Division I Safe Drug Disposal Stewardship | |
Title. | |
Findings. | |
Definitions. | |
Stewardship Plans – Participation. | |
Stewardship Plans – Components. | |
Stewardship Plans – Collection of Covered Drugs. | |
Stewardship Plans – Promotion. | |
Stewardship Plans – Disposal of Covered Drugs. | |
Stewardship Plans – Administrative and Operational Costs and Fees. | |
Stewardship Plans – Reporting Requirements. | |
Stewardship Plans – List of Producers of Covered Drugs. | |
Stewardship Plans – Review of Proposed Plans. | |
Stewardship Plans – Prior Approval for Change. | |
Stewardship Plans – Enforcement and Penalties. | |
Stewardship Plans – Rules, Performance Standards, and Report. | |
Plan Review and Annual Operation Fees. | |
Undertaking for the General Welfare. | |
No Conflict with Federal or State Law. | |
Severability. | |
Effect of Grant of Certiorari. | |
Short Title. | |
Definitions. | |
Information Required at Point of Sale. | |
Implementation. | |
Enforcement. | |
This Division I may be cited as the San Francisco Safe Drug Disposal Stewardship Ordinance.
(a) Legal medicinal drugs allow us to live longer, healthier, and more productive lives.
(b) A Mayo Clinic study issued in June 2013 found that nearly 70 percent of Americans take one prescription drug, up from 48 percent in 2007-2008. According to the Centers for Disease Control and Prevention, health care providers in the United States wrote 259 million prescriptions for painkillers in 2012, enough for every American adult to have a bottle of pills.
(c) Municipal wastewater treatment plants are not designed to treat complex drug compounds that end up in the sewer system after being flushed down toilets and sinks. As a result, drugs can pass through wastewater treatment systems and contaminate receiving waters.
(d) An Environmental Protection Agency report on drinking water released in December 2013 tested effluent samples from 50 large wastewater treatment plants for active pharmaceutical ingredients and metabolites. Out of the 63 total compounds tested for, 43 were detected in at least one of the samples and all samples were found to contain at least one pharmaceutical compound. The presence of pharmaceuticals in surface water are well documented to have ecological impacts, including negative effects to fish and other aquatic life. Properly disposing of leftover, expired, and unwanted drugs would reduce the quantity of pharmaceutical compounds that are discharged into the San Francisco Bay and other receiving waters.
(e) Providing proper disposal options for leftover, expired, and unwanted drugs is also important in preventing unintentional poisoning deaths attributable to drugs, by making such drugs less accessible to persons who might abuse them. Deaths from drug overdose have been rising steadily over the past two decades. Every day in the United States, 113 people die as a result of drug overdose, and another 6,748 are treated in emergency departments for the misuse or abuse of drugs. Nearly 9 out of 10 poisoning deaths are caused by drugs. In 2011, 80 percent of the 41,340 drug overdose deaths in the United States were unintentional.
(f) Proper drug disposal could also impact the number of people who become addicted to prescription drugs. Results from the 2013 National Survey on Drug Use and Health indicate that about 15.3 million people aged 12 or older used prescription drugs non-medically in the past year, and 6. 5 million did so in the past month. Seventy percent of those addicted to prescription drugs say they first accessed drugs by taking them from friends and family who kept them unlocked in the house.
(g) San Francisco has adopted a goal of achieving Zero Waste to landfill by the year 2020. To meet this goal, it is expected that all discarded materials will need to be sorted or processed to maximize recovery of valuable resources. Additional and separate disposal options for medicines are needed to protect the health and safety of refuse sortline workers and to ensure the maximum recovery from San Francisco's waste stream.
(h) Extended Producer Responsibility (EPR), also called Product Stewardship, is a strategy that places some responsibility for end-of-life management of consumer products on the manufacturers of the products, while encouraging product design that minimizes negative impacts on human health and the environment at every stage of the product's lifecycle.
(i) San Francisco passed Producer Responsibility Resolutions in 2006 (Resolution No. 154-10) and in 2010 (Resolution No. 94-06) to state its support for managing product waste under an EPR system. Many other local and national government bodies support EPR including CalRecycle (formerly the California Integrated Waste Management Board), the National Association of Counties, and the National League of Cities.
(j) California has passed four significant product stewardship laws for mercury thermostats (AB 2347, enacted as Chapter 572 of the statutes of 2008), carpet (AB 2398, enacted as Chapter 681 of the statutes of 2010), paint (AB 1343, enacted as Chapter 420 of the statutes of 2010), and mattresses (SB 254, enacted as Chapter 21 of the statutes of 2013). All four laws require producers to establish and fund product stewardship programs for their waste stream.
(k) California Senate Bill 966, enacted as Chapter 542 of the Statutes of 2007, required CalRecycle to survey existing drug collection programs, evaluate them for several factors including cost effectiveness, and make recommendations for implementation of statewide programs.
(l) In 2010, Congress passed the "Secure and Responsible Drug Disposal Act of 2010," Public Law No. 111-273, which authorized the Attorney General to increase the methods – formerly restricted to law enforcement – by which controlled substances may be collected including collection at pharmacies. The goal of the bill was to increase opportunities for drug collection in order to reduce the instances of substance abuse, accidental poisoning, and release of harmful substances into the environment. On October 9, 2014, the Drug Enforcement Agency promulgated regulations implementing the bill, 21 C.F.R. Parts 1300, 1301, 1304, 1305, 1307, and 1317. These regulations, among other things, authorize retail pharmacies to maintain secure collection bins for controlled substances.
(m) A number of Canadian provinces and other countries already have active, well-established drug product stewardship programs in place. British Columbia has had a manufacturer-funded drug collection program in place since 1996. Ontario began a program in July 2010. And Manitoba began its program in April 2011. France, Spain and Portugal, among other countries, have national, well-established collection programs for home-generated drugs, which are paid for by drug companies and operated by Product Stewardship Associations on their behalf
(n) In 2012, Alameda County became the first local government in the United States to pass legislation, Ordinance No. 0-2012-27, requiring pharmaceutical companies to design, fund, and operate a safe drug collection and management program which could operate like the take-back programs found in Canada's pharmacies. On September 30, 2014, the Ninth Circuit Court of Appeal rejected a legal challenge to Alameda County's ordinance brought by drug manufacturers. Pharmaceutical Research and Manufacturers of America v. County of Alameda, 13-16833, 2014 WL 4814407 (9th Cir. Sept. 30, 2014).
(o) On June 20, 2013, the King County Board of Health passed Rule and Regulation No. #13-03 which created a drug take-back system for King County residents. The King County take-back system is also funded and operated by drug companies.
(p) To date, there is no voluntary or mandatory statewide product stewardship program for unwanted drugs in California. In 2013, the California State Senate passed a bill, SB 1014, that would have required drug companies to fund and operate a Product Stewardship program to collect and properly dispose of home-generated pharmaceutical waste, but the California Assembly did not take up the bill for a vote.
(q) There is considerable demand in San Francisco for a permanent drug stewardship program. Since 2012, the San Francisco Department of the Environment has operated a pilot program for the collection of controlled and non-controlled substances. As of January l, 2015, the program consists of 12 retail pharmacies and one community center collecting non-controlled substances and all 10 of the City's police stations collecting both controlled and non-controlled substances. The pilot program collects an average of 1,429 pounds of controlled and non-controlled substances per month, and as of December 31, 2014, has collected over 46,749 pounds.
(r) The pilot program, with only 23 drop-off locations, does not offer adequate convenient disposal options for all City residents. Moreover, only 45 percent of the pilot program's cost is covered by industry funding, and that funding is not reliable or sustainable.
For the purposes of this Division I the following definitions apply:
"City" means the City and County of San Francisco.
"City residents" means human beings residing in the City.
"Collector" means a Person that gathers Unwanted Covered Drugs from City residents for the purpose of collection, transportation, and disposal.
"Covered Drug" means a Drug sold in any form and used by City residents, including prescription, nonprescription, brand name and generic drugs. Notwithstanding the previous sentence, "Covered Drug" does not include: (1) vitamins or supplements; (2) herbal-based remedies and homeopathic drugs, products, or remedies; (3) cosmetics, shampoos, sunscreens, toothpaste, lip balm, antiperspirants, or other personal care products that are regulated as both cosmetics and nonprescription drugs under the federal Food, Drug, and Cosmetic Act (Title 21 U.S.C. Chapter 9); (4) Drugs for which Producers provide a pharmaceutical product stewardship or take-back program as part of a federal Food and Drug Administration-managed risk evaluation and mitigation strategy (Title 21 U.S.C. Sec. 355-1); (5) Drugs that are biological products as defined by 21 C.F.R. 600.3(h) as it exists on the effective date of this Division I if the Producer already provides a pharmaceutical product stewardship or take-back program; and (6) medical devices or their component parts or accessories.
"Department" means the Department of the Environment.
"Director" means the Director of the Department of the Environment or his or her designee.
"Drug Wholesaler" means a Person who buys Drugs for resale and distribution to corporations, individuals, or entities other than consumers.
“Drug" means: (1) any article recognized in the official United States pharmacopoeia, the official national formulary, the official homeopathic pharmacopoeia of the United States or any supplement of the formulary or those pharmacopoeias as published by the U.S. Pharmacopeial Convention and the Homeopathic Pharmacopoeia Convention of the United States; (2) any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; (3) any substance, other than food, intended to affect the structure or any function of the body of humans or other animals; or (4) any substance intended for use as a component of any substance specified in (1), (2), or (3) of this definition.
"Manufacture" means the production, preparation, propagation, compounding, or processing of a Drug but does not include the activities of a Repackager or Wholesaler, or practitioner who distributes or dispenses such substance or device in the course of his or her professional practice or prepares, compounds, packages, or labels such substance or device.
"Manufacturer" means a Person engaged in the Manufacture of Drugs.
"Mail-back services" means a collection method for the return of Unwanted Covered Drugs from City residents utilizing prepaid and pre-addressed mailing envelopes.
"Nonprescription Drug" means a Drug that may be lawfully sold without a prescription.
"Person" means a human being, firm, sole proprietorship, corporation, limited liability company, general partnership, limited partnership, limited liability partnership, association, cooperative, or other entity of any kind or nature.
"Pharmacy" means a place licensed by the state of California Board of Pharmacy where the practice of pharmacy is conducted
"Prescription Drug" means any Drug, including any controlled substance, that is required by federal or state law or regulation to be dispensed by prescription only or is restricted to use by practitioners only.
"Producer" means a Manufacturer engaged in the Manufacture of a Covered Drug sold in the City, including a brand-name or generic Drug. Notwithstanding the previous sentence, "Producer" does not include: (1) a retailer whose store label appears on a Covered Drug or the drug's packaging if the Manufacturer from whom the retailer obtains the drug is identified under Section 2203(d) of this Division I; (2) a Repackager if the Manufacturer from whom the Repackager obtains the Drug is identified under Section 2203(d) of this Division I; (3) a pharmacist who compounds or repackages a prescribed individual drug product for a consumer; or (4) a wholesaler who is not also the Manufacturer.
“Repackager" means a person who owns or operates an establishment that repacks and relabels a product or package for further sale, or for distribution without a further transaction.
"Retail Pharmacy" means a Pharmacy licensed by the state of California Board of Pharmacy for retail sale and dispensing of drugs.
"Stewardship Plan" means a plan for the collection, transportation and disposal of Unwanted Covered Drugs required under Section 2204 of this Division I that is: (1) financed, developed, implemented and participated in by one or more Producers; (2) operated by the participating Producers or a Stewardship Organization; and (3) approved by the Director.
"Stewardship Organization" means an organization designated by a Producer or group of Producers to act as an agent on behalf of one or more Producers to develop and implement and operate a Stewardship Plan.
"Unwanted Covered Drug" means any Covered Drug that the owner has discarded or intends to discard.
(a) Each Producer shall participate in a Stewardship Plan. Each Producer must: (1) operate, individually or jointly with other Producers, a Stewardship Plan approved by the Director; or (2) enter into an agreement with a Stewardship Organization to operate, on the Producer's behalf, a Stewardship Plan approved by the Director.
(b) Each Stewardship Plan must be approved by the Director before the entity administering the plan starts collecting Unwanted Covered Drugs. Once approved, each Stewardship Plan must have prior written approval of the Director for proposed changes as described under Section 2212.
(c) By six months after the effective date of this Division I or by six months after a Producer starts sale of a Covered Drug in the City, a Producer must notify the Director in writing of the Producer's intent to participate in a Stewardship Plan, or to form a new Stewardship Plan.
(d) By six months after the effective date of this Division I, or by six months after a retailer whose label appears on a Covered Drug or the Covered Drug's packaging starts selling the Covered Drug in the City, or by six months after a Covered Drug repackaged by Repackager is first sold in the City, and, thereafter, upon request from the Director, a retailer or Repackager whose label appears on a Covered Drug or the Covered Drug's packaging must provide:
(1) written notification as to whether the Manufacturer from whom the retailer or Repackager obtains the Covered Drug has provided its notice of intent to participate; and
(2) the contact information of the Manufacturer from whom the retailer or Repackager obtains the Covered Drug, including the telephone number, mailing address and email address of the retailer's or Repackager's point of contact at the Manufacturer.
(e) A Producer, either individually or jointly with other Producers, shall:
(1) By nine months after the effective date of this Division I, or nine months after starting sale of a Covered Drug in the City, identify in writing to the Director a Stewardship Plan operator, including the operator's telephone, mailing address and email contact information, that is authorized to be the official point of contact for the Stewardship Plan;
(2) By nine months after the effective date of this Division I, or nine months after starting sale of a Covered Drug in the City, notify all Retail Pharmacies and law enforcement agencies in the City of the opportunity to participate as a drop-off site in accordance with Sections 2205 of this Division I and provide a process for forming an agreement between the Stewardship Plan and interested Collectors; and annually thereafter, make the same notification to any nonparticipating or new Retail Pharmacies in the City;
(3) By one year after the effective date of this Division I, or one year after starting sale of a Covered Drug in the City, submit a proposed Stewardship Plan as described in Section 2204 to the Director for review;
(4) Within three months after the Director's approval of the Stewardship Plan, operate or participate in the Stewardship Plan in accordance with this Division I;
(5) At least every four years after the Stewardship Plan starts operations, submit an updated Stewardship Plan to the Director explaining any substantive changes to components of the Stewardship Plan required in Section 2204. The updated Stewardship Plan shall be accompanied by the plan review fee in accordance with Section 2215 of this Division I. The Director shall review updated Stewardship Plans using the process described in Section 2210 of this Division I; and
(6) Pay all administrative and operational costs and fees associated with its Stewardship Plan.
(f) A Producer, either individually or jointly with other Producers, may:
(1) Enter into contracts and agreements with Stewardship Organizations, other service providers, or other entities as necessary, useful or convenient to carry out all or portions of their Stewardship Plan;
(2) Notify the Director of any Producer selling Covered Drugs Manufactured by that Producer or group of Producers in the City that is failing to participate in a Stewardship Plan; and
(3) Perform any other functions as may be necessary or proper to carry out the Stewardship Plan and to fulfill any or all of the purposes for which the plan is organized.
(g) After the first full year of participation in a Stewardship Plan, a Producer or group of Producers may notify the Director in writing of intent to form a new Stewardship Plan, and identify a plan operator, including the plan operator's telephone, mailing address, and email contact information, that is authorized to be the official point of contact for the proposed new Stewardship Plan. Within three months of such notification, the Producer or group of Producers shall submit a proposed Stewardship Plan as described under Section 2204 to the Director for review.
(h) The Director may, on a case-by-case basis, approve in writing requests for extensions of time for the submission dates and deadlines in this Section 2203.
(i) The Director may audit the records of a Producer, group of Producers, or Stewardship Organization related to a Stewardship Plan or request that the Producer, group of Producers, or Stewardship Organization arrange for the Director to inspect at reasonable times a Stewardship Plan's or a Collector's facilities, vehicles, and equipment used in carrying out the Stewardship Plan.
Each Stewardship Plan, which must be submitted and reviewed according to Section 2211, shall include:
(a) Contact information for all Producers participating in the Stewardship Plan, including each Drug Producer's name, address, phone number, and email address, and the name , address, phone number, and email address of a human being to whom the Director may direct all inquires regarding the Producer's participation in the Stewardship Plan;
(b) A description of the proposed collection system to provide convenient ongoing collection service for all Unwanted Covered Drugs from City residents in compliance with the provisions and requirements in Section 2205, including a list of all collection methods and participating Collectors, a list of drop-off sites, a description of how any periodic collection events will be scheduled and located, a description of how any mail-back services will be provided and an example of the prepaid, pre-addressed mailers the plan will use. The description of the collection service shall include a list of Retail Pharmacies and law enforcement agencies contacted by the plan under Section 2203(d)(2) of this Division I and a list of all Collectors who offered to participate;
(d) A description of the policies and procedures to be followed by Persons handling Unwanted Covered Drugs collected under the Stewardship Plan, including a description of how all Collectors, transporters and waste disposal facilities used will ensure that the collected Unwanted Covered Drugs are safely and securely tracked from collection through final disposal, and how all entities participating in the Stewardship Plan will operate under and comply with all applicable federal and state laws, rules and guidelines, including but not limited to those of the United States Drug Enforcement Administration, and how any Pharmacy collection site will operate under applicable rules and guidelines of the State of California Board of Pharmacy;
(e) A certification that any patient information on Drug packaging will be promptly destroyed;
(f) A description of the public education effort and promotion strategy required in Section 2206 of this Division I including a copy of standardized instructions for City residents, signage developed for Collectors, and required promotional materials;
(g) Proposed short-term and long-term goals of the Stewardship Plan for collection amounts, education and promotion; and
(h) A description of how the Stewardship Plan will consider: (1) use of existing providers of waste pharmaceutical services; (2) separating Covered Drugs from packaging to the extent possible to reduce transportation and disposal costs; and (3) recycling of Drug packaging to the extent feasible.
Loading...