S T A T E O F N E W Y O R K
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11368
I N A S S E M B L Y
June 7, 2010
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Introduced by COMMITTEE ON RULES -- (at request of M. of A. Sweeney,
Arroyo, Crespo, DelMonte, DenDekker, Jaffee, Koon, Lifton, Lupardo,
Maisel, Mayersohn, Millman, Peoples-Stokes, Robinson, Schimel, Skarta-
dos, Weisenberg, Gibson, Glick, Jacobs, McEneny, Russell, Thiele,
Titone, Towns) -- (at request of the Department of Environmental
Conservation) -- read once and referred to the Committee on Environ-
mental Conservation
AN ACT to amend the environmental conservation law, in relation to
prohibiting certain means of disposal of pharmaceutical waste
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Title 27 of article 27 and sections 27-2701 and 27-2703 of
the environmental conservation law, as added by chapter 625 of the laws
of 2008, are renumbered title 29 and sections 27-2901 and 27-2903.
S 2. Section 27-2901 of the environmental conservation law, as added
by chapter 625 of the laws of 2008 and as renumbered by section one of
this act, is amended to read as follows:
S 27-2901. [Definition] DEFINITIONS.
1. As used in this title, "drug" means any drug, as defined in [subdi-
vision seven of] section sixty-eight hundred two of the education law.
2. "INSTITUTIONAL DISPENSER" SHALL HAVE THE SAME MEANING AS THAT TERM
IS DEFINED IN SECTION THIRTY-THREE HUNDRED TWO OF THE PUBLIC HEALTH LAW.
3. "LANDFILL" SHALL HAVE THE SAME MEANING AS THAT TERM IS DEFINED IN
SECTION 27-0901 OF THIS ARTICLE.
4. "PHARMACEUTICAL MANUFACTURER" MEANS ANY PERSON WHO:
(A) HAS LEGAL OWNERSHIP OF THE BRAND, BRAND NAME, OR CO-BRAND OF A
PRESCRIPTION DRUG OR MANUFACTURES A GENERIC PRESCRIPTION DRUG SOLD IN OR
INTO THE STATE. "PHARMACEUTICAL MANUFACTURER" DOES NOT INCLUDE A RETAIL-
ER WHO PUTS ITS STORE LABEL ON A COVERED PRODUCT OR A PHARMACIST WHO
COMPOUNDS A PRESCRIBED INDIVIDUAL DRUG PRODUCT FOR A PATIENT;
(B) IMPORTS FOR SALE IN THE STATE A PRESCRIPTION DRUG BRANDED OR MANU-
FACTURED BY A PHARMACEUTICAL MANUFACTURER AS DEFINED BY PARAGRAPH (A) OF
THIS SUBDIVISION WHERE THAT PHARMACEUTICAL MANUFACTURER HAS NO PHYSICAL
PRESENCE IN THE UNITED STATES; OR
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD17184-02-0
A. 11368 2
(C) SELLS AT WHOLESALE A PRESCRIPTION DRUG AND ELECTS TO FULFILL THE
RESPONSIBILITIES OF THE PHARMACEUTICAL MANUFACTURER AS DEFINED BY PARA-
GRAPHS (A) AND (B) OF THIS SUBDIVISION FOR THAT DRUG.
5. "PRESCRIPTION PHARMACEUTICAL WASTE" MEANS A DISCARDED, UNWANTED, OR
EXPIRED PRESCRIPTION DRUG WHICH IS NOT CLASSIFIED AS A REGULATED MEDICAL
WASTE PURSUANT TO TITLE FIFTEEN OF THIS ARTICLE. PRESCRIPTION DRUG MEANS
THE SAME AS SUCH TERM IS DEFINED IN SECTION TWO HUNDRED SEVENTY OF THE
PUBLIC HEALTH LAW.
S 3. The environmental conservation law is amended by adding a new
section 27-2905 to read as follows:
S 27-2905. PROHIBITION ON CERTAIN PRESCRIPTION PHARMACEUTICAL WASTE
DISPOSAL.
1. NO INSTITUTIONAL DISPENSER SHALL DISPOSE OF PRESCRIPTION PHARMACEU-
TICAL WASTE IN A MANNER THAT RESULTS IN PLACEMENT IN A LANDFILL OR BY A
MEANS THAT RESULTS, DIRECTLY OR INDIRECTLY, IN A DISCHARGE INTO ANY
WATERS OF THE STATE.
2. AN OWNER OR OPERATOR OF A LANDFILL SHALL NOT KNOWINGLY ACCEPT
PRESCRIPTION PHARMACEUTICAL WASTE FROM ANY INSTITUTIONAL DISPENSER FOR
DISPOSAL. AN OWNER OR OPERATOR OF A LANDFILL SHALL NOT BE FOUND TO HAVE
ACCEPTED PRESCRIPTION PHARMACEUTICAL WASTE FOR DISPOSAL IN VIOLATION OF
THIS SUBDIVISION IF THE OWNER OR OPERATOR HAS (A) MADE A GOOD FAITH
EFFORT TO COMPLY WITH THIS SECTION, (B) PROVIDED WRITTEN INFORMATION TO
USERS OF ITS FACILITY THAT IT IS UNLAWFUL FOR INSTITUTIONAL DISPENSERS
TO DISPOSE OF PRESCRIPTION PHARMACEUTICAL WASTE AT A LANDFILL AND (C)
POSTED SIGNS, IN CONSPICUOUS LOCATIONS AT THE LANDFILL, STATING THAT
PRESCRIPTION PHARMACEUTICAL WASTE FROM INSTITUTIONAL DISPENSERS MAY NOT
BE DISPOSED AT THE LANDFILL.
S 4. The environmental conservation law is amended by adding a new
section 27-2907 to read as follows:
S 27-2907. PHARMACEUTICAL WASTE STEWARDSHIP.
1. EVERY PHARMACEUTICAL MANUFACTURER SELLING PRESCRIPTION DRUGS IN
THIS STATE SHALL PROVIDE FOR THE FREE COLLECTION OF PRESCRIPTION PHARMA-
CEUTICAL WASTE FROM INSTITUTIONAL DISPENSERS UNLESS THE COLLECTION IS
OTHERWISE PROHIBITED BY LAW. COLLECTION SHALL BE BY DIRECT PICK-UP,
MAIL OR ANOTHER METHOD APPROVED BY THE DEPARTMENT, AND SHALL BE PROVIDED
AT LEAST EVERY NINETY DAYS. IN ADDITION, IN THE CASE OF PRESCRIPTION
PHARMACEUTICAL WASTE THAT IS HAZARDOUS WASTE, COLLECTION SHALL ALSO
OCCUR WHEN ONE HUNDRED POUNDS OF HAZARDOUS WASTE OR ONE POUND OF ACUTE
HAZARDOUS WASTE, AS THOSE TERMS ARE DEFINED IN REGULATIONS PROMULGATED
PURSUANT TO TITLE NINE OF THIS ARTICLE, ARE ACCUMULATED AT THE INSTITU-
TIONAL DISPENSER.
2. PRESCRIPTION PHARMACEUTICAL WASTE COLLECTED FROM INSTITUTIONAL
DISPENSERS AND DISPOSED OF IN THE STATE SHALL BE DISPOSED OF AT A
COMBUSTION FACILITY PERMITTED PURSUANT TO THIS ARTICLE AND ARTICLE NINE-
TEEN OF THIS CHAPTER OR BY OTHER DISPOSAL TECHNOLOGY APPROVED BY THE
DEPARTMENT WHICH PREVENTS THE DISCHARGE OF THE WASTE TO THE WATERS OF
THE STATE; PROVIDED, HOWEVER, THAT NOTHING IN THIS SUBDIVISION SHALL BE
DEEMED TO EXEMPT ANY PHARMACEUTICAL WASTE FROM ANY APPLICABLE PROVISION
OF STATE OR FEDERAL LAW.
3. BEGINNING MARCH FIRST, TWO THOUSAND TWELVE, EVERY PHARMACEUTICAL
MANUFACTURER SHALL PROVIDE AN ANNUAL REPORT TO THE DEPARTMENT FOR THE
PREVIOUS CALENDAR YEAR. THE ANNUAL REPORT SHALL BE ON A FORM PRESCRIBED
BY THE DEPARTMENT AND INCLUDE:
(A) THE MANUFACTURER'S NAME, ADDRESS AND TELEPHONE NUMBER;
(B) THE NAME AND TITLE OF AN OFFICER, DIRECTOR, OR OTHER INDIVIDUAL
DESIGNATED AS THE MANUFACTURER'S CONTACT FOR PURPOSES OF THIS SECTION;
A. 11368 3
(C) A GENERAL DESCRIPTION OF THE MANNER IN WHICH THE MANUFACTURER
PROVIDED FOR THE COLLECTION AND PROPER MANAGEMENT OF PHARMACEUTICAL
WASTE, INCLUDING THE IDENTITY OF THE FACILITIES USED FOR DISPOSAL;
(D) THE TOTAL AMOUNT, BY WEIGHT, OF PHARMACEUTICAL WASTE COLLECTED,
DISPOSED OF, AND OTHERWISE PROPERLY MANAGED;
(E) THE INSTITUTIONAL DISPENSERS SERVED BY THE MANUFACTURER'S PROGRAM;
AND
(F) ANY OTHER INFORMATION AS THE DEPARTMENT MAY REQUIRE TO ASSURE THAT
PHARMACEUTICAL WASTE FROM INSTITUTIONAL DISPENSERS IS BEING MANAGED IN
ACCORDANCE WITH APPLICABLE REGULATIONS.
4. A PHARMACEUTICAL MANUFACTURER MAY SATISFY ITS COLLECTION AND
REPORTING REQUIREMENTS OF THIS SECTION BY PARTICIPATING IN A COLLECTIVE
PRESCRIPTION PHARMACEUTICAL WASTE STEWARDSHIP PROGRAM WITH OTHER
MANUFACTURERS. ANY COLLECTIVE PRESCRIPTION PHARMACEUTICAL WASTE STEWARD-
SHIP PROGRAM SHALL FILE AN ANNUAL REPORT AND PROVIDE A LIST OF MANUFAC-
TURERS THAT ARE PARTICIPATING IN THE PROGRAM ALONG WITH OTHER IDENTIFY-
ING AND COMPLIANCE INFORMATION AS MAY BE REQUIRED BY THE DEPARTMENT.
5. PHARMACEUTICAL MANUFACTURERS SHALL PROVIDE EDUCATIONAL MATERIALS TO
INSTITUTIONAL DISPENSERS ON HOW TO PROPERLY MANAGE PRESCRIPTION PHARMA-
CEUTICAL WASTE, INCLUDING INFORMATION ON THE PROHIBITION AGAINST DISPOS-
ING OF PRESCRIPTION PHARMACEUTICAL WASTE IN A LANDFILL, THE PROHIBITION
ON FLUSHING OF PHARMACEUTICAL WASTE, AND ESTABLISH A PHONE NUMBER AND
WEBSITE WHERE THIS INFORMATION IS AVAILABLE.
S 5. Subdivision 4 of section 27-0303 of the environmental conserva-
tion law, as amended by chapter 226 of the laws of 1990, is amended to
read as follows:
4. "Regulated waste" means any one of the following types of waste:
raw sewage, septage, sludge from a sewage or water supply treatment
plant, industrial-commercial waste, low-level radioactive waste as
defined in subdivision nine of this section, waste tires, [or] waste oil
OR PRESCRIPTION PHARMACEUTICAL WASTE AS DEFINED IN TITLE TWENTY-NINE OF
THIS ARTICLE.
S 6. Section 17-0105 of the environmental conservation law is amended
by adding a new subdivision 24 to read as follows:
24. "PHARMACEUTICAL WASTE" MEANS A DISCARDED, UNWANTED, OR EXPIRED
DRUG. DRUG MEANS THE SAME AS SUCH TERM IS DEFINED IN SECTION SIXTY-EIGHT
HUNDRED TWO OF THE EDUCATION LAW.
S 7. The environmental conservation law is amended by adding a new
section 17-0513 to read as follows:
S 17-0513. RESTRICTIONS ON DISCHARGE OF PHARMACEUTICAL WASTE.
IN ADDITION TO THE DISPOSAL PROHIBITIONS SPECIFIED IN SECTION 27-2905
OF THIS CHAPTER, NO INSTITUTIONAL DISPENSER, AS THAT TERM IS DEFINED IN
SECTION THIRTY-THREE HUNDRED TWO OF THE PUBLIC HEALTH LAW, SHALL,
DIRECTLY OR INDIRECTLY, THROW, DRAIN, RUN OR OTHERWISE DISCHARGE ANY
PHARMACEUTICAL WASTE IN A MANNER THAT RESULTS IN A DISCHARGE TO THE
WATERS OF THE STATE, INCLUDING BY FLUSHING, POURING, EMPTYING OR DISPOS-
ING INTO A DRAIN OR SEWER SYSTEM.
S 8. This act shall take effect July 1, 2011.