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S09100 Summary:

Add Art 2-B §§290 - 294, amd §3343-b, Pub Health L
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.
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S09100 Actions:

06/20/2018referred to ways and means
06/20/2018substituted for a9576b
06/20/2018ordered to third reading rules cal.450
06/20/2018passed assembly
06/20/2018returned to senate
07/10/2018SIGNED CHAP.120
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S09100 Text:

                STATE OF NEW YORK
                    IN SENATE
                                      June 16, 2018
        Introduced  by  Sens.  HANNON, O'MARA -- read twice and ordered printed,
          and when printed to be committed to the Committee on Rules
        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:

     1    Section 1. This act shall be known and may be cited as the "drug  take
     2  back act."
     3    §  2.  The public health law is amended by adding a new article 2-B to
     4  read as follows:
     5                                 ARTICLE 2-B
     6                               DRUG TAKE BACK
     7  Section 290. Definitions.
     8          291. Drug take back.
     9          292. Collection.
    10          293. Violations.
    11          294. Jurisdiction.
    12    § 290. Definitions. As used in this article, unless the context clear-
    13  ly requires otherwise:
    14    1. "Authorized collector" means: (a) a person, company, corporation or
    15  other entity that is registered with the United States Drug  Enforcement
    16  Administration to collect controlled substances for the purposes of safe
    17  disposal and destruction; (b) a law enforcement agency; or (c) a person,
    18  company,  corporation  or  other  entity authorized by the department to
    19  provide alternative collection methods for covered drugs  that  are  not
    20  controlled substances.
    21    2.  "Covered  drug"  means any substance recognized as a drug under 21
    22  USC § 321(g)(1), as amended, and any regulations promulgated  thereunder
    23  that  is  sold,  offered  for  sale  or  dispensed in the state, whether
    24  directly or through a wholesaler, in any form including prescription and
    25  nonprescription  drugs,  drugs  in  medical  devices   and   combination
    26  products, brand and generic drugs and drugs for veterinary use; provided
    27  however,  covered  drug  shall not include: (a) vitamins or supplements;
    28  (b) herbal-based remedies and homeopathic drugs, products  or  remedies;
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.

        S. 9100                             2
     1  (c)  cosmetics, soap (with or without germicidal agents), laundry deter-
     2  gent, bleach, household cleaning products, shampoos, sunscreens,  tooth-
     3  paste,  lip  balm,  antiperspirants or other personal care products that
     4  are  regulated  as  both  cosmetics  and nonprescription drugs under the
     5  Federal Food,  Drug,  and  Cosmetic  Act;  (d)  pet  pesticide  products
     6  contained  in  pet  collars, powders, shampoos, topical applications, or
     7  other forms; (e) drugs that are biological products as defined in subdi-
     8  vision twenty-seven of section sixty-eight hundred two of the  education
     9  law  if the manufacturer already provides a take back program; (f) drugs
    10  for which a manufacturer provides a take  back  program  as  part  of  a
    11  Federal  Food  and Drug Administration managed risk evaluation and miti-
    12  gation strategy;  (g)  emptied  injector  products  or  emptied  medical
    13  devices and their component parts or accessories; and (h) drugs that are
    14  used solely in a clinical setting.
    15    3. "Manufacturer" means a person, company, corporation or other entity
    16  engaged in the manufacture of covered drugs sold in the state.  Manufac-
    17  turer does not include a repackager or wholesaler.
    18    4.  "Pharmacies"  means all pharmacies registered under section sixty-
    19  eight hundred eight of the education law that are part of a group of ten
    20  or more establishments that conduct business under  the  same  name,  or
    21  operate  under  a common ownership or management, or pursuant to a fran-
    22  chise agreement with the same franchisor, and all nonresident pharmacies
    23  registered pursuant to section sixty-eight hundred eight-b of the educa-
    24  tion law that provide covered drugs to state residents by mail.
    25    5. "Drug take back organization" means an organization designated by a
    26  manufacturer or a group of manufacturers to act as an agent on behalf of
    27  the manufacturer or group of manufacturers to operate  and  implement  a
    28  drug take back program as authorized by this article.
    29    6. "Wholesaler" means any person, company, corporation or other entity
    30  that sells or distributes drugs and covered drugs for resale to an enti-
    31  ty in the state other than a consumer.
    32    7. "Repackager" means an entity that owns or operates an establishment
    33  that repacks and relabels a product or package containing a covered drug
    34  for further sale or for distribution without further transaction.
    35    § 291. Drug take back. 1. Any manufacturer of a covered drug shall:
    36    (a)  operate a drug take back program approved by the department indi-
    37  vidually or jointly with other manufacturers;
    38    (b) enter into an agreement with a drug take back  organization  which
    39  shall operate a drug take back program approved by the department; or
    40    (c) enter into an agreement with the department to operate a drug take
    41  back program on its behalf.
    42    2.  Any  manufacturer of a covered drug, individually or jointly, or a
    43  drug take back organization contracted by a manufacturer  of  a  covered
    44  drug  shall  within  one  hundred eighty days from the effective date of
    45  this section submit to the department, in a manner and  form  determined
    46  by  the  department,  a proposed drug take back program that meets, at a
    47  minimum, the following requirements:
    48    (a) Certifies the drug take back program will accept all covered drugs
    49  regardless of who produced them;
    50    (b) Provides contact information for the person submitting the planned
    51  drug take back  program  with  whom  the  department  shall  direct  all
    52  inquiries;
    53    (c)  Details  a  collection  system  to  provide  convenient,  ongoing
    54  collection services to all persons seeking to dispose of  covered  drugs
    55  pursuant  to  section  two  hundred  ninety-two  of this article that is

        S. 9100                             3
     1  geographically distributed in a way to ensure access in rural and under-
     2  served areas;
     3    (d)  Describes other collection methods by which covered drugs will be
     4  collected by authorized collectors;
     5    (e) Explains how covered drugs will be safely and securely tracked and
     6  handled from collection through final disposal and destruction, policies
     7  to ensure security and compliance with all  applicable  laws  and  regu-
     8  lations including disposal and destruction at a permitted waste disposal
     9  facility meeting federal requirements;
    10    (f)  Describes  the public education and outreach activities that will
    11  be undertaken which shall include advertising of collection locations on
    12  a website and through use of signage and other  written  materials,  and
    13  how effectiveness will be evaluated;
    14    (g)  Details how the costs of pharmacy collection and other authorized
    15  collectors will be reimbursed which shall include costs  retroactive  to
    16  the effective date of this article, and where more than one manufacturer
    17  will  be  involved in the planned drug take back program, a plan for the
    18  fair and reasonable manner of allocated costs among the participants  in
    19  such program such that the costs paid by each manufacturer is reasonably
    20  related to the volume or value of covered drugs sold in the state; and
    21    (h) Provides any further information deemed appropriate by the depart-
    22  ment.
    23    3.  Within  thirty  days  of  the effective date of this section, each
    24  wholesaler that sells covered drugs in or into the state  shall  provide
    25  the  department with a list of manufacturers that produce covered drugs.
    26  The department may request updated lists at its discretion.
    27    4. A manufacturer, individually or jointly, must pay  all  administra-
    28  tive  and  operational  fees associated with the drug take back program,
    29  including the cost of collecting, transporting and disposing of  covered
    30  drugs  from pharmacies and other authorized collectors and the recycling
    31  or disposal, or both,  of  packing  collected  with  the  covered  drug.
    32  Manufacturers shall also pay costs incurred by the state in the adminis-
    33  tration  and  enforcement  of  the drug take back program.  Exclusive of
    34  fines and penalties, the state shall only recover  its  actual  cost  of
    35  administration and enforcement. In instances where manufacturers jointly
    36  conduct  a  drug  take  back  program,  the  costs of administration and
    37  enforcement shall be fairly  and  reasonably  allocated  such  that  the
    38  portion of costs is reasonably related to the volume or value of covered
    39  drugs  the manufacturers sell in the state. No manufacturer may charge a
    40  point-of-sale or other fee to consumers, or a fee that could  be  passed
    41  on to consumers, to recoup the cost of their drug take back program.
    42    5.  Within sixty days of receipt of a proposed drug take back program,
    43  the department, in consultation with  the  department  of  environmental
    44  conservation,  shall  determine  whether  such  proposed  drug take back
    45  program complies with the requirements of this article  and  notify  the
    46  applicant.  The department may conduct a noticed public hearing prior to
    47  approval. If the drug take back  program  is  approved,  the  department
    48  shall  notify the applicant in writing. If the drug take back program is
    49  not approved, the department shall notify the applicant in  writing  and
    50  the  applicant  shall  submit  a revised drug take back program proposal
    51  within thirty days.  If the department rejects the subsequent  proposal,
    52  the  manufacturer  or  manufacturers at issue shall be out of compliance
    53  with this article and subject to the enforcement provisions pursuant  to
    54  section  two  hundred  ninety-four of this article. The department shall
    55  provide, and update annually, on its website a list of all manufacturers
    56  participating in a drug take back program approved by the department.

        S. 9100                             4
     1    6. At least every three years, a manufacturer, jointly or  individual-
     2  ly,  or  a  drug  take back organization shall update its drug take back
     3  program and submit an updated proposal to the department. A manufacturer
     4  who begins to offer a covered drug in the state after the effective date
     5  of  this article, shall provide evidence of joining an existing approved
     6  drug take back program or submit a proposal for a drug take back program
     7  within ninety days following the initial offer for  sale  of  a  covered
     8  drug. Any proposed change to a drug take back program shall be submitted
     9  in writing and approved by the department prior to any change.
    10    7. Each approved drug take back program shall report to the department
    11  at  a date and manner set by the department. The department shall submit
    12  an annual report to the governor, speaker of the assembly and  temporary
    13  president  of  the  senate by January first detailing all program activ-
    14  ities, the weight collected by each program, a description of collection
    15  activities, the name and location of all collection sites, public educa-
    16  tion and outreach activities, an  evaluation  of  the  efficacy  of  the
    17  program  and each collection method, and any manufacturer out of compli-
    18  ance or subject to penalties pursuant to section two hundred ninety-four
    19  of this article.
    20    § 292. Collection. 1.  All  pharmacies  shall  provide  for  the  safe
    21  collection of drugs, which shall include:
    22    (a) Offering drug collection by one or more of the following methods:
    23    (i)  On-site collection, dropbox, or receptacle meeting federal stand-
    24  ards;
    25    (ii) Mail-back collection by prepaid envelopes as authorized by feder-
    26  al law and regulation; or
    27    (iii) Other  federal  drug  enforcement  agency  approved  methods  of
    28  collection.
    29    (b)  Signage prominently displayed advertising such drug collection to
    30  consumers.
    31    2. All drug take back program operators shall notify  other  potential
    32  authorized  collectors  of  the  opportunity  to  serve as an authorized
    33  collector for the drug take back program.  Participation  of  authorized
    34  collectors besides pharmacies shall be voluntary.
    35    3.  All  costs  of pharmacies and other authorized collectors shall be
    36  paid or reimbursed by the manufacturer, jointly or individually, as part
    37  of the drug take back programs required by this article.
    38    4. For any city with a population of one hundred twenty-five  thousand
    39  or  more  as of the last decennial census, the commissioner shall estab-
    40  lish by  regulation  a  distribution  plan  that  ensures  that  on-site
    41  collection  receptacle or dropbox placement shall be reasonably accessi-
    42  ble to all residents and that provides for program cost efficiency.
    43    5. Pharmacies providing for mail-back collection as part of  the  drug
    44  take  back  program  shall provide a voucher for a prepaid envelope upon
    45  dispensing a covered drug. Such voucher shall include    information  on
    46  drug take back and safe drug disposal methods.
    47    § 293. Violations. Violation of this article shall be subject to fines
    48  pursuant  to  section  twelve  of  this  chapter.  Each day in which the
    49  violation continues shall constitute a separate violation.
    50    § 294. Jurisdiction. Jurisdiction of all matters  pertaining  to  drug
    51  disposal  by  this  article  is  vested  exclusively  in  the state. Any
    52  provision of any local law or  ordinance,  or  any  rule  or  regulation
    53  promulgated  prior to, or upon the effective date of this section, shall
    54  be preempted.
    55    § 3. Section 3343-b of the public health law, as  amended  by  chapter
    56  379 of the laws of 2015, is amended to read as follows:

        S. 9100                             5
     1    §  3343-b.  Safe  disposal  of  unused  controlled  substances. 1. The
     2  department shall oversee a program  for  the  safe  disposal  of  unused
     3  controlled  substances  by  consumers in accordance with federal law and
     4  article two-B of this chapter.  Individual members of the  public  shall
     5  be  authorized  to voluntarily surrender controlled substances listed on
     6  schedule II, III, IV or V of section thirty-three hundred  six  of  this
     7  article  in  a  secure  manner,  without  identifying  themselves.  Safe
     8  disposal methods shall be publicized consistent  with  the  prescription
     9  pain  medication awareness program established pursuant to section thir-
    10  ty-three hundred nine-a of this article and article two-B of this  chap-
    11  ter.
    12    2.  The  surrender  of a controlled substance pursuant to this section
    13  and article two-B of this chapter shall not constitute  the  possession,
    14  transfer or sale of such controlled substance for purposes of this arti-
    15  cle or the penal law.
    16    3.  [Disposal]  Except  as  provided in article two-B of this chapter,
    17  disposal sites shall be operated by law enforcement agencies, pharmacies
    18  and other Federal Drug Enforcement Administration authorized  collectors
    19  on  a voluntary basis, provided, however, that such disposal sites shall
    20  not be precluded from operating as part of  a  drug  take  back  program
    21  established  pursuant  to article two-B of this chapter. Nothing in this
    22  section shall require any political subdivision of the state to  partic-
    23  ipate in the program established in this section.
    24    §  4.  The  department of health may adopt regulations as necessary to
    25  implement and enforce the provisions of this title.
    26    § 5. This act shall take effect on the one hundred eightieth day after
    27  it shall have become a law.  Effective immediately, the addition, amend-
    28  ment and/or repeal of any rule or regulation necessary for the implemen-
    29  tation of this act on its effective date are authorized to be  made  and
    30  completed on or before such effective date.
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S09100 LFIN:

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