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HomeMy WebLinkAboutReportNATIONAL CITY POLICE DEPARTMENT MEMORANDUM Date: April 8, 2014 To: Manuel Rodriguez, Chief of Police From: Jose Tellez, Captain Subject: Prescription Drug Drop -Off Container During a recent City Council meeting Vice Mayor Luis Natividad requested staff evaluate locating a Prescription Drug Drop -Off Container at National City's police department, similar to the one located at the San Diego Police Department (SDPD) — Southeastern Station. As part of the request, department personnel met with Captain Tony McElroy to learn more about this specific program. SDPD Program The San Diego Police Department's Southeastern Division serves a population of 175,757 residents and encompasses 19.1 square miles. In response to their successful participation in the Drug Enforcement Administration's (DEA's) Prescription Drop -Off events, the Command Staff at the Southeastern Division decided to provide this service to their community year round. There is a large population of senior citizens living in Southeast San Diego and SDPD felt it was important to provide seniors with a local drop off location. The container they selected was a standard metal mail box, painted white and covered with decals identifying it as a prescription drop-off container. The container is located inside the lobby of the station. The drop-off container is accessible to all members of the public; the desk officer on - duty does not screen the items. The only item they discourage the public from placing into the container are syringes and there is a sign on the container with this information. SDPD decided to place the drop-off container in the police lobby for security reasons. The desk officer checks the container and empties it when full; the contents are boxed up and transported to the main narcotics locker at headquarters (downtown) by a patrol officer. Property & Evidence personnel sort the contents of the box for destruction. There is no written policy on the Prescription Drugs Drop -Off Container at Southeastem Division, however this practice described above is common knowledge to the desk officers, who are primarily responsible for checking and emptying the container. SDPD was unable to obtain the exact weight of prescription drugs collected since the start of the program because the drugs are sorted at headquarters. The desk officer on duty at the time of the visit estimates he empties the container about every six to eight 1 weeks. Based on the feedback from the community, SDPD considers this program a success. NCPD PARTICIPATION The National City Police Department serves a population of 59,869 residents and encompasses 9 square miles. The Department has participated in the DEA Prescription Take Back Day since 2010. At least twice annually, the police department has set-up a collection point at the police department or a city facility during the event, these collection points not only serve residents but serve as a drop-off location for all of the South Bay region. This year, the Prescription Take Back Day is scheduled in April and the collection point will be at the police department's storefront at Plaza Bonita. Attached are the collection numbers since the Department started participating in the program: Date: Boxes: Pounds: September 2010 7 99.3 April 2011 8 83.2 October 2011 6 89.2 April 2012 13 193.2 September 2012 10 128.6 April 2013 10 182.7 October 2013 8 109.9 ANALYSIS Southeastern Division serves almost three times the population and is twice the service area of National City; they empty the Prescription Drugs Drop -Off Container approximately every two months. Speculating on the numbers it would appear that If the SDPD Program were adopted it would take six months for the container to fill, which is the approximate time the current Prescription Drugs Drop -Off event takes place. In addition, Senate Bill 1014 introduced by Senator Hannah -Beth Jackson would require drug manufacturers to create, finance and manage a statewide system for collecting and disposing of unwanted drugs (http://www.leginfo.ca.gov/pub/13-14/bill/sen/sb 1001- 1050/sb 1014 bill 20140401 amended sen v98.htm). 2 RECOMMENDATION Based on the pending State legislation and the projected low use of a Prescription Drug Drop -Off Container (6 month interval) it is recommended the City await the outcome of the legislation and continue to participate in the DEA's program. If the City chooses to implement a Prescription Drug Drop -Off Container the Department would need to develop a policy for accountability and the destruction of the drugs. In addition, this program would require additional staff time to process and destroy collections and the purchase of equipment. Attached is information on the pending State Legislation and pictures of the Prescription Drug Drop -Off Container at SDPD (http://www.leginfo.ca.gov/pub/13-14/bill/sen/sb 1001- 1050/sb 1014 bill 20140401 amended sen v98.htm; httn://www.californiahealthline.org/insight/2014/drug-takeback-bill-faces-opposition?view=print). JOSE TELLEZ 3 DRUG TAKE -BACK BILL FACES OPPOSITION by George Lauer, California Healthline Features EditorThursday, March 20, 2014 A bill introduced last month in the California Legislature would make pharmaceutical manufacturers responsible for the end of their products' lives -- not just the beginning. SB 1014 by Sen. Hannah -Beth Jackson (D-Santa Barbara) would require drug manufacturers to create, finance and manage a statewide system for collecting and disposing of unwanted drugs. Jackson said new rules are needed to address a growing problem of prescription drug abuse, accidental poisonings and traces of pharmaceuticals found in California drinking water. Jackson's bill is modeled after an Alameda County ordinance -- the first governmental effort in this country to make drug manufacturers responsible for product stewardship. Three pharmaceutical organizations filed suit against the Alameda County ordinance, which requires drug makers to fund and operate a countywide take -back program for unused prescription drugs. A federal court judge ruled in favor of Alameda County last summer, rejecting the challenge by Pharmaceutical Research and Manufacturers Association of America, the Generic Pharmaceutical Association, and the Biotechnology Industry Organization. The case is now on appeal to the Ninth U.S. Circuit Court of Appeals. Jackson's bill will be heard in the Senate Environmental Quality Committee next week. 'Should Not Be Municipal Function' Physicians prescribe more than $10 billion in drugs every year in California, "but as much as 40% to 50% of those drugs can end up unused," Jackson said. The drugs -- usually pills -- gather dust in medicine cabinets until kids find them or they get flushed down toilets or thrown into landfills, Jackson said. "Keeping track of and properly disposing of these drugs should not be a municipal function, and it should not be paid for by taxpayers," Jackson said. 4 The Pharmaceutical Research and Manufacturers Association of America disagrees. "PhRMA believes strongly that the creation of a take -back program like that proposed by SB 1014 is a mistake," said John Murphy, associate general counsel for PhRMA. "It places the entire responsibility for the execution, finance, management and administration of otherwise municipal operations on pharmaceutical manufacturers and shifts the costs and burden of such local programs to out -of -county consumers and companies," Murphy wrote in an email response to questions from Califomia Healthline. Murphy said Jackson's bill would "assuredly burden California's health care system without addressing the underlying issues of prescription drug abuse and diversion due to unused and expired medicine, or impacting environmental quality in a substantive way." Jackson said she has invited PhRMA representatives as well as officials from other organizations to participate in the crafting of statewide legislation addressing these problems. 'We have had no success in getting them to the table," Jackson said. "If they're not willing to be part of the solution then we'll have to move forward on our own. I took what I see as an intelligent and reasonable ordinance drafted by the county of Alameda and tweaked and expanded it to cover the entire state," Jackson said. Other city and county governments in California have drug disposal programs in place, but Alameda's is the only one requiring pharmaceutical companies to create and pay for the program. Califomia has 305 safe drug disposal sites, an inadequate number for a state the size of California with 38 million residents, according to Jackson. 'While a number of local governments have admirably stepped up to establish their own drug take - back programs, it's the taxpayers who end up footing the bill for this, with no assistance from the multibillion dollar drug industry," Jackson said. 'We are hoping that the industry will join us in sharing the responsibility for what happens to these unused medications." The bill is sponsored by the California Product Stewardship Council, Clean Water Action, the California Alliance of Retired Americans, the City and County of San Francisco, and Alameda County. PhRMA Predicts Costs Will Rise; Jackson Disagrees In a letter to Jackson last week, PhRMA Vice President Merrill Jacobs wrote: "Secure disposal is a complex issue and the legislation, as drafted, is impractical and will have numerous unintended consequences, including possibly increasing health care costs." 5 Jackson said she was puzzled by the claim that costs might rise. "There's been a successful take -back program in place for almost 15 years in British Columbia and the drug companies -- the same companies we're talking about in California -- aren't complaining about it and prices haven't gone up there," Jackson said. The Vancouver, British Columbia, program -- similar in many ways to Jackson's proposal -- costs about $400,000 a year and annually diverts more than 110,000 pounds of medicine from improper use or disposal, according to Take Back Your Meds, a group of environmental and health organizations. Similar programs are in operation in Italy, Spain and France, according to Take Back Your Meds. Neither Jackson nor PhRMA officials had an estimate for how much a statewide take -back program might cost in California. Jackson said "the cost would be minimal." "Remember these companies are making billions and billions of dollars every year. The cost of these take -back programs we're proposing would be minimal. They can certainly afford it without hurting their profit margins too much," Jackson said. Jackson expects opposition to her bill will be well -funded and well -organized. "Pharmaceutical manufacturers are one of the big boys in the game," Jackson said. "I'm sure there will be very intense lobbying against this. Pharmaceutical manufacturers produce some lifesaving medications, and we all should be thankful to them for that, but I think it's time for them to take res onsibilit for the entire life c cle of their products, not just the earl , profitable stases." © 1998 - 2014. All Rights Reserved. California Healthline is published daily for the California HealthCare Foundation b The Adviso Board Company. 6 The following photographs show the container for reference. 9nLY f�rr},ulpk!nn�hlcd!ca;lc�i • nrdnn tlia:n Gi It cb to coell.11or.r nt'In ke.n nn0 nI co In p,opar rhulu. ' i [mop Ofir C1idt:d P e .criptionfriledreatiorr Briop thorn nt il' CI O50fll contnitu1r j 41' xip lock Gary i�+ .... piano inpropor oh lte. .. �1'I.R;4.41.,�. 7 AMENDED IN SENATE APRIL 1, 2014 Senate Bil1No. 1014 Introduced by Senator Jackson begin insert (Principal coauthor: Senator Leno) end insertbegin insert (Coauthors: Senators Evans, Hancock, Liu, and Pavley) end insertbegin insert (Coauthors: Assembly Members Ammiano and Williams) end insert February 13, 2014 1bpm74p45pnssp/a7 4u5hpof gp45p48ap d3uba33 pmEEp. -5 a3 3u5b3p05sai p45p►ja bsp/a74u5bp gg ffp5 ipntsp45pmssp/a74u5b pgg f g p45ip43ap am; 49pnbsp/m a 4rp05saipm bsp45prss p 1-4u7;ap6 op 75) )a b7ubvp u 49p/a74u5 bpo g nf? p45p09 m 4a-pgp5 p.m-4p p5 ptu u3u5bp6fp5 p 49ap. dc;u7pla 35d -7a 3p05saip-a; m4bvp45p 9 m-) m7ad4u7n;p m34a pp LEGISLATIVE COUNSEL'S DIGEST SB 1014, as amended, Jackson. Pharmaceutical waste: begin inserthome generated.end insert (1) The Department of Resources Recycling and Recovery was required, pursuant to provisions repealed on January 1, 2013, to develop, in consultation with appropriate state, local, and federal agencies, model programs for the collection and proper disposal of drug waste. This bill would enact the Home -Generated Pharmaceutical Waste Collection Disposal Act and would define terms for purposes of the act. The bill would require a producer of covered pharmaceuticals to submit to the Department of Resources Recycling and Recovery, by July 1, 2015, except as specified, a product stewardship plan and would authorize one or more producers to submit a plan or designate a stewardship organization to act as an agent on behalf of the producers to submit a plan. The bill would require the stewardship plan to contain specified elements with regard to the collection and disposal of home -generated pharmaceutical waste, including provisions for the payment of all administrative and operational fees associated with the product stewardship program. The bill would specify procedures for the approval of the plan by the department and would require a producer, group of producers, or stewardship organization operating a 8 stewardship program to take specified actions with regard to the disposal of home - generated pharmaceutical waste and promoting product stewardship programs to consumers, pharmacists, retailers of covered pharmaceuticals, and health care practitioners. The bill would require a producer, group of producers, or stewardship organization operating a product stewardship program to prepare and submit to the department an annual written report describing the program's activities during the previous calendar year by July 1, 2016, or at a later date as approved by the department, and on or before July 1 annually thereafter. The bill would authorize the department to adopt regulations to implement the act and would require the department to adopt regulations to provide for the appropriate management of consolidated home -generated pharmaceutical waste, to establish a schedule of fees to be charged to cover the department's costs of administering and enforcing the act, and to adopt a schedule setting the amounts of administrative civil penalties that the department would be authorized to impose. The bill would require a producer, group of producers, or a stewardship organization submitting a plan to the department to pay the fees set by the department and would require the department to deposit the fees into the Home -Generated Pharmaceutical Waste Program Account, which the bill would create in the Integrated Waste Management Fund. The department would be authorized to expend the fees, upon appropriation by the Legislature, to administer and enforce the act. The bill would authorize the department to issue an administrative order to, or impose a civil penalty upon, a producer who is in violation of the act or a regulation adopted pursuant to the act. The bill would require the department to deposit the penalties into the Home -Generated Pharmaceutical Waste Penalty Account, which the bill would create in the Integrated Waste Management Fund, and would authorize the department to expend the moneys in that account, upon appropriation by the Legislature, to enforce the act. (2) The Medical Waste Management Act, administered by the State Department of Public Health, regulates the management and handling of medical waste, including pharmaceutical waste, as defined. Existing law defines the term medical waste and excludes certain types of waste from that definition. This bill would define the term "home -generated pharmaceutical waste" for purposes of that act. The bill would exclude, from the definition of medical waste, home -generated pharmaceutical waste that is handled by a collection and disposal program operating in accordance with the act specified above. This exclusion would not become operative until the Secretary of State posts a notice regarding the effective date of the regulations that the department is required to adopt pursuant to that act. (3) The Pharmacy Law provides for the licensure and regulation of pharmacists and pharmacy establishments by the California State Board of Pharmacy, and makes a knowing violation of that law a misdemeanor. 9 The bill would also authorize a pharmacy to accept the return of home -generated pharmaceutical waste from a consumer, consistent with specified federal laws. Because a knowing violation of this provision would be a crime, the bill would impose a state - mandated local program. (4) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. Vote: majority. Appropriation: no. Fiscal committee: yes. State -mandated local program: yes. The people of the State of California do enact as follows: P3 1 SECTION 1. Section 4068.1 is added to the Business and 2Professions Code, to read: 3 4068.1. A pharmacy may accept the return of home -generated 4pharmaceutical waste, as defined in Section 117670.1 of the Health Sand Safety Code, from a consumer, consistent with the Federal 6Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) and 7thebegin insert federalend insert Controlled Substances Act (21 U.S.C. Sec. 801 et seq.). 8 SEC. 2. Section 117670.1 is added to the Health and Safety 9Code, to read: P4 1 117670.1. "Home -generated pharmaceutical waste" means a 2prescription or over-the-counter human or veterinary 3home-generated pharmaceutical, including, but not limited to, a 4drug, as defined in Section 109925 or in Section 321(g)(1) of Title 521 of the United States Code, that is a waste, as defined in Section 625124, derived from a household, including, but not limited to, a 7multifamily residence or household. 8 10 SEC. 3. Section 117700 of the Health and Safety Code is 9amended to read: 10 117700. Medical waste does not include any of the following: 11(a) Waste generated in food processing or biotechnology that 12does not contain an infectious agent as defined in Section 117675. 13(b) Waste generated in biotechnology that does not contain 14human blood or blood products or animal blood or blood products 15suspected of being contaminated with infectious agents known to 16be communicable to humans. 17(c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears, 18or vomitus, unless it contains fluid blood, as provided in 19subdivision (d) of Section 117635. 20(d) Waste which is not biohazardous, such as paper towels, 2lpaper products, articles containing nonfluid blood, and other 22medical solid waste products commonly found in the facilities of 23medical waste generators. 24(e) Hazardous waste, radioactive waste, or household waste, 25including, but not limited to, home -generated sharps waste, as 26deflned in Section 117671. 27(f) Waste generated from normal and legal veterinarian, 28agricultural, and animal livestock management practices on a farm 29or ranch. 30(g) (1) Home -generated pharmaceutical waste, including, but 31not limited to, consolidated home -generated pharmaceutical waste, 32that is handled by a collection and disposal program operating in 33accordance with Article 3.4 (commencing with Section 47120) of 34Chapter 1 of Part 7 of Division 30 of the Public Resources Code. 35(2) The Department of Resources Recycling and Recovery shall 36notify the Secretary of State of the effective date of the reguiations 37adopted pursuant to subdivision (b) of Section 47129 of the Public 38Resources Code. The Secretary of State shall post this notification 39on its Internet Web site within 15 days after receiving that notice. 11 P5 1(3) Paragraph (1) shall not become operative until the Secretary 2of State posts the notice described in paragraph (2) on its Internet 3Web site. 4 SEC. 4. Article 3.4 (commencing with Section 47120) is added 5to Chapter 1 of Part 7 of Division 30 of the Public Resources Code, 6to read: 7 8Article 3.4. Home -Generated Pharmaceutical Waste Collection 9and Disposal 10 11 47120. The Legislature hereby finds and declares all of the 12following: 13(a) Prescription and nonprescription drugs successfully allow 14us to live longer, healthier, and more productive lives. 15(b) The public, particularly children and the elderly, are at 16significant and unnecessary risk of poisoning due to improper or 17careless disposal of drugs and the illegal resale of drugs. 18(c) Our source water for drinking water is being contaminated 19by unwanted, leftover, or expired drugs passing through our 20wastewater and treatment centers. 21(d) There is no mandatory statewide drug stewardship program 22for unwanted drugs in California. 23(e) It is the intent of the Legislature that all members of the 24supply chain work together to implement an effective program to 25maximize the collection and disposal of unused drugs in California. 26 47121. This article shall be known, and may be cited, as the 27"Home-Generated Pharmaceutical Waste Collection and Disposal 28Act." 29 12 47122. For the purposes of this article, the following terms 30have the following meanings: 31(a) "Consumer" means an individual purchaser or owner of a 32covered pharmaceutical. "Consumer" does not include a business, 33corporation, limited partnership, or an entity involved in a 34wholesale transaction between a distributor and retailer. 35(b) "Controlled substance" means a substance listed in Chapter 36begin insert 2end insert (commencing with Section 11053) of Division 10 of the Health 37and Safety Code, or in Section 812 of Title 21 of the United States 38Code or subject to Section 813 of Title 21 of the United States 39Code. P6 1(c) "Cosmetic" means anything defined as a cosmetic in Section 2109900 of the Health and Safety Code. 3(d) (1) "Covered pharmaceutical" means a prescription drug 4or an over-the-counter human or veterinary drug. 5(2) "Covered pharmaceutical" does not include any of the 6following: 7(A) A drug that is regulated pursuant to either of the following: 8(i) The federal Resource Conservation and Recovery Act of 91976, as amended (42 U.S.C. Sec. 6901 et seq.). 10(ii) The Radiation Control Law (Chapter 8 (commencing with 11Section 114960) of Part 9) of Division 104 of the Health and Safety 12Code. 13(B) A vitamin or supplement. 14(C) begin insertAn end insertherbal-based remedy or a homeopathic drug, product, 15or remedy. 16(D) Cosmetics, soap, with or without germicidal agents, laundry 17detergent, bleach, household cleaning products, shampoos, 18sunscreens, toothpaste, lip balm, antiperspirants, or other personal 19care products that are regulated cosmetics under the Federal Food, 20Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.). 13 21(E) A drug for which a producer provides a take -back program 22as part of a federal Food and Drug Administration managed risk 23evaluation and mitigation strategy (21 U.S.C. Sec. 355-1). 24(F) A drug that is a biological product, as defined in subsection 25(h) of Section 600.3 of Title 21 of the Code of Federal Regulations, 26as it read on January 1, 2015, if the producer provides a take -back 27program. 28(G) A pet pesticide product contained in a pet collar, powder, 29shampoo, topical application, or other delivery system. 30(e) "Drug" means anything defined as a drug in Section 109925 31of the Health and Safety Code or in Section 321 (g)(1) of Title 21 32of the United States Code. 33(f) "Home -generated pharmaceutical waste" means a covered 34pharmaceutical that is a waste, as defined in Section 25124 of the 35Health and Safety Code, derived from a household, including, but 36not limited to, a multifamily residence or household. 37(g) "Mail -back program" means a system whereby a generator 38of home -generated pharmaceutical waste may obtain a prepaid 39and preaddressed mailing envelope in which to place P7 lhome-generated pharmaceutical waste for shipment to an entity 2that will dispose of it safely and legally. 3(h) "Over-the-counter drug" means a drug that may be lawfully 4sold without a prescription. 5(i) "Pharmaceutical wholesaler" means a person that sells or 6distributes covered pharmaceuticals for resale to an entity other 7than a consumer. 8(j) "Plan" or "product stewardship plan" means a product 9stewardship plan to implement a program to collect and dispose 10of home -generated pharmaceutical waste. 11(k) "Prescription drug" means a drug required by federal or state 12law to be dispensed lawfully only on prescription. 13(/) (1) "Producer" shall be determined with regard to a covered 14pharmaceutical that is sold, offered for sale, or distributed in the 15state as meaning one of the following: 16(A) The person that manufactures a covered pharmaceutical 17and that sells, offers for sale, or distributes that covered 18pharmaceutical in the state under that person's own name or brand. 14 19(B) If there is no person who meets the condition specified in 20subparagraph (A), the producer of the covered pharmaceutical is 21the owner or licensee of a trademark or brand under which the 22covered pharmaceutical is sold or distributed in Califomia, whether 23or not the trademark is registered. 24(C) If there is no person who meets the conditions specified in 25subparagraph (A) or (B), the producer of that covered 26pharmaceutical is the person who brings the pharmaceutical into 27the state for sale or distribution. 28(2) "Producer" does not include either of the following: 29(A) A retailer that puts its store label on a covered 30pharmaceutical. 31 (B) A pharmacist who dispenses prescription drugs to, or 32compounds a prescribed individual drug product for, a consumer. 33(m) "Product stewardship program" or "program" means a 34program financed and operated by one or more producers to collect, 35transport, and dispose of home -generated pharmaceutical waste. 36(n) "Stewardship organization" means an organization 37designated by a group of producers to act as an agent on behalf of 38each producer to operate a product stewardship program. 39 47124. (a) On or before July 1, 2015, or on a later date that 40may be specified by the department, a producer shall submit to the P8 ldepartment a product stewardship, plan that complies with the 2requirements of subdivision (b). One or more producers may submit 3a plan or designate a stewardship organization to act as an agent 4on behalf of the producers to submit a plan. A producer that 5designates a stewardship organization shall enter into an agreement 6with that stewardship organization to operate, on the producer's 7behalf, a product stewardship program and the stewardship 8organization shall submit a plan pursuant to this section on or 9before July 1, 2015, or on a later date that may be specified by the 10department. 11(b) A product stewardship plan shall contain all of the following 12elements: 13(1) A certification that the product stewardship program will 14accept all home -generated pharmaceutical waste that results from 15a covered pharmaceutical sold by the producer, or by the producers 15 16that enter into agreement with the stewardship organization, from 17a11 households, including multifamily households, unless excused 18from this requirement by the department as part of the approval 19of the plan. 20(2) Contact information for the producer submitting the plan or 21for each of the producers participating in the product stewardship 22program submitting the plan. 23(3) A description of the methods by which home -generated 24pharmaceutical waste will be collected and an explanation of how 25the collection system will conveniently and adequately serve the 26residents of the state. 27(4) A description of how the product stewardship plan will 28provide collection services for home -generated pharmaceutical 29waste in all areas of that state that are convenient to the public and 30adequate to meet the needs of the population in the area being 3lserved. 32(5) The location of each collection site and locations where 33envelopes for a mail -back program are available, if applicable. 34(6) A list containing the name, location, permit status, and record 35of any penalties, violations, or regulatory orders received in the 36previous five years by each person that will be involved in 37transporting home -generated pharmaceutical waste and each 38medical waste disposal facility proposed to participate in the 39product stewardship program. P9 1(7) A description of how the home -generated pharmaceutical 2waste will be safely and securely tracked and handled from 3collection through final disposal and the policies and procedures 4to be followed to ensure security. 5(8) A description of how the public education and outreach 6activities required by subdivision (c) of Section 47126 will be 7implemented and how the effectiveness of those activities will be 8evaluated. 9(9) A description of how the scope and extent of the product 10stewardship program are reasonably related to the amount of llcovered pharmaceuticals that are sold in the state by the producer 12or group of producers. 13(10) A starting date when the collection of home -generated 14pharmaceutical waste will begin. 16 15(11) A description of how support will be provided to any law 16 enforcement agencies within the state that have, or later agree to 17have, a collection program for controlled substances, including all 18of the following: 19(A) The provision of a collection kiosk with appropriate 20accessories and signage. 21(B) An ability to accept controlled substances and other 22home-generated covered pharmaceutical waste. 23(C) Technical support, including an appropriate person to 24provide onsite assistance with the sorting and separation of 25controlled substances at no cost to a participating law enforcement 26agency. 27(12) A description of how collection sites for home -generated 28pharmaceutical waste may be placed at appropriate retail stores in 29the state, including a description of the involvement of the retail 30stores. 31(13) If more than one producer will be involved in a proposed 32product stewardship program, the product stewardship plan for 33that program shall include a fair and reasonable manner for 34allocating the costs of the program among the participants in that 35program, so that the portion of costs paid by each producer is 36reasonably related to the amount of covered pharmaceutical sold 37by the producer in the state. 38(14) (A) Provisions for the payment of all administrative and 39operational fees associated with the product stewardship program, 40including the cost of collecting, transporting, and disposing of P10 lhome-generated pharmaceutical waste and the recycling or 2disposal, or both, of packaging collected with the home -generated 3pharmaceutical waste. 4(B) The plan shall not allow a person or producer to charge a 5 specific point -of -sale fee to consumers to recoup the costs of their 6product stewardship program, or charge a specific 7point-of-collection fee at the time the home -generated 8pharmaceutical waste is collected or delivered for disposal. 9 47125. (a) A producer, group of producers, or stewardship 10organization shall not collect home -generated pharmaceutical llwaste until it has received written approval of its product 12stewardship plan from the department. 17 13(b) Within 180 days after receipt and review of a product 14stewardship plan, the department shall conduct a noticed public 15hearing and determine whether the plan complies with the 16requirements of this article and any regulations adopted pursuant 17to this article. As part of its approval, the department may set 18reasonable performance goals for the program proposed to be 19implemented by the plan. 20(c) The department shall notify the applicant in writing of the 2lapproval of the plan. 22(d) If the department rejects a plan, it shall notify the applicant 23in writing of its reasons for rejecting the plan. The department may 24reject a plan without conducting a public hearing, other than the 25hearing required by subdivision (b). 26(e) An applicant whose plan has been rejected by the department 27shall submit a revised plan to the department within 60 days after 28receiving notice of the rejection. The department may require the 29submission of a further revised plan or may develop, approve, and 30impose its own product stewardship plan or an approved plan 3lsubmitted by other producers pursuant to this article. The 32department shall present the imposed plan at a public hearing. The 33department is not required, and nothing in this article shall be 34interpreted as requiring the department, to create or impose a 35product stewardship plan. 36(f) If the department rejects a revised product stewardship plan 37or any other subsequently revised plan, a producer that is subject 38to the plan shall be considered to be out of compliance with this 39article and subject to the enforcement provisions contained in this 40article. If the department imposes its own plan, the producer shall P11 lnot be considered out of compliance with this article if the producer 2complies with that plan. 3(g) At least every three years, a producer, group of producers, 4or stewardship organization operating a product stewardship 5program shall update the product stewardship plan and submit the 6updated plan to the department for review and approval. 7(h) Any proposed changes to a product stewardship plan shall 8be submitted in writing to the department and approved by the 9department in writing prior to implementation of any change. 10(i) On and after July 1, 2015, a producer who commences to llsell a covered pharmaceutical in the state shall submit a product 12stewardship plan to the department or provide evidence of having 13joined an existing approved product stewardship program no later 14than 180 days after the date the producer commences to tell that 18 15covered pharmaceutical, following the producer's initial sale of 16the offer for sale of a covered pharmaceutical. 17 47126. A producer, group of producers, or stewardship 18organization operating a stewardship program shall comply with 19all local, state, and federal laws and regulations applicable to its 20operations, including laws and regulations governing the disposal 21of medical waste and controlled substances, and shall additionally 22take all of the following actions when operating the program: 23(a) (1) Dispose of all home -generated pharmaceutical waste, 24in accordance with paragraph (1) of subdivision (a) of Section 25118215 of the Health and Safety Code. 26(2) A producer or stewardship organization operating a 27stewardship program may petition the department for approval to 28use a final disposal technology, if lawful, that provides superior 29environmental and human health protection than provided by 30current medical waste disposal technology for covered 3lpharmaceuticals, if and when the technology is proven and 32available. The department may approve that technology, if it 33provides equivalent protection in each, and superior protection in 34one or more, of the following areas: 35(A) Monitoring of any emissions or waste. 36(B) Worker health and safety. 37(C) Air, water, or land emissions contributing to persistent, 38bioaccumulative, or toxic pollution. 39(D) Overall impact on the environment and human health. P12 1(b) Encourage the separation of home -generated pharmaceutical 2waste from its original containers, when appropriate, prior to 3collection or disposal. 4(c) Promote the product stewardship program to consumers, 5pharmacists, retailers of covered pharmaceuticals, and health care 6practitioners as to the proper and safe method to dispose of 7home-generated pharmaceutical waste, in accordance with the 8following: 9(1) Develop and update as necessary, educational and other 10outreach materials aimed at retailers of covered pharmaceuticals. 19 11These materials may include, but are not limited to, one or more 12of the following: 13(A) Signage that is prominently displayed and easily visible to 14the consumer. 15(B) Written materials and templates of materials for reproduction 16by retailers to be provided to the consumer at the time of purchase 17or delivery, or both. 18(C) Advertising or other promotional materials related to the 19product stewardship program. 20(2) Prepare education and outreach materials that publicize the 2llocation and operation of collection locations in the state and 22disseminate the materials to health care facilities, pharmacies, and 23other interested parties. 24(3) Establish an Internet Web site publicizing collection 25locations and program operations and a toll -free telephone number 26that residential generators can call to find nearby collection 27locations and understand how the program works. 28 47127. On or before July 1, 2016, or at a later date as approved 291n writing by the department, and on or before July 1 annually 30thereafter, a producer, group of producers, or stewardship 3lorganization operating a product stewardship program shall prepare 32and submit to the department an annual written report describing 33the programs activities during the previous calendar year. The 34report shall include all of the following information: 35(a) A list of producers participating in the product stewardship 36program. 37(b) The amount, by weight, of home -generated pharmaceutical 38waste collected at each drop-off site and in the entire state and, if 39applicable, the total amount by weight collected by a mail -back 40program. P13 1(c) A description of the collection system, including the location 2of each collection site and if applicable, locations where envelopes 3for a mail -back program are provided. 4(d) The name and location of disposal facilities at which 5home-generated pharmaceutical waste were disposed of and the 20 6weight of home -generated pharmaceutical waste collected from 7residential generators disposed of at each facility. 8(e) Whether policies and procedures for collecting, transporting, 9and disposing of home -generated pharmaceutical waste, as 10established in the plan, were followed during the previous calendar 11year and a description of any noncompliance. 12(f) Whether any safety or security problems occurred during 13collection, transportation, or disposal of home -generated 14 pharmaceutical waste during the previous calendar year and, if so, 15what changes have been or will be made to policies, procedures, 16or tracking mechanisms to alleviate the problem and to improve 17safety and security. 18(g) A description of public education and outreach activities 19implemented during the reporting period, including the 20methodology used to evaluate the outreach and program activities. 21(h) How the product stewardship program complied with all 22other elements in the product stewardship plan approved by the 23department, including its degree of success in meeting any 24performance goals set by the department as part of the approval 25of the plan. 26(i) Any other information that the department may reasonably 27require. 28 47128. The department shall provide on its Internet Web site 29a list of all producers participating in product stewardship programs 30approved by the department and a list of all producers the 3ldepartment has identified as noncompliant with this article or the 32regulations adopted pursuant to this article. 33 47129. (a) The department may adopt regulations to implement 34this article. 35(b) The department shall adopt regulations to do all of the 36following: 37(1) Provide for the appropriate management of consolidated 38home-generated pharmaceutical waste to ensure public and 21 39environmental safety, including, but not limited to, handling, 40storage, containment, tracking, transportation, and disposal. P14 1(2) Establish a schedule of fees to be charged to the producers 2to cover the department's costs of administering and enforcing 3this article. In setting the fee schedule, the department shall only 4recover its actual costs of administration and enforcement under 5this article and shall not charge any amounts under this article in 6excess of its actual administrative and enforcement costs. 7(3) Adopt a schedule setting the amounts of administrative civil 8penalties that the department may impose pursuant to Section 947130, based on the nature, extent, and severity of the violation 10and any other relevant factors. 11(c) A producer, group of producers, or a stewardship 12organization submitting a plan to the department shall pay the fees 13set by the department pursuant to subdivision (b). 14(d) The department shall deposit all fees collected pursuant to 15this section into the Home -Generated Pharmaceutical Waste 16Program Account, which is hereby created in the Integrated Waste 17Management Fund. Upon appropriation by the Legislature, moneys 18deposited into the account may be expended by the department to 19administer and enforce this article. 20 47130. (a) The department may issue an administrative order 21to, or impose an administrative civil penalty upon, a producer who 22is in violation of this article or a regulation adopted pursuant to 23this article, to require compliance with this article or the regulation. 24(b) The department shall deposit all penalties collected pursuant 25to this article into the Home -Generated Pharmaceutical Waste 26Penalty Account, which is hereby created in the Integrated Waste 27Management Fund. Upon appropriation by the Legislature, moneys 28deposited into the account may be expended by the department to 29enforce this article. 30 47134. This article does not require a retailer to host a 3lcollection site and nothing in this article shall be interpreted as 32requiring this participation. 33 47135. 22 A producer or stewardship organization that creates 34and operates a plan that is approved by the department is not in 35violation of the Cartwright Act (Chapter 2 (commencing with 36Section 16700) of Part 2 of Division 7 of the Business and 37Professions Code), the Unfair Practices Act (Chapter 4 38(commencing with Section 17000) of Part 2 of Division 7 of the 39Business and Professions Code), or the Unfair Competition Law 40(Chapter 5 (commencing with Section 17200) of Part 2 of Division P15 17 of the Business and Professions Code), with regard to actions 2that are taken in accordance with the plan or this article. 3 SEC. 5. No reimbursement is required by this act pursuant to 4Section 6 of Article XIII B of the California Constitution because 5the only costs that may be incurred by a local agency or school 6district will be incurred because this act creates a new crime or 7infraction, eliminates a crime or infraction, or changes the penalty 8for a crime or infraction, within the meaning of Section 17556 of 9the Government Code, or changes the definition of a crime within 10the meaning of Section 6 of Article XIII B of the California 11Constitution. PPP PP 23