N.Y. Public Health Law § 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.