(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.