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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.
(a) This Division I does not require any Person to serve as a Collector in a Stewardship Plan. A Person may offer to serve as a Collector voluntarily, or may agree to serve as a Collector in exchange for incentives or payment offered by a Producer, group of Producers or Stewardship Organization. Collectors may include law enforcement agencies, Pharmacies, mail-back services or other entities, operating in accordance with state and federal laws and regulations for the handling of Covered Drugs, including but not limited to those of the United States Drug Enforcement Administration, and in compliance with this Division I. A Pharmacy collection site shall operate under applicable rules and guidelines of the State of California Board of Pharmacy.
(b) The collection system for each Stewardship Plan shall:
(1) Provide reasonably convenient and equitable access for all City residents in all Supervisorial Districts. The system of drop-off sites shall provide at least five drop-off sites in every Supervisorial District, geographically distributed to provide reasonably convenient and equitable access. If the service convenience goal in this subsection (b)(1) cannot be achieved due to a lack of drop-off sites at pharmacies, law enforcement agencies, or other qualified Collectors in each Supervisorial District, then those areas shall be served through periodic collection events and/or mail-back services;
(2) Be safe and secure, including providing for the prompt destruction of patient information on Drug packaging;
(3) Give preference to having Retail Pharmacies and law enforcement agencies serve as drop-off sites;
(4) Include, as Collectors, any Retail Pharmacy or any law enforcement agency willing to serve voluntarily as a drop-off site for Unwanted Covered Drugs and able to meet the requirements of this Division I within three months of their offer to participate, unless the Collector requests a longer time frame. A Stewardship Plan may also accept other Collectors willing to serve as a drop-off site for Unwanted Covered Drugs and able to meet the requirements of this Division I; and
(5) Make mail-back services available, free of charge, to disabled and home-bound residents upon request through the Stewardship Plan's toll-free telephone number and web site, and through distribution of prepaid, pre-addressed mailers to Persons providing services to such residents. The toll-free telephone number and web site required by this subsection (b)(5) shall be in English, Spanish, Chinese, Russian, and Tagalog.
(c) In addition to the collection system described in subsection (b)(1), all stewardship plans shall jointly operate a drop-off site within each City-owned pharmacy.
(d) Drop-off sites shall accept all Covered Drugs from City residents during all hours that the Retail Pharmacy, law enforcement agency, or other Collector is normally open for business with the public. Drop-off sites not operated by a law enforcement agency shall utilize secure collection bins in compliance with all applicable requirements, including but not limited to those of the United States Drug Enforcement Administration and the State of California Board of Pharmacy. In the event that more than one Stewardship Plan operates a drop-off site at a particular location, each drop-off site must accept all Covered Drugs.
(a) All Stewardship Plans shall coordinate with each other and develop a single system of promotion that shall:
(1) Promote the Stewardship Plans so that collection options for Covered Drugs are widely understood by residents, pharmacists, retailers of Covered Drugs and health care practitioners including doctors and other prescribers, veterinarians and veterinary hospitals, and promote the safe storage of Covered Drugs by City residents;
(2) Work with Collectors participating in Stewardship Plans to develop clear, standardized instructions for City residents on the use of collection bins and a readily-recognizable, consistent design of collection bins;
(3) Establish a single toll-free telephone number and single web site where collection options and current locations of drop-off sites will be publicized, and prepare educational and outreach materials promoting safe storage of medicines and describing where and how to return Unwanted Covered Drugs to the Stewardship Plan. These materials must be provided to Pharmacies, health care facilities, veterinary facilities, and other interested parties for dissemination to City residents. Plain language and explanatory images should be used to make use of medicine collection services readily understandable by all residents, including individuals with limited English proficiency;
(4) Conduct a biennial survey of City residents and a survey of pharmacists, veterinarians, and health professionals in the City who interact with patients on use of medicines after the first full year of operation of the plans. Survey questions shall measure percent awareness of the Stewardship Plans, assess to what extent drop-off sites and other collection methods are convenient and easy to use, and assess knowledge and attitudes about risks of abuse, poisonings and overdoses from prescription and nonprescription medicines used in the home. Draft survey questions shall be submitted to the Director tor review and comment at least 30 days prior to initiation of the survey. Results of the survey shall be reported to the Director and made available to the public on the website required in this Section 2206 within 90 days of the end of the survey period. The privacy of all survey respondents shall be maintained.
(b) All surveys, outreach, education, promotion, web sites, and toll-free phone numbers required by this Section 2206 shall be in English. Spanish. Chinese, Russian, and Tagalog.
(c) The Director shall provide guidance on the development of a single system of promotion.
Covered Drugs collected under a Stewardship Plan must be disposed of at a permitted waste disposal facility operating in compliance with all local, state, and Federal requirements applicable to that waste disposal facility. For purposes of this Section, the Director shall determine that a waste disposal facility is in compliance with all local, state, and federal requirements applicable to that waste disposal facility if no local, state, or federal agency with jurisdiction over that facility has issued a notice finding a violation by the facility in the preceding 12-month period.
(a) A Producer or group of Producers participating in a Stewardship Plan shall pay all administrative and operational costs related to their Stewardship Plan, except as provided under this Section 2208. Administrative and operational costs related to the Stewardship Plan include but are not limited to the following:
(1) Collection and transportation supplies for each drop-off site;
(2) Acquisition of all secure collection bins for drop-off sites;
(3) Ongoing maintenance or replacement of secure collection bins, as requested by Collectors;
(4) Prepaid, pre-addressed mailers provided to disabled and/or home-bound residents;
(5) Operation of periodic collection events, including costs of law enforcement staff time if necessary;
(6) Transportation of all collected Covered Drugs to final disposal, including costs of law enforcement escort if necessary;
(7) Environmentally sound disposal of all collected Covered Drugs under Section 2207 of this Division I;
(8) Program promotion under Section 2206 of this Division I; and
(9) Costs related to any review of a Product Stewardship Plan for purposes of obtaining compliance with the California Environmental Quality Act (Cal. Pub. Res. Code §§ 21000 et seq.).
(b) No Person or Producer may charge a point-of-sale fee to consumers to recoup the costs of their Stewardship Plan, nor may they charge a specific point-of-collection fee at the time the Covered Drugs are collected.
(c) Producers are not required to pay for costs of staff time at drop-off sites provided by Collectors volunteering to participate in a Stewardship Plan.
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