New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter E - Food And Drug Products; Research › Part 60 - Food And Drug Products › Subpart 60-4 - Drug Take Back › Section 60-4.3 - Drug Take Back Programs

Current through Register Vol. 46, No. 28, July 10, 2024
Operators of Drug Take Back Program.
(a) Before implementing or modifying a drug
					 take back program, an operator must submit a proposal to, and obtain approval
					 of such program from, the Department, in consultation with the Department of
					 Environmental Conservation. Drug take back program proposals shall be submitted
					 to the Department in such a manner and form as determined by the
					 Department.
(b) A drug take back
					 program proposal shall include, but is not limited to, the following:
(1) The name, address, phone, e-mail address,
					 and any additional contact information requested by the Department for the
					 responsible person submitting the planned drug take back program and to whom
					 the Department may direct all inquiries;
(2) Certification that the drug take back
					 program will accept all covered drugs regardless of who produced
					 them;
(3) A detailed description of
					 the drug take back collection system which includes: information on geographic
					 distribution (and specifically how it ensures access in rural and underserved
					 areas), convenience for all consumers across the state, and ongoing services of
					 the program;
(4) A detailed
					 description of how pharmacies providing collection boxes for take back in areas
					 outside of the counties with convenience standards will be included in the
					 program.
(5) The name, address,
					 phone, e-mail address, DEA number, and Bureau of Narcotic Enforcement license
					 number, for any entity that will reverse distribute covered drugs for the drug
					 take back program;
(6) A list of
					 participating pharmacies and other authorized collectors, their DEA number, and
					 their Education Department registration number (if applicable), their
					 locations, and methods of collection, including collection receptacles, mail
					 back programs, and other approved collection methods;
(7) A description of other approved
					 collection methods, including drug take back events, that will be utilized to
					 collect covered drugs;
(8) Detailed
					 policies and procedures on how the drug take back program will safely and
					 securely track and handle collection of covered drugs through final disposal
					 and destruction, which includes information on 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;
(9) Detailed
					 information on the public education and outreach activities the drug take back
					 program will undertake, which includes information on advertisement, website,
					 signage, and other written materials;
(10) Detailed descriptions of how the
					 effectiveness of public education and outreach activities of the drug take back
					 program will be evaluated;
(11)
					 Detailed information on how the costs of pharmacy collection and other
					 authorized collectors of the drug take back program will be paid or reimbursed
					 by all manufacturers involved in the proposed program, including but not
					 limited to the following: who pays for the purchase and installation of
					 collection receptacles, the inner liners, mail back vouchers, envelopes,
					 packages, postage, transportation and disposal costs, communications, and
					 public education and outreach efforts, as well as how the costs are managed and
					 by whom;
(12) A detailed drug take
					 back program timeline for implementation, including specific expected
					 dates;
(13) Detailed information on
					 the methods to be used for outreach and participation by pharmacies and other
					 authorized collectors;
(14)
					 Detailed description of the methods to be used to retain data and information
					 necessary for reporting, pursuant to article 2-B of the Public Health Law as
					 deemed necessary by the Department. At a minimum, this must include the weight
					 of covered drugs collected, a description of collection activities, the names
					 and locations of all collection sites with collection method and weight
					 collected by method, and the public education and outreach
					 activities;
(15) A detailed list of
					 manufacturers that are partners in the proposed drug take back program which
					 includes: name of the manufacturer, name of the manufacturer's parent company
					 and any subsidiaries, mailing address, FDA labeler code, if applicable, DEA
					 number, if applicable, and any additional identifiers as requested by the
					 Department;
(16) Detailed
					 information on how the operator will identify and resolve safety and security
					 issues arising from the collection, transportation or disposal of covered
					 drugs; and
(17) Any additional
					 information as required by the Department to evaluate the proposal.