Bill Text: NY A10298 | 2015-2016 | General Assembly | Introduced
Bill Title: Establishes a drug stewardship program; requires any pharmaceutical product manufacturer selling or distributing a covered drug in the state to operate a drug stewardship program approved by the department of environmental conservation.
Spectrum: Partisan Bill (Democrat 2-0)
Status: (Introduced - Dead) 2016-05-20 - referred to environmental conservation [A10298 Detail]
Download: New_York-2015-A10298-Introduced.html
STATE OF NEW YORK ________________________________________________________________________ 10298 IN ASSEMBLY May 20, 2016 ___________ Introduced by M. of A. ENGLEBRIGHT, ROSENTHAL -- read once and referred to the Committee on Environmental Conservation AN ACT to amend the environmental conservation law, in relation to establishing a drug stewardship program The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Title 27 of article 27 of the environmental conservation 2 law, as added by chapter 625 of the laws of 2008, is amended by adding a 3 new section 27-2705 to read as follows: 4 § 27-2705. Drug stewardship program. 5 1. As used in this section, the following terms shall have the follow- 6 ing meanings unless the context clearly requires otherwise: 7 (a) "covered drug" means any brand name or generic opioid drug placed 8 in schedule I, schedule II or schedule III of section thirty-three 9 hundred six of the public health law; provided, however, that "covered 10 drug" shall also include benzodiazepines; provided, further, that 11 "covered drug" shall not include: (i) drugs intended for use solely in 12 veterinary care; (ii) substances that are regulated as cosmetic products 13 under the United States Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et 14 seq.; (iii) hypodermic needles, lancets or other sharps products subject 15 to collection and disposal procedures established in subdivision four of 16 section thirteen hundred eighty-nine-dd of the public health law, or 17 (iv) drugs approved and use primarily for medication-assisted substance 18 use disorder treatment. 19 (b) "drug stewardship program" means a program financed by a pharma- 20 ceutical product manufacturer or a group of manufacturers to collect, 21 secure, transport and safely dispose of unwanted drugs. 22 (c) "pharmaceutical product manufacturer" or "manufacturer" means an 23 entity that manufactures a controlled substance under a United States 24 food and drug administration manufacturer's license. 25 (d) "prescription drug" shall have the same meaning as subdivision 26 nine of section two hundred seventy of the public health law. 27 (e) "stewardship organization" means an organization designated by a 28 manufacturer or a group of manufacturers to act as an agent on behalf of EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD15156-01-6A. 10298 2 1 the manufacturer or the group of manufacturers to implement and operate 2 a drug stewardship program. 3 (f) "unwanted drug" means a covered drug: (i) that is no longer wanted 4 or intended to be consumed, or that is abandoned, discarded, expired or 5 surrendered by the person to whom it was prescribed; or (ii) voluntarily 6 deposited at collection points co-located with a law enforcement agency; 7 provided, however, that "unwanted drug" shall not include: (A) waste or 8 unused drug products from a pharmacy, hospital or health clinic or other 9 commercial sources that the department, based upon recommendations from 10 the department of health, may determine by regulation to be a nonresi- 11 dential source; or (B) drug products seized by law enforcement officers 12 in the course of their law enforcement duties. 13 2. (a) Any pharmaceutical product manufacturer selling or distributing 14 a covered drug to consumers in the state, whether directly or through a 15 wholesaler, retailer or other agent, shall: (i) operate a drug steward- 16 ship program approved by the department individually or jointly with 17 other manufacturers; (ii)enter into an agreement with a stewardship 18 organization that shall operate a drug stewardship program approved by 19 the department; or (iii) enter into an agreement with the department to 20 operate an alternative plan under subdivision six of this section. 21 (b) The department, in consultation with the department of health, 22 shall establish a process, pursuant to regulation, to review applica- 23 tions for approval and renewal of a manufacturer's drug stewardship 24 program. The department shall consult with the office of alcoholism and 25 substance abuse services and other interested parties in developing the 26 requirements of a drug stewardship program. 27 (c) Each operator of a drug stewardship program shall file an annual 28 written report to the department describing the program's activities for 29 the prior year and the volume and type of unwanted drugs collected not 30 later than March first. 31 (d) The department shall review for renewal each drug stewardship 32 program at a frequency to be determined by the department pursuant to 33 regulation. 34 (e) The department shall publish and make publicly available a list 35 and description of each approved drug stewardship program and shall 36 regularly update this list. 37 3. A manufacturer or stewardship organization seeking approval for a 38 drug stewardship program shall submit, in a manner and form determined 39 by the department pursuant to regulations developed, in consultation 40 with the department of health, a plan that meets, but is not limited to, 41 the following requirements: 42 (a) identification of all participating manufacturers; 43 (b) a collection system to provide convenient, ongoing collection 44 services to all persons seeking to dispose of unwanted drugs; provided, 45 however, that the collection system may accept any covered drug and any 46 other prescription drug in a pill formulation regardless of its sched- 47 ule, brand or source of manufacture; provided further, that the 48 collection system shall include two methods as recommended by the 49 department, which may include, but not be limited to: (i) a mail-back 50 program that provides prepaid and preaddressed packaging for a pharmacy 51 to distribute when filling a prescription for a covered drug or upon 52 request by a consumer; (ii) collection kiosks; (iii) drop-off day events 53 at regional locations; or (iv) any other method recommended pursuant to 54 United States drug enforcement administration guidelines;A. 10298 3 1 (c) adequate provisions for the security of unwanted drugs throughout 2 the collection process and the safety of any person involved in monitor- 3 ing, staffing or servicing the stewardship program; 4 (d) a plan for public outreach and education about the drug steward- 5 ship program; 6 (e) a plan for the manufacturer or stewardship organization that 7 provides the operational and administrative costs associated with the 8 program; provided, however, that no point-of-sale, point-of-collection, 9 processing fees or other drug cost increases may be charged to individ- 10 ual consumers to recoup program costs; 11 (f) an attestation that the program shall comply with all applicable 12 state and federal requirements for the collection, security, transport 13 and disposal of drug products, including any requirements established by 14 rule or regulation of either the United States drug enforcement adminis- 15 tration or the United States environmental protection agency; and 16 (g) any other requirements established by the department pursuant to 17 regulation for the safe and effective administration of a drug steward- 18 ship program. 19 4. (a) The department shall send a notice to a pharmaceutical product 20 manufacturer that sells or distributes a covered drug in the state that 21 has not submitted an application for approval under subdivision two of 22 this section, informing the manufacturer of the requirements to comply 23 with this section. Any manufacturer in receipt of a notice shall submit 24 an application for approval under subdivision two of this section within 25 one hundred eighty calendar days of receipt of such initial notice. 26 (b) Upon becoming aware that a pharmaceutical product manufacturer has 27 discontinued its drug stewardship program or has altered the program 28 such that the program no longer fulfills the requirements of this 29 section, the department shall send a notice of noncompliance to the 30 manufacturer. A manufacturer in receipt of a notice of noncompliance 31 shall take all required corrective steps to reestablish compliance with 32 this section or submit a written appeal of the notice of noncompliance 33 to the department within ninety days of receipt of the notice of noncom- 34 pliance. 35 (c) If after consideration of an appeal or if the manufacturer does 36 not appeal within ninety days of receipt of the notice of noncompliance 37 the department determines that the manufacturer continues to be in 38 noncompliance with this section, the department may assess the manufac- 39 turer a penalty after a hearing and an opportunity to be heard. If the 40 department plans to assess a noncompliance penalty against a manufactur- 41 er pursuant to this subdivision, the department shall send notice of the 42 penalty and the right to appeal the penalty to the manufacturer. 43 5. (a) Any requirements or regulations, may exceed, but shall not 44 conflict with, any obligations imposed on a manufacturer by a risk eval- 45 uation and mitigation strategy approved by the United States food and 46 drug administration. 47 (b) Nothing in this section shall require a pharmacy or a pharmacist 48 practicing in a retail setting to participate in the collection, secur- 49 ing, transport or disposal of unwanted drugs unless the pharmacy certi- 50 fies, in writing, that this participation is voluntary. 51 6. (a) The department shall, in consultation with the department of 52 health and the office of alcoholism and substance abuse services pursu- 53 ant to rules and regulations, develop, pursuant to regulation, an alter- 54 native plan to the drug stewardship program established under subdivi- 55 sions two through five of this section, inclusive. A manufacturer whoA. 10298 4 1 opts into a plan established under such rules and regulations shall be 2 exempt from subdivision two through five of this section, inclusive. 3 (b) A plan established under this subdivision may permit contributions 4 by manufacturers to the chemical dependence service fund established in 5 section ninety-seven-w of the state finance law and the environmental 6 protection fund established in section ninety-two-s of the state finance 7 law, in a manner determined by the department pursuant to regulation; 8 provided, however not more than fifty percent of any one contribution 9 may be contributed to any one fund. A manufacturer participating in a 10 plan established under this subdivision shall not pass the cost of any 11 contribution on to the consumer or a health insurance carrier. 12 § 2. This act shall take effect on the one hundred twentieth day after 13 it shall have become a law; provided, however, that effective immediate- 14 ly, the addition, amendment and/or repeal of any rule or regulation 15 necessary for the implementation of this act on its effective date are 16 authorized and directed to be made and completed on or before such 17 effective date.
