NY State Assembly Bill A9576B

Archive: Last Bill Status Via S9100 - Signed by Governor

Introduced
In Committee
On Floor Calendar
- Passed Senate
- Passed Assembly
Delivered to Governor
Signed by Governor

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Actions

view actions (17)

	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jul 10, 2018	signed chap.120
Jun 28, 2018	delivered to governor
Jun 20, 2018	returned to senate passed assembly ordered to third reading rules cal.450 substituted for a9576b
Jun 20, 2018	substituted by s9100 rules report cal.450 reported
Jun 19, 2018	reported referred to rules
Jun 18, 2018	reported referred to ways and means
Jun 17, 2018	print number 9576b
Jun 17, 2018	amend and recommit to codes
May 31, 2018	reported referred to codes
Apr 24, 2018	print number 9576a
Apr 24, 2018	amend and recommit to health
Jan 23, 2018	referred to health

Votes

Bill Amendments

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B (Active)

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B (Active)

Co-Sponsors

A9576 - Details

See Senate Version of this Bill:: S9100
Law Section:: Public Health Law
Laws Affected:: Add Art 2-B §§290 - 294, amd §3343-b, Pub Health L

A9576 - Summary

Enacts the drug take back act requiring certain manufacturers to operate a drug take back program to accept and dispose of covered drugs; provides that for any city with a population of one hundred twenty-five thousand or more as of the last decennial census, the commissioner of health shall establish by regulation a distribution plan that ensures that on-site collection receptacle or dropbox placement shall be reasonably accessible to all residents.

A9576 - Bill Text download pdf


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

                                  9576

                          I N  A S S E M B L Y

                            January 23, 2018
                               ___________

Introduced  by M. of A. GUNTHER -- read once and referred to the Commit-
  tee on Health

AN ACT to amend the public health law, in relation to enacting the  drug
  take back act

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

  Section 1. This act shall be known and may be cited as the "drug  take
back act."
  §  2.  The public health law is amended by adding a new article 2-B to
read as follows:
                               ARTICLE 2-B
                             DRUG TAKE BACK
SECTION 290. DEFINITIONS.
        291. DRUG TAKE BACK.
        292. COLLECTION.
        293. VIOLATIONS.
        294. JURISDICTION.
  § 290. DEFINITIONS. AS USED IN THIS ARTICLE, UNLESS THE CONTEXT CLEAR-
LY REQUIRES OTHERWISE:
  1. "AUTHORIZED COLLECTOR" MEANS: (A) A PERSON, COMPANY, CORPORATION OR
OTHER ENTITY THAT IS REGISTERED WITH THE UNITED STATES DRUG  ENFORCEMENT
ADMINISTRATION TO COLLECT CONTROLLED SUBSTANCES FOR THE PURPOSES OF SAFE
DISPOSAL  AND  DESTRUCTION;  (B) A LAW ENFORCEMENT AGENCY; (C) A MUNICI-
PALITY; OR (D) A PERSON, COMPANY, CORPORATION OR OTHER ENTITY AUTHORIZED
BY THE DEPARTMENT TO PROVIDE ALTERNATIVE COLLECTION METHODS FOR  COVERED
DRUGS THAT ARE NOT CONTROLLED SUBSTANCES.
  2.  "COVERED  DRUG"  MEANS ANY SUBSTANCE RECOGNIZED AS A DRUG UNDER 21
USC § 321(G)(1), AS AMENDED, THAT IS SOLD, OFFERED FOR SALE OR DISPENSED
IN THE STATE, WHETHER DIRECTLY OR THROUGH  A  WHOLESALER,  IN  ANY  FORM
INCLUDING  PRESCRIPTION  AND  NONPRESCRIPTION  DRUGS,  DRUGS  IN MEDICAL
DEVICES AND COMBINATION PRODUCTS, BRAND AND GENERIC DRUGS AND DRUGS  FOR
VETERINARY  USE;  PROVIDED  HOWEVER, COVERED DRUG SHALL NOT INCLUDE: (A)
VITAMINS OR  SUPPLEMENTS;  (B)  HERBAL-BASED  REMEDIES  AND  HOMEOPATHIC
DRUGS, PRODUCTS OR REMEDIES; (C) COSMETICS, SOAP (WITH OR WITHOUT GERMI-

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets

                      [ ] is old law to be omitted.
                                                           LBD14168-02-8

A. 9576                             2

CIDAL  AGENTS),  LAUNDRY DETERGENT, BLEACH, HOUSEHOLD CLEANING PRODUCTS,
SHAMPOOS, SUNSCREENS, TOOTHPASTE, LIP  BALM,  ANTIPERSPIRANTS  OR  OTHER
PERSONAL CARE PRODUCTS THAT ARE REGULATED AS BOTH COSMETICS AND NONPRES-
CRIPTION  DRUGS  UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT; (D) PET
PESTICIDE PRODUCTS CONTAINED IN PET COLLARS, POWDERS, SHAMPOOS,  TOPICAL
APPLICATIONS,  OR OTHER FORMS; (E) DRUGS THAT ARE BIOLOGICAL PRODUCTS AS
DEFINED IN SUBDIVISION TWENTY-SEVEN OF SECTION SIXTY-EIGHT  HUNDRED  TWO
OF  THE  EDUCATION  LAW IF THE MANUFACTURER ALREADY PROVIDES A TAKE BACK
PROGRAM; (F) DRUGS FOR WHICH A MANUFACTURER PROVIDES A TAKE BACK PROGRAM
AS PART OF A FEDERAL FOOD AND DRUG ADMINISTRATION  MANAGED  RISK  EVALU-
ATION AND MITIGATION STRATEGY; (G) MEDICAL DEVICES OR THE COMPONENT PART
OF SUCH DEVICES OR ACCESSORIES IF SUCH DEVICE OR COMPONENT PART CONTAINS
NO  COVERED  DRUG;  AND  (H)  DRUGS  THAT  ARE USED SOLELY IN A CLINICAL
SETTING.
  3. "MANUFACTURER" MEANS A PERSON, COMPANY, CORPORATION OR OTHER ENTITY
ENGAGED IN THE MANUFACTURE OF DRUGS SOLD IN THE STATE.
  4. "PHARMACIES" MEANS ALL PHARMACIES REGISTERED UNDER  SECTION  SIXTY-
EIGHT HUNDRED EIGHT OF THE EDUCATION LAW THAT ARE PART OF A GROUP OF TEN
OR  MORE  ESTABLISHMENTS  THAT  CONDUCT BUSINESS UNDER THE SAME NAME, OR
OPERATE UNDER A COMMON OWNERSHIP OR MANAGEMENT, OR PURSUANT TO  A  FRAN-
CHISE AGREEMENT WITH THE SAME FRANCHISOR, AND ALL NONRESIDENT PHARMACIES
REGISTERED PURSUANT TO SECTION SIXTY-EIGHT HUNDRED EIGHT-B OF THE EDUCA-
TION LAW THAT PROVIDE COVERED DRUGS TO STATE RESIDENTS BY MAIL.
  5. "DRUG TAKE BACK ORGANIZATION" MEANS AN ORGANIZATION DESIGNATED BY A
MANUFACTURER OR A GROUP OF MANUFACTURERS TO ACT AS AN AGENT ON BEHALF OF
THE  MANUFACTURER  OR  GROUP OF MANUFACTURERS TO OPERATE AND IMPLEMENT A
DRUG TAKE BACK PROGRAM AS AUTHORIZED BY THIS ARTICLE.
  6. "WHOLESALER" MEANS ANY PERSON, COMPANY, CORPORATION OR OTHER ENTITY
THAT SELLS OR DISTRIBUTES DRUGS AND COVERED DRUGS FOR RESALE TO AN ENTI-
TY IN THE STATE OTHER THAN A CONSUMER.
  § 291. DRUG TAKE BACK. 1. ANY MANUFACTURER OF A COVERED DRUG SHALL:
  (A) OPERATE A DRUG TAKE BACK PROGRAM APPROVED BY THE DEPARTMENT  INDI-
VIDUALLY OR JOINTLY WITH OTHER MANUFACTURERS;
  (B)  ENTER  INTO AN AGREEMENT WITH A DRUG TAKE BACK ORGANIZATION WHICH
SHALL OPERATE A DRUG TAKE BACK PROGRAM APPROVED BY THE DEPARTMENT; OR
  (C) ENTER INTO AN AGREEMENT WITH THE DEPARTMENT TO OPERATE A DRUG TAKE
BACK PROGRAM ON ITS BEHALF.
  2. ANY MANUFACTURER OF A COVERED DRUG, INDIVIDUALLY OR JOINTLY,  OR  A
DRUG  TAKE  BACK  ORGANIZATION CONTRACTED BY A MANUFACTURER OF A COVERED
DRUG SHALL WITHIN ONE HUNDRED EIGHTY DAYS FROM  THE  EFFECTIVE  DATE  OF
THIS  SECTION  SUBMIT TO THE DEPARTMENT, IN A MANNER AND FORM DETERMINED
BY THE DEPARTMENT, A PROPOSED DRUG TAKE BACK PROGRAM THAT  MEETS,  AT  A
MINIMUM, THE FOLLOWING REQUIREMENTS:
  (A) CERTIFIES THE DRUG TAKE BACK PROGRAM WILL ACCEPT ALL COVERED DRUGS
REGARDLESS OF WHO PRODUCED THEM;
  (B) PROVIDES CONTACT INFORMATION FOR THE PERSON SUBMITTING THE PLANNED
DRUG  TAKE  BACK  PROGRAM  WITH  WHOM  THE  DEPARTMENT  SHALL DIRECT ALL
INQUIRIES;
  (C) DETAILS A PHARMACY COLLECTION SYSTEM TO PROVIDE CONVENIENT,  ONGO-
ING  COLLECTION  SERVICES  TO  ALL PERSONS SEEKING TO DISPOSE OF COVERED
DRUGS PURSUANT TO SECTION TWO HUNDRED NINETY-TWO OF THIS ARTICLE;
  (D) DESCRIBES OTHER COLLECTION METHODS BY WHICH COVERED DRUGS WILL  BE
COLLECTED BY AUTHORIZED COLLECTORS;
  (E) EXPLAINS HOW COVERED DRUGS WILL BE SAFELY AND SECURELY TRACKED AND
HANDLED FROM COLLECTION THROUGH FINAL DISPOSAL AND DESTRUCTION, POLICIES
TO  ENSURE  SECURITY  AND  COMPLIANCE WITH ALL APPLICABLE LAWS AND REGU-

A. 9576                             3

LATIONS INCLUDING DISPOSAL AND  DESTRUCTION  AT  A  PERMITTED  HAZARDOUS
WASTE DISPOSAL FACILITY MEETING FEDERAL REQUIREMENTS;
  (F)  DESCRIBES  THE PUBLIC EDUCATION AND OUTREACH ACTIVITIES THAT WILL
BE UNDERTAKEN WHICH SHALL INCLUDE ADVERTISING OF COLLECTION LOCATIONS ON
A WEBSITE AND THROUGH USE OF SIGNAGE AND OTHER  WRITTEN  MATERIALS,  AND
HOW EFFECTIVENESS WILL BE EVALUATED;
  (G)  DETAILS HOW THE COSTS OF PHARMACY COLLECTION AND OTHER AUTHORIZED
COLLECTORS WILL BE REIMBURSED WHICH SHALL INCLUDE COSTS  RETROACTIVE  TO
THE EFFECTIVE DATE OF THIS ARTICLE, AND WHERE MORE THAN ONE MANUFACTURER
WILL  BE  INVOLVED IN THE PLANNED DRUG TAKE BACK PROGRAM, A PLAN FOR THE
FAIR AND REASONABLE MANNER OF ALLOCATED COSTS AMONG THE PARTICIPANTS  IN
SUCH PROGRAM SUCH THAT THE COSTS PAID BY EACH MANUFACTURER IS REASONABLY
RELATED TO THE NUMBER OR VALUE OF COVERED DRUGS SOLD IN THE STATE; AND
  (H) PROVIDES ANY FURTHER INFORMATION DEEMED APPROPRIATE BY THE DEPART-
MENT.
  3.  WITHIN  THIRTY  DAYS  OF  THE EFFECTIVE DATE OF THIS SECTION, EACH
WHOLESALER THAT SELLS COVERED DRUGS IN OR INTO THE STATE  SHALL  PROVIDE
THE  DEPARTMENT WITH A LIST OF MANUFACTURERS THAT PRODUCE COVERED DRUGS.
THE DEPARTMENT MAY REQUEST UPDATED LISTS AT ITS DISCRETION.
  4. A MANUFACTURER, INDIVIDUALLY OR JOINTLY, MUST PAY  ALL  ADMINISTRA-
TIVE  AND  OPERATIONAL  FEES ASSOCIATED WITH THE DRUG TAKE BACK PROGRAM,
INCLUDING THE COST OF COLLECTING, TRANSPORTING AND DISPOSING OF  COVERED
DRUGS  FROM PHARMACIES AND OTHER AUTHORIZED COLLECTORS AND THE RECYCLING
OR DISPOSAL, OR BOTH,  OF  PACKING  COLLECTED  WITH  THE  COVERED  DRUG.
MANUFACTURERS SHALL ALSO PAY COSTS INCURRED BY THE STATE IN THE ADMINIS-
TRATION  AND  ENFORCEMENT  OF  THE DRUG TAKE BACK PROGRAM.  EXCLUSIVE OF
FINES AND PENALTIES, THE STATE SHALL ONLY RECOVER  ITS  ACTUAL  COST  OF
ADMINISTRATION AND ENFORCEMENT. IN INSTANCES WHERE MANUFACTURERS JOINTLY
CONDUCT  A  DRUG  TAKE  BACK  PROGRAM,  THE  COSTS OF ADMINISTRATION AND
ENFORCEMENT SHALL BE FAIRLY  AND  REASONABLY  ALLOCATED  SUCH  THAT  THE
PORTION OF COSTS IS REASONABLY RELATED TO THE NUMBER OR VALUE OF COVERED
DRUGS  THE MANUFACTURERS SELL IN THE STATE. NO MANUFACTURER MAY CHARGE A
POINT-OF-SALE OR OTHER FEE TO CONSUMERS, OR A FEE THAT COULD  BE  PASSED
ON TO CONSUMERS, TO RECOUP THE COST OF THEIR DRUG TAKE BACK PROGRAM.
  5.  WITHIN SIXTY DAYS OF RECEIPT OF A PROPOSED DRUG TAKE BACK PROGRAM,
THE DEPARTMENT, IN CONSULTATION WITH  THE  DEPARTMENT  OF  ENVIRONMENTAL
CONSERVATION,  SHALL  DETERMINE  WHETHER  SUCH  PROPOSED  DRUG TAKE BACK
PROGRAM COMPLIES WITH THE REQUIREMENTS OF THIS ARTICLE  AND  NOTIFY  THE
APPLICANT.  THE DEPARTMENT MAY CONDUCT A NOTICED PUBLIC HEARING PRIOR TO
APPROVAL. IF THE DRUG TAKE BACK  PROGRAM  IS  APPROVED,  THE  DEPARTMENT
SHALL  NOTIFY THE APPLICANT IN WRITING. IF THE DRUG TAKE BACK PROGRAM IS
NOT APPROVED, THE DEPARTMENT SHALL NOTIFY THE APPLICANT IN  WRITING  AND
THE  APPLICANT  SHALL  SUBMIT  A REVISED DRUG TAKE BACK PROGRAM PROPOSAL
WITHIN THIRTY DAYS.  IF THE DEPARTMENT REJECTS THE SUBSEQUENT  PROPOSAL,
THE  MANUFACTURER  OR  MANUFACTURERS AT ISSUE SHALL BE OUT OF COMPLIANCE
WITH THIS ARTICLE AND SUBJECT TO THE ENFORCEMENT PROVISIONS PURSUANT  TO
SECTION  TWO  HUNDRED  NINETY-FOUR OF THIS ARTICLE. THE DEPARTMENT SHALL
PROVIDE, AND UPDATE ANNUALLY, ON ITS WEBSITE A LIST OF ALL MANUFACTURERS
PARTICIPATING IN A DRUG TAKE BACK PROGRAM APPROVED BY THE DEPARTMENT.
  6. AT LEAST EVERY THREE YEARS, A MANUFACTURER, JOINTLY OR  INDIVIDUAL-
LY,  OR  A  DRUG  TAKE BACK ORGANIZATION SHALL UPDATE ITS DRUG TAKE BACK
PROGRAM AND SUBMIT AN UPDATED PROPOSAL TO THE DEPARTMENT. A MANUFACTURER
WHO BEGINS TO OFFER A COVERED DRUG IN THE STATE AFTER THE EFFECTIVE DATE
OF THIS ARTICLE, SHALL PROVIDE EVIDENCE OF JOINING AN EXISTING  APPROVED
DRUG TAKE BACK PROGRAM OR SUBMIT A PROPOSAL FOR A DRUG TAKE BACK PROGRAM
WITHIN  NINETY  DAYS  FOLLOWING  THE INITIAL OFFER FOR SALE OF A COVERED

A. 9576                             4

DRUG. ANY PROPOSED CHANGE TO A DRUG TAKE BACK PROGRAM SHALL BE SUBMITTED
IN WRITING AND APPROVED BY THE DEPARTMENT PRIOR TO ANY CHANGE.
  7. EACH APPROVED DRUG TAKE BACK PROGRAM SHALL REPORT TO THE DEPARTMENT
AT  A DATE AND MANNER SET BY THE DEPARTMENT. THE DEPARTMENT SHALL SUBMIT
AN ANNUAL REPORT TO THE GOVERNOR, SPEAKER OF THE ASSEMBLY AND  TEMPORARY
PRESIDENT  OF  THE  SENATE BY JANUARY FIRST DETAILING ALL PROGRAM ACTIV-
ITIES, THE VOLUME COLLECTED BY EACH PROGRAM, A DESCRIPTION OF COLLECTION
ACTIVITIES, THE NAME AND LOCATION OF ALL COLLECTION SITES, PUBLIC EDUCA-
TION AND OUTREACH ACTIVITIES, AND ANY MANUFACTURER OUT OF COMPLIANCE  OR
SUBJECT TO PENALTIES PURSUANT TO SECTION TWO HUNDRED NINETY-FOUR OF THIS
ARTICLE.
  §  292.  COLLECTION.  1.  ALL  PHARMACIES  SHALL  PROVIDE FOR THE SAFE
COLLECTION OF DRUGS, WHICH SHALL INCLUDE:
  (A) OFFERING DRUG COLLECTION BY:
  (I) ON-SITE COLLECTION RECEPTACLES MEETING FEDERAL STANDARDS;
  (II) MAIL-BACK COLLECTION BY PREPAID ENVELOPES AS AUTHORIZED BY FEDER-
AL LAW AND REGULATION; OR
  (III) OTHER  FEDERAL  DRUG  ENFORCEMENT  AGENCY  APPROVED  METHODS  OF
COLLECTION.
  (B)  SIGNAGE PROMINENTLY DISPLAYED ADVERTISING SUCH DRUG COLLECTION TO
CONSUMERS.
  2. ALL DRUG TAKE BACK PROGRAM OPERATORS SHALL NOTIFY  OTHER  POTENTIAL
AUTHORIZED  COLLECTORS  OF  THE  OPPORTUNITY  TO  SERVE AS AN AUTHORIZED
COLLECTOR FOR THE DRUG TAKE BACK PROGRAM.  PARTICIPATION  OF  AUTHORIZED
COLLECTORS BESIDES PHARMACIES SHALL BE VOLUNTARY.
  3.  ALL  COSTS  OF PHARMACIES AND OTHER AUTHORIZED COLLECTORS SHALL BE
PAID OR REIMBURSED BY THE MANUFACTURER, JOINTLY OR INDIVIDUALLY, AS PART
OF THE DRUG TAKE BACK PROGRAMS REQUIRED BY THIS ARTICLE.
  § 293. VIOLATIONS. VIOLATION OF THIS ARTICLE SHALL BE SUBJECT TO FINES
PURSUANT TO SECTION TWELVE OF  THIS  CHAPTER.  EACH  DAY  IN  WHICH  THE
VIOLATION CONTINUES SHALL CONSTITUTE A SEPARATE VIOLATION.
  §  294.  JURISDICTION.  JURISDICTION OF ALL MATTERS PERTAINING TO DRUG
DISPOSAL BY THIS  ARTICLE  IS  VESTED  EXCLUSIVELY  IN  THE  STATE.  ANY
PROVISION  OF  ANY  LOCAL  LAW  OR  ORDINANCE, OR ANY RULE OR REGULATION
PROMULGATED PRIOR TO, OR UPON THE EFFECTIVE DATE OF THIS SECTION,  SHALL
BE PREEMPTED.
  §  3.  Section  3343-b of the public health law, as amended by chapter
379 of the laws of 2015, is amended to read as follows:
  § 3343-b. Safe  disposal  of  unused  controlled  substances.  1.  The
department  shall  oversee  a  program  for  the safe disposal of unused
controlled substances by consumers in accordance with  federal  law  AND
ARTICLE  TWO-B  OF THIS CHAPTER.  Individual members of the public shall
be authorized to voluntarily surrender controlled substances  listed  on
schedule  II,  III,  IV or V of section thirty-three hundred six of this
article  in  a  secure  manner,  without  identifying  themselves.  Safe
disposal  methods  shall  be publicized consistent with the prescription
pain medication awareness program established pursuant to section  thir-
ty-three  hundred nine-a of this article AND ARTICLE TWO-B OF THIS CHAP-
TER.
  2. The surrender of a controlled substance pursuant  to  this  section
AND  ARTICLE  TWO-B OF THIS CHAPTER shall not constitute the possession,
transfer or sale of such controlled substance for purposes of this arti-
cle or the penal law.
  [3. Disposal sites shall be  operated  by  law  enforcement  agencies,
pharmacies  and other Federal Drug Enforcement Administration authorized
collectors on a voluntary basis. Nothing in this section  shall  require

A. 9576                             5

any  political  subdivision  of  the state to participate in the program
established in this section.]
  §  4.  The  department of health may adopt regulations as necessary to
implement and enforce the provisions of this title.
  § 5. This act shall take effect immediately; provided,  however,  that
the amendments to subdivision 1 of section 292 of the public health law,
as  added  by  section  two  of  this  act, shall take effect on the one
hundred eightieth day after it shall have become a law.

Co-Sponsors

view additional co-sponsors

Multi-Sponsors

A9576A - Details

See Senate Version of this Bill:: S9100
Law Section:: Public Health Law
Laws Affected:: Add Art 2-B §§290 - 294, amd §3343-b, Pub Health L

A9576A - Summary

A9576A - Bill Text download pdf


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

                                 9576--A

                          I N  A S S E M B L Y

                            January 23, 2018
                               ___________

Introduced  by  M.  of  A.  GUNTHER,  THIELE, ORTIZ, ENGLEBRIGHT, STECK,
  SEPULVEDA, STIRPE, HUNTER, COLTON, PELLEGRINO, PHEFFER AMATO,  BRINDI-
  SI,  CURRAN,  ABINANTI,  DE LA ROSA,  GALEF, FAHY, MAGNARELLI, LIFTON,
  JAFFEE, HYNDMAN -- read once and referred to the Committee  on  Health
  --  committee  discharged,  bill amended, ordered reprinted as amended
  and recommitted to said committee

AN ACT to amend the public health law, in relation to enacting the  drug
  take back act

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

  Section 1. This act shall be known and may be cited as the "drug  take
back act."
  §  2.  The public health law is amended by adding a new article 2-B to
read as follows:
                               ARTICLE 2-B
                             DRUG TAKE BACK
SECTION 290. DEFINITIONS.
        291. DRUG TAKE BACK.
        292. COLLECTION.
        293. VIOLATIONS.
        294. JURISDICTION.
  § 290. DEFINITIONS. AS USED IN THIS ARTICLE, UNLESS THE CONTEXT CLEAR-
LY REQUIRES OTHERWISE:
  1. "AUTHORIZED COLLECTOR" MEANS: (A) A PERSON, COMPANY, CORPORATION OR
OTHER ENTITY THAT IS REGISTERED WITH THE UNITED STATES DRUG  ENFORCEMENT
ADMINISTRATION TO COLLECT CONTROLLED SUBSTANCES FOR THE PURPOSES OF SAFE
DISPOSAL AND DESTRUCTION; (B) A LAW ENFORCEMENT AGENCY; OR (C) A PERSON,
COMPANY,  CORPORATION  OR  OTHER  ENTITY AUTHORIZED BY THE DEPARTMENT TO
PROVIDE ALTERNATIVE COLLECTION METHODS FOR COVERED DRUGS  THAT  ARE  NOT
CONTROLLED SUBSTANCES.
  2.  "COVERED  DRUG"  MEANS ANY SUBSTANCE RECOGNIZED AS A DRUG UNDER 21
USC § 321(G)(1), AS AMENDED, THAT IS SOLD, OFFERED FOR SALE OR DISPENSED
IN THE STATE, WHETHER DIRECTLY OR THROUGH  A  WHOLESALER,  IN  ANY  FORM
INCLUDING  PRESCRIPTION  AND  NONPRESCRIPTION  DRUGS,  DRUGS  IN MEDICAL

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets

                      [ ] is old law to be omitted.
                                                           LBD14168-03-8

A. 9576--A                          2

DEVICES AND COMBINATION PRODUCTS, BRAND AND GENERIC DRUGS AND DRUGS  FOR
VETERINARY  USE;  PROVIDED  HOWEVER, COVERED DRUG SHALL NOT INCLUDE: (A)
VITAMINS OR  SUPPLEMENTS;  (B)  HERBAL-BASED  REMEDIES  AND  HOMEOPATHIC
DRUGS, PRODUCTS OR REMEDIES; (C) COSMETICS, SOAP (WITH OR WITHOUT GERMI-
CIDAL  AGENTS),  LAUNDRY DETERGENT, BLEACH, HOUSEHOLD CLEANING PRODUCTS,
SHAMPOOS, SUNSCREENS, TOOTHPASTE, LIP  BALM,  ANTIPERSPIRANTS  OR  OTHER
PERSONAL CARE PRODUCTS THAT ARE REGULATED AS BOTH COSMETICS AND NONPRES-
CRIPTION  DRUGS  UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT; (D) PET
PESTICIDE PRODUCTS CONTAINED IN PET COLLARS, POWDERS, SHAMPOOS,  TOPICAL
APPLICATIONS,  OR OTHER FORMS; (E) DRUGS THAT ARE BIOLOGICAL PRODUCTS AS
DEFINED IN SUBDIVISION TWENTY-SEVEN OF SECTION SIXTY-EIGHT  HUNDRED  TWO
OF  THE  EDUCATION  LAW IF THE MANUFACTURER ALREADY PROVIDES A TAKE BACK
PROGRAM; (F) DRUGS FOR WHICH A MANUFACTURER PROVIDES A TAKE BACK PROGRAM
AS PART OF A FEDERAL FOOD AND DRUG ADMINISTRATION  MANAGED  RISK  EVALU-
ATION AND MITIGATION STRATEGY; (G) MEDICAL DEVICES OR THE COMPONENT PART
OF SUCH DEVICES OR ACCESSORIES IF SUCH DEVICE OR COMPONENT PART CONTAINS
NO  COVERED  DRUG;  AND  (H)  DRUGS  THAT  ARE USED SOLELY IN A CLINICAL
SETTING.
  3. "MANUFACTURER" MEANS A PERSON, COMPANY, CORPORATION OR OTHER ENTITY
ENGAGED IN THE MANUFACTURE OF DRUGS SOLD IN THE STATE.
  4. "PHARMACIES" MEANS ALL PHARMACIES REGISTERED UNDER  SECTION  SIXTY-
EIGHT HUNDRED EIGHT OF THE EDUCATION LAW THAT ARE PART OF A GROUP OF TEN
OR  MORE  ESTABLISHMENTS  THAT  CONDUCT BUSINESS UNDER THE SAME NAME, OR
OPERATE UNDER A COMMON OWNERSHIP OR MANAGEMENT, OR PURSUANT TO  A  FRAN-
CHISE AGREEMENT WITH THE SAME FRANCHISOR, AND ALL NONRESIDENT PHARMACIES
REGISTERED PURSUANT TO SECTION SIXTY-EIGHT HUNDRED EIGHT-B OF THE EDUCA-
TION LAW THAT PROVIDE COVERED DRUGS TO STATE RESIDENTS BY MAIL.
  5. "DRUG TAKE BACK ORGANIZATION" MEANS AN ORGANIZATION DESIGNATED BY A
MANUFACTURER OR A GROUP OF MANUFACTURERS TO ACT AS AN AGENT ON BEHALF OF
THE  MANUFACTURER  OR  GROUP OF MANUFACTURERS TO OPERATE AND IMPLEMENT A
DRUG TAKE BACK PROGRAM AS AUTHORIZED BY THIS ARTICLE.
  6. "WHOLESALER" MEANS ANY PERSON, COMPANY, CORPORATION OR OTHER ENTITY
THAT SELLS OR DISTRIBUTES DRUGS AND COVERED DRUGS FOR RESALE TO AN ENTI-
TY IN THE STATE OTHER THAN A CONSUMER.
  § 291. DRUG TAKE BACK. 1. ANY MANUFACTURER OF A COVERED DRUG SHALL:
  (A) OPERATE A DRUG TAKE BACK PROGRAM APPROVED BY THE DEPARTMENT  INDI-
VIDUALLY OR JOINTLY WITH OTHER MANUFACTURERS;
  (B)  ENTER  INTO AN AGREEMENT WITH A DRUG TAKE BACK ORGANIZATION WHICH
SHALL OPERATE A DRUG TAKE BACK PROGRAM APPROVED BY THE DEPARTMENT; OR
  (C) ENTER INTO AN AGREEMENT WITH THE DEPARTMENT TO OPERATE A DRUG TAKE
BACK PROGRAM ON ITS BEHALF.
  2. ANY MANUFACTURER OF A COVERED DRUG, INDIVIDUALLY OR JOINTLY,  OR  A
DRUG  TAKE  BACK  ORGANIZATION CONTRACTED BY A MANUFACTURER OF A COVERED
DRUG SHALL WITHIN ONE HUNDRED EIGHTY DAYS FROM  THE  EFFECTIVE  DATE  OF
THIS  SECTION  SUBMIT TO THE DEPARTMENT, IN A MANNER AND FORM DETERMINED
BY THE DEPARTMENT, A PROPOSED DRUG TAKE BACK PROGRAM THAT  MEETS,  AT  A
MINIMUM, THE FOLLOWING REQUIREMENTS:
  (A) CERTIFIES THE DRUG TAKE BACK PROGRAM WILL ACCEPT ALL COVERED DRUGS
REGARDLESS OF WHO PRODUCED THEM;
  (B) PROVIDES CONTACT INFORMATION FOR THE PERSON SUBMITTING THE PLANNED
DRUG  TAKE  BACK  PROGRAM  WITH  WHOM  THE  DEPARTMENT  SHALL DIRECT ALL
INQUIRIES;
  (C)  DETAILS  A  COLLECTION  SYSTEM  TO  PROVIDE  CONVENIENT,  ONGOING
COLLECTION  SERVICES  TO ALL PERSONS SEEKING TO DISPOSE OF COVERED DRUGS
PURSUANT TO SECTION TWO HUNDRED NINETY-TWO OF THIS ARTICLE;

A. 9576--A                          3

  (D) DESCRIBES OTHER COLLECTION METHODS BY WHICH COVERED DRUGS WILL  BE
COLLECTED BY AUTHORIZED COLLECTORS;
  (E) EXPLAINS HOW COVERED DRUGS WILL BE SAFELY AND SECURELY TRACKED AND
HANDLED FROM COLLECTION THROUGH FINAL DISPOSAL AND DESTRUCTION, POLICIES
TO  ENSURE  SECURITY  AND  COMPLIANCE WITH ALL APPLICABLE LAWS AND REGU-
LATIONS INCLUDING DISPOSAL AND DESTRUCTION AT A PERMITTED WASTE DISPOSAL
FACILITY MEETING FEDERAL REQUIREMENTS;
  (F) DESCRIBES THE PUBLIC EDUCATION AND OUTREACH ACTIVITIES  THAT  WILL
BE UNDERTAKEN WHICH SHALL INCLUDE ADVERTISING OF COLLECTION LOCATIONS ON
A  WEBSITE  AND  THROUGH USE OF SIGNAGE AND OTHER WRITTEN MATERIALS, AND
HOW EFFECTIVENESS WILL BE EVALUATED;
  (G) DETAILS HOW THE COSTS OF PHARMACY COLLECTION AND OTHER  AUTHORIZED
COLLECTORS  WILL  BE REIMBURSED WHICH SHALL INCLUDE COSTS RETROACTIVE TO
THE EFFECTIVE DATE OF THIS ARTICLE, AND WHERE MORE THAN ONE MANUFACTURER
WILL BE INVOLVED IN THE PLANNED DRUG TAKE BACK PROGRAM, A PLAN  FOR  THE
FAIR  AND REASONABLE MANNER OF ALLOCATED COSTS AMONG THE PARTICIPANTS IN
SUCH PROGRAM SUCH THAT THE COSTS PAID BY EACH MANUFACTURER IS REASONABLY
RELATED TO THE NUMBER OR VALUE OF COVERED DRUGS SOLD IN THE STATE; AND
  (H) PROVIDES ANY FURTHER INFORMATION DEEMED APPROPRIATE BY THE DEPART-
MENT.
  3. WITHIN THIRTY DAYS OF THE EFFECTIVE  DATE  OF  THIS  SECTION,  EACH
WHOLESALER  THAT  SELLS COVERED DRUGS IN OR INTO THE STATE SHALL PROVIDE
THE DEPARTMENT WITH A LIST OF MANUFACTURERS THAT PRODUCE COVERED  DRUGS.
THE DEPARTMENT MAY REQUEST UPDATED LISTS AT ITS DISCRETION.
  4.  A  MANUFACTURER, INDIVIDUALLY OR JOINTLY, MUST PAY ALL ADMINISTRA-
TIVE AND OPERATIONAL FEES ASSOCIATED WITH THE DRUG  TAKE  BACK  PROGRAM,
INCLUDING  THE COST OF COLLECTING, TRANSPORTING AND DISPOSING OF COVERED
DRUGS FROM PHARMACIES AND OTHER AUTHORIZED COLLECTORS AND THE  RECYCLING
OR  DISPOSAL,  OR  BOTH,  OF  PACKING  COLLECTED  WITH THE COVERED DRUG.
MANUFACTURERS SHALL ALSO PAY COSTS INCURRED BY THE STATE IN THE ADMINIS-
TRATION AND ENFORCEMENT OF THE DRUG TAKE BACK  PROGRAM.    EXCLUSIVE  OF
FINES  AND  PENALTIES,  THE  STATE SHALL ONLY RECOVER ITS ACTUAL COST OF
ADMINISTRATION AND ENFORCEMENT. IN INSTANCES WHERE MANUFACTURERS JOINTLY
CONDUCT A DRUG TAKE  BACK  PROGRAM,  THE  COSTS  OF  ADMINISTRATION  AND
ENFORCEMENT  SHALL  BE  FAIRLY  AND  REASONABLY  ALLOCATED SUCH THAT THE
PORTION OF COSTS IS REASONABLY RELATED TO THE NUMBER OR VALUE OF COVERED
DRUGS THE MANUFACTURERS SELL IN THE STATE. NO MANUFACTURER MAY CHARGE  A
POINT-OF-SALE  OR  OTHER FEE TO CONSUMERS, OR A FEE THAT COULD BE PASSED
ON TO CONSUMERS, TO RECOUP THE COST OF THEIR DRUG TAKE BACK PROGRAM.
  5. WITHIN SIXTY DAYS OF RECEIPT OF A PROPOSED DRUG TAKE BACK  PROGRAM,
THE  DEPARTMENT,  IN  CONSULTATION  WITH THE DEPARTMENT OF ENVIRONMENTAL
CONSERVATION, SHALL DETERMINE  WHETHER  SUCH  PROPOSED  DRUG  TAKE  BACK
PROGRAM  COMPLIES  WITH  THE REQUIREMENTS OF THIS ARTICLE AND NOTIFY THE
APPLICANT. THE DEPARTMENT MAY CONDUCT A NOTICED PUBLIC HEARING PRIOR  TO
APPROVAL.  IF  THE  DRUG  TAKE  BACK PROGRAM IS APPROVED, THE DEPARTMENT
SHALL NOTIFY THE APPLICANT IN WRITING. IF THE DRUG TAKE BACK PROGRAM  IS
NOT  APPROVED,  THE DEPARTMENT SHALL NOTIFY THE APPLICANT IN WRITING AND
THE APPLICANT SHALL SUBMIT A REVISED DRUG  TAKE  BACK  PROGRAM  PROPOSAL
WITHIN  THIRTY DAYS.  IF THE DEPARTMENT REJECTS THE SUBSEQUENT PROPOSAL,
THE MANUFACTURER OR MANUFACTURERS AT ISSUE SHALL BE  OUT  OF  COMPLIANCE
WITH  THIS ARTICLE AND SUBJECT TO THE ENFORCEMENT PROVISIONS PURSUANT TO
SECTION TWO HUNDRED NINETY-FOUR OF THIS ARTICLE.  THE  DEPARTMENT  SHALL
PROVIDE, AND UPDATE ANNUALLY, ON ITS WEBSITE A LIST OF ALL MANUFACTURERS
PARTICIPATING IN A DRUG TAKE BACK PROGRAM APPROVED BY THE DEPARTMENT.
  6.  AT LEAST EVERY THREE YEARS, A MANUFACTURER, JOINTLY OR INDIVIDUAL-
LY, OR A DRUG TAKE BACK ORGANIZATION SHALL UPDATE  ITS  DRUG  TAKE  BACK

A. 9576--A                          4

PROGRAM AND SUBMIT AN UPDATED PROPOSAL TO THE DEPARTMENT. A MANUFACTURER
WHO BEGINS TO OFFER A COVERED DRUG IN THE STATE AFTER THE EFFECTIVE DATE
OF  THIS ARTICLE, SHALL PROVIDE EVIDENCE OF JOINING AN EXISTING APPROVED
DRUG TAKE BACK PROGRAM OR SUBMIT A PROPOSAL FOR A DRUG TAKE BACK PROGRAM
WITHIN  NINETY  DAYS  FOLLOWING  THE INITIAL OFFER FOR SALE OF A COVERED
DRUG. ANY PROPOSED CHANGE TO A DRUG TAKE BACK PROGRAM SHALL BE SUBMITTED
IN WRITING AND APPROVED BY THE DEPARTMENT PRIOR TO ANY CHANGE.
  7. EACH APPROVED DRUG TAKE BACK PROGRAM SHALL REPORT TO THE DEPARTMENT
AT A DATE AND MANNER SET BY THE DEPARTMENT. THE DEPARTMENT SHALL  SUBMIT
AN  ANNUAL REPORT TO THE GOVERNOR, SPEAKER OF THE ASSEMBLY AND TEMPORARY
PRESIDENT OF THE SENATE BY JANUARY FIRST DETAILING  ALL  PROGRAM  ACTIV-
ITIES, THE WEIGHT COLLECTED BY EACH PROGRAM, A DESCRIPTION OF COLLECTION
ACTIVITIES, THE NAME AND LOCATION OF ALL COLLECTION SITES, PUBLIC EDUCA-
TION  AND OUTREACH ACTIVITIES, AND ANY MANUFACTURER OUT OF COMPLIANCE OR
SUBJECT TO PENALTIES PURSUANT TO SECTION TWO HUNDRED NINETY-FOUR OF THIS
ARTICLE.
  § 292. COLLECTION. 1.  ALL  PHARMACIES  SHALL  PROVIDE  FOR  THE  SAFE
COLLECTION OF DRUGS, WHICH SHALL INCLUDE:
  (A) OFFERING DRUG COLLECTION BY:
  (I)  ON-SITE COLLECTION, DROPBOX, OR RECEPTACLE MEETING FEDERAL STAND-
ARDS;
  (II) MAIL-BACK COLLECTION BY PREPAID ENVELOPES AS AUTHORIZED BY FEDER-
AL LAW AND REGULATION; OR
  (III) OTHER  FEDERAL  DRUG  ENFORCEMENT  AGENCY  APPROVED  METHODS  OF
COLLECTION.
  (B)  SIGNAGE PROMINENTLY DISPLAYED ADVERTISING SUCH DRUG COLLECTION TO
CONSUMERS.
  2. ALL DRUG TAKE BACK PROGRAM OPERATORS SHALL NOTIFY  OTHER  POTENTIAL
AUTHORIZED  COLLECTORS  OF  THE  OPPORTUNITY  TO  SERVE AS AN AUTHORIZED
COLLECTOR FOR THE DRUG TAKE BACK PROGRAM.  PARTICIPATION  OF  AUTHORIZED
COLLECTORS BESIDES PHARMACIES SHALL BE VOLUNTARY.
  3.  ALL  COSTS  OF PHARMACIES AND OTHER AUTHORIZED COLLECTORS SHALL BE
PAID OR REIMBURSED BY THE MANUFACTURER, JOINTLY OR INDIVIDUALLY, AS PART
OF THE DRUG TAKE BACK PROGRAMS REQUIRED BY THIS ARTICLE.
  § 293. VIOLATIONS. VIOLATION OF THIS ARTICLE SHALL BE SUBJECT TO FINES
PURSUANT TO SECTION TWELVE OF  THIS  CHAPTER.  EACH  DAY  IN  WHICH  THE
VIOLATION CONTINUES SHALL CONSTITUTE A SEPARATE VIOLATION.
  §  294.  JURISDICTION.  JURISDICTION OF ALL MATTERS PERTAINING TO DRUG
DISPOSAL BY THIS  ARTICLE  IS  VESTED  EXCLUSIVELY  IN  THE  STATE.  ANY
PROVISION  OF  ANY  LOCAL  LAW  OR  ORDINANCE, OR ANY RULE OR REGULATION
PROMULGATED PRIOR TO, OR UPON THE EFFECTIVE DATE OF THIS SECTION,  SHALL
BE PREEMPTED.
  §  3.  Section  3343-b of the public health law, as amended by chapter
379 of the laws of 2015, is amended to read as follows:
  § 3343-b. Safe  disposal  of  unused  controlled  substances.  1.  The
department  shall  oversee  a  program  for  the safe disposal of unused
controlled substances by consumers in accordance with  federal  law  AND
ARTICLE  TWO-B  OF THIS CHAPTER.  Individual members of the public shall
be authorized to voluntarily surrender controlled substances  listed  on
schedule  II,  III,  IV or V of section thirty-three hundred six of this
article  in  a  secure  manner,  without  identifying  themselves.  Safe
disposal  methods  shall  be publicized consistent with the prescription
pain medication awareness program established pursuant to section  thir-
ty-three  hundred nine-a of this article AND ARTICLE TWO-B OF THIS CHAP-
TER.

A. 9576--A                          5

  2. The surrender of a controlled substance pursuant  to  this  section
AND  ARTICLE  TWO-B OF THIS CHAPTER shall not constitute the possession,
transfer or sale of such controlled substance for purposes of this arti-
cle or the penal law.
  [3.  Disposal  sites  shall  be  operated by law enforcement agencies,
pharmacies and other Federal Drug Enforcement Administration  authorized
collectors  on  a voluntary basis. Nothing in this section shall require
any political subdivision of the state to  participate  in  the  program
established in this section.]
  §  4.  The  department of health may adopt regulations as necessary to
implement and enforce the provisions of this title.
  § 5. This act shall take effect immediately; provided,  however,  that
subdivision  1  of  section  292  of  the public health law, as added by
section two of this act, shall take effect on the one hundred  eightieth
day after it shall have become a law.

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A9576B (ACTIVE) - Details

See Senate Version of this Bill:: S9100
Law Section:: Public Health Law
Laws Affected:: Add Art 2-B §§290 - 294, amd §3343-b, Pub Health L

A9576B (ACTIVE) - Summary

A9576B (ACTIVE) - Bill Text download pdf


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

                                 9576--B

                          I N  A S S E M B L Y

                            January 23, 2018
                               ___________

Introduced  by  M.  of  A.  GUNTHER,  THIELE, ORTIZ, ENGLEBRIGHT, STECK,
  STIRPE, HUNTER, COLTON, PELLEGRINO, PHEFFER AMATO,  BRINDISI,  CURRAN,
  ABINANTI,  DE LA ROSA,  GALEF, FAHY, MAGNARELLI, LIFTON, JAFFEE, HYND-
  MAN, CARROLL, MOSLEY, GOTTFRIED,  O'DONNELL,  STERN,  LUPARDO,  GLICK,
  BRONSON,   SKOUFIS,   L. ROSENTHAL,   DINOWITZ,  D. ROSENTHAL,  JONES,
  SEAWRIGHT, WOERNER, PAULIN, BOHEN, BARNWELL, TAYLOR,  WEPRIN,  ARROYO,
  McDONOUGH,  SANTABARBARA  --  Multi-Sponsored  by  --  M. of A. BYRNE,
  EPSTEIN -- read once and  referred  to  the  Committee  on  Health  --
  committee  discharged,  bill amended, ordered reprinted as amended and
  recommitted to said committee -- reported and referred to the  Commit-
  tee  on Codes -- committee discharged, bill amended, ordered reprinted
  as amended and recommitted to said committee

AN ACT to amend the public health law, in relation to enacting the  drug
  take back act

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

  Section 1. This act shall be known and may be cited as the "drug  take
back act."
  §  2.  The public health law is amended by adding a new article 2-B to
read as follows:
                               ARTICLE 2-B
                             DRUG TAKE BACK
SECTION 290. DEFINITIONS.
        291. DRUG TAKE BACK.
        292. COLLECTION.
        293. VIOLATIONS.
        294. JURISDICTION.
  § 290. DEFINITIONS. AS USED IN THIS ARTICLE, UNLESS THE CONTEXT CLEAR-
LY REQUIRES OTHERWISE:
  1. "AUTHORIZED COLLECTOR" MEANS: (A) A PERSON, COMPANY, CORPORATION OR
OTHER ENTITY THAT IS REGISTERED WITH THE UNITED STATES DRUG  ENFORCEMENT
ADMINISTRATION TO COLLECT CONTROLLED SUBSTANCES FOR THE PURPOSES OF SAFE
DISPOSAL AND DESTRUCTION; (B) A LAW ENFORCEMENT AGENCY; OR (C) A PERSON,
COMPANY,  CORPORATION  OR  OTHER  ENTITY AUTHORIZED BY THE DEPARTMENT TO

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets

                      [ ] is old law to be omitted.
                                                           LBD14168-15-8

A. 9576--B                          2

PROVIDE ALTERNATIVE COLLECTION METHODS FOR COVERED DRUGS  THAT  ARE  NOT
CONTROLLED SUBSTANCES.
  2.  "COVERED  DRUG"  MEANS ANY SUBSTANCE RECOGNIZED AS A DRUG UNDER 21
USC § 321(G)(1), AS AMENDED, AND ANY REGULATIONS PROMULGATED  THEREUNDER
THAT  IS  SOLD,  OFFERED  FOR  SALE  OR  DISPENSED IN THE STATE, WHETHER
DIRECTLY OR THROUGH A WHOLESALER, IN ANY FORM INCLUDING PRESCRIPTION AND
NONPRESCRIPTION  DRUGS,  DRUGS  IN  MEDICAL  DEVICES   AND   COMBINATION
PRODUCTS, BRAND AND GENERIC DRUGS AND DRUGS FOR VETERINARY USE; PROVIDED
HOWEVER,  COVERED  DRUG  SHALL NOT INCLUDE: (A) VITAMINS OR SUPPLEMENTS;
(B) HERBAL-BASED REMEDIES AND HOMEOPATHIC DRUGS, PRODUCTS  OR  REMEDIES;
(C)  COSMETICS, SOAP (WITH OR WITHOUT GERMICIDAL AGENTS), LAUNDRY DETER-
GENT, BLEACH, HOUSEHOLD CLEANING PRODUCTS, SHAMPOOS, SUNSCREENS,  TOOTH-
PASTE,  LIP  BALM,  ANTIPERSPIRANTS OR OTHER PERSONAL CARE PRODUCTS THAT
ARE REGULATED AS BOTH COSMETICS  AND  NONPRESCRIPTION  DRUGS  UNDER  THE
FEDERAL  FOOD,  DRUG,  AND  COSMETIC  ACT;  (D)  PET  PESTICIDE PRODUCTS
CONTAINED IN PET COLLARS, POWDERS, SHAMPOOS,  TOPICAL  APPLICATIONS,  OR
OTHER FORMS; (E) DRUGS THAT ARE BIOLOGICAL PRODUCTS AS DEFINED IN SUBDI-
VISION  TWENTY-SEVEN OF SECTION SIXTY-EIGHT HUNDRED TWO OF THE EDUCATION
LAW IF THE MANUFACTURER ALREADY PROVIDES A TAKE BACK PROGRAM; (F)  DRUGS
FOR  WHICH  A  MANUFACTURER  PROVIDES  A  TAKE BACK PROGRAM AS PART OF A
FEDERAL FOOD AND DRUG ADMINISTRATION MANAGED RISK EVALUATION  AND  MITI-
GATION  STRATEGY;  (G)  EMPTIED  INJECTOR  PRODUCTS  OR  EMPTIED MEDICAL
DEVICES AND THEIR COMPONENT PARTS OR ACCESSORIES; AND (H) DRUGS THAT ARE
USED SOLELY IN A CLINICAL SETTING.
  3. "MANUFACTURER" MEANS A PERSON, COMPANY, CORPORATION OR OTHER ENTITY
ENGAGED IN THE MANUFACTURE OF COVERED DRUGS SOLD IN THE STATE.  MANUFAC-
TURER DOES NOT INCLUDE A REPACKAGER OR WHOLESALER.
  4. "PHARMACIES" MEANS ALL PHARMACIES REGISTERED UNDER  SECTION  SIXTY-
EIGHT HUNDRED EIGHT OF THE EDUCATION LAW THAT ARE PART OF A GROUP OF TEN
OR  MORE  ESTABLISHMENTS  THAT  CONDUCT BUSINESS UNDER THE SAME NAME, OR
OPERATE UNDER A COMMON OWNERSHIP OR MANAGEMENT, OR PURSUANT TO  A  FRAN-
CHISE AGREEMENT WITH THE SAME FRANCHISOR, AND ALL NONRESIDENT PHARMACIES
REGISTERED PURSUANT TO SECTION SIXTY-EIGHT HUNDRED EIGHT-B OF THE EDUCA-
TION LAW THAT PROVIDE COVERED DRUGS TO STATE RESIDENTS BY MAIL.
  5. "DRUG TAKE BACK ORGANIZATION" MEANS AN ORGANIZATION DESIGNATED BY A
MANUFACTURER OR A GROUP OF MANUFACTURERS TO ACT AS AN AGENT ON BEHALF OF
THE  MANUFACTURER  OR  GROUP OF MANUFACTURERS TO OPERATE AND IMPLEMENT A
DRUG TAKE BACK PROGRAM AS AUTHORIZED BY THIS ARTICLE.
  6. "WHOLESALER" MEANS ANY PERSON, COMPANY, CORPORATION OR OTHER ENTITY
THAT SELLS OR DISTRIBUTES DRUGS AND COVERED DRUGS FOR RESALE TO AN ENTI-
TY IN THE STATE OTHER THAN A CONSUMER.
  7. "REPACKAGER" MEANS AN ENTITY THAT OWNS OR OPERATES AN ESTABLISHMENT
THAT REPACKS AND RELABELS A PRODUCT OR PACKAGE CONTAINING A COVERED DRUG
FOR FURTHER SALE OR FOR DISTRIBUTION WITHOUT FURTHER TRANSACTION.
  § 291. DRUG TAKE BACK. 1. ANY MANUFACTURER OF A COVERED DRUG SHALL:
  (A) OPERATE A DRUG TAKE BACK PROGRAM APPROVED BY THE DEPARTMENT  INDI-
VIDUALLY OR JOINTLY WITH OTHER MANUFACTURERS;
  (B)  ENTER  INTO AN AGREEMENT WITH A DRUG TAKE BACK ORGANIZATION WHICH
SHALL OPERATE A DRUG TAKE BACK PROGRAM APPROVED BY THE DEPARTMENT; OR
  (C) ENTER INTO AN AGREEMENT WITH THE DEPARTMENT TO OPERATE A DRUG TAKE
BACK PROGRAM ON ITS BEHALF.
  2. ANY MANUFACTURER OF A COVERED DRUG, INDIVIDUALLY OR JOINTLY,  OR  A
DRUG  TAKE  BACK  ORGANIZATION CONTRACTED BY A MANUFACTURER OF A COVERED
DRUG SHALL WITHIN ONE HUNDRED EIGHTY DAYS FROM  THE  EFFECTIVE  DATE  OF
THIS  SECTION  SUBMIT TO THE DEPARTMENT, IN A MANNER AND FORM DETERMINED

A. 9576--B                          3

BY THE DEPARTMENT, A PROPOSED DRUG TAKE BACK PROGRAM THAT  MEETS,  AT  A
MINIMUM, THE FOLLOWING REQUIREMENTS:
  (A) CERTIFIES THE DRUG TAKE BACK PROGRAM WILL ACCEPT ALL COVERED DRUGS
REGARDLESS OF WHO PRODUCED THEM;
  (B) PROVIDES CONTACT INFORMATION FOR THE PERSON SUBMITTING THE PLANNED
DRUG  TAKE  BACK  PROGRAM  WITH  WHOM  THE  DEPARTMENT  SHALL DIRECT ALL
INQUIRIES;
  (C)  DETAILS  A  COLLECTION  SYSTEM  TO  PROVIDE  CONVENIENT,  ONGOING
COLLECTION  SERVICES  TO ALL PERSONS SEEKING TO DISPOSE OF COVERED DRUGS
PURSUANT TO SECTION TWO HUNDRED  NINETY-TWO  OF  THIS  ARTICLE  THAT  IS
GEOGRAPHICALLY DISTRIBUTED IN A WAY TO ENSURE ACCESS IN RURAL AND UNDER-
SERVED AREAS;
  (D)  DESCRIBES OTHER COLLECTION METHODS BY WHICH COVERED DRUGS WILL BE
COLLECTED BY AUTHORIZED COLLECTORS;
  (E) EXPLAINS HOW COVERED DRUGS WILL BE SAFELY AND SECURELY TRACKED AND
HANDLED FROM COLLECTION THROUGH FINAL DISPOSAL AND DESTRUCTION, POLICIES
TO ENSURE SECURITY AND COMPLIANCE WITH ALL  APPLICABLE  LAWS  AND  REGU-
LATIONS INCLUDING DISPOSAL AND DESTRUCTION AT A PERMITTED WASTE DISPOSAL
FACILITY MEETING FEDERAL REQUIREMENTS;
  (F)  DESCRIBES  THE PUBLIC EDUCATION AND OUTREACH ACTIVITIES THAT WILL
BE UNDERTAKEN WHICH SHALL INCLUDE ADVERTISING OF COLLECTION LOCATIONS ON
A WEBSITE AND THROUGH USE OF SIGNAGE AND OTHER  WRITTEN  MATERIALS,  AND
HOW EFFECTIVENESS WILL BE EVALUATED;
  (G)  DETAILS HOW THE COSTS OF PHARMACY COLLECTION AND OTHER AUTHORIZED
COLLECTORS WILL BE REIMBURSED WHICH SHALL INCLUDE COSTS  RETROACTIVE  TO
THE EFFECTIVE DATE OF THIS ARTICLE, AND WHERE MORE THAN ONE MANUFACTURER
WILL  BE  INVOLVED IN THE PLANNED DRUG TAKE BACK PROGRAM, A PLAN FOR THE
FAIR AND REASONABLE MANNER OF ALLOCATED COSTS AMONG THE PARTICIPANTS  IN
SUCH PROGRAM SUCH THAT THE COSTS PAID BY EACH MANUFACTURER IS REASONABLY
RELATED TO THE VOLUME OR VALUE OF COVERED DRUGS SOLD IN THE STATE; AND
  (H) PROVIDES ANY FURTHER INFORMATION DEEMED APPROPRIATE BY THE DEPART-
MENT.
  3.  WITHIN  THIRTY  DAYS  OF  THE EFFECTIVE DATE OF THIS SECTION, EACH
WHOLESALER THAT SELLS COVERED DRUGS IN OR INTO THE STATE  SHALL  PROVIDE
THE  DEPARTMENT WITH A LIST OF MANUFACTURERS THAT PRODUCE COVERED DRUGS.
THE DEPARTMENT MAY REQUEST UPDATED LISTS AT ITS DISCRETION.
  4. A MANUFACTURER, INDIVIDUALLY OR JOINTLY, MUST PAY  ALL  ADMINISTRA-
TIVE  AND  OPERATIONAL  FEES ASSOCIATED WITH THE DRUG TAKE BACK PROGRAM,
INCLUDING THE COST OF COLLECTING, TRANSPORTING AND DISPOSING OF  COVERED
DRUGS  FROM PHARMACIES AND OTHER AUTHORIZED COLLECTORS AND THE RECYCLING
OR DISPOSAL, OR BOTH,  OF  PACKING  COLLECTED  WITH  THE  COVERED  DRUG.
MANUFACTURERS SHALL ALSO PAY COSTS INCURRED BY THE STATE IN THE ADMINIS-
TRATION  AND  ENFORCEMENT  OF  THE DRUG TAKE BACK PROGRAM.  EXCLUSIVE OF
FINES AND PENALTIES, THE STATE SHALL ONLY RECOVER  ITS  ACTUAL  COST  OF
ADMINISTRATION AND ENFORCEMENT. IN INSTANCES WHERE MANUFACTURERS JOINTLY
CONDUCT  A  DRUG  TAKE  BACK  PROGRAM,  THE  COSTS OF ADMINISTRATION AND
ENFORCEMENT SHALL BE FAIRLY  AND  REASONABLY  ALLOCATED  SUCH  THAT  THE
PORTION OF COSTS IS REASONABLY RELATED TO THE VOLUME OR VALUE OF COVERED
DRUGS  THE MANUFACTURERS SELL IN THE STATE. NO MANUFACTURER MAY CHARGE A
POINT-OF-SALE OR OTHER FEE TO CONSUMERS, OR A FEE THAT COULD  BE  PASSED
ON TO CONSUMERS, TO RECOUP THE COST OF THEIR DRUG TAKE BACK PROGRAM.
  5.  WITHIN SIXTY DAYS OF RECEIPT OF A PROPOSED DRUG TAKE BACK PROGRAM,
THE DEPARTMENT, IN CONSULTATION WITH  THE  DEPARTMENT  OF  ENVIRONMENTAL
CONSERVATION,  SHALL  DETERMINE  WHETHER  SUCH  PROPOSED  DRUG TAKE BACK
PROGRAM COMPLIES WITH THE REQUIREMENTS OF THIS ARTICLE  AND  NOTIFY  THE
APPLICANT.  THE DEPARTMENT MAY CONDUCT A NOTICED PUBLIC HEARING PRIOR TO

A. 9576--B                          4

APPROVAL. IF THE DRUG TAKE BACK  PROGRAM  IS  APPROVED,  THE  DEPARTMENT
SHALL  NOTIFY THE APPLICANT IN WRITING. IF THE DRUG TAKE BACK PROGRAM IS
NOT APPROVED, THE DEPARTMENT SHALL NOTIFY THE APPLICANT IN  WRITING  AND
THE  APPLICANT  SHALL  SUBMIT  A REVISED DRUG TAKE BACK PROGRAM PROPOSAL
WITHIN THIRTY DAYS.  IF THE DEPARTMENT REJECTS THE SUBSEQUENT  PROPOSAL,
THE  MANUFACTURER  OR  MANUFACTURERS AT ISSUE SHALL BE OUT OF COMPLIANCE
WITH THIS ARTICLE AND SUBJECT TO THE ENFORCEMENT PROVISIONS PURSUANT  TO
SECTION  TWO  HUNDRED  NINETY-FOUR OF THIS ARTICLE. THE DEPARTMENT SHALL
PROVIDE, AND UPDATE ANNUALLY, ON ITS WEBSITE A LIST OF ALL MANUFACTURERS
PARTICIPATING IN A DRUG TAKE BACK PROGRAM APPROVED BY THE DEPARTMENT.
  6. AT LEAST EVERY THREE YEARS, A MANUFACTURER, JOINTLY OR  INDIVIDUAL-
LY,  OR  A  DRUG  TAKE BACK ORGANIZATION SHALL UPDATE ITS DRUG TAKE BACK
PROGRAM AND SUBMIT AN UPDATED PROPOSAL TO THE DEPARTMENT. A MANUFACTURER
WHO BEGINS TO OFFER A COVERED DRUG IN THE STATE AFTER THE EFFECTIVE DATE
OF THIS ARTICLE, SHALL PROVIDE EVIDENCE OF JOINING AN EXISTING  APPROVED
DRUG TAKE BACK PROGRAM OR SUBMIT A PROPOSAL FOR A DRUG TAKE BACK PROGRAM
WITHIN  NINETY  DAYS  FOLLOWING  THE INITIAL OFFER FOR SALE OF A COVERED
DRUG. ANY PROPOSED CHANGE TO A DRUG TAKE BACK PROGRAM SHALL BE SUBMITTED
IN WRITING AND APPROVED BY THE DEPARTMENT PRIOR TO ANY CHANGE.
  7. EACH APPROVED DRUG TAKE BACK PROGRAM SHALL REPORT TO THE DEPARTMENT
AT A DATE AND MANNER SET BY THE DEPARTMENT. THE DEPARTMENT SHALL  SUBMIT
AN  ANNUAL REPORT TO THE GOVERNOR, SPEAKER OF THE ASSEMBLY AND TEMPORARY
PRESIDENT OF THE SENATE BY JANUARY FIRST DETAILING  ALL  PROGRAM  ACTIV-
ITIES, THE WEIGHT COLLECTED BY EACH PROGRAM, A DESCRIPTION OF COLLECTION
ACTIVITIES, THE NAME AND LOCATION OF ALL COLLECTION SITES, PUBLIC EDUCA-
TION  AND  OUTREACH  ACTIVITIES,  AN  EVALUATION  OF THE EFFICACY OF THE
PROGRAM AND EACH COLLECTION METHOD, AND ANY MANUFACTURER OUT OF  COMPLI-
ANCE OR SUBJECT TO PENALTIES PURSUANT TO SECTION TWO HUNDRED NINETY-FOUR
OF THIS ARTICLE.
  §  292.  COLLECTION.  1.  ALL  PHARMACIES  SHALL  PROVIDE FOR THE SAFE
COLLECTION OF DRUGS, WHICH SHALL INCLUDE:
  (A) OFFERING DRUG COLLECTION BY ONE OR MORE OF THE FOLLOWING METHODS:
  (I) ON-SITE COLLECTION, DROPBOX, OR RECEPTACLE MEETING FEDERAL  STAND-
ARDS;
  (II) MAIL-BACK COLLECTION BY PREPAID ENVELOPES AS AUTHORIZED BY FEDER-
AL LAW AND REGULATION; OR
  (III)  OTHER  FEDERAL  DRUG  ENFORCEMENT  AGENCY  APPROVED  METHODS OF
COLLECTION.
  (B) SIGNAGE PROMINENTLY DISPLAYED ADVERTISING SUCH DRUG COLLECTION  TO
CONSUMERS.
  2.  ALL  DRUG TAKE BACK PROGRAM OPERATORS SHALL NOTIFY OTHER POTENTIAL
AUTHORIZED COLLECTORS OF THE  OPPORTUNITY  TO  SERVE  AS  AN  AUTHORIZED
COLLECTOR  FOR  THE  DRUG TAKE BACK PROGRAM. PARTICIPATION OF AUTHORIZED
COLLECTORS BESIDES PHARMACIES SHALL BE VOLUNTARY.
  3. ALL COSTS OF PHARMACIES AND OTHER AUTHORIZED  COLLECTORS  SHALL  BE
PAID OR REIMBURSED BY THE MANUFACTURER, JOINTLY OR INDIVIDUALLY, AS PART
OF THE DRUG TAKE BACK PROGRAMS REQUIRED BY THIS ARTICLE.
  4.  FOR ANY CITY WITH A POPULATION OF ONE HUNDRED TWENTY-FIVE THOUSAND
OR MORE AS OF THE LAST DECENNIAL CENSUS, THE COMMISSIONER  SHALL  ESTAB-
LISH  BY  REGULATION  A  DISTRIBUTION  PLAN  THAT  ENSURES  THAT ON-SITE
COLLECTION RECEPTACLE OR DROPBOX PLACEMENT SHALL BE REASONABLY  ACCESSI-
BLE TO ALL RESIDENTS AND THAT PROVIDES FOR PROGRAM COST EFFICIENCY.
  5.  PHARMACIES  PROVIDING FOR MAIL-BACK COLLECTION AS PART OF THE DRUG
TAKE BACK PROGRAM SHALL PROVIDE A VOUCHER FOR A  PREPAID  ENVELOPE  UPON
DISPENSING  A  COVERED  DRUG. SUCH VOUCHER SHALL INCLUDE  INFORMATION ON
DRUG TAKE BACK AND SAFE DRUG DISPOSAL METHODS.

A. 9576--B                          5

  § 293. VIOLATIONS. VIOLATION OF THIS ARTICLE SHALL BE SUBJECT TO FINES
PURSUANT TO SECTION TWELVE OF  THIS  CHAPTER.  EACH  DAY  IN  WHICH  THE
VIOLATION CONTINUES SHALL CONSTITUTE A SEPARATE VIOLATION.
  §  294.  JURISDICTION.  JURISDICTION OF ALL MATTERS PERTAINING TO DRUG
DISPOSAL BY THIS  ARTICLE  IS  VESTED  EXCLUSIVELY  IN  THE  STATE.  ANY
PROVISION  OF  ANY  LOCAL  LAW  OR  ORDINANCE, OR ANY RULE OR REGULATION
PROMULGATED PRIOR TO, OR UPON THE EFFECTIVE DATE OF THIS SECTION,  SHALL
BE PREEMPTED.
  §  3.  Section  3343-b of the public health law, as amended by chapter
379 of the laws of 2015, is amended to read as follows:
  § 3343-b. Safe  disposal  of  unused  controlled  substances.  1.  The
department  shall  oversee  a  program  for  the safe disposal of unused
controlled substances by consumers in accordance with  federal  law  AND
ARTICLE  TWO-B  OF THIS CHAPTER.  Individual members of the public shall
be authorized to voluntarily surrender controlled substances  listed  on
schedule  II,  III,  IV or V of section thirty-three hundred six of this
article  in  a  secure  manner,  without  identifying  themselves.  Safe
disposal  methods  shall  be publicized consistent with the prescription
pain medication awareness program established pursuant to section  thir-
ty-three  hundred nine-a of this article AND ARTICLE TWO-B OF THIS CHAP-
TER.
  2. The surrender of a controlled substance pursuant  to  this  section
AND  ARTICLE  TWO-B OF THIS CHAPTER shall not constitute the possession,
transfer or sale of such controlled substance for purposes of this arti-
cle or the penal law.
  3. [Disposal] EXCEPT AS PROVIDED IN ARTICLE  TWO-B  OF  THIS  CHAPTER,
DISPOSAL sites shall be operated by law enforcement agencies, pharmacies
and  other Federal Drug Enforcement Administration authorized collectors
on a voluntary basis, PROVIDED, HOWEVER, THAT SUCH DISPOSAL SITES  SHALL
NOT  BE  PRECLUDED  FROM  OPERATING  AS PART OF A DRUG TAKE BACK PROGRAM
ESTABLISHED PURSUANT TO ARTICLE TWO-B OF THIS CHAPTER. Nothing  in  this
section  shall require any political subdivision of the state to partic-
ipate in the program established in this section.
  § 4. The department of health may adopt regulations  as  necessary  to
implement and enforce the provisions of this title.
  § 5. 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 are authorized to be made and
completed on or before such effective date.

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The New York State Senate

assembly Bill A9576B

Sponsored By

Archive: Last Bill Status Via S9100 - Signed by Governor

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Votes

Jun 19, 2018 - floor Vote

Floor Vote: Jun 19, 2018

Jun 19, 2018 - Rules committee Vote

Committee Vote: Jun 19, 2018

Bill Amendments

Co-Sponsors

A9576 - Details

A9576 - Summary

A9576 - Bill Text download pdf

Co-Sponsors

Multi-Sponsors

A9576A - Details

A9576A - Summary

A9576A - Bill Text download pdf

Co-Sponsors

Multi-Sponsors

A9576B (ACTIVE) - Details

A9576B (ACTIVE) - Summary

A9576B (ACTIVE) - Bill Text download pdf

Comments

assembly Bill A9576B

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Sponsored By

GUNTHER

Archive: Last Bill Status Via S9100 - Signed by Governor

Your Voice

Actions

Votes

Jun 19, 2018 - floor Vote

Floor Vote: Jun 19, 2018

Jun 19, 2018 - Rules committee Vote

Committee Vote: Jun 19, 2018

Bill Amendments

Co-Sponsors

Fred Thiele

Felix Ortiz

Steven Englebright

Phil Steck

Luis R. Sepúlveda

Albert A. Stirpe

Pamela J. Hunter

William Colton

Christine Pellegrino

Stacey Pheffer Amato

Anthony Brindisi

Brian F. Curran

Thomas Abinanti

Carmen De La Rosa

Sandy Galef

Patricia Fahy

William Magnarelli

Barbara Lifton

Ellen C. Jaffee

Alicia Hyndman

A9576 - Details

A9576 - Summary

A9576 - Bill Text download pdf

Co-Sponsors

Fred Thiele

Felix Ortiz

Steven Englebright

Phil Steck

Luis R. Sepúlveda

Albert A. Stirpe

Pamela J. Hunter

William Colton

Christine Pellegrino

Stacey Pheffer Amato

Anthony Brindisi

Brian F. Curran

Thomas Abinanti

Carmen De La Rosa

Sandy Galef

Patricia Fahy

William Magnarelli

Barbara Lifton

Ellen C. Jaffee

Alicia Hyndman

Robert C. Carroll

Walter T. Mosley

Richard Gottfried

Daniel O'Donnell

Steve Stern

Donna Lupardo

Deborah Glick

Harry B. Bronson

James Skoufis

Linda Rosenthal

Jeffrey Dinowitz

Daniel Rosenthal

Billy Jones

Rebecca Seawright

Carrie Woerner

Amy Paulin

Erik T. Bohen

Brian Barnwell

Al Taylor

David Weprin

Carmen E. Arroyo

David McDonough