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A09576 Summary:

BILL NOA09576A
 
SAME ASNo Same As
 
SPONSORGunther
 
COSPNSRThiele, Ortiz, Englebright, Steck, Sepulveda, Stirpe, Hunter, Colton, Pellegrino, Pheffer Amato, Brindisi, Curran, Abinanti, De La Rosa, Galef, Fahy, Magnarelli, Lifton, Jaffee, Hyndman
 
MLTSPNSR
 
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:

BILL NOA09576A
 
01/23/2018referred to health
04/24/2018amend and recommit to health
04/24/2018print number 9576a
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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: A9576A
 
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--A
 
                   IN ASSEMBLY
 
                                    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:
 
     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, 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
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD14168-03-8

        A. 9576--A                          2
 
     1  devices and combination products, brand and generic drugs and drugs  for
     2  veterinary  use;  provided  however, covered drug shall not include: (a)
     3  vitamins or  supplements;  (b)  herbal-based  remedies  and  homeopathic
     4  drugs, products or remedies; (c) cosmetics, soap (with or without germi-
     5  cidal  agents),  laundry detergent, bleach, household cleaning products,
     6  shampoos, sunscreens, toothpaste, lip  balm,  antiperspirants  or  other
     7  personal care products that are regulated as both cosmetics and nonpres-
     8  cription  drugs  under the Federal Food, Drug, and Cosmetic Act; (d) pet
     9  pesticide products contained in pet collars, powders, shampoos,  topical
    10  applications,  or other forms; (e) drugs that are biological products as
    11  defined in subdivision twenty-seven of section sixty-eight  hundred  two
    12  of  the  education  law if the manufacturer already provides a take back
    13  program; (f) drugs for which a manufacturer provides a take back program
    14  as part of a Federal Food and Drug Administration  managed  risk  evalu-
    15  ation and mitigation strategy; (g) medical devices or the component part
    16  of such devices or accessories if such device or component part contains
    17  no  covered  drug;  and  (h)  drugs  that  are used solely in a clinical
    18  setting.
    19    3. "Manufacturer" means a person, company, corporation or other entity
    20  engaged in the manufacture of drugs sold in the state.
    21    4. "Pharmacies" means all pharmacies registered under  section  sixty-
    22  eight hundred eight of the education law that are part of a group of ten
    23  or  more  establishments  that  conduct business under the same name, or
    24  operate under a common ownership or management, or pursuant to  a  fran-
    25  chise agreement with the same franchisor, and all nonresident pharmacies
    26  registered pursuant to section sixty-eight hundred eight-b of the educa-
    27  tion law that provide covered drugs to state residents by mail.
    28    5. "Drug take back organization" means an organization designated by a
    29  manufacturer or a group of manufacturers to act as an agent on behalf of
    30  the  manufacturer  or  group of manufacturers to operate and implement a
    31  drug take back program as authorized by this article.
    32    6. "Wholesaler" means any person, company, corporation or other entity
    33  that sells or distributes drugs and covered drugs for resale to an enti-
    34  ty in the state other than a consumer.
    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;

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

        A. 9576--A                          4
 
     1  program and submit an updated proposal to the department. A manufacturer
     2  who begins to offer a covered drug in the state after the effective date
     3  of  this article, shall provide evidence of joining an existing approved
     4  drug take back program or submit a proposal for a drug take back program
     5  within  ninety  days  following  the initial offer for sale of a covered
     6  drug. Any proposed change to a drug take back program shall be submitted
     7  in writing and approved by the department prior to any change.
     8    7. Each approved drug take back program shall report to the department
     9  at a date and manner set by the department. The department shall  submit
    10  an  annual report to the governor, speaker of the assembly and temporary
    11  president of the senate by January first detailing  all  program  activ-
    12  ities, the weight collected by each program, a description of collection
    13  activities, the name and location of all collection sites, public educa-
    14  tion  and outreach activities, and any manufacturer out of compliance or
    15  subject to penalties pursuant to section two hundred ninety-four of this
    16  article.
    17    § 292. Collection. 1.  All  pharmacies  shall  provide  for  the  safe
    18  collection of drugs, which shall include:
    19    (a) Offering drug collection by:
    20    (i)  On-site collection, dropbox, or receptacle meeting federal stand-
    21  ards;
    22    (ii) Mail-back collection by prepaid envelopes as authorized by feder-
    23  al law and regulation; or
    24    (iii) Other  federal  drug  enforcement  agency  approved  methods  of
    25  collection.
    26    (b)  Signage prominently displayed advertising such drug collection to
    27  consumers.
    28    2. All drug take back program operators shall notify  other  potential
    29  authorized  collectors  of  the  opportunity  to  serve as an authorized
    30  collector for the drug take back program.  Participation  of  authorized
    31  collectors besides pharmacies shall be voluntary.
    32    3.  All  costs  of pharmacies and other authorized collectors shall be
    33  paid or reimbursed by the manufacturer, jointly or individually, as part
    34  of the drug take back programs required by this article.
    35    § 293. Violations. Violation of this article shall be subject to fines
    36  pursuant to section twelve of  this  chapter.  Each  day  in  which  the
    37  violation continues shall constitute a separate violation.
    38    §  294.  Jurisdiction.  Jurisdiction of all matters pertaining to drug
    39  disposal by this  article  is  vested  exclusively  in  the  state.  Any
    40  provision  of  any  local  law  or  ordinance, or any rule or regulation
    41  promulgated prior to, or upon the effective date of this section,  shall
    42  be preempted.
    43    §  3.  Section  3343-b of the public health law, as amended by chapter
    44  379 of the laws of 2015, is amended to read as follows:
    45    § 3343-b. Safe  disposal  of  unused  controlled  substances.  1.  The
    46  department  shall  oversee  a  program  for  the safe disposal of unused
    47  controlled substances by consumers in accordance with  federal  law  and
    48  article  two-B  of this chapter.  Individual members of the public shall
    49  be authorized to voluntarily surrender controlled substances  listed  on
    50  schedule  II,  III,  IV or V of section thirty-three hundred six of this
    51  article  in  a  secure  manner,  without  identifying  themselves.  Safe
    52  disposal  methods  shall  be publicized consistent with the prescription
    53  pain medication awareness program established pursuant to section  thir-
    54  ty-three  hundred nine-a of this article and article two-B of this chap-
    55  ter.

        A. 9576--A                          5
 
     1    2. The surrender of a controlled substance pursuant  to  this  section
     2  and  article  two-B of this chapter shall not constitute the possession,
     3  transfer or sale of such controlled substance for purposes of this arti-
     4  cle or the penal law.
     5    [3.  Disposal  sites  shall  be  operated by law enforcement agencies,
     6  pharmacies and other Federal Drug Enforcement Administration  authorized
     7  collectors  on  a voluntary basis. Nothing in this section shall require
     8  any political subdivision of the state to  participate  in  the  program
     9  established in this section.]
    10    §  4.  The  department of health may adopt regulations as necessary to
    11  implement and enforce the provisions of this title.
    12    § 5. This act shall take effect immediately; provided,  however,  that
    13  subdivision  1  of  section  292  of  the public health law, as added by
    14  section two of this act, shall take effect on the one hundred  eightieth
    15  day after it shall have become a law.
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