San Francisco County Municipal Code Art. 48 Requiring

ANTAGONISTS AND BUPRENORPHINE Sec. 4801. Findings. Sec. 4802. Definitions. Sec. 4803. Opioid Antagonist Stocking Requirement. Sec. 4804. Buprenorphine Stocking Requirement. Sec. 4805. Administration and Enforcement. Sec. 4806. Enforcement by City Attorney. Sec. 4807. Undertaking for the General Welfare. Sec. 4808. Severability. Sec. 4809. No Conflict with Federal or State Law.

SEC. 4801. FINDINGS.

(a) According to the U.S. Centers for Disease Control and Prevention, overdose deaths remain a leading cause of injury-related deaths in the United States, and the majority of overdose deaths involve opioids. From 2000 to 2015, more than half a million people died from drug overdoses across the United States. In 2021, more than 71,000 people died from synthetic opioid-related drug overdoses in the United States. On October 26, 2017, the U.S. Department of Health and Human Services declared the opioid crisis a national public health emergency and has renewed such declaration every 90 days since 2017. (b) According to the California Department of Public Health, based on preliminary data, there were 6,843 opioid-related overdose deaths in California in 2021; 5,722 of these deaths were related to fentanyl, and 224 of the fentanyl-related overdose deaths were teens, ages 15–19 years old. (c) According to the San Francisco Office of the Chief Medical Examiner, there were 647 accidental drug overdose deaths in San Francisco in 2022, and over 70% of those deaths were attributable to fentanyl. pPreliminary preliminary1 reports indicate there were 813 accidental drug overdose deaths in San Francisco in 2023, a 25% increase from 2022, with more than 80% of those deaths attributable to fentanyl. (d) Naloxone and other opioid antagonists are life-saving medications that are used to reverse a drug overdose. They are safe to use, work almost immediately, and are not addictive. According to peer-reviewed articles published in the journals “Drug and Alcohol Dependence” and “JAMA Internal Medicine,” state laws allowing pharmacist dispensing of naloxone have been associated with a 53% increase in naloxone dispensing, and a significant reduction in overdose deaths. The California Public Health Officer has issued a standing order to allow pharmacies, community organizations, and other approved entities to distribute prescription naloxone and allow for the administration of prescription naloxone by a family member, friend, or other person, to a person experiencing an overdose. (e) On March 29, 2023, the U.S. Food and Drug Administration announced that it approved NARCAN®, a four milligram (mg) naloxone hydrochloride nasal spray, for over-the-counter, nonprescription use. It is the first naloxone product approved for use without a prescription. (f) Despite the efficacy of naloxone and other opioid antagonists, and the fact that pharmacy distribution of naloxone is the second- most effective way—after community distribution—to provide naloxone to people most likely to use it and reverse an overdose, naloxone remains largely inaccessible. (g) Buprenorphine is a medication approved for the treatment of Opioid Use Disorder (“OUD”) and reduces the risk of dying from use of opioids by up to 50%. Buprenorphine can be prescribed by physicians, nurse practitioners, and physician assistants who have a Drug Enforcement Administration (“DEA”) license, as well as pharmacists with a DEA license (and who have state authority to prescribe controlled substances independent of a physician). The medication can be prescribed in an outpatient setting (in person or via telehealth) and dispensed at retail pharmacies. Recent federal legislation (Section 1262 of the 2023 Consolidated Appropriations Act) removed requirements for practitioners to obtain specific waivers to prescribe buprenorphine for the treatment of OUD. Despite these efforts toward accessibility, data show that retail pharmacy availability is a significant barrier to distributing buprenorphine to patients in the community. (h) According to a peer-reviewed 2022 article published in the “Drug and Alcohol Dependence” journal, between May 2020 and April 2021, only 31% of California pharmacies stocked buprenorphine, limiting access for those who seek the medication for OUD treatment. To understand the impact on San Franciscans, in January 2024, the Department of Public Health’s Office of Overdose Prevention conducted a survey of all retail pharmacies in San Francisco. When surveyed, only 37 of 84 responding pharmacies (44%) were able to fill a day-of prescription for a 2-week supply of buprenorphine. Of the 47 pharmacies that did not have buprenorphine in stock at the time of the survey, just 17 (36%) indicated that they would be able to fill a prescription within one business day. (i) Same-day access is particularly critical for Medication-Assisted Treatment (“MAT”) of OUD. Any delay is a missed opportunity to get someone started on this lifesaving treatment. Ensuring that individuals can immediately obtain buprenorphine at their local pharmacy will contribute to citywide goals of increasing the number of patients on MAT and reducing overdose fatalities. (j) The Board of Supervisors hereby finds that the public interest is served by ensuring that retail pharmacies in San Francisco stock a minimum number of opioid antagonists for purchase and a minimum number of buprenorphine doses to fill new prescriptions. (Added by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; amended by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) CODIFICATION NOTE

So in Ord. 206-24. SEC. 4802. DEFINITIONS. For purposes of this Article 48, the following terms have the following meanings: “Buprenorphine” means the drug buprenorphine including any official name, common or usual name, chemical name, or brand name used to describe buprenorphine prescribed for the treatment of Opioid Use Disorder. “City” means the City and County of San Francisco. “Controlled Substance” means those substances referred to in the Federal Controlled Substances Act, Chapter 13 (commencing with

Section 801) of Title 21 of the United States Code and the California Uniformed Controlled Substances Act, Division 10 (commencing with Section 11000) of the California Health and Safety Code. “Department” means the San Francisco Department of Public Health. “Director” means the Director of the San Francisco Department of Public Health or the Director’s designee. “FDA” means the United States Food and Drug Administration. “Opioid Antagonist” means Naloxone nasal spray (such as NARCAN®) or any other formulation of naloxone hydrochloride or similar drug approved or authorized by the FDA for the treatment of an opioid overdose. “Pharmacist” means an individual licensed by the California State Board of Pharmacy to engage in the practice of pharmacy. “Retail Pharmacy” means a licensed pharmacy, as defined in subdivision (a) of Section 4037 of the California Business and Professions Code, that is located in the City and dispenses drugs for retail sale. (Added by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; amended by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) SEC. 4803. OPIOID ANTAGONIST STOCKING REQUIREMENT. (a) Each Retail Pharmacy shall maintain a pharmaceutical stock of Opioid Antagonists sufficient to fill at least two purchases of Opioid Antagonists by consumers. (b) The following shall constitute a sufficient stock of Opioid Antagonist for purposes of this Section 4803: (1) two boxes of nonprescription Opioid Antagonist; (2) two boxes of prescription Opioid Antagonist; or (3) one box of prescription Opioid Antagonist and one box of nonprescription Opioid Antagonist. (c) It shall be an affirmative defense to a violation of subsection (a) of this Section 4803 for a Retail Pharmacy to demonstrate by a preponderance of the evidence that: (1) No more than three days had elapsed since the Retail Pharmacy maintained a pharmaceutical stock of Opioid Antagonists sufficient to fill at least two requests for Opioid Antagonists; and (2) During that three-day grace period, the Retail Pharmacy had ordered replacement stock and was waiting for the supplier or wholesaler to fill the order. (d) Retail Pharmacies shall post clear and legible signage advising customers of the availability of Opioid Antagonists at the following locations: (1) At all points of sale at which a Pharmacist dispenses pharmaceuticals; and (2) If the Retail Pharmacy stocks nonprescription, over-the-counter Opioid Antagonists, at all points of sale where the Retail Pharmacy sells nonprescription medication. (e) The Department may develop model signage for use by Retail Pharmacies. (Added by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; amended by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) SEC. 4804. BUPRENORPHINE STOCKING REQUIREMENT. (a) Each Retail Pharmacy that stocks Controlled Substances shall maintain a pharmaceutical stock of Buprenorphine sufficient to fill all active existing prescriptions for Buprenorphine for patients of the Retail Pharmacy as of the effective date of the ordinance in Board of Supervisors File No. 240502 enacting this Section 4804 and at least two additional prescriptions for Buprenorphine. (b) For purposes of this Section 4804, “prescription for Buprenorphine” means sufficient Buprenorphine tablets or film or both to provide a patient with 24 milligrams per day for one week. (c) It shall be an affirmative defense to a violation of subsection (a) of this Section 4804 for a Retail Pharmacy to demonstrate by a preponderance of the evidence that: (1) No more than three days had elapsed since the Retail Pharmacy maintained a pharmaceutical stock of Buprenorphine sufficient to fill at least two additional prescriptions for Buprenorphine; and (2) During that three-day grace period: (A) the Retail Pharmacy had ordered replacement stock and was waiting for the supplier or wholesaler to fill the order, or (B) the Retail Pharmacy had requested the supplier or wholesaler increase the Retail Pharmacy’s allotment of Controlled

Substances and, once the supplier or wholesaler approved the increase, ordered replacement stock within three days of approval, or (3) The Retail Pharmacy had requested the supplier or wholesaler increase the Retail Pharmacy’s allotment of Controlled Substances and the supplier or wholesaler denied the request. (Added by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) (Former Sec. 4804 added by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; amended and redesignated as Sec. 4805 by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) SEC. 4805. ADMINISTRATION AND ENFORCEMENT. (a) This Article 48 shall be administered and enforced by the Department. The Director may adopt regulations, guidelines, and forms to carry out the provisions and purposes of this Article 48. (b) For purposes of assessing penalties for violation of this Article 48, each of the following shall constitute a separate violation: (1) each day in which a Retail Pharmacy fails to maintain a sufficient stock of Opioid Antagonists as required under Section 4803(a), subject to the affirmative defense set forth in Section 4803(c); (2) each day in which a Retail Pharmacy that stocks Controlled Substances fails to maintain a sufficient stock of Buprenorphine as required under Section 4804(a), subject to the affirmative defense set forth in Section 4804(c); and (3) each day in which a Retail Pharmacy fails to display the signage required under Section 4803(d). (c) The Director shall issue a notice of violation for violations of subsections (a) and (d) of Section 4803 or subsection (a) of Section 4804. The Director may impose an administrative penalty of not less than $250 and not more than $1,000 per violation. Administrative Code Chapter 100, “Procedures Governing the Imposition of Administrative Fines,” is hereby incorporated in its entirety, except as it relates to the definition of a violation and the calculation of penalty amounts, addressed in Sections 4805(b) and (c), and that the Director shall appoint the hearing officer to conduct hearings for appeals. (Added as Sec. 4804 by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; amended and redesignated by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) (Former Sec. 4805 added by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; amended and redesignated as Sec. 4806 by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) SEC. 4806. ENFORCEMENT BY CITY ATTORNEY. (a) The City Attorney may at any time institute civil proceedings for injunctive and monetary relief, including civil penalties, against any person for violations of this Article 48, without regard to whether the Director has issued a notice of violation, instituted abatement proceedings, scheduled or held a hearing on a notice of violation, or issued a final decision. (b) At any time, the Director may refer a case to the City Attorney’s Office for civil enforcement, but a referral is not required for the City Attorney to bring a civil action under this Section 4806. (c) Any person that violates any provision of this Article 48 shall be enjoined and shall be subject to a civil penalty of not less than $250 and not more than $1,000 for each violation, as defined in Section 4805(b), which penalty shall be assessed and recovered in a civil action brought in the name of the people of the City and County of San Francisco by the City Attorney in any court of competent jurisdiction. In assessing the amount of the civil penalty, the court shall consider any one or more of the relevant circumstances presented by any of the parties to the case, including but not limited to, the following: the nature and seriousness of the misconduct giving rise to the violation, the number of violations, the persistence of the misconduct, the length of time over which the misconduct occurred, the willfulness of the defendant’s misconduct, and the defendant’s assets, liabilities and net worth. (d) The prevailing party in any court case or special proceeding to enforce this Article 48 shall recover reasonable attorneys’ fees if the City Attorney elects, at the initiation of the action, to seek recovery of attorneys’ fees and provides notice of such intention to the adverse party or parties. In no court case or special proceeding shall an award of attorneys’ fees to a prevailing party exceed the amount of reasonable attorneys’ fees incurred by the City. (e) Remedies under this Section 4806 are non-exclusive and cumulative to all other remedies available at law or equity. (Added as Sec. 4805 by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; amended and redesignated by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) (Former Sec. 4806 added by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; redesignated as Sec. 4807 by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) SEC. 4807. UNDERTAKING FOR THE GENERAL WELFARE.

In enacting and implementing Article 48, the City is assuming an undertaking only to promote the general welfare. It is not assuming, nor is it imposing on its officers and employees, an obligation for breach of which it is liable in money damages to any person who claims that such breach proximately caused injury. (Added as Sec. 4806 by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; redesignated by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) (Former Sec. 4807 added by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; redesignated as Sec. 4808 by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) SEC. 4808. SEVERABILITY. If any section, subsection, sentence, clause, phrase, or word of Article 48, or any application thereof to any person or circumstance, is held to be invalid or unconstitutional by a decision of a court of competent jurisdiction, such decision shall not affect the validity of the remaining portions or applications of this Article. The Board of Supervisors hereby declares that it would have passed this Article and each and every section, subsection, sentence, clause, phrase, and word not declared invalid or unconstitutional without regard to whether any other portion of these sections or application thereof would be subsequently declared invalid or unconstitutional. (Added as Sec. 4807 by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; redesignated by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) (Former Sec. 4808 added by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; amended and redesignated as Sec. 4809 by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024) SEC. 4809. NO CONFLICT WITH FEDERAL OR STATE LAW. Nothing in this Article 48 shall be interpreted or applied so as to create any requirement, power, or duty in conflict with any federal or state law. (Added as Sec. 4808 by Ord. 219-23, File No. 230766, App. 11/3/2023, Eff. 12/4/2023; amended and redesignated by Ord. 206-24, File No. 240502, App. 8/1/2024, Eff. 9/1/2024)