1. (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.

2. (b) A drug take back program proposal shall include, but is not limited to, the following:

   1. (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. (2) certification that the drug take back program will accept all covered drugs regardless of who produced them;
   3. (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. (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. (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. (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. (7) a description of other approved collection methods, including drug take back events, that will be utilized to collect covered drugs;
   8. (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. (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. (10) detailed descriptions of how the effectiveness of public education and outreach activities of the drug take back program will be evaluated;
   11. (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. (12) a detailed drug take back program timeline for implementation, including specific expected dates;
   13. (13) detailed information on the methods to be used for outreach and participation by pharmacies and other authorized collectors;
   14. (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. (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. (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. (17) any additional information as required by the department to evaluate the proposal.
3. (c) A drug take back program operator must update its proposal and submit it to the department at least every three years, from the date of the previous department approval, in such a manner and form as determined by the department.

4. (d) An operator of a drug take back program shall maintain records of program details that include participating manufacturers, authorized collectors, and functions performed in accordance with such program, including but not limited to the following:

   1. (1) the name of the manufacturer, name of the manufacturer’s parent company and any subsidiaries, mailing address, FDA labeler code and DEA number, as applicable, for each manufacturer of covered drug(s) contracted with the drug take back program and the date enrolled;
   2. (2) 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 tack back program;
   3. (3) the name and address of each location in which a collection receptacle is installed and the date of its installation, as well as the dates of its discontinuance, removal, or relocation;
   4. (4) the name and address of each location providing mail back packages, and the date initiated;
   5. (5) the total weight of covered drugs collected by each collection method annually; and
   6. (6) any other details as the department may direct.
5. (e) A report shall be made within 30 days to the department upon the discontinuance of participation in the program by any manufacturer of covered drug(s) or authorized collector. If the discontinuance involves an authorized collector in a city or county described in section 60-4.2(a) of this Subpart, the report must state the resulting impact on the convenience standard.

6. (f) A report in such form as the department directs shall be made annually to the department, on or before August 1st, detailing for the preceding calendar year all program activities, including but not limited to the following:

   1. (1) a list of manufacturers that participated during the reporting period that includes: name of parent company and/or subsidiary(ies), address, FDA labeler code and DEA number, as applicable, for each manufacturer of covered drug(s) contracted with the drug take back program and the date enrolled;
   2. (2) the name, address, phone, e-mail address, DEA number, and Bureau of Narcotic Enforcement license number, for any entity that reverse distribute covered drugs for the drug take back program;
   3. (3) a list of all pharmacies and other authorized collectors that maintained collection receptacles across the state during the reporting period that includes: DEA number, Education Department registration number (if applicable), name, address, total weight collected by method of collection, and the number of times each collection receptacle liner was replaced;
   4. (4) a list of pharmacies and other authorized collectors that provided mail back envelopes and/or packages during the reporting period that includes: DEA number, Education Department registration number (if applicable), name, address, process for patient accessing mail back envelopes or packages, number of vouchers and/or mail back envelopes and/or packages utilized, and total weight collected by mail back envelope and/or package;
   5. (5) a list of drug take back events held during the reporting period that includes: date of event, name of authorized collector, address, and total weight collected per event;
   6. (6) total weight of covered drugs collected by method of collection, and by location address, as well as aggregate weights for each of the 62 counties of New York State and the cities of Buffalo, Rochester, Syracuse, and Yonkers;
   7. (7) description of collection activities, including policies and procedures for methods of collection;
   8. (8) description of program’s statewide outreach and public education activities, including marketing materials, public service messages, and website information;
   9. (9) evaluation of the program and of each collection method, including an evaluation of education and outreach, an evaluation of program costs and of costs involved for each method and suggestions for overall program improvement;
   10. (10) a list of manufacturers and authorized collectors that have discontinued participation; and
   11. (11) additional information as determined by the department.

Operators of Drug Take Back Program.