTICLE ONE HUNDRED THIRTY-NINE OF THIS TITLE;
  (3) PHYSICIAN ASSISTANTS AUTHORIZED  TO  PRACTICE  UNDER  ARTICLE  ONE
HUNDRED THIRTY-ONE-B OF THIS TITLE;
  (4)  DENTISTS AND DENTAL HYGIENISTS LICENSED UNDER ARTICLE ONE HUNDRED
THIRTY-THREE OF THIS TITLE;
  (5) OPTOMETRISTS LICENSED UNDER ARTICLE  ONE  HUNDRED  FORTY-THREE  OF
THIS TITLE;
  (6) PHARMACISTS LICENSED UNDER THIS ARTICLE.
  B.  THE  STATE  BOARD  OF  PHARMACY;  THE  COMMISSIONER OF HEALTH; ANY
PERSON, INCLUDING A DRUG MANUFACTURER OR GOVERNMENT ENTITY THAT  DONATES
PRESCRIPTION  DRUGS  TO  THE REPOSITORY PROGRAM; ANY PHARMACY, HOSPITAL,
NONPROFIT CLINIC OR HEALTH CARE PROFESSIONAL THAT ACCEPTS  OR  DISPENSES
PRESCRIPTION  DRUGS  UNDER  THE  PROGRAM;  AND ANY PHARMACY, HOSPITAL OR
NONPROFIT CLINIC THAT EMPLOYS A HEALTH CARE PROFESSIONAL WHO, REASONABLY
AND IN GOOD FAITH, ACCEPTS OR DISPENSES  PRESCRIPTION  DRUGS  UNDER  THE
PROGRAM SHALL NOT BE SUBJECT TO ANY OF THE FOLLOWING FOR MATTERS RELATED
TO  DONATING,  ACCEPTING  OR  DISPENSING  PRESCRIPTION  DRUGS  UNDER THE
PROGRAM: CRIMINAL PROSECUTION; LIABILITY IN TORT OR OTHER  CIVIL  ACTION
FOR  INJURY, DEATH OR LOSS TO PERSON OR PROPERTY; OR PROFESSIONAL DISCI-
PLINARY ACTION.
  A DRUG MANUFACTURER, WHO ACTS REASONABLY AND IN GOOD FAITH, SHALL  NOT
BE  SUBJECT  TO CRIMINAL PROSECUTION OR LIABILITY IN TORT OR OTHER CIVIL
ACTION FOR INJURY, DEATH OR LOSS  TO  PERSON  OR  PROPERTY  FOR  MATTERS
RELATED TO THE DONATION, ACCEPTANCE OR DISPENSING OF A PRESCRIPTION DRUG
MANUFACTURED  BY  THE  DRUG  MANUFACTURER  THAT IS DONATED BY ANY PERSON
UNDER THE PROGRAM, INCLUDING BUT NOT LIMITED TO LIABILITY FOR FAILURE TO
TRANSFER OR COMMUNICATE PRODUCT OR CONSUMER INFORMATION OR  THE  EXPIRA-
TION DATE OF THE DONATED PRESCRIPTION DRUG.
  5. IN CONSULTATION WITH THE COMMISSIONER OF HEALTH, THE STATE BOARD OF
PHARMACY SHALL ADOPT RULES AND REGULATIONS GOVERNING THE DRUG REPOSITORY
PROGRAM THAT ESTABLISH ALL OF THE FOLLOWING:
  A.  ELIGIBILITY CRITERIA FOR PHARMACIES, HOSPITALS AND NONPROFIT CLIN-
ICS TO  RECEIVE  AND  DISPENSE  DONATED  PRESCRIPTION  DRUGS  UNDER  THE
PROGRAM;
  B. STANDARDS AND PROCEDURES FOR ACCEPTING, SAFELY STORING AND DISPENS-
ING DONATED PRESCRIPTION DRUGS;
  C.  STANDARDS AND PROCEDURES FOR INSPECTING DONATED PRESCRIPTION DRUGS
TO DETERMINE THAT  THE  ORIGINAL  UNIT  DOSE  PACKAGING  IS  SEALED  AND
TAMPER-EVIDENT  AND  THAT THE DRUGS ARE UNADULTERATED, SAFE AND SUITABLE
FOR DISPENSING;
  D. ELIGIBILITY STANDARDS BASED ON ECONOMIC  NEED  FOR  INDIVIDUALS  TO
RECEIVE PRESCRIPTION DRUGS;
  E. A MEANS, SUCH AS AN IDENTIFICATION CARD, BY WHICH AN INDIVIDUAL WHO
IS  ELIGIBLE  TO  RECEIVE  DONATED  PRESCRIPTION DRUGS SHALL DEMONSTRATE
ELIGIBILITY TO THE PHARMACY, HOSPITAL OR NONPROFIT CLINIC DISPENSING THE
DRUGS;
  F. A FORM THAT AN INDIVIDUAL RECEIVING A PRESCRIPTION  DRUG  FROM  THE
REPOSITORY  SHALL  SIGN  BEFORE  RECEIVING  THE DRUG TO CONFIRM THAT THE
INDIVIDUAL UNDERSTANDS THE IMMUNITY PROVISIONS OF THE PROGRAM;
  G. A FORMULA TO DETERMINE THE AMOUNT OF A HANDLING  FEE  THAT  PHARMA-
CIES,  HOSPITALS AND NONPROFIT CLINICS SHALL CHARGE TO PRESCRIPTION DRUG
RECIPIENTS TO COVER RESTOCKING AND DISPENSING COSTS;

A. 3329                             4

  H. IN ADDITION, FOR PRESCRIPTION DRUGS DONATED TO  THE  REPOSITORY  BY
INDIVIDUALS:
  (1)  A  LIST  OF PRESCRIPTION DRUGS, ARRANGED EITHER BY CATEGORY OR BY
INDIVIDUAL DRUG, THAT THE REPOSITORY SHALL ACCEPT FROM INDIVIDUALS;
  (2) A LIST OF PRESCRIPTION DRUGS, ARRANGED EITHER BY  CATEGORY  OR  BY
INDIVIDUAL  DRUG, THAT THE REPOSITORY SHALL NOT ACCEPT FROM INDIVIDUALS.
THE LIST SHALL INCLUDE BUT NOT BE LIMITED TO, A STATEMENT AS TO WHY  THE
DRUG IS INELIGIBLE FOR DONATION.
  (3)  A  FORM EACH DONOR SHALL SIGN STATING THAT THE DONOR IS THE OWNER
OF THE PRESCRIPTION DRUGS AND INTENDS TO VOLUNTARILY DONATE  SUCH  DRUGS
TO THE REPOSITORY.
  I.  IN  ADDITION,  FOR PRESCRIPTION DRUGS DONATED TO THE REPOSITORY BY
HEALTH CARE FACILITIES:
  (1) A LIST OF PRESCRIPTION DRUGS, ARRANGED EITHER BY  CATEGORY  OR  BY
INDIVIDUAL  DRUG,  THAT  THE  REPOSITORY  SHALL  ACCEPT FROM HEALTH CARE
FACILITIES;
  (2) A LIST OF PRESCRIPTION DRUGS, ARRANGED EITHER BY  CATEGORY  OR  BY
INDIVIDUAL  DRUG,  THAT THE REPOSITORY SHALL NOT ACCEPT FROM HEALTH CARE
FACILITIES. THE LIST SHALL INCLUDE A STATEMENT AS TO WHY  SUCH  DRUG  IS
INELIGIBLE FOR DONATION.
  J. ANY OTHER STANDARDS AND PROCEDURES THE BOARD CONSIDERS APPROPRIATE.
  S 2. This act shall take effect on the one hundred eightieth day after
it  shall have become a law. Effective immediately, the addition, amend-
ment and/or repeal of any rule or regulation necessary for the implemen-
tation of this act on its effective date is authorized to be made on  or
before such effective date.