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A09576 Summary:

COSPNSRThiele, Ortiz, Englebright, Steck, Sepulveda, Stirpe, Hunter, Colton
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.
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A09576 Actions:

01/23/2018referred to health
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A09576 Memo:

submitted in accordance with Assembly Rule III, Sec 1(f)
SPONSOR: Gunther
  TITLE OF BILL: An act to amend the public health law, in relation to enacting the drug take back act   PURPOSE: To establish a statewide drug take back program for the safe disposal of drugs.   SUMMARY OF PROVISIONS: Section one provides the bill shall be known as the Drug Take Back Act. Section two adds a new Article 2-b to the Public Health Law which provides for the safe disposal of drugs statewide. Under this Act, manufacturers of covered drugs must either submit, individually or jointly, a drug take back program for approval by the Department of Health, or enter into an agreement with the Department to operate a drug take back program on its behalf. Under such program, manufacturers are responsible for all administrative and operational fees associated with their 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. This Act further requires chain pharmacies and mail-order pharmacies to provide for the collection of covered drugs by providing consumers with on-site collection, prepaid mail-back envelopes or other Drug Enforcement Agency (DEA) approved methods. Section three amends Public Health Law § 3343-b to make conforming changes. Section four provides the effective date.   JUSTIFICATION: New York, like the rest of the nation, continues to struggle with the opioid addiction crisis. Despite our best effects to stem the tide of opioid related deaths by, among other things, increasing access to Naloxone, enacting I-STOP to prevent doctor shopping, limiting initial prescriptions to 7 days, and changing the Insurance Law to make treat- ment more accessible, the number of deaths continue to rise. It is well known the first supply of opioids is often leftover medication a family member or friend received and did not use. To cut off this supply, we must make the take back and disposal of these drugs more prominent and accessible. In addition to getting excess drugs out of medicine cabinets where they are ripe for abuse, a statewide drug take back program will help ensure these and other drugs are not improperly disposed by flushing or other means that results in harm to our water bodies and impacts aquatic life. Last year New York made a historic investment in improving and protect- ing our water, keeping drugs out of our water supplies is another impor- tant and necessary step. While law enforcement agencies have drop-off points and elected offi- cials hold drug take back days that help properly dispose of many drugs, more must be done. Chapter 79 of the Laws of 2015, allowed pharmacies and other DEA authorized collectors to collect unused controlled substances in New York. While this was an important step in making it easier for people to take back their unused medications, voluntarily participation remains low. The Department of Environmental Conservation recently announced a pilot program that provides take back receptacles at participating pharmacies, hospitals and long-term care facilities, but again this program is voluntary and limited in scope. Meanwhile, a recent effort to require chain pharmacies statewide, and mail-order pharmacies, to participate in drug take back was vetoed by the Governor. Product Stewardship is the concept that whoever manufactures, produces, or sells a product take responsibility for minimizing the product's environmental impact throughout all stages of the products' life cycle, including its disposal or destruction. Over the years, New York has developed product stewardship programs for products such as electronic waste, rechargeable batteries, and mercury thermostats. Drug steward- ship programs are however, still largely in their infancy. In 2012, Alameda County, CA became the first government to pass legislation requiring pharmaceutical manufacturers to design, fund and operate a program to safely collect and dispose unwanted drugs. Alameda's program withstood court scrutiny, with the Ninth Circuit Court of Appeals find- ing its provisions did not violate the Dormant Commerce Clause. On May 26, 2015, the Supreme Court of the United States denied certiorari. The Alameda case paved the way, with now nine counties in California and more recently the state of Massachusetts and several counties in New York adopting similar programs. However, many of the existing drug stewardship programs continue to rely solely on voluntary retail partic- ipation, which has already proven to be low in New York. Retail partic- ipation is critical in reaching consumers and getting the most benefit from a take back program. Just as individuals can return tires, car batteries and motor oil to the businesses they purchased them from, New Yorkers should be able dispose of drugs, or obtain a prepaid mail-back envelope, at a pharmacy. Thus, this legislation will provide for unified, statewide drug take back, to be paid for by manufacturers, and require participation of chain and mail-order pharmacies. Manufacturers will be responsible for all costs from public education and awareness to collection, transport and destruction, and pharmacies will provide meth- ods for convenient drop-off and collection.   LEGISLATIVE HISTORY: New bill.   FISCAL IMPLICATIONS: None.   EFFECTIVE DATE: 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 180 days after enactment.
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A09576 Text:

                STATE OF NEW YORK
                   IN ASSEMBLY
                                    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:
     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; (c) a munici-
    18  pality; or (d) a person, company, corporation or other entity authorized
    19  by the department to provide alternative collection methods for  covered
    20  drugs that are not controlled substances.
    21    2.  "Covered  drug"  means any substance recognized as a drug under 21
    22  USC § 321(g)(1), as amended, that is sold, offered for sale or dispensed
    23  in the state, whether directly or through  a  wholesaler,  in  any  form
    24  including  prescription  and  nonprescription  drugs,  drugs  in medical
    25  devices and combination products, brand and generic drugs and drugs  for
    26  veterinary  use;  provided  however, covered drug shall not include: (a)
    27  vitamins or  supplements;  (b)  herbal-based  remedies  and  homeopathic
    28  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.

        A. 9576                             2
     1  cidal  agents),  laundry detergent, bleach, household cleaning products,
     2  shampoos, sunscreens, toothpaste, lip  balm,  antiperspirants  or  other
     3  personal care products that are regulated as both cosmetics and nonpres-
     4  cription  drugs  under the Federal Food, Drug, and Cosmetic Act; (d) pet
     5  pesticide products contained in pet collars, powders, shampoos,  topical
     6  applications,  or other forms; (e) drugs that are biological products as
     7  defined in subdivision twenty-seven of section sixty-eight  hundred  two
     8  of  the  education  law if the manufacturer already provides a take back
     9  program; (f) drugs for which a manufacturer provides a take back program
    10  as part of a Federal Food and Drug Administration  managed  risk  evalu-
    11  ation and mitigation strategy; (g) medical devices or the component part
    12  of such devices or accessories if such device or component part contains
    13  no  covered  drug;  and  (h)  drugs  that  are used solely in a clinical
    14  setting.
    15    3. "Manufacturer" means a person, company, corporation or other entity
    16  engaged in the manufacture of drugs sold in the state.
    17    4. "Pharmacies" means all pharmacies registered under  section  sixty-
    18  eight hundred eight of the education law that are part of a group of ten
    19  or  more  establishments  that  conduct business under the same name, or
    20  operate under a common ownership or management, or pursuant to  a  fran-
    21  chise agreement with the same franchisor, and all nonresident pharmacies
    22  registered pursuant to section sixty-eight hundred eight-b of the educa-
    23  tion law that provide covered drugs to state residents by mail.
    24    5. "Drug take back organization" means an organization designated by a
    25  manufacturer or a group of manufacturers to act as an agent on behalf of
    26  the  manufacturer  or  group of manufacturers to operate and implement a
    27  drug take back program as authorized by this article.
    28    6. "Wholesaler" means any person, company, corporation or other entity
    29  that sells or distributes drugs and covered drugs for resale to an enti-
    30  ty in the state other than a consumer.
    31    § 291. Drug take back. 1. Any manufacturer of a covered drug shall:
    32    (a) operate a drug take back program approved by the department  indi-
    33  vidually or jointly with other manufacturers;
    34    (b)  enter  into an agreement with a drug take back organization which
    35  shall operate a drug take back program approved by the department; or
    36    (c) enter into an agreement with the department to operate a drug take
    37  back program on its behalf.
    38    2. Any manufacturer of a covered drug, individually or jointly,  or  a
    39  drug  take  back  organization contracted by a manufacturer of a covered
    40  drug shall within one hundred eighty days from  the  effective  date  of
    41  this  section  submit to the department, in a manner and form determined
    42  by the department, a proposed drug take back program that  meets,  at  a
    43  minimum, the following requirements:
    44    (a) Certifies the drug take back program will accept all covered drugs
    45  regardless of who produced them;
    46    (b) Provides contact information for the person submitting the planned
    47  drug  take  back  program  with  whom  the  department  shall direct all
    48  inquiries;
    49    (c) Details a pharmacy collection system to provide convenient,  ongo-
    50  ing  collection  services  to  all persons seeking to dispose of covered
    51  drugs pursuant to section two hundred ninety-two of this article;
    52    (d) Describes other collection methods by which covered drugs will  be
    53  collected by authorized collectors;
    54    (e) Explains how covered drugs will be safely and securely tracked and
    55  handled from collection through final disposal and destruction, policies
    56  to  ensure  security  and  compliance with all applicable laws and regu-

        A. 9576                             3
     1  lations including disposal and  destruction  at  a  permitted  hazardous
     2  waste disposal facility meeting federal requirements;
     3    (f)  Describes  the public education and outreach activities that will
     4  be undertaken which shall include advertising of collection locations on
     5  a website and through use of signage and other  written  materials,  and
     6  how effectiveness will be evaluated;
     7    (g)  Details how the costs of pharmacy collection and other authorized
     8  collectors will be reimbursed which shall include costs  retroactive  to
     9  the effective date of this article, and where more than one manufacturer
    10  will  be  involved in the planned drug take back program, a plan for the
    11  fair and reasonable manner of allocated costs among the participants  in
    12  such program such that the costs paid by each manufacturer is reasonably
    13  related to the number or value of covered drugs sold in the state; and
    14    (h) Provides any further information deemed appropriate by the depart-
    15  ment.
    16    3.  Within  thirty  days  of  the effective date of this section, each
    17  wholesaler that sells covered drugs in or into the state  shall  provide
    18  the  department with a list of manufacturers that produce covered drugs.
    19  The department may request updated lists at its discretion.
    20    4. A manufacturer, individually or jointly, must pay  all  administra-
    21  tive  and  operational  fees associated with the drug take back program,
    22  including the cost of collecting, transporting and disposing of  covered
    23  drugs  from pharmacies and other authorized collectors and the recycling
    24  or disposal, or both,  of  packing  collected  with  the  covered  drug.
    25  Manufacturers shall also pay costs incurred by the state in the adminis-
    26  tration  and  enforcement  of  the drug take back program.  Exclusive of
    27  fines and penalties, the state shall only recover  its  actual  cost  of
    28  administration and enforcement. In instances where manufacturers jointly
    29  conduct  a  drug  take  back  program,  the  costs of administration and
    30  enforcement shall be fairly  and  reasonably  allocated  such  that  the
    31  portion of costs is reasonably related to the number or value of covered
    32  drugs  the manufacturers sell in the state. No manufacturer may charge a
    33  point-of-sale or other fee to consumers, or a fee that could  be  passed
    34  on to consumers, to recoup the cost of their drug take back program.
    35    5.  Within sixty days of receipt of a proposed drug take back program,
    36  the department, in consultation with  the  department  of  environmental
    37  conservation,  shall  determine  whether  such  proposed  drug take back
    38  program complies with the requirements of this article  and  notify  the
    39  applicant.  The department may conduct a noticed public hearing prior to
    40  approval. If the drug take back  program  is  approved,  the  department
    41  shall  notify the applicant in writing. If the drug take back program is
    42  not approved, the department shall notify the applicant in  writing  and
    43  the  applicant  shall  submit  a revised drug take back program proposal
    44  within thirty days.  If the department rejects the subsequent  proposal,
    45  the  manufacturer  or  manufacturers at issue shall be out of compliance
    46  with this article and subject to the enforcement provisions pursuant  to
    47  section  two  hundred  ninety-four of this article. The department shall
    48  provide, and update annually, on its website a list of all manufacturers
    49  participating in a drug take back program approved by the department.
    50    6. At least every three years, a manufacturer, jointly or  individual-
    51  ly,  or  a  drug  take back organization shall update its drug take back
    52  program and submit an updated proposal to the department. A manufacturer
    53  who begins to offer a covered drug in the state after the effective date
    54  of this article, shall provide evidence of joining an existing  approved
    55  drug take back program or submit a proposal for a drug take back program
    56  within  ninety  days  following  the initial offer for sale of a covered

        A. 9576                             4
     1  drug. Any proposed change to a drug take back program shall be submitted
     2  in writing and approved by the department prior to any change.
     3    7. Each approved drug take back program shall report to the department
     4  at  a date and manner set by the department. The department shall submit
     5  an annual report to the governor, speaker of the assembly and  temporary
     6  president  of  the  senate by January first detailing all program activ-
     7  ities, the volume collected by each program, a description of collection
     8  activities, the name and location of all collection sites, public educa-
     9  tion and outreach activities, and any manufacturer out of compliance  or
    10  subject to penalties pursuant to section two hundred ninety-four of this
    11  article.
    12    §  292.  Collection.  1.  All  pharmacies  shall  provide for the safe
    13  collection of drugs, which shall include:
    14    (a) Offering drug collection by:
    15    (i) On-site collection receptacles meeting federal standards;
    16    (ii) Mail-back collection by prepaid envelopes as authorized by feder-
    17  al law and regulation; or
    18    (iii) Other  federal  drug  enforcement  agency  approved  methods  of
    19  collection.
    20    (b)  Signage prominently displayed advertising such drug collection to
    21  consumers.
    22    2. All drug take back program operators shall notify  other  potential
    23  authorized  collectors  of  the  opportunity  to  serve as an authorized
    24  collector for the drug take back program.  Participation  of  authorized
    25  collectors besides pharmacies shall be voluntary.
    26    3.  All  costs  of pharmacies and other authorized collectors shall be
    27  paid or reimbursed by the manufacturer, jointly or individually, as part
    28  of the drug take back programs required by this article.
    29    § 293. Violations. Violation of this article shall be subject to fines
    30  pursuant to section twelve of  this  chapter.  Each  day  in  which  the
    31  violation continues shall constitute a separate violation.
    32    §  294.  Jurisdiction.  Jurisdiction of all matters pertaining to drug
    33  disposal by this  article  is  vested  exclusively  in  the  state.  Any
    34  provision  of  any  local  law  or  ordinance, or any rule or regulation
    35  promulgated prior to, or upon the effective date of this section,  shall
    36  be preempted.
    37    §  3.  Section  3343-b of the public health law, as amended by chapter
    38  379 of the laws of 2015, is amended to read as follows:
    39    § 3343-b. Safe  disposal  of  unused  controlled  substances.  1.  The
    40  department  shall  oversee  a  program  for  the safe disposal of unused
    41  controlled substances by consumers in accordance with  federal  law  and
    42  article  two-B  of this chapter.  Individual members of the public shall
    43  be authorized to voluntarily surrender controlled substances  listed  on
    44  schedule  II,  III,  IV or V of section thirty-three hundred six of this
    45  article  in  a  secure  manner,  without  identifying  themselves.  Safe
    46  disposal  methods  shall  be publicized consistent with the prescription
    47  pain medication awareness program established pursuant to section  thir-
    48  ty-three  hundred nine-a of this article and article two-B of this chap-
    49  ter.
    50    2. The surrender of a controlled substance pursuant  to  this  section
    51  and  article  two-B of this chapter shall not constitute the possession,
    52  transfer or sale of such controlled substance for purposes of this arti-
    53  cle or the penal law.
    54    [3. Disposal sites shall be  operated  by  law  enforcement  agencies,
    55  pharmacies  and other Federal Drug Enforcement Administration authorized
    56  collectors on a voluntary basis. Nothing in this section  shall  require

        A. 9576                             5

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