S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1018
 
                        2021-2022 Regular Sessions
 
                           I N  A S S E M B L Y
 
                              January 7, 2021
                                ___________
 
 Introduced  by M. of A. BRONSON -- read once and referred to the Commit-
   tee 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  6833
 to read as follows:
   §  6833.  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.
   (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-
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD05203-01-1

 A. 1018                             2
 
 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:
   (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;

 A. 1018                             3
 
   (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;
   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;

 A. 1018                             4
 
   (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.
   § 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.