NY Pub Health L § 291 (2021)
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.