2021 New York Laws
PBH - Public Health
Article 2-B - Drug Take Back
291 - Drug Take Back.

§ 291. Drug take back. 1. Any manufacturer of a covered drug shall:
  (a)  operate  a  drug  take  back  program  approved by the department
individually 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 that is
geographically distributed in a  way  to  ensure  access  in  rural  and
underserved 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
regulations  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
department.
  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
administrative  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
administration  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
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
individually,  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
activities,  the  weight  collected  by  each  program, a description of
collection activities, the name and location of  all  collection  sites,
public  education and outreach activities, an evaluation of the efficacy
of the program and each collection method, and any manufacturer  out  of
compliance  or  subject  to  penalties  pursuant  to section two hundred
ninety-four of this article.