|SAME AS||SAME AS S07354|
|COSPNSR||Thiele, Ortiz, Englebright, Steck, Sepulveda, Stirpe, Hunter, Colton|
|Add Art 2-B §§290 - 294, amd §3343-b, Pub Health L|
|Enacts the drug take back act requiring certain manufacturers to operate a drug take back program to accept and dispose of covered drugs.|
|01/23/2018||referred to health|
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NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
BILL NUMBER: A9576 SPONSOR: Gunther
TITLE OF BILL: An act to amend the public health law, in relation to enacting the drug take back act   PURPOSE: To establish a statewide drug take back program for the safe disposal of drugs.   SUMMARY OF PROVISIONS: Section one provides the bill shall be known as the Drug Take Back Act. Section two adds a new Article 2-b to the Public Health Law which provides for the safe disposal of drugs statewide. Under this Act, manufacturers of covered drugs must either submit, individually or jointly, a drug take back program for approval by the Department of Health, or enter into an agreement with the Department to operate a drug take back program on its behalf. Under such program, manufacturers are responsible for all administrative and operational fees associated with their 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. This Act further requires chain pharmacies and mail-order pharmacies to provide for the collection of covered drugs by providing consumers with on-site collection, prepaid mail-back envelopes or other Drug Enforcement Agency (DEA) approved methods. Section three amends Public Health Law § 3343-b to make conforming changes. Section four provides the effective date.   JUSTIFICATION: New York, like the rest of the nation, continues to struggle with the opioid addiction crisis. Despite our best effects to stem the tide of opioid related deaths by, among other things, increasing access to Naloxone, enacting I-STOP to prevent doctor shopping, limiting initial prescriptions to 7 days, and changing the Insurance Law to make treat- ment more accessible, the number of deaths continue to rise. It is well known the first supply of opioids is often leftover medication a family member or friend received and did not use. To cut off this supply, we must make the take back and disposal of these drugs more prominent and accessible. In addition to getting excess drugs out of medicine cabinets where they are ripe for abuse, a statewide drug take back program will help ensure these and other drugs are not improperly disposed by flushing or other means that results in harm to our water bodies and impacts aquatic life. Last year New York made a historic investment in improving and protect- ing our water, keeping drugs out of our water supplies is another impor- tant and necessary step. While law enforcement agencies have drop-off points and elected offi- cials hold drug take back days that help properly dispose of many drugs, more must be done. Chapter 79 of the Laws of 2015, allowed pharmacies and other DEA authorized collectors to collect unused controlled substances in New York. While this was an important step in making it easier for people to take back their unused medications, voluntarily participation remains low. The Department of Environmental Conservation recently announced a pilot program that provides take back receptacles at participating pharmacies, hospitals and long-term care facilities, but again this program is voluntary and limited in scope. Meanwhile, a recent effort to require chain pharmacies statewide, and mail-order pharmacies, to participate in drug take back was vetoed by the Governor. Product Stewardship is the concept that whoever manufactures, produces, or sells a product take responsibility for minimizing the product's environmental impact throughout all stages of the products' life cycle, including its disposal or destruction. Over the years, New York has developed product stewardship programs for products such as electronic waste, rechargeable batteries, and mercury thermostats. Drug steward- ship programs are however, still largely in their infancy. In 2012, Alameda County, CA became the first government to pass legislation requiring pharmaceutical manufacturers to design, fund and operate a program to safely collect and dispose unwanted drugs. Alameda's program withstood court scrutiny, with the Ninth Circuit Court of Appeals find- ing its provisions did not violate the Dormant Commerce Clause. On May 26, 2015, the Supreme Court of the United States denied certiorari. The Alameda case paved the way, with now nine counties in California and more recently the state of Massachusetts and several counties in New York adopting similar programs. However, many of the existing drug stewardship programs continue to rely solely on voluntary retail partic- ipation, which has already proven to be low in New York. Retail partic- ipation is critical in reaching consumers and getting the most benefit from a take back program. Just as individuals can return tires, car batteries and motor oil to the businesses they purchased them from, New Yorkers should be able dispose of drugs, or obtain a prepaid mail-back envelope, at a pharmacy. Thus, this legislation will provide for unified, statewide drug take back, to be paid for by manufacturers, and require participation of chain and mail-order pharmacies. Manufacturers will be responsible for all costs from public education and awareness to collection, transport and destruction, and pharmacies will provide meth- ods for convenient drop-off and collection.   LEGISLATIVE HISTORY: New bill.   FISCAL IMPLICATIONS: None.   EFFECTIVE DATE: Immediately; provided, however, that the amendments to subdivision 1 of section 292 of the Public Health Law as added by section two of this Act, shall take effect 180 days after enactment.
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STATE OF NEW YORK ________________________________________________________________________ 9576 IN ASSEMBLY January 23, 2018 ___________ Introduced by M. of A. GUNTHER -- read once and referred to the Commit- tee on Health AN ACT to amend the public health law, in relation to enacting the drug take back act The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. This act shall be known and may be cited as the "drug take 2 back act." 3 § 2. The public health law is amended by adding a new article 2-B to 4 read as follows: 5 ARTICLE 2-B 6 DRUG TAKE BACK 7 Section 290. Definitions. 8 291. Drug take back. 9 292. Collection. 10 293. Violations. 11 294. Jurisdiction. 12 § 290. Definitions. As used in this article, unless the context clear- 13 ly requires otherwise: 14 1. "Authorized collector" means: (a) a person, company, corporation or 15 other entity that is registered with the United States Drug Enforcement 16 Administration to collect controlled substances for the purposes of safe 17 disposal and destruction; (b) a law enforcement agency; (c) a munici- 18 pality; or (d) a person, company, corporation or other entity authorized 19 by the department to provide alternative collection methods for covered 20 drugs that are not controlled substances. 21 2. "Covered drug" means any substance recognized as a drug under 21 22 USC § 321(g)(1), as amended, that is sold, offered for sale or dispensed 23 in the state, whether directly or through a wholesaler, in any form 24 including prescription and nonprescription drugs, drugs in medical 25 devices and combination products, brand and generic drugs and drugs for 26 veterinary use; provided however, covered drug shall not include: (a) 27 vitamins or supplements; (b) herbal-based remedies and homeopathic 28 drugs, products or remedies; (c) cosmetics, soap (with or without germi- EXPLANATION--Matter in italics (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD14168-02-8A. 9576 2 1 cidal agents), laundry detergent, bleach, household cleaning products, 2 shampoos, sunscreens, toothpaste, lip balm, antiperspirants or other 3 personal care products that are regulated as both cosmetics and nonpres- 4 cription drugs under the Federal Food, Drug, and Cosmetic Act; (d) pet 5 pesticide products contained in pet collars, powders, shampoos, topical 6 applications, or other forms; (e) drugs that are biological products as 7 defined in subdivision twenty-seven of section sixty-eight hundred two 8 of the education law if the manufacturer already provides a take back 9 program; (f) drugs for which a manufacturer provides a take back program 10 as part of a Federal Food and Drug Administration managed risk evalu- 11 ation and mitigation strategy; (g) medical devices or the component part 12 of such devices or accessories if such device or component part contains 13 no covered drug; and (h) drugs that are used solely in a clinical 14 setting. 15 3. "Manufacturer" means a person, company, corporation or other entity 16 engaged in the manufacture of drugs sold in the state. 17 4. "Pharmacies" means all pharmacies registered under section sixty- 18 eight hundred eight of the education law that are part of a group of ten 19 or more establishments that conduct business under the same name, or 20 operate under a common ownership or management, or pursuant to a fran- 21 chise agreement with the same franchisor, and all nonresident pharmacies 22 registered pursuant to section sixty-eight hundred eight-b of the educa- 23 tion law that provide covered drugs to state residents by mail. 24 5. "Drug take back organization" means an organization designated by a 25 manufacturer or a group of manufacturers to act as an agent on behalf of 26 the manufacturer or group of manufacturers to operate and implement a 27 drug take back program as authorized by this article. 28 6. "Wholesaler" means any person, company, corporation or other entity 29 that sells or distributes drugs and covered drugs for resale to an enti- 30 ty in the state other than a consumer. 31 § 291. Drug take back. 1. Any manufacturer of a covered drug shall: 32 (a) operate a drug take back program approved by the department indi- 33 vidually or jointly with other manufacturers; 34 (b) enter into an agreement with a drug take back organization which 35 shall operate a drug take back program approved by the department; or 36 (c) enter into an agreement with the department to operate a drug take 37 back program on its behalf. 38 2. Any manufacturer of a covered drug, individually or jointly, or a 39 drug take back organization contracted by a manufacturer of a covered 40 drug shall within one hundred eighty days from the effective date of 41 this section submit to the department, in a manner and form determined 42 by the department, a proposed drug take back program that meets, at a 43 minimum, the following requirements: 44 (a) Certifies the drug take back program will accept all covered drugs 45 regardless of who produced them; 46 (b) Provides contact information for the person submitting the planned 47 drug take back program with whom the department shall direct all 48 inquiries; 49 (c) Details a pharmacy collection system to provide convenient, ongo- 50 ing collection services to all persons seeking to dispose of covered 51 drugs pursuant to section two hundred ninety-two of this article; 52 (d) Describes other collection methods by which covered drugs will be 53 collected by authorized collectors; 54 (e) Explains how covered drugs will be safely and securely tracked and 55 handled from collection through final disposal and destruction, policies 56 to ensure security and compliance with all applicable laws and regu-A. 9576 3 1 lations including disposal and destruction at a permitted hazardous 2 waste disposal facility meeting federal requirements; 3 (f) Describes the public education and outreach activities that will 4 be undertaken which shall include advertising of collection locations on 5 a website and through use of signage and other written materials, and 6 how effectiveness will be evaluated; 7 (g) Details how the costs of pharmacy collection and other authorized 8 collectors will be reimbursed which shall include costs retroactive to 9 the effective date of this article, and where more than one manufacturer 10 will be involved in the planned drug take back program, a plan for the 11 fair and reasonable manner of allocated costs among the participants in 12 such program such that the costs paid by each manufacturer is reasonably 13 related to the number or value of covered drugs sold in the state; and 14 (h) Provides any further information deemed appropriate by the depart- 15 ment. 16 3. Within thirty days of the effective date of this section, each 17 wholesaler that sells covered drugs in or into the state shall provide 18 the department with a list of manufacturers that produce covered drugs. 19 The department may request updated lists at its discretion. 20 4. A manufacturer, individually or jointly, must pay all administra- 21 tive and operational fees associated with the drug take back program, 22 including the cost of collecting, transporting and disposing of covered 23 drugs from pharmacies and other authorized collectors and the recycling 24 or disposal, or both, of packing collected with the covered drug. 25 Manufacturers shall also pay costs incurred by the state in the adminis- 26 tration and enforcement of the drug take back program. Exclusive of 27 fines and penalties, the state shall only recover its actual cost of 28 administration and enforcement. In instances where manufacturers jointly 29 conduct a drug take back program, the costs of administration and 30 enforcement shall be fairly and reasonably allocated such that the 31 portion of costs is reasonably related to the number or value of covered 32 drugs the manufacturers sell in the state. No manufacturer may charge a 33 point-of-sale or other fee to consumers, or a fee that could be passed 34 on to consumers, to recoup the cost of their drug take back program. 35 5. Within sixty days of receipt of a proposed drug take back program, 36 the department, in consultation with the department of environmental 37 conservation, shall determine whether such proposed drug take back 38 program complies with the requirements of this article and notify the 39 applicant. The department may conduct a noticed public hearing prior to 40 approval. If the drug take back program is approved, the department 41 shall notify the applicant in writing. If the drug take back program is 42 not approved, the department shall notify the applicant in writing and 43 the applicant shall submit a revised drug take back program proposal 44 within thirty days. If the department rejects the subsequent proposal, 45 the manufacturer or manufacturers at issue shall be out of compliance 46 with this article and subject to the enforcement provisions pursuant to 47 section two hundred ninety-four of this article. The department shall 48 provide, and update annually, on its website a list of all manufacturers 49 participating in a drug take back program approved by the department. 50 6. At least every three years, a manufacturer, jointly or individual- 51 ly, or a drug take back organization shall update its drug take back 52 program and submit an updated proposal to the department. A manufacturer 53 who begins to offer a covered drug in the state after the effective date 54 of this article, shall provide evidence of joining an existing approved 55 drug take back program or submit a proposal for a drug take back program 56 within ninety days following the initial offer for sale of a coveredA. 9576 4 1 drug. Any proposed change to a drug take back program shall be submitted 2 in writing and approved by the department prior to any change. 3 7. Each approved drug take back program shall report to the department 4 at a date and manner set by the department. The department shall submit 5 an annual report to the governor, speaker of the assembly and temporary 6 president of the senate by January first detailing all program activ- 7 ities, the volume collected by each program, a description of collection 8 activities, the name and location of all collection sites, public educa- 9 tion and outreach activities, and any manufacturer out of compliance or 10 subject to penalties pursuant to section two hundred ninety-four of this 11 article. 12 § 292. Collection. 1. All pharmacies shall provide for the safe 13 collection of drugs, which shall include: 14 (a) Offering drug collection by: 15 (i) On-site collection receptacles meeting federal standards; 16 (ii) Mail-back collection by prepaid envelopes as authorized by feder- 17 al law and regulation; or 18 (iii) Other federal drug enforcement agency approved methods of 19 collection. 20 (b) Signage prominently displayed advertising such drug collection to 21 consumers. 22 2. All drug take back program operators shall notify other potential 23 authorized collectors of the opportunity to serve as an authorized 24 collector for the drug take back program. Participation of authorized 25 collectors besides pharmacies shall be voluntary. 26 3. All costs of pharmacies and other authorized collectors shall be 27 paid or reimbursed by the manufacturer, jointly or individually, as part 28 of the drug take back programs required by this article. 29 § 293. Violations. Violation of this article shall be subject to fines 30 pursuant to section twelve of this chapter. Each day in which the 31 violation continues shall constitute a separate violation. 32 § 294. Jurisdiction. Jurisdiction of all matters pertaining to drug 33 disposal by this article is vested exclusively in the state. Any 34 provision of any local law or ordinance, or any rule or regulation 35 promulgated prior to, or upon the effective date of this section, shall 36 be preempted. 37 § 3. Section 3343-b of the public health law, as amended by chapter 38 379 of the laws of 2015, is amended to read as follows: 39 § 3343-b. Safe disposal of unused controlled substances. 1. The 40 department shall oversee a program for the safe disposal of unused 41 controlled substances by consumers in accordance with federal law and 42 article two-B of this chapter. Individual members of the public shall 43 be authorized to voluntarily surrender controlled substances listed on 44 schedule II, III, IV or V of section thirty-three hundred six of this 45 article in a secure manner, without identifying themselves. Safe 46 disposal methods shall be publicized consistent with the prescription 47 pain medication awareness program established pursuant to section thir- 48 ty-three hundred nine-a of this article and article two-B of this chap- 49 ter. 50 2. The surrender of a controlled substance pursuant to this section 51 and article two-B of this chapter shall not constitute the possession, 52 transfer or sale of such controlled substance for purposes of this arti- 53 cle or the penal law. 54 [ 3. Disposal sites shall be operated by law enforcement agencies,55 pharmacies and other Federal Drug Enforcement Administration authorized56 collectors on a voluntary basis. Nothing in this section shall requireA. 9576 5 1 any political subdivision of the state to participate in the program2 established in this section.] 3 § 4. The department of health may adopt regulations as necessary to 4 implement and enforce the provisions of this title. 5 § 5. This act shall take effect immediately; provided, however, that 6 the amendments to subdivision 1 of section 292 of the public health law, 7 as added by section two of this act, shall take effect on the one 8 hundred eightieth day after it shall have become a law.