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A09576 Summary:

BILL NOA09576B
 
SAME ASSAME AS S09100
 
SPONSORGunther
 
COSPNSRThiele, Ortiz, Englebright, Steck, Sepulveda, Stirpe, Hunter, Colton, Pellegrino, Pheffer Amato, Brindisi, Curran, Abinanti, De La Rosa, Galef, Fahy, Magnarelli, Lifton, Jaffee, Hyndman, Carroll, Mosley, Gottfried, O'Donnell, Stern, Lupardo, Glick, Bronson, Skoufis, Rosenthal L, Dinowitz, Rosenthal D, Jones, Seawright, Woerner, Paulin, Bohen, Barnwell, Taylor, Weprin, Arroyo, McDonough, Santabarbara, Finch
 
MLTSPNSRBuchwald, Byrne, Epstein
 
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 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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A09576 Actions:

BILL NOA09576B
 
01/23/2018referred to health
04/24/2018amend and recommit to health
04/24/2018print number 9576a
05/31/2018reported referred to codes
06/17/2018amend and recommit to codes
06/17/2018print number 9576b
06/18/2018reported referred to ways and means
06/19/2018reported referred to rules
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A09576 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A9576B
 
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
        ________________________________________________________________________
 
                                         9576--B
 
                   IN ASSEMBLY
 
                                    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:
 
     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
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD14168-15-8

        A. 9576--B                          2
 
     1  provide alternative collection methods for covered drugs  that  are  not
     2  controlled substances.
     3    2.  "Covered  drug"  means any substance recognized as a drug under 21
     4  USC § 321(g)(1), as amended, and any regulations promulgated  thereunder
     5  that  is  sold,  offered  for  sale  or  dispensed in the state, whether
     6  directly or through a wholesaler, in any form including prescription and
     7  nonprescription  drugs,  drugs  in  medical  devices   and   combination
     8  products, brand and generic drugs and drugs for veterinary use; provided
     9  however,  covered  drug  shall not include: (a) vitamins or supplements;
    10  (b) herbal-based remedies and homeopathic drugs, products  or  remedies;
    11  (c)  cosmetics, soap (with or without germicidal agents), laundry deter-
    12  gent, bleach, household cleaning products, shampoos, sunscreens,  tooth-
    13  paste,  lip  balm,  antiperspirants or other personal care products that
    14  are regulated as both cosmetics  and  nonprescription  drugs  under  the
    15  Federal  Food,  Drug,  and  Cosmetic  Act;  (d)  pet  pesticide products
    16  contained in pet collars, powders, shampoos,  topical  applications,  or
    17  other forms; (e) drugs that are biological products as defined in subdi-
    18  vision  twenty-seven of section sixty-eight hundred two of the education
    19  law if the manufacturer already provides a take back program; (f)  drugs
    20  for  which  a  manufacturer  provides  a  take back program as part of a
    21  Federal Food and Drug Administration managed risk evaluation  and  miti-
    22  gation  strategy;  (g)  emptied  injector  products  or  emptied medical
    23  devices and their component parts or accessories; and (h) drugs that are
    24  used solely in a clinical setting.
    25    3. "Manufacturer" means a person, company, corporation or other entity
    26  engaged in the manufacture of covered drugs sold in the state.  Manufac-
    27  turer does not include a repackager or wholesaler.
    28    4. "Pharmacies" means all pharmacies registered under  section  sixty-
    29  eight hundred eight of the education law that are part of a group of ten
    30  or  more  establishments  that  conduct business under the same name, or
    31  operate under a common ownership or management, or pursuant to  a  fran-
    32  chise agreement with the same franchisor, and all nonresident pharmacies
    33  registered pursuant to section sixty-eight hundred eight-b of the educa-
    34  tion law that provide covered drugs to state residents by mail.
    35    5. "Drug take back organization" means an organization designated by a
    36  manufacturer or a group of manufacturers to act as an agent on behalf of
    37  the  manufacturer  or  group of manufacturers to operate and implement a
    38  drug take back program as authorized by this article.
    39    6. "Wholesaler" means any person, company, corporation or other entity
    40  that sells or distributes drugs and covered drugs for resale to an enti-
    41  ty in the state other than a consumer.
    42    7. "Repackager" means an entity that owns or operates an establishment
    43  that repacks and relabels a product or package containing a covered drug
    44  for further sale or for distribution without further transaction.
    45    § 291. Drug take back. 1. Any manufacturer of a covered drug shall:
    46    (a) operate a drug take back program approved by the department  indi-
    47  vidually or jointly with other manufacturers;
    48    (b)  enter  into an agreement with a drug take back organization which
    49  shall operate a drug take back program approved by the department; or
    50    (c) enter into an agreement with the department to operate a drug take
    51  back program on its behalf.
    52    2. Any manufacturer of a covered drug, individually or jointly,  or  a
    53  drug  take  back  organization contracted by a manufacturer of a covered
    54  drug shall within one hundred eighty days from  the  effective  date  of
    55  this  section  submit to the department, in a manner and form determined

        A. 9576--B                          3
 
     1  by the department, a proposed drug take back program that  meets,  at  a
     2  minimum, the following requirements:
     3    (a) Certifies the drug take back program will accept all covered drugs
     4  regardless of who produced them;
     5    (b) Provides contact information for the person submitting the planned
     6  drug  take  back  program  with  whom  the  department  shall direct all
     7  inquiries;
     8    (c)  Details  a  collection  system  to  provide  convenient,  ongoing
     9  collection  services  to all persons seeking to dispose of covered drugs
    10  pursuant to section two hundred  ninety-two  of  this  article  that  is
    11  geographically distributed in a way to ensure access in rural and under-
    12  served areas;
    13    (d)  Describes other collection methods by which covered drugs will be
    14  collected by authorized collectors;
    15    (e) Explains how covered drugs will be safely and securely tracked and
    16  handled from collection through final disposal and destruction, policies
    17  to ensure security and compliance with all  applicable  laws  and  regu-
    18  lations including disposal and destruction at a permitted waste disposal
    19  facility meeting federal requirements;
    20    (f)  Describes  the public education and outreach activities that will
    21  be undertaken which shall include advertising of collection locations on
    22  a website and through use of signage and other  written  materials,  and
    23  how effectiveness will be evaluated;
    24    (g)  Details how the costs of pharmacy collection and other authorized
    25  collectors will be reimbursed which shall include costs  retroactive  to
    26  the effective date of this article, and where more than one manufacturer
    27  will  be  involved in the planned drug take back program, a plan for the
    28  fair and reasonable manner of allocated costs among the participants  in
    29  such program such that the costs paid by each manufacturer is reasonably
    30  related to the volume or value of covered drugs sold in the state; and
    31    (h) Provides any further information deemed appropriate by the depart-
    32  ment.
    33    3.  Within  thirty  days  of  the effective date of this section, each
    34  wholesaler that sells covered drugs in or into the state  shall  provide
    35  the  department with a list of manufacturers that produce covered drugs.
    36  The department may request updated lists at its discretion.
    37    4. A manufacturer, individually or jointly, must pay  all  administra-
    38  tive  and  operational  fees associated with the drug take back program,
    39  including the cost of collecting, transporting and disposing of  covered
    40  drugs  from pharmacies and other authorized collectors and the recycling
    41  or disposal, or both,  of  packing  collected  with  the  covered  drug.
    42  Manufacturers shall also pay costs incurred by the state in the adminis-
    43  tration  and  enforcement  of  the drug take back program.  Exclusive of
    44  fines and penalties, the state shall only recover  its  actual  cost  of
    45  administration and enforcement. In instances where manufacturers jointly
    46  conduct  a  drug  take  back  program,  the  costs of administration and
    47  enforcement shall be fairly  and  reasonably  allocated  such  that  the
    48  portion of costs is reasonably related to the volume or value of covered
    49  drugs  the manufacturers sell in the state. No manufacturer may charge a
    50  point-of-sale or other fee to consumers, or a fee that could  be  passed
    51  on to consumers, to recoup the cost of their drug take back program.
    52    5.  Within sixty days of receipt of a proposed drug take back program,
    53  the department, in consultation with  the  department  of  environmental
    54  conservation,  shall  determine  whether  such  proposed  drug take back
    55  program complies with the requirements of this article  and  notify  the
    56  applicant.  The department may conduct a noticed public hearing prior to

        A. 9576--B                          4

     1  approval. If the drug take back  program  is  approved,  the  department
     2  shall  notify the applicant in writing. If the drug take back program is
     3  not approved, the department shall notify the applicant in  writing  and
     4  the  applicant  shall  submit  a revised drug take back program proposal
     5  within thirty days.  If the department rejects the subsequent  proposal,
     6  the  manufacturer  or  manufacturers at issue shall be out of compliance
     7  with this article and subject to the enforcement provisions pursuant  to
     8  section  two  hundred  ninety-four of this article. The department shall
     9  provide, and update annually, on its website a list of all manufacturers
    10  participating in a drug take back program approved by the department.
    11    6. At least every three years, a manufacturer, jointly or  individual-
    12  ly,  or  a  drug  take back organization shall update its drug take back
    13  program and submit an updated proposal to the department. A manufacturer
    14  who begins to offer a covered drug in the state after the effective date
    15  of this article, shall provide evidence of joining an existing  approved
    16  drug take back program or submit a proposal for a drug take back program
    17  within  ninety  days  following  the initial offer for sale of a covered
    18  drug. Any proposed change to a drug take back program shall be submitted
    19  in writing and approved by the department prior to any change.
    20    7. Each approved drug take back program shall report to the department
    21  at a date and manner set by the department. The department shall  submit
    22  an  annual report to the governor, speaker of the assembly and temporary
    23  president of the senate by January first detailing  all  program  activ-
    24  ities, the weight collected by each program, a description of collection
    25  activities, the name and location of all collection sites, public educa-
    26  tion  and  outreach  activities,  an  evaluation  of the efficacy of the
    27  program and each collection method, and any manufacturer out of  compli-
    28  ance or subject to penalties pursuant to section two hundred ninety-four
    29  of this article.
    30    §  292.  Collection.  1.  All  pharmacies  shall  provide for the safe
    31  collection of drugs, which shall include:
    32    (a) Offering drug collection by one or more of the following methods:
    33    (i) On-site collection, dropbox, or receptacle meeting federal  stand-
    34  ards;
    35    (ii) Mail-back collection by prepaid envelopes as authorized by feder-
    36  al law and regulation; or
    37    (iii)  Other  federal  drug  enforcement  agency  approved  methods of
    38  collection.
    39    (b) Signage prominently displayed advertising such drug collection  to
    40  consumers.
    41    2.  All  drug take back program operators shall notify other potential
    42  authorized collectors of the  opportunity  to  serve  as  an  authorized
    43  collector  for  the  drug take back program. Participation of authorized
    44  collectors besides pharmacies shall be voluntary.
    45    3. All costs of pharmacies and other authorized  collectors  shall  be
    46  paid or reimbursed by the manufacturer, jointly or individually, as part
    47  of the drug take back programs required by this article.
    48    4.  For any city with a population of one hundred twenty-five thousand
    49  or more as of the last decennial census, the commissioner  shall  estab-
    50  lish  by  regulation  a  distribution  plan  that  ensures  that on-site
    51  collection receptacle or dropbox placement shall be reasonably  accessi-
    52  ble to all residents and that provides for program cost efficiency.
    53    5.  Pharmacies  providing for mail-back collection as part of the drug
    54  take back program shall provide a voucher for a  prepaid  envelope  upon
    55  dispensing  a  covered  drug. Such voucher shall include  information on
    56  drug take back and safe drug disposal methods.

        A. 9576--B                          5
 
     1    § 293. Violations. Violation of this article shall be subject to fines
     2  pursuant to section twelve of  this  chapter.  Each  day  in  which  the
     3  violation continues shall constitute a separate violation.
     4    §  294.  Jurisdiction.  Jurisdiction of all matters pertaining to drug
     5  disposal by this  article  is  vested  exclusively  in  the  state.  Any
     6  provision  of  any  local  law  or  ordinance, or any rule or regulation
     7  promulgated prior to, or upon the effective date of this section,  shall
     8  be preempted.
     9    §  3.  Section  3343-b of the public health law, as amended by chapter
    10  379 of the laws of 2015, is amended to read as follows:
    11    § 3343-b. Safe  disposal  of  unused  controlled  substances.  1.  The
    12  department  shall  oversee  a  program  for  the safe disposal of unused
    13  controlled substances by consumers in accordance with  federal  law  and
    14  article  two-B  of this chapter.  Individual members of the public shall
    15  be authorized to voluntarily surrender controlled substances  listed  on
    16  schedule  II,  III,  IV or V of section thirty-three hundred six of this
    17  article  in  a  secure  manner,  without  identifying  themselves.  Safe
    18  disposal  methods  shall  be publicized consistent with the prescription
    19  pain medication awareness program established pursuant to section  thir-
    20  ty-three  hundred nine-a of this article and article two-B of this chap-
    21  ter.
    22    2. The surrender of a controlled substance pursuant  to  this  section
    23  and  article  two-B of this chapter shall not constitute the possession,
    24  transfer or sale of such controlled substance for purposes of this arti-
    25  cle or the penal law.
    26    3. [Disposal] Except as provided in article  two-B  of  this  chapter,
    27  disposal sites shall be operated by law enforcement agencies, pharmacies
    28  and  other Federal Drug Enforcement Administration authorized collectors
    29  on a voluntary basis, provided, however, that such disposal sites  shall
    30  not  be  precluded  from  operating  as part of a drug take back program
    31  established pursuant to article two-B of this chapter. Nothing  in  this
    32  section  shall require any political subdivision of the state to partic-
    33  ipate in the program established in this section.
    34    § 4. The department of health may adopt regulations  as  necessary  to
    35  implement and enforce the provisions of this title.
    36    § 5. This act shall take effect on the one hundred eightieth day after
    37  it shall have become a law.  Effective immediately, the addition, amend-
    38  ment and/or repeal of any rule or regulation necessary for the implemen-
    39  tation  of  this act on its effective date are authorized to be made and
    40  completed on or before such effective date.
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