S T A T E O F N E W Y O R K
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3264--A
2009-2010 Regular Sessions
I N A S S E M B L Y
January 23, 2009
___________
Introduced by M. of A. CHRISTENSEN, GUNTHER, COOK -- Multi-Sponsored by
-- M. of A. CLARK, DelMONTE, DESTITO, HOOPER, JAFFEE, KOON, MAGEE,
SWEENEY -- read once and referred to the Committee on Higher Education
-- committee discharged, bill amended, ordered reprinted as amended
and recommitted to said committee
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 6829
to read as follows:
S 6829. 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.
LBD04088-03-9
A. 3264--A 2
(2) UNDER THIS ARTICLE, THE DRUG MAY BE DISPENSED ONLY UPON A
PRESCRIPTION.
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 DRUGS IN THEIR ORIGINAL SEALED AND TAMPER-EVIDENT UNIT DOSE PACKAG-
ING 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. DRUGS DONATED BY INDIVIDUALS BEARING AN EXPI-
RATION DATE THAT IS LESS THAN SIX MONTHS FROM THE DATE THE DRUG IS
DONATED SHALL NOT BE ACCEPTED OR DISPENSED. A 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 DRUGS
DISPENSED FOR PURPOSES OF THE MEDICAID PROGRAM MAY BE ACCEPTED AND
DISPENSED UNDER THE DRUG REPOSITORY 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 DRUGS DONATED UNDER THIS SECTION TO INDI-
VIDUALS WHO ARE RESIDENTS OF THIS STATE AND MEET THE ELIGIBILITY STAND-
ARDS 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 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 DRUGS PRIOR TO DISPENSING THEM TO DETERMINE THAT SUCH DRUGS
ARE NOT ADULTERATED. THE PHARMACY, HOSPITAL, OR NONPROFIT CLINIC SHALL
CHARGE INDIVIDUALS RECEIVING DONATED DRUGS A HANDLING FEE ESTABLISHED IN
ACCORDANCE WITH RULES AND REGULATIONS ADOPTED BY THE BOARD UNDER SUBDI-
VISION FIVE OF THIS SECTION. 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, OSTEOPATHIC MEDICINE AND SURGERY, OR PODIATRIC MEDICINE AND
SURGERY;
(2) REGISTERED 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;
A. 3264--A 3
(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
DRUGS TO THE REPOSITORY PROGRAM; ANY PHARMACY, HOSPITAL, NONPROFIT CLIN-
IC, OR HEALTH CARE PROFESSIONAL THAT ACCEPTS OR DISPENSES DRUGS UNDER
THE PROGRAM; AND ANY PHARMACY, HOSPITAL, OR NONPROFIT CLINIC THAT
EMPLOYS A HEALTH CARE PROFESSIONAL WHO ACCEPTS OR DISPENSES DRUGS UNDER
THE PROGRAM SHALL NOT, IN THE ABSENCE OF BAD FAITH, BE SUBJECT TO ANY OF
THE FOLLOWING FOR MATTERS RELATED TO DONATING, ACCEPTING, OR DISPENSING
DRUGS UNDER THE PROGRAM: CRIMINAL PROSECUTION; LIABILITY IN TORT OR
OTHER CIVIL ACTION FOR INJURY, DEATH, OR LOSS TO PERSON OR PROPERTY; OR
PROFESSIONAL DISCIPLINARY ACTION.
A DRUG MANUFACTURER SHALL NOT, IN THE ABSENCE OF BAD FAITH, 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 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 EXPIRATION DATE OF THE DONATED
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 DRUGS UNDER THE PROGRAM;
B. STANDARDS AND PROCEDURES FOR ACCEPTING, SAFELY STORING, AND
DISPENSING DONATED DRUGS;
C. STANDARDS AND PROCEDURES FOR INSPECTING DONATED 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 DRUGS;
E. A MEANS, SUCH AS AN IDENTIFICATION CARD, BY WHICH AN INDIVIDUAL WHO
IS ELIGIBLE TO RECEIVE DONATED DRUGS SHALL DEMONSTRATE ELIGIBILITY TO
THE PHARMACY, HOSPITAL, OR NONPROFIT CLINIC DISPENSING THE DRUGS;
F. A FORM THAT AN INDIVIDUAL RECEIVING A 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 DRUG RECIPIENTS
TO COVER RESTOCKING AND DISPENSING COSTS;
H. IN ADDITION, FOR DRUGS DONATED TO THE REPOSITORY BY INDIVIDUALS:
(1) A LIST OF DRUGS, ARRANGED EITHER BY CATEGORY OR BY INDIVIDUAL
DRUG, THAT THE REPOSITORY SHALL ACCEPT FROM INDIVIDUALS;
(2) A LIST OF 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 DRUGS AND INTENDS TO VOLUNTARILY DONATE SUCH DRUGS TO THE REPOSI-
TORY.
A. 3264--A 4
I. IN ADDITION, FOR DRUGS DONATED TO THE REPOSITORY BY HEALTH CARE
FACILITIES:
(1) A LIST OF DRUGS, ARRANGED EITHER BY CATEGORY OR BY INDIVIDUAL
DRUG, THAT THE REPOSITORY SHALL ACCEPT FROM HEALTH CARE FACILITIES;
(2) A LIST OF 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 DRUG IN WHICH THE DISTRIBUTION THEREOF IS RESTRICTED BY THE
FEDERAL FOOD AND DRUG ADMINISTRATION SHALL NOT BE PERMITTED TO BE REDIS-
TRIBUTED THROUGH THE DRUG REPOSITORY PROGRAM.
K. ANY OTHER STANDARDS AND PROCEDURES THE BOARD CONSIDERS APPROPRIATE.
S 2. This act shall take effect on the one hundred twentieth 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 are authorized and directed to
be made and completed on or before such effective date.