S T A T E O F N E W Y O R K
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10298
I N A S S E M B L Y
May 20, 2016
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Introduced by M. of A. ENGLEBRIGHT, ROSENTHAL -- read once and referred
to the Committee on Environmental Conservation
AN ACT to amend the environmental conservation law, in relation to
establishing a drug stewardship program
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 of the environmental conservation
law, as added by chapter 625 of the laws of 2008, is amended by adding a
new section 27-2705 to read as follows:
S 27-2705. DRUG STEWARDSHIP PROGRAM.
1. AS USED IN THIS SECTION, THE FOLLOWING TERMS SHALL HAVE THE FOLLOW-
ING MEANINGS UNLESS THE CONTEXT CLEARLY REQUIRES OTHERWISE:
(A) "COVERED DRUG" MEANS ANY BRAND NAME OR GENERIC OPIOID DRUG PLACED
IN SCHEDULE I, SCHEDULE II OR SCHEDULE III OF SECTION THIRTY-THREE
HUNDRED SIX OF THE PUBLIC HEALTH LAW; PROVIDED, HOWEVER, THAT "COVERED
DRUG" SHALL ALSO INCLUDE BENZODIAZEPINES; PROVIDED, FURTHER, THAT
"COVERED DRUG" SHALL NOT INCLUDE: (I) DRUGS INTENDED FOR USE SOLELY IN
VETERINARY CARE; (II) SUBSTANCES THAT ARE REGULATED AS COSMETIC PRODUCTS
UNDER THE UNITED STATES FOOD, DRUG AND COSMETIC ACT, 21 U.S.C. S 301 ET
SEQ.; (III) HYPODERMIC NEEDLES, LANCETS OR OTHER SHARPS PRODUCTS SUBJECT
TO COLLECTION AND DISPOSAL PROCEDURES ESTABLISHED IN SUBDIVISION FOUR OF
SECTION THIRTEEN HUNDRED EIGHTY-NINE-DD OF THE PUBLIC HEALTH LAW, OR
(IV) DRUGS APPROVED AND USE PRIMARILY FOR MEDICATION-ASSISTED SUBSTANCE
USE DISORDER TREATMENT.
(B) "DRUG STEWARDSHIP PROGRAM" MEANS A PROGRAM FINANCED BY A PHARMA-
CEUTICAL PRODUCT MANUFACTURER OR A GROUP OF MANUFACTURERS TO COLLECT,
SECURE, TRANSPORT AND SAFELY DISPOSE OF UNWANTED DRUGS.
(C) "PHARMACEUTICAL PRODUCT MANUFACTURER" OR "MANUFACTURER" MEANS AN
ENTITY THAT MANUFACTURES A CONTROLLED SUBSTANCE UNDER A UNITED STATES
FOOD AND DRUG ADMINISTRATION MANUFACTURER'S LICENSE.
(D) "PRESCRIPTION DRUG" SHALL HAVE THE SAME MEANING AS SUBDIVISION
NINE OF SECTION TWO HUNDRED SEVENTY OF THE PUBLIC HEALTH LAW.
(E) "STEWARDSHIP ORGANIZATION" MEANS AN ORGANIZATION DESIGNATED BY A
MANUFACTURER OR A GROUP OF MANUFACTURERS TO ACT AS AN AGENT ON BEHALF OF
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD15156-01-6
A. 10298 2
THE MANUFACTURER OR THE GROUP OF MANUFACTURERS TO IMPLEMENT AND OPERATE
A DRUG STEWARDSHIP PROGRAM.
(F) "UNWANTED DRUG" MEANS A COVERED DRUG: (I) THAT IS NO LONGER WANTED
OR INTENDED TO BE CONSUMED, OR THAT IS ABANDONED, DISCARDED, EXPIRED OR
SURRENDERED BY THE PERSON TO WHOM IT WAS PRESCRIBED; OR (II) VOLUNTARILY
DEPOSITED AT COLLECTION POINTS CO-LOCATED WITH A LAW ENFORCEMENT AGENCY;
PROVIDED, HOWEVER, THAT "UNWANTED DRUG" SHALL NOT INCLUDE: (A) WASTE OR
UNUSED DRUG PRODUCTS FROM A PHARMACY, HOSPITAL OR HEALTH CLINIC OR OTHER
COMMERCIAL SOURCES THAT THE DEPARTMENT, BASED UPON RECOMMENDATIONS FROM
THE DEPARTMENT OF HEALTH, MAY DETERMINE BY REGULATION TO BE A NONRESI-
DENTIAL SOURCE; OR (B) DRUG PRODUCTS SEIZED BY LAW ENFORCEMENT OFFICERS
IN THE COURSE OF THEIR LAW ENFORCEMENT DUTIES.
2. (A) ANY PHARMACEUTICAL PRODUCT MANUFACTURER SELLING OR DISTRIBUTING
A COVERED DRUG TO CONSUMERS IN THE STATE, WHETHER DIRECTLY OR THROUGH A
WHOLESALER, RETAILER OR OTHER AGENT, SHALL: (I) OPERATE A DRUG STEWARD-
SHIP PROGRAM APPROVED BY THE DEPARTMENT INDIVIDUALLY OR JOINTLY WITH
OTHER MANUFACTURERS; (II)ENTER INTO AN AGREEMENT WITH A STEWARDSHIP
ORGANIZATION THAT SHALL OPERATE A DRUG STEWARDSHIP PROGRAM APPROVED BY
THE DEPARTMENT; OR (III) ENTER INTO AN AGREEMENT WITH THE DEPARTMENT TO
OPERATE AN ALTERNATIVE PLAN UNDER SUBDIVISION SIX OF THIS SECTION.
(B) THE DEPARTMENT, IN CONSULTATION WITH THE DEPARTMENT OF HEALTH,
SHALL ESTABLISH A PROCESS, PURSUANT TO REGULATION, TO REVIEW APPLICA-
TIONS FOR APPROVAL AND RENEWAL OF A MANUFACTURER'S DRUG STEWARDSHIP
PROGRAM. THE DEPARTMENT SHALL CONSULT WITH THE OFFICE OF ALCOHOLISM AND
SUBSTANCE ABUSE SERVICES AND OTHER INTERESTED PARTIES IN DEVELOPING THE
REQUIREMENTS OF A DRUG STEWARDSHIP PROGRAM.
(C) EACH OPERATOR OF A DRUG STEWARDSHIP PROGRAM SHALL FILE AN ANNUAL
WRITTEN REPORT TO THE DEPARTMENT DESCRIBING THE PROGRAM'S ACTIVITIES FOR
THE PRIOR YEAR AND THE VOLUME AND TYPE OF UNWANTED DRUGS COLLECTED NOT
LATER THAN MARCH FIRST.
(D) THE DEPARTMENT SHALL REVIEW FOR RENEWAL EACH DRUG STEWARDSHIP
PROGRAM AT A FREQUENCY TO BE DETERMINED BY THE DEPARTMENT PURSUANT TO
REGULATION.
(E) THE DEPARTMENT SHALL PUBLISH AND MAKE PUBLICLY AVAILABLE A LIST
AND DESCRIPTION OF EACH APPROVED DRUG STEWARDSHIP PROGRAM AND SHALL
REGULARLY UPDATE THIS LIST.
3. A MANUFACTURER OR STEWARDSHIP ORGANIZATION SEEKING APPROVAL FOR A
DRUG STEWARDSHIP PROGRAM SHALL SUBMIT, IN A MANNER AND FORM DETERMINED
BY THE DEPARTMENT PURSUANT TO REGULATIONS DEVELOPED, IN CONSULTATION
WITH THE DEPARTMENT OF HEALTH, A PLAN THAT MEETS, BUT IS NOT LIMITED TO,
THE FOLLOWING REQUIREMENTS:
(A) IDENTIFICATION OF ALL PARTICIPATING MANUFACTURERS;
(B) A COLLECTION SYSTEM TO PROVIDE CONVENIENT, ONGOING COLLECTION
SERVICES TO ALL PERSONS SEEKING TO DISPOSE OF UNWANTED DRUGS; PROVIDED,
HOWEVER, THAT THE COLLECTION SYSTEM MAY ACCEPT ANY COVERED DRUG AND ANY
OTHER PRESCRIPTION DRUG IN A PILL FORMULATION REGARDLESS OF ITS SCHED-
ULE, BRAND OR SOURCE OF MANUFACTURE; PROVIDED FURTHER, THAT THE
COLLECTION SYSTEM SHALL INCLUDE TWO METHODS AS RECOMMENDED BY THE
DEPARTMENT, WHICH MAY INCLUDE, BUT NOT BE LIMITED TO: (I) A MAIL-BACK
PROGRAM THAT PROVIDES PREPAID AND PREADDRESSED PACKAGING FOR A PHARMACY
TO DISTRIBUTE WHEN FILLING A PRESCRIPTION FOR A COVERED DRUG OR UPON
REQUEST BY A CONSUMER; (II) COLLECTION KIOSKS; (III) DROP-OFF DAY EVENTS
AT REGIONAL LOCATIONS; OR (IV) ANY OTHER METHOD RECOMMENDED PURSUANT TO
UNITED STATES DRUG ENFORCEMENT ADMINISTRATION GUIDELINES;
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(C) ADEQUATE PROVISIONS FOR THE SECURITY OF UNWANTED DRUGS THROUGHOUT
THE COLLECTION PROCESS AND THE SAFETY OF ANY PERSON INVOLVED IN MONITOR-
ING, STAFFING OR SERVICING THE STEWARDSHIP PROGRAM;
(D) A PLAN FOR PUBLIC OUTREACH AND EDUCATION ABOUT THE DRUG STEWARD-
SHIP PROGRAM;
(E) A PLAN FOR THE MANUFACTURER OR STEWARDSHIP ORGANIZATION THAT
PROVIDES THE OPERATIONAL AND ADMINISTRATIVE COSTS ASSOCIATED WITH THE
PROGRAM; PROVIDED, HOWEVER, THAT NO POINT-OF-SALE, POINT-OF-COLLECTION,
PROCESSING FEES OR OTHER DRUG COST INCREASES MAY BE CHARGED TO INDIVID-
UAL CONSUMERS TO RECOUP PROGRAM COSTS;
(F) AN ATTESTATION THAT THE PROGRAM SHALL COMPLY WITH ALL APPLICABLE
STATE AND FEDERAL REQUIREMENTS FOR THE COLLECTION, SECURITY, TRANSPORT
AND DISPOSAL OF DRUG PRODUCTS, INCLUDING ANY REQUIREMENTS ESTABLISHED BY
RULE OR REGULATION OF EITHER THE UNITED STATES DRUG ENFORCEMENT ADMINIS-
TRATION OR THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY; AND
(G) ANY OTHER REQUIREMENTS ESTABLISHED BY THE DEPARTMENT PURSUANT TO
REGULATION FOR THE SAFE AND EFFECTIVE ADMINISTRATION OF A DRUG STEWARD-
SHIP PROGRAM.
4. (A) THE DEPARTMENT SHALL SEND A NOTICE TO A PHARMACEUTICAL PRODUCT
MANUFACTURER THAT SELLS OR DISTRIBUTES A COVERED DRUG IN THE STATE THAT
HAS NOT SUBMITTED AN APPLICATION FOR APPROVAL UNDER SUBDIVISION TWO OF
THIS SECTION, INFORMING THE MANUFACTURER OF THE REQUIREMENTS TO COMPLY
WITH THIS SECTION. ANY MANUFACTURER IN RECEIPT OF A NOTICE SHALL SUBMIT
AN APPLICATION FOR APPROVAL UNDER SUBDIVISION TWO OF THIS SECTION WITHIN
ONE HUNDRED EIGHTY CALENDAR DAYS OF RECEIPT OF SUCH INITIAL NOTICE.
(B) UPON BECOMING AWARE THAT A PHARMACEUTICAL PRODUCT MANUFACTURER HAS
DISCONTINUED ITS DRUG STEWARDSHIP PROGRAM OR HAS ALTERED THE PROGRAM
SUCH THAT THE PROGRAM NO LONGER FULFILLS THE REQUIREMENTS OF THIS
SECTION, THE DEPARTMENT SHALL SEND A NOTICE OF NONCOMPLIANCE TO THE
MANUFACTURER. A MANUFACTURER IN RECEIPT OF A NOTICE OF NONCOMPLIANCE
SHALL TAKE ALL REQUIRED CORRECTIVE STEPS TO REESTABLISH COMPLIANCE WITH
THIS SECTION OR SUBMIT A WRITTEN APPEAL OF THE NOTICE OF NONCOMPLIANCE
TO THE DEPARTMENT WITHIN NINETY DAYS OF RECEIPT OF THE NOTICE OF NONCOM-
PLIANCE.
(C) IF AFTER CONSIDERATION OF AN APPEAL OR IF THE MANUFACTURER DOES
NOT APPEAL WITHIN NINETY DAYS OF RECEIPT OF THE NOTICE OF NONCOMPLIANCE
THE DEPARTMENT DETERMINES THAT THE MANUFACTURER CONTINUES TO BE IN
NONCOMPLIANCE WITH THIS SECTION, THE DEPARTMENT MAY ASSESS THE MANUFAC-
TURER A PENALTY AFTER A HEARING AND AN OPPORTUNITY TO BE HEARD. IF THE
DEPARTMENT PLANS TO ASSESS A NONCOMPLIANCE PENALTY AGAINST A MANUFACTUR-
ER PURSUANT TO THIS SUBDIVISION, THE DEPARTMENT SHALL SEND NOTICE OF THE
PENALTY AND THE RIGHT TO APPEAL THE PENALTY TO THE MANUFACTURER.
5. (A) ANY REQUIREMENTS OR REGULATIONS, MAY EXCEED, BUT SHALL NOT
CONFLICT WITH, ANY OBLIGATIONS IMPOSED ON A MANUFACTURER BY A RISK EVAL-
UATION AND MITIGATION STRATEGY APPROVED BY THE UNITED STATES FOOD AND
DRUG ADMINISTRATION.
(B) NOTHING IN THIS SECTION SHALL REQUIRE A PHARMACY OR A PHARMACIST
PRACTICING IN A RETAIL SETTING TO PARTICIPATE IN THE COLLECTION, SECUR-
ING, TRANSPORT OR DISPOSAL OF UNWANTED DRUGS UNLESS THE PHARMACY CERTI-
FIES, IN WRITING, THAT THIS PARTICIPATION IS VOLUNTARY.
6. (A) THE DEPARTMENT SHALL, IN CONSULTATION WITH THE DEPARTMENT OF
HEALTH AND THE OFFICE OF ALCOHOLISM AND SUBSTANCE ABUSE SERVICES PURSU-
ANT TO RULES AND REGULATIONS, DEVELOP, PURSUANT TO REGULATION, AN ALTER-
NATIVE PLAN TO THE DRUG STEWARDSHIP PROGRAM ESTABLISHED UNDER SUBDIVI-
SIONS TWO THROUGH FIVE OF THIS SECTION, INCLUSIVE. A MANUFACTURER WHO
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OPTS INTO A PLAN ESTABLISHED UNDER SUCH RULES AND REGULATIONS SHALL BE
EXEMPT FROM SUBDIVISION TWO THROUGH FIVE OF THIS SECTION, INCLUSIVE.
(B) A PLAN ESTABLISHED UNDER THIS SUBDIVISION MAY PERMIT CONTRIBUTIONS
BY MANUFACTURERS TO THE CHEMICAL DEPENDENCE SERVICE FUND ESTABLISHED IN
SECTION NINETY-SEVEN-W OF THE STATE FINANCE LAW AND THE ENVIRONMENTAL
PROTECTION FUND ESTABLISHED IN SECTION NINETY-TWO-S OF THE STATE FINANCE
LAW, IN A MANNER DETERMINED BY THE DEPARTMENT PURSUANT TO REGULATION;
PROVIDED, HOWEVER NOT MORE THAN FIFTY PERCENT OF ANY ONE CONTRIBUTION
MAY BE CONTRIBUTED TO ANY ONE FUND. A MANUFACTURER PARTICIPATING IN A
PLAN ESTABLISHED UNDER THIS SUBDIVISION SHALL NOT PASS THE COST OF ANY
CONTRIBUTION ON TO THE CONSUMER OR A HEALTH INSURANCE CARRIER.
S 2. This act shall take effect on the one hundred twentieth day after
it shall have become a law; provided, however, that effective immediate-
ly, the addition, amendment and/or repeal of any rule or regulation
necessary for the implementation of this act on its effective date are
authorized and directed to be made and completed on or before such
effective date.