text:
(a) The department, in collaboration with the State Department of Health Care Services, may contract, or develop and administer a capacity data solution to collect, aggregate, and display information about the availability of beds in specified entities. The development of the capacity data solution shall be subject to state information technology policies, as applicable.

(1) The department may determine entities in addition to subdivision (g) of Section 131400 to be included in the capacity data solution.

(2) The State Department of Health Care Services shall determine the behavioral health facilities to be included in the capacity data solution to comply with the Special Terms and Conditions of the federal Centers for Medicare and Medicaid Services for the purposes of the Medicaid demonstration project pursuant to subdivision (c) of Section 14184.400 of the Welfare and Institutions Code, including, but not limited to:

(A) Acute psychiatric hospitals.

(B) General acute care hospitals with psychiatric units.

(C) Psychiatric health facilities.

(D) Provider sites certified to provide crisis stabilization services by the State Department of Health Care Services or a mental health plan.

(E) Psychiatric residential treatment facilities.

(b) (1) The determination of additional specified entities, list of data elements, electronic transmission standards, the data transmission schedule, and instructions pertaining to the capacity data solution may be modified by the department, in collaboration with the State Department of Health Care Services and in consultation with stakeholders, at any time. The list of data elements to be collected or disclosed shall not, at any time, include personal information or personal health information.

(2) The determination of additional specified entities, list of data elements, electronic transmission standards, the data transmission schedule, and instructions pertaining to the capacity data solution for behavioral health facilities may be modified by the State Department of Health Care Services, in collaboration with the department and in consultation with stakeholders, at any time. The list of data elements to be collected or disclosed shall not, at any time, include personal information or personal health information.

(c) The lists, standards, schedules, and instructions implemented pursuant to this section and any subsequent modifications shall be exempt from the administrative regulation and rulemaking requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code and shall be implemented without being adopted as a regulation, except that the revisions shall be filed with the Secretary of State and printed and published in Title 17 of the California Code of Regulations.

(d) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department and the State Department of Health Care Services may implement, interpret, or make specific this chapter, in whole or in part, by means of all-county letters, plan letters, provider bulletins, information notices, or other similar instructions, without taking any further regulatory action.

(e) A civil penalty, fine, sanction, or finding, or a denial, suspension, or revocation of licensure for a person or facility, shall not be imposed based upon a failure to provide the data elements required under this chapter, unless the required data elements, electronic transmission standards, and data transmission schedule submissions by specified entities were published in the California Code of Regulations and the department notified the person or facility of the data reporting requirements at least six months before the date of the claimed failure to report or submit.

(f) Notwithstanding subdivision (e), the State Department of Health Care Services may impose a plan of correction or assess civil money penalties for specified entities licensed or certified by the State Department of Health Care Services pursuant to subdivision (a) of Section 5964 of the Welfare and Institutions Code.

chapter: 6. Hospital, Emergency Medical Services, and Behavioral Health Facilities Bed Capacity Data Solution

article: 1. General Provisions


kind: section

code: HSC

text:
(a) The department may contract for any purpose to implement this chapter.

(b) This chapter shall be implemented subject to an appropriation and the availability of funds for this purpose.

history: (History: Added by Stats. 2024, Ch. 999, Sec. 3. (AB 177) Effective September 30, 2024.)

division: 112. PUBLIC HEALTH

part: 1. GENERAL PROVISIONS

article: 1. General Provisions

path: 112. PUBLIC HEALTH > 1. GENERAL PROVISIONS > 6. Hospital, Emergency Medical Services, and Behavioral Health Facilities Bed Capacity Data Solution > 1. General Provisions


text:
(a) Subject to appropriation or upon availability of funds, the department, in collaboration with the State Department of Health Care Services, shall implement a capacity data solution. The development of the capacity data solution shall be subject to state information technology policies, as applicable.

(b) The purpose of the capacity data solution is to monitor bed capacity in near real time in specified entities during normal operations and emergencies, with the goal of reducing morbidity and mortality by facilitating patient transfers and placement, and to support response to public health and medical emergencies affecting or impacting the health of California residents.

(c) The capacity data solution shall not include any information relating to state hospitals under the jurisdiction of the State Department of State Hospitals.

path: 112. PUBLIC HEALTH > 1. GENERAL PROVISIONS > 6. Hospital, Emergency Medical Services, and Behavioral Health Facilities Bed Capacity Data Solution


text:
(a) Subject to appropriation or upon availability of funds, the department, in collaboration with the State Department of Health Care Services, shall designate and administer a capacity data solution to which the specified entities shall submit data.

(b) The department, in collaboration with the State Department of Health Care Services, shall identify the data elements that shall be submitted by the specified entities and the schedule and format for data submission.

(1) The data elements to be submitted by behavioral health facilities that are specified entities shall include, but not be limited to, the following:

(A) Number of available beds.

(B) For each available bed, the age ranges for which the bed is appropriate.

(C) For each available bed, whether the bed is secure for individuals who have been determined to be a danger to themselves or others or are gravely disabled.

(D) Other data elements the State Department of Health Care Services identifies, in consultation with interested organizations representing behavioral health facilities and other relevant stakeholders, as necessary for effective implementation of the capacity data solution.

(2) The data elements to be submitted by general acute care hospitals and emergency departments that are specified entities shall include, but not be limited to, the following:

(A) Hospital bed census.

(B) Bed availability by level of care, unit, and hospital.

(C) Other data elements the department identifies, in consultation with interested organizations representing general acute care hospitals and emergency departments and other relevant stakeholders, as necessary for effective implementation of the capacity data solution.

(c) The capacity data solution shall have both of the following capabilities, at a minimum:

(1) Collecting data.

(2) Enabling searches by authorized users to identify available behavioral health beds that are appropriate for individuals in need of treatment provided by the specified entities.

(d) The capacity data solution shall be subject to all applicable state and federal privacy laws.

(e) The specified entities shall submit the required data electronically in accordance with the schedule established by the department.


text: This division shall be known and may be cited as the Adult Health Coverage Expansion Program.

history: (History: Added by Stats. 2007, Ch. 677, Sec. 2. Effective January 1, 2008.)

chapter: 1. General Provisions

path: 113. THE ADULT HEALTH COVERAGE EXPANSION PROGRAM > 1. General Provisions


text: It is the intent of the Legislature that the Adult Health Coverage Expansion Program provide health care coverage on a pilot program basis to eligible adults domiciled and employed in Santa Clara County who are without health care coverage.

division: 113. THE ADULT HEALTH COVERAGE EXPANSION PROGRAM


text:
The following definitions apply for purposes of this division:

(a) “Local initiative” has the same meaning as set forth in Section 12693.08 of the Insurance Code.

(b) “Program” means the Adult Health Coverage Expansion Program.

(c) “Small business” means an entity located in Santa Clara County that employs 50 or fewer persons, with at least 35 percent of the employees earning less than 350 percent of the federal poverty level for a family size of one, and that has not offered health care coverage to its employees for, at minimum, 12 consecutive months, provided that the provisions of any such prior coverage required the employer to contribute at least 50 percent of the total amount of the premium for that coverage. For purposes of the program authorized by this division, a small business shall be a “small employer” pursuant to Article 3.1 (commencing with Section 1357) of Chapter 2.2 of Division 2, subject to the provisions and exceptions of this division. Notwithstanding the company affiliation and tax filing provision of paragraph (1) of subdivision (l) of Section 1357, an individual franchise outlet shall be considered a small business.


text: The program may be implemented in Santa Clara County at the option of the local initiative, but if so implemented shall be as a pilot program. A maximum of 5,000 employees may be covered in the county, provided, however, that the number of enrollees may be increased pursuant to the prior approval of the Department of Managed Health Care. The local initiative shall administer the program.

chapter: 2. Administration

path: 113. THE ADULT HEALTH COVERAGE EXPANSION PROGRAM > 2. Administration


text:
(a) In implementing the pilot program established pursuant to this division, the local initiative in Santa Clara County shall not be subject to the requirements of subdivision (a) of Section 1357.03. The program shall be otherwise subject to the requirements of Chapter 2.2 (commencing with Section 1340) of Division 2, including Article 3.1 (commencing with Section 1357) thereof, except as otherwise provided in this division, and shall be subject to approval as to regulatory filings with the Department of Managed Health Care as prescribed in Chapter 2.2 (commencing with Section 1340) of Division 2 and in implementing regulations promulgated by the department.

(b) Except in the case of a late enrollee or for satisfaction of a preexisting condition clause in the case of initial coverage for an eligible employee, the local initiative may not exclude any eligible employee who would otherwise be eligible for health care coverage under this division on the basis of an actual or expected health care condition. The local initiative may not limit or exclude coverage for any eligible employee by type of illness, treatment, medical condition, or accident, except for preexisting conditions as permitted under Section 1357.06.

(c) Coverage provided through the program to an eligible small business shall be renewable with respect to all eligible employees at the option of the participating small business.


text: Notwithstanding subdivision (b) of Section 1357, only an adult age 19 to 64 years, inclusive, employed by a small business for a minimum of 20 hours per week is eligible to participate in the program if he or she has a gross annual income that is less than 350 percent of the federal poverty level for a family size of one, and his or her employer participates in the program. Dependents, spouses, and domestic partners of employees are not eligible for the program.

chapter: 3. Eligibility

path: 113. THE ADULT HEALTH COVERAGE EXPANSION PROGRAM > 3. Eligibility


text:
(a) A small business may apply to the local initiative that administers the program to obtain coverage for its employees who meet the requirements of Section 131520.

(b) At least 50 percent of the employees of an otherwise eligible small business must meet the eligibility requirements of Section 131520, and at least 50 percent of those eligible employees must choose to receive coverage through the program in order for the small business to qualify to participate in the program.


text: The program shall screen potential enrollees to determine if they meet the eligibility requirements for the Medi-Cal program.


text: The local initiative that establishes a program shall offer health care coverage through the program, and all health care services shall be provided to participants by a provider operated by the county or by a provider with whom or with which the county or the local initiative has contracted to provide health care services, except for emergency or out-of-area care or instances in which a required specialized service is not contracted for by the county or the local initiative.

chapter: 4. Benefits

path: 113. THE ADULT HEALTH COVERAGE EXPANSION PROGRAM > 4. Benefits


text: The health care services provided through the program to eligible employees shall, to the extent practicable, be substantially similar to the benefits offered to adults under the Healthy Families Program pursuant to Chapter 5 (commencing with Section 12693.60) of Part 6.2 of the Insurance Code, but shall include at least all of the basic health care services included in subdivision (b) of Section 1345 and in Section 1300.67 of Title 28 of the California Code of Regulations.


text:
(a) (1) The cost of the health care coverage provided through the program shall be paid through a combination of contributions paid by the small business, premiums paid by participating employees, and county, federal, state, or private sector funding made available for this purpose.

(2) The local initiative may determine the amount of the employer contribution for each participating eligible employee, which shall not exceed one hundred fifty dollars ($150) per month, and the amount of the employee premium, which shall not exceed seventy-five dollars ($75) per month. The local initiative may adjust employer contribution and employee premium levels after the first year if necessary for changes in health care costs.

(3) The local initiative may structure the required employee premium amounts according to a schedule that takes into account the individual employee’s age or income level, or both, in a manner similar, but not necessarily identical, to that described in Section 12693.43 of the Insurance Code, pertaining to the Healthy Families Program.

(4) The local initiative shall establish copayment levels and amounts in a manner substantially similar to that described in Section 12693.615 of the Insurance Code, pertaining to the Healthy Families Program.

(5) For purposes of the program, “applicable rate charged for a covered employee” in Section 1366.26 means the total premium amount paid to the health plan on behalf of an employee, including amounts paid by the small business on behalf of the employee, the premium paid by the employee, and any county, federal, state, or private sector funding, which funding shall include the value of the discounted rates negotiated pursuant to subdivision (b), as apportioned to the employee. The program shall submit to the Department of Managed Health Care the procedures the local initiative will use for purposes of establishing the rates to be paid by a person eligible for continuation coverage under Section 1366.26, and the department shall only approve those procedures if it determines that they are consistent with the requirements of the Cal-COBRA program.

(b) In order to enhance the affordability of coverage offered through the program to eligible small businesses and employees, the county and the local initiative shall negotiate discounted rates for services provided to participants in the program by providers operated by the county or by providers with whom, or with which, the county has contracted to provide health care services.

history: (History: Amended by Stats. 2008, Ch. 179, Sec. 164. Effective January 1, 2009.)

chapter: 5. Funding

path: 113. THE ADULT HEALTH COVERAGE EXPANSION PROGRAM > 5. Funding


text: The local initiative shall be authorized to establish, participate in, or apply to funding sources in the public and private sectors for purposes of providing or securing premium subsidies for eligible employees, pursuant to fair and equitable procedures to be established by the local initiative.


text: The county and the local initiative shall together evaluate the pilot program after three years, including all of the following: the number of individuals served, the demographics of the individuals served, the number of employees turned away due to the limitation on enrollment in Section 131510, the number of small businesses participating, the number of small businesses turned away due to the limitation on enrollment of individuals, funding sources (including employees, employers, county, state, federal, and other sources), and the health status of enrollees.

chapter: 6. Evaluation

path: 113. THE ADULT HEALTH COVERAGE EXPANSION PROGRAM > 6. Evaluation


text:
(a) Except as provided in Section 132004, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in an individual’s out-of-pocket expenses associated with his or her health insurance, health care service plan, or other health coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if a lower cost generic drug is covered under the individual’s health insurance, health care service plan, or other health coverage on a lower cost-sharing tier that is designated to be therapeutically equivalent as indicated by the United States Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations.”

(b) The prohibition in subdivision (a) shall not apply to a branded prescription drug, until the time that the first drug designated in the United States Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations” as therapeutically equivalent to that branded prescription drug has been nationally available for three calendar months.

history: (History: Added by Stats. 2017, Ch. 611, Sec. 1. (AB 265) Effective January 1, 2018.)

division: 114. PRESCRIPTION DRUG DISCOUNT PROHIBITION


text: Except as provided in Section 132004, a person who manufactures a prescription drug shall not offer in the state a discount, repayment, product voucher, or other reduction in the individual’s out-of-pocket expenses associated with his or her health insurance, health care service plan, or other health coverage, including, but not limited to, a copayment, coinsurance, or deductible, for a prescription drug if the active ingredients of the drug are contained in products regulated by the federal Food and Drug Administration, are available without prescription at a lower cost, and are not otherwise contraindicated for treatment of the condition for which the prescription drug is approved.

path: 114. PRESCRIPTION DRUG DISCOUNT PROHIBITION


text:
The prohibitions in Sections 132000 and 132002 shall not apply to any of the following:

(a) A discount, repayment, product voucher, or other payment to a patient or another person on the patient’s behalf for a prescription drug required under a United States Food and Drug Administration Risk Evaluation and Mitigation Strategy for the purpose of monitoring or facilitating the use of that prescription drug in a manner consistent with the approved labeling of the prescription drug.

(b) A single-tablet drug regimen for treatment or prevention of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) that is as effective as a multitablet regimen, unless, consistent with clinical guidelines and peer-reviewed scientific and medical literature, the multitablet regimen is clinically equally effective or more effective and is more likely to result in adherence to the drug regimen.

(c) The individual has completed any applicable step therapy or prior authorization requirements for the branded prescription drug as mandated by the individual’s health insurer, health care service plan, or other health coverage.

(d) A discount, repayment, product voucher, or other reduction in an individual’s out-of-pocket expenses is not associated with his or her health insurance, health care service plan, or other health coverage.

(e) Rebates received by a state agency.


text: This division does not prohibit an entity, including an entity that manufactures prescription drugs or a patient assistance program that is solely funded by one or more manufacturers, from offering a pharmaceutical product free of any cost, if the product is free of cost to both the patient and his or her health insurer, health care service plan, or other health coverage.


text:
(a) This division shall not be deemed to affect a pharmacist’s ability to substitute a prescription drug pursuant to Section 4073 of the Business and Professions Code.

(b) (1) This division shall not prohibit or limit assistance to a patient provided by an independent charity patient assistance program.

(2) For purposes of this section, “independent charity patient assistance program” means a program that meets all of the following requirements:

(A) The program does not allow a pharmaceutical manufacturer or an affiliate of the manufacturer, including, but not limited to, an employee, agent, officer, shareholder, contractor, wholesaler, distributor, or pharmacy benefits manager, to exert any direct or indirect influence or control over the charity or subsidy program.

(B) Assistance is awarded in a truly independent manner that severs any link between a pharmaceutical manufacturer’s funding and the beneficiary.

(C) Assistance is awarded without regard to the pharmaceutical manufacturer’s interest and without regard to the beneficiary’s choice of product, provider, practitioner, supplier, health insurance, health care service plan, or other health coverage.

(D) Assistance is awarded based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.

(E) The pharmaceutical manufacturer does not solicit or receive data from the program that would facilitate the manufacturer in correlating the amount or frequency of its donations with the number of subsidized prescriptions for its products.


text:
For purposes of this division:

(a) “ANDA” means abbreviated new drug application.

(b) “ANDA filer” means a party that owns or controls an ANDA filed with the Food and Drug Administration or has the exclusive rights under that ANDA to distribute the ANDA product.

(c) “Agreement” means anything that would constitute an agreement under California state law or a “trust” under the Cartwright Act (Chapter 2 (commencing with Section 16700) of Division 7 of the Business and Professions Code).

(d) “Agreement resolving or settling a patent infringement claim” includes any agreement that is entered into within 30 days of the resolution or the settlement of the claim, or any other agreement that is contingent upon, provides a contingent condition for, or is otherwise related to the resolution or settlement of the claim. This shall include, but is not limited to, the following:

(1) Any agreement required to be provided to the Federal Trade Commission or the Antitrust Division of the United States Department of Justice under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173).

(2) Any agreement between a biosimilar or interchangeable product applicant and a reference product sponsor under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) (Public Law 111-148) that resolves patent claims between the applicant and sponsor.

(e) “Biosimilar biological product application filer” means a party that owns or controls a biosimilar biological product application filed with the Food and Drug Administration under Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) for licensure of a biological product as biosimilar to, or interchangeable with, a reference product, or that has the exclusive rights under the application to distribute the biosimilar biological product.

(f) “NDA” means new drug application.

(g) “Nonreference drug filer” means either:

(1) An ANDA filer.

(2) A biosimilar biological product application filer.

(h) “Nonreference drug product” means the product to be manufactured under an ANDA that is the subject of the patent infringement claim, a biosimilar biological product that is the product to be manufactured under the biosimilar biological product application that is the subject of the patent infringement claim, or both.

(i) “Patent infringement” means infringement of any patent or of any filed patent application, extension, reissue, renewal, division, continuation, continuation in part, reexamination, patent term restoration, patents of addition, and extensions thereof.

(j) “Patent infringement claim” means any allegation made to a nonreference drug filer, whether or not included in a complaint filed with a court of law, that its nonreference drug product or application infringes any patent held by, or exclusively licensed to, the reference drug holder.

(k) “Reference drug holder” means either:

(1) A brand holder that is any of the following:

(A) The holder of an approved NDA for a drug product application filed under Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)).

(B) A person owning or controlling enforcement of the patent listed in the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the “FDA Orange Book”) in connection with the NDA.

(C) The predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with, any of the entities described in subparagraph (A) or (B), with control to be presumed by direct or indirect share ownership of 50 percent or greater, as well as the licensees, licensors, successors, and assigns of each of those entities.

(2) A biological product licenseholder, which means any of the following:

(A) The holder of an approved biological product license application for a biological drug product under Section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)).

(B) A person owning or controlling enforcement of any patents that claim the biological product that is the subject of the approved biological patent license application.

(C) The predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with, any of the entities described in subparagraph (A) or (B), with control to be presumed by direct or indirect share ownership of 50 percent or greater, as well as the licensees, licensors, successors, and assigns of each of those entities.

(l) “Reference drug product” means the product to be manufactured by the reference drug holder and includes both branded drugs of the NDA holder and the biologic drug product of the biologic product license applicant.

(m) “Statutory exclusivity” means those prohibitions on the approval of drug applications under clauses (ii) through (iv), inclusive, of Section 505(c)(3)(E) (5-year and 3-year data exclusivity), Section 527 (orphan drug exclusivity), or Section 505A (pediatric exclusivity), of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E), 360cc, and 355a, respectively) or on the licensing of biological product applications under Section 262(k)(7) of Title 42 of the United States Code (12-year exclusivity) or Section 262(m)(2) or (3) of Title 42 of the United States Code (pediatric exclusivity).

history: (History: Added by Stats. 2019, Ch. 531, Sec. 1. (AB 824) Effective January 1, 2020.)

division: 114.01. PRESERVING ACCESS TO AFFORDABLE DRUGS


text:
(a) (1) Except as provided in paragraph (3), an agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a pharmaceutical product, shall be presumed to have anticompetitive effects and shall be a violation of this section if both of the following apply:

(A) A nonreference drug filer receives anything of value from another company asserting patent infringement, including, but not limited to, an exclusive license or a promise that the brand company will not launch an authorized generic version of its brand drug.

(B) The nonreference drug filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the nonreference drug filer’s product for any period of time.

(2) As used in subparagraph (A) of paragraph (1), “anything of value” does not include a settlement of a patent infringement claim in which the consideration granted by the brand or reference drug filer to the nonreference drug filer as part of the resolution or settlement consists of only one or more of the following:

(A) The right to market the competing product in the United States before the expiration of either:

(i) A patent that is the basis for the patent infringement claim.

(ii) A patent right or other statutory exclusivity that would prevent the marketing of the drug.

(B) A covenant not to sue on a claim that the nonreference drug product infringes a United States patent.

(C) Compensation for saved reasonable future litigation expenses of the reference drug holder but only if both of the following are true:

(i) The total compensation for saved litigation expenses is reflected in budgets that the reference drug holder documented and adopted at least six months before the settlement.

(ii) The compensation does not exceed the lower of the following:

(I) Seven million five hundred thousand dollars ($7,500,000).

(II) Five percent of the revenue that the nonreference drug holder projected or forecasted it would receive in the first three years of sales of its version of the reference drug documented at least 12 months before the settlement. If no projections or forecasts are available, the compensation does not exceed two hundred fifty thousand dollars ($250,000).

(D) An agreement resolving or settling a patent infringement claim that permits a nonreference drug filer to begin selling, offering for sale, or distributing the nonreference drug product if the reference drug holder seeks approval to launch, obtains approval to launch, or launches a different dosage, strength, or form of the reference drug having the same active ingredient before the date set by the agreement for entry of the nonreference drug filer. A different form of the reference drug does not include an authorized generic version of the reference drug.

(E) An agreement by the reference drug holder not to interfere with the nonreference drug filer’s ability to secure and maintain regulatory approval to market the nonreference drug product or an agreement to facilitate the nonreference drug filer’s ability to secure and maintain regulatory approval to market the nonreference drug product.

(F) An agreement resolving a patent infringement claim in which the reference drug holder forgives the potential damages accrued by a nonreference drug holder for an at-risk launch of the nonreference drug product that is the subject of that claim.

(3) Parties to an agreement are not in violation of paragraph (1) if they can demonstrate by a preponderance of the evidence that either of the following are met:

(A) The value received by the nonreference drug filer described in subparagraph (A) of paragraph (1) is a fair and reasonable compensation solely for other goods or services that the nonreference drug filer has promised to provide.

(B) The agreement has directly generated procompetitive benefits and the procompetitive benefits of the agreement outweigh the anticompetitive effects of the agreement.

(b) In determining whether the parties to the agreement have met their burden under paragraph (3) of subdivision (a), the factfinder shall not presume any of the following:

(1) That entry into the marketplace could not have occurred until the expiration of the relevant patent exclusivity or that the agreement’s provision for entry of the nonreference drug product before the expiration of any patent exclusivity means that the agreement is procompetitive within the meaning of subparagraph (B) of paragraph (3) of subdivision (a).

(2) That any patent is enforceable and infringed by the nonreference drug filer in the absence of a final adjudication binding on the filer of those issues.

(3) That the agreement caused no delay in entry of the nonreference drug filer’s drug product because of the lack of federal Food and Drug Administration (FDA) approval of that or of another nonreference drug product.

(4) That the agreement caused no harm or delay due to the possibility that the nonreference drug filer’s drug product might infringe some patent that has not been asserted against the nonreference drug filer or that is not subject to a final and binding adjudication on that filer as to the patent’s scope, enforceability, and infringement.

(5) This subdivision shall not be construed to preclude a party from introducing evidence regarding paragraphs (1) to (4), inclusive, and shall not be construed to preclude the factfinder from making a determination regarding paragraphs (1) to (4), inclusive, based on the full scope of the evidence.

(c) In determining whether the parties to the agreement have met their burden under paragraph (3) of subdivision (a), the factfinder shall presume that the relevant product market is that market consisting of the brand or reference drug of the company alleging patent infringement and the drug product of the nonreference company accused of infringement and any other biological product that is licensed as biosimilar or is an AB-rated generic to the reference product.

(d) (1) This section does not modify, impair, limit, or supersede the applicability of the antitrust laws of California as defined in the Cartwright Act (Chapter 2 (commencing with Section 16700) of Part 2 of Division 7 of the Business and Professions Code), the Unfair Practices Act (Chapter 4 (commencing with Section 17000) of Part 2 of Division 7 of the Business and Professions Code), or the unfair competition law (Chapter 5 (commencing with Section 17200) of Part 2 of Division 7 of the Business and Professions Code), or the availability of damages or remedies provided therein. This section does not modify, impair, limit, or supersede the right of any drug company applicant to assert claims or counterclaims against any person, under the antitrust laws or other laws relating to unfair competition of the federal antitrust law or state law.

(2) If any provision of this division, an amendment made to this division, or the application of any provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this division, the amendments made to this division, and the application of the provisions of this division or amendments to any person or circumstance shall not be affected.

(e) (1) (A) Each person that violates or assists in the violation of this section shall forfeit and pay to the State of California a civil penalty sufficient to deter violations of this section, as follows:

(i) If the person who violated this section received any value due to that violation, an amount up to three times the value received by the party that is reasonably attributable to the violation of this section, or twenty million dollars ($20,000,000), whichever is greater.

(ii) If the violator has not received anything of value as described in clause (i), an amount up to three times the value given to other parties to the agreement reasonably attributable to the violation of this section, or twenty million dollars ($20,000,000), whichever is greater.

(iii) For purposes of this subdivision, “reasonably attributable to the violation” shall be determined by California’s share of the market for the brand drug at issue in the agreement.

(B) Any penalty described in subparagraph (A) shall accrue only to the State of California and shall be recovered in a civil action brought by the Attorney General in its own name, or by any of its attorneys designated by it for that purpose, against any party to an agreement that violates this section.

(2) Each party that violates or assists in the violation of this section shall be liable for any damages, penalties, costs, fees, injunctions, or other remedies that may be just and reasonable and available under the Cartwright Act (Chapter 2 (commencing with Section 16700) of Part 2 of Division 7 of the Business and Professions Code), the Unfair Practices Act (Chapter 4 (commencing with Section 17000) of Part 2 of Division 7 of the Business and Professions Code), or the unfair competition law (Chapter 5 (commencing with Section 17200) of Part 2 of Division 7 of the Business and Professions Code), as applicable.

(3) If the State of California is awarded penalties under subparagraph (A) of paragraph (1), it may not recover penalties pursuant to another law identified in paragraph (2). This section shall not be construed to foreclose the State of California’s ability to claim any relief or damages available in paragraph (2), other than those that are penalties.

(4) An action to enforce a cause of action for a violation of this section shall be commenced within four years after the cause of action accrued.

path: 114.01. PRESERVING ACCESS TO AFFORDABLE DRUGS


text: It is the intent of the Legislature in enacting this division to authorize the establishment of a voluntary drug repository and distribution program for the purpose of distributing surplus medications to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. It is also the intent of the Legislature that the health and safety of Californians are protected and promoted through this program, while reducing unnecessary waste at licensed health and care facilities, by allowing those facilities to donate unused and unexpired medications that were never in the hands of a patient or resident and for which no credit or refund to the patient or resident could be received.

history: (History: Amended by Stats. 2012, Ch. 709, Sec. 1. (SB 1329) Effective January 1, 2013.)

division: 116. SURPLUS MEDICATION COLLECTION AND DISTRIBUTION


text:
For purposes of this division:

(a) “Donor organization” means an entity described in subdivision (a) of Section 150202.

(b) “Eligible entity” means all of the following:

(1) A licensed pharmacy, as defined in subdivision (a) of Section 4037 of the Business and Professions Code, that is county owned or that contracts with the county pursuant to this division and is not on probation with the California State Board of Pharmacy.

(2) A licensed pharmacy, as defined in subdivision (a) of Section 4037 of the Business and Professions Code, that is owned and operated by a primary care clinic, as defined in Section 1204, that is licensed by the State Department of Public Health and is not on probation with the California State Board of Pharmacy.

(3) A primary care clinic, as defined in Section 1204, that is licensed by the State Department of Public Health and licensed to administer and dispense drugs pursuant to subparagraph (A) of paragraph (1) of subdivision (a) of Section 4180 of the Business and Professions Code and is not on probation with the California State Board of Pharmacy.

(c) “Medication” or “medications” means a dangerous drug, as defined in Section 4022 of the Business and Professions Code.

(d) “Participating entity” means an eligible entity that has received written or electronic documentation from the county health department pursuant to paragraph (3) of subdivision (a) of Section 150204 and that operates a repository and distribution program pursuant to this division.

history: (History: Amended by Stats. 2014, Ch. 10, Sec. 3. (AB 467) Effective April 9, 2014.)

path: 116. SURPLUS MEDICATION COLLECTION AND DISTRIBUTION


text:
(a) Notwithstanding any other law, a donor organization is defined, for purposes of this division, to refer to the following facilities, hospitals, and entities that legally possess centrally stored, unused medication:

(1) A licensed general acute care hospital, as defined in Section 1250.

(2) A licensed acute psychiatric hospital, as defined in Section 1250.

(3) A licensed skilled nursing facility, as defined in Section 1250, including a skilled nursing facility designated as an institution for mental disease.

(4) A licensed intermediate care facility, as defined in Section 1250.

(5) A licensed intermediate care facility/developmentally disabled-habilitative facility, as defined in Section 1250.

(6) A licensed intermediate care facility/developmentally disabled-nursing facility, as defined in Section 1250.

(7) A licensed correctional treatment center, as defined in Section 1250.

(8) A licensed psychiatric health facility, as defined in Section 1250.2.

(9) A licensed chemical dependency recovery hospital, as defined in Section 1250.3.

(10) A licensed residential care facility for the elderly, as defined in Section 1569.2, with 16 or more residents.

(11) An approved mental health rehabilitation center, as described in Section 5675 of the Welfare and Institutions Code.

(12) An eligible entity, as defined in subdivision (b) of Section 150201.

(13) A juvenile facility, as described in Section 208.3 of the Welfare and Institutions Code.

(14) A local detention facility, as described in Section 6031.4 of the Penal Code.

(15) A facility that is any of the following:

(A) Licensed by the State Department of Social Services.

(B) Licensed by the State Department of Public Health.

(C) Licensed by the State Department of Health Care Services.

(D) Licensed by or under the jurisdiction of the Department of Corrections and Rehabilitation.

(E) Licensed by or under the jurisdiction of the Division of Juvenile Justice.

(16) A licensed home health agency, as defined in Section 1725.

(17) A licensed hospice agency, as defined in Section 1745.

(18) A licensed hospice facility, as defined in subdivision (n) of Section 1250.

(b) Medication donated by facilities pursuant to subdivision (a) shall meet the requirements of subdivisions (c) and (d) of Section 150204 and shall be unexpired medication that would have otherwise been destroyed by the facility or another appropriate entity.

(c) Medication eligible for donation by facilities pursuant to subdivision (a) shall be directly delivered from the dispensing pharmacy, wholesaler or manufacturer, to the facility and subsequently centrally stored. Centrally stored medication that originated from a patient or resident is not eligible for donation under this division.

history: (History: Amended by Stats. 2022, Ch. 886, Sec. 1. (SB 1346) Effective January 1, 2023.)


text:
Notwithstanding any other law, a pharmacy, licensed in California and not on probation with the California State Board of Pharmacy may donate unused, unexpired medication that meets the requirements of subdivisions (c) and (d) of Section 150204, under a program established pursuant to this division and that meets either of the following requirements:

(a) The medication was received directly from a manufacturer or wholesaler.

(b) The medication was returned from a health facility to the issuing pharmacy, in a manner consistent with state and federal law.

history: (History: Amended by Stats. 2022, Ch. 886, Sec. 2. (SB 1346) Effective January 1, 2023.)


text: Notwithstanding any other provision of law, a wholesaler licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code and a drug manufacturer that is legally authorized under federal law to manufacture and sell pharmaceutical drugs may donate unused medications under the voluntary drug repository and distribution program established by a county pursuant to this division.

history: (History: Added by Stats. 2005, Ch. 444, Sec. 1. Effective January 1, 2006.)


text:
(a) (1) A county may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program.

(2) Only an eligible entity, pursuant to Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program.

(3) An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent.

(4) (A) A participating entity shall disclose to the county health department on a quarterly basis the name and location of the source of all donated medication it receives.

(B) A participating primary care clinic, as described in Section 150201, shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinic’s program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code.

(C) The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division.

(5) The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall ensure that this notice also is provided to one another.

(b) A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, at a minimum, all of the following:

(1) Establishing eligibility for medically indigent patients who may participate in the program.

(2) Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.

(3) Developing a formulary of medications appropriate for the repository and distribution program.

(4) Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.

(5) Ensuring the privacy of individuals for whom the medication was originally prescribed.

(c) Any medication donated to the repository and distribution program shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria:

(1) The medication shall not be a controlled substance.

(2) The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.

(3) The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a health or care facility, as described in Section 150202, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69.

(d) (1) Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104).

(2) (A) A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication.

(B) A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy.

(e) A pharmacist or physician at a participating entity shall use his or her professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program.

(f) A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.

(g) Medication that is donated to the repository and distribution program shall be handled in the following ways:

(1) Dispensed to an eligible patient.

(2) Destroyed.

(3) Returned to a reverse distributor or licensed waste hauler.

(4) (A) Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy may transfer eligible donated medication to a participating county-owned pharmacy within another adjacent county that has adopted a program pursuant to this division, if the pharmacies transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division.

(B) Medication donated under this division shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.

(C) Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, and the donation facility from where the medication originated shall be identified on medication packaging or in accompanying documentation. The document shall include a statement that the medication may not be transferred to another participating entity and must be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication.

(h) Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity.

(i) (1) Except as provided in paragraph (2), medication donated to the repository and distribution program shall be maintained in the donated packaging units until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under this program, the medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. Expired medication shall not be dispensed.

(2) A pharmacy that exists solely to operate the repository and distribution program may repackage a reasonable quantity of donated medicine in anticipation of dispensing the medicine to its patient population. The pharmacy shall have repackaging policies and procedures in place for identifying and recalling medications. Medication that is repackaged shall be labeled with the earliest expiration date.

(j) Medication donated to the repository and distribution program shall be segregated from the participating entity’s other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.

(k) A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution program. These records shall be kept separate from the participating entity’s other acquisition and disposition records and shall conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code), including being readily retrievable.

(l) Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.

(m) County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.

(n) Notwithstanding any other provision of law, a participating entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.

history: (History: Amended by Stats. 2016, Ch. 316, Sec. 1. (AB 1069) Effective January 1, 2017.)


text:
(a) A regional pilot program may be established in the Counties of Santa Clara and San Mateo and the City and County of San Francisco to determine the feasibility and benefits of implementing and maintaining a repository and distribution program. The regional pilot program shall run until January 1, 2030.

(b) Participating pharmacies in the regional pilot program shall be owned or operated by the Counties of Santa Clara or San Mateo or the City and County of San Francisco, licensed in California, and not on probation with the California State Board of Pharmacy.

(c) (1) Participants in the regional pilot program shall develop and implement their programs in accordance with this division.

(2) While participating in the regional pilot program, participants shall continue to meet all other legal responsibilities and requirements relating to pharmacy services and comply with all relevant state and federal statutes when administering their programs.

(d) Section 150204 shall not apply to a pilot program established pursuant to this section and Section 150204.6.

history: (History: Amended by Stats. 2023, Ch. 131, Sec. 133. (AB 1754) Effective January 1, 2024.)


text:
(a) (1) A county specified in Section 150204.5 may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program.

(2) Only an eligible entity, pursuant to Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program.

(3) An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent.

(4) (A) A participating primary care clinic, as described in Section 150201, shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinic’s program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code.

(B) The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division.

(5) The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall each ensure that this notice is also provided to the other two entities.

(b) A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, at a minimum, all of the following:

(1) Establishing eligibility for medically indigent patients who may participate in the program.

(2) Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.

(3) Developing a formulary of medications appropriate for the repository and distribution program.

(4) Ensuring proper safety and management of any medications collected by and maintained under the authority of a participating entity.

(5) Ensuring the privacy of individuals for whom the medication was originally prescribed.

(c) Medication donated to the repository and distribution program or transferred between participating entities shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria:

(1) The medication shall not be a controlled substance.

(2) The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.

(3) The medication shall not have been in the possession of a patient or any individual member of the public, and in the case of medications donated by a hospital, facility, or entity, as described in Section 150202, shall have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69.

(d) (1) Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided lot numbers and expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104).

(2) (A) A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication.

(B) A medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy.

(e) A pharmacist or physician at a participating entity shall use their professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing medication under the repository and distribution program.

(f) A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.

(g) Medication that is donated to the repository and distribution program shall be handled in the following ways:

(1) Dispensed to an eligible patient.

(2) Destroyed.

(3) Returned to a reverse distributor or licensed waste hauler.

(4) (A) Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy may transfer eligible donated medication to a participating county-owned pharmacy within another adjacent county that has adopted a program pursuant to this division, if the pharmacies transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division.

(B) Medication donated under this division may be transferred more than once only within the county and after the final transfer shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler.

(C) Medication transferred pursuant to this paragraph shall be transferred with documentation that identifies the drug name, strength, and quantity of the medication, original manufacturer lot numbers, and current expiration date. The document shall include a statement that the medication shall be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication.

(D) Medication donated from multiple facilities under this division may be commingled by the participating entity. However, in the event of a recall, recalled medication shall be destroyed at the National Drug Code level.

(E) Participating facilities shall maintain a system for recording and logging donated medication which allows the tracking of medication in each repackaged container back to the facility or facilities that donated the medication.

(h) Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity.

(i) (1) When dispensed to an eligible patient under this program, the donated medication shall be in a new, properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed. However, medications donated in sealed manufacturer’s packaging are not required to be placed into a new container, but shall otherwise be appropriately labeled. Expired medication shall not be dispensed.

(2) The pharmacy shall have repackaging policies and procedures in place for identifying and recalling medications. Medication that is repackaged shall be labeled with the earliest expiration date. Repackaged medication can only be dispensed to patients within the county.

(j) A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution program. Notwithstanding any other law, the acquisition record created by a participating entity may be used as the donation, destruction, or disposition record required of a donor organization for donated medication.

(k) Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.

(l) County protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, a biological product as defined in Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.

(m) Notwithstanding any other law, a participating entity shall follow the same federal and state procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.

(n) On January 1, 2028, the California State Board of Pharmacy shall submit to the Legislature an evaluation of the regional pilot programs and pilot participants’ compliance to program requirements as specified in this division. The report shall comply with Section 9795 of the Government Code.

(o) A participating entity shall disclose to the California State Board of Pharmacy any “medication errors,” as that term is described in Section 1716 of Title 16 of the California Code of Regulations, arising out of a program under this division, within 30 days of a participating entity discovering the medication error.

(p) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.

history: (History: Amended by Stats. 2023, Ch. 131, Sec. 134. (AB 1754) Effective January 1, 2024. Repealed as of January 1, 2030, by its own provisions.)


text:
(a) The following persons and entities shall not be subject to criminal or civil liability for injury caused when any entity or person donates, accepts, or dispenses prescription drugs in compliance with this division:

(1) A prescription drug manufacturer, wholesaler, governmental entity, or participating entity.

(2) A pharmacist or physician who accepts or dispenses prescription drugs.

(3) A licensed facility, as described in Section 150202, or a pharmacy, as described in Section 150202.5.

(b) A surplus medication collection and distribution intermediary, as described in Section 150208, shall not be subject to criminal or civil liability for injury caused when facilitating the donation of medications to or transfer of medications in compliance with this division.

history: (History: Amended by Stats. 2022, Ch. 886, Sec. 5. (SB 1346) Effective January 1, 2023.)


text: The immunities provided in Section 150205 shall not apply in cases of noncompliance with this division, bad faith, or gross negligence.


text: Nothing in this division shall affect disciplinary actions taken by licensing and regulatory agencies.


text:
(a) A surplus medication collection and distribution intermediary that is licensed pursuant to Section 4169.5 of the Business and Professions Code, established for the purpose of facilitating the donation of medications to or transfer of medications between participating entities under a program established pursuant to this division is authorized to operate under this section.

(b) A surplus medication collection and distribution intermediary shall comply with the following:

(1) It shall not take possession, custody, or control of dangerous drugs and devices.

(2) It shall ensure that notification is provided to participating entities that a package has been shipped when the surplus medication collection and distribution intermediary has knowledge of the shipment and provided logistical support to facilitate a shipment directly from a donor organization, as defined in subdivision (a) of Section 150202, to a participating entity.

(3) It shall not select, or direct a donor organization, as defined in subdivision (a) of Section 150202, to select, a specific participating entity to receive surplus medications.

(c) A surplus medication collection and distribution intermediary is authorized to do the following:

(1) Charge membership, administrative, or overhead fees sufficient to cover the reasonable costs of the support and services provided.

(2) Contract directly with a county to facilitate the donation of medications to or transfer of medications between participating entities and provide general support in a county’s implementation of a program established pursuant to this division.

(d) No participating entities shall receive donated medication directly from the surplus medication collection and distribution intermediary.

history: (History: Added by Stats. 2014, Ch. 10, Sec. 6. (AB 467) Effective April 9, 2014.)


text: This division shall be known, and may be cited, as the Cancer Medication Recycling Act.

history: (History: Added by Stats. 2021, Ch. 541, Sec. 2. (SB 310) Effective January 1, 2022. Repealed as of January 1, 2027, pursuant to Section 150404.)

division: 117. CANCER MEDICATION RECYCLING ACT

path: 117. CANCER MEDICATION RECYCLING ACT


text:
For purposes of this division, the following definitions apply:

(a) “Donor” means an individual who donates unused prescription drugs to a participating practitioner for the purpose of redistribution to established patients of that practitioner.

(b) “Ineligible drugs” means drugs that are not able to be accepted for redistribution as part of the program established pursuant to this division. “Ineligible drugs” include all controlled substances, including all opioids, all compounded medications, injectable medications, drugs that have an approved United States Food and Drug Administration Risk Evaluation and Mitigation Strategy (REMS) requirement, and all growth factor medications.

(c) “Participating practitioner” means a person who is licensed to practice medicine by the Medical Board of California and is board certified in medical oncology or hematology and is registered with a surplus medication collection and distribution intermediary.

(d) “Recipient” means an individual who voluntarily receives donated prescription medications.

(e) “Surplus medication collection and distribution intermediary” means an entity licensed pursuant to Section 4169.5 of the Business and Professions Code as a surplus medication collection and distribution intermediary, as described in Section 150208.

(f) “Unused cancer medication” or “medication” means a medication or drug, including a “dangerous drug” as defined in Section 4022 of the Business and Professions Code or a “drug” as defined in Section 4025 of the Business and Professions Code, that is prescribed as part of a cancer treatment plan and is in its original container or packaging.


text: An unused cancer medication that is not an ineligible drug as defined in subdivision (b) of Section 150401 may be donated to a participating practitioner, and a participating practitioner may accept and redistribute the donated prescription drugs.


text:
(a) A participating practitioner shall comply with all of the following:

(1) Be registered with a surplus medication collection and distribution intermediary in order to participate in the program established pursuant to this division and Article 11.7 (commencing with Section 4169.7) of Chapter 9 of Division 2 of the Business and Professions Code.

(2) Only accept donated medications originally prescribed for use by established patients of that participating practitioner or practice.

(3) Distribute a medication only if it will not expire before the proper use by the recipient based on the participating practitioner’s directions for use.

(4) Refuse a medication that has previously been redistributed.

(5) Store all donated medications separately from all other medication stock.

(6) Store all donated medications in compliance with the manufacturer’s storage requirements per the drug monograph.

(7) Remove or redact all confidential patient information, personal information, and any other information through which the prior patient could be identified from donated medications.

(8) Require all donors to read and sign the donor form approved by the surplus medication collection and distribution intermediary.

(9) Keep all donor forms and recipient forms in the records for at least three years.

(10) Examine the donated drug to determine that it has not been adulterated or misbranded and certify that the medication has been stored in compliance with the requirements of the product.

(11) Require all recipients of a donated medication to read and sign the recipient form approved by the surplus medication collection and distribution intermediary.

(12) Dispose of any donated medications that were collected but not redistributed in accordance with all local, state, and federal requirements for the disposal of medications.

(13) Monitor all United States Food and Drug Administration (FDA) or manufacturer recalls, market withdrawals, and safety alerts and communicate with recipients if medications they received may be impacted by the FDA action.

(14) Inspect all donated medications to determine that the drugs are unaltered, safe, and suitable for redistribution and meet all of the following conditions:

(A) Tamper-resistant packaging is unopened and intact or, in the case of unit dose packaging, the tamper-resistant dose packaging is intact for each dose donated.

(B) Tablets or capsules have a uniformity of color, shape, imprint or markings, texture, and odor.

(C) Liquids have a uniformity of color, thickness, particulates, transparency, and odor.

(D) The date of donation is less than six months from the date of the initial prescription or prescription refill.

(15) Establish policies and procedures for the administration of the cancer medication recycling program, including, but not limited to, criteria for determining medication distribution to patients. Provide the surplus medication collection and distribution intermediary with updated sections of their policy and procedures manual that indicate how the practitioner will accept, reuse, and keep records of donated medications, if requested.

(b) A donor is not subject to a penalty pursuant to the Sherman Food, Drug, and Cosmetic Law, as set forth in Part 5 (commencing with Section 109875) of Division 104, for an injury caused when donating, accepting, or dispensing medication in compliance with this division, unless an injury arising from the donated medication is caused by the gross negligence, recklessness, or intentional conduct of the donor, or in cases of noncompliance with this division.

(c) A participating practitioner that receives and redistributes a donated medication is not subject to a penalty pursuant to the Sherman Food, Drug, and Cosmetic Law, as set forth in Part 5 (commencing with Section 109875) of Division 104, resulting from the condition of the donated medication unless an injury arising from the donated medication is caused by the gross negligence, recklessness, or intentional conduct of the participating practitioner, in cases of noncompliance with this division, or in cases of malpractice unrelated to the quality of the medication.

(d) The following persons and entities are not subject to criminal or civil liability for an injury caused when participating in the program established pursuant to this division, including, but not limited to, donating, accepting, or dispensing prescription drugs in compliance with this division:

(1) A prescription drug manufacturer, wholesaler, or participating entity.

(2) A participating practitioner who accepts or dispenses prescription drugs.

(3) A donor, as defined in Section 150401.

(4) A surplus medication collection and distribution intermediary.

(e) The immunities provided in subdivision (d) do not apply in cases of noncompliance with this division, gross negligence, recklessness, intentional conduct, or in cases of malpractice unrelated to the quality of the medication.

(f) This division shall not affect disciplinary actions taken by licensing and regulatory agencies.


text: This division shall remain in effect only until January 1, 2027, and as of that date is repealed.

history: (History: Added by Stats. 2021, Ch. 541, Sec. 2. (SB 310) Effective January 1, 2022. Repealed as of January 1, 2027, by its own provisions. Note: Repeal affects Division 117, commencing with Section 150400.)


text:
(a) The State Department of Public Health, the Department of Food and Agriculture, and the Department of Fish and Wildlife shall jointly establish and administer the One Health Program for the purpose of developing a framework for interagency coordination in responding to zoonotic diseases and reducing hazards to human and nonhuman animal health, in accordance with the One Health principles set forth by the federal Centers for Disease Control and Prevention (CDC).

(b) The State Department of Public Health, the Department of Food and Agriculture, and the Department of Fish and Wildlife shall develop the framework for the One Health Program in consultation with stakeholders, which may include, but are not limited to, the One Health Office of the CDC, the Medical Board of California, the Veterinary Medical Board, agricultural programs, institutes, or schools within the University of California system or California State University system, animal welfare organizations, and community-based organizations.

(c) (1) The State Department of Public Health, the Department of Food and Agriculture, and the Department of Fish and Wildlife, in developing the framework, shall establish goals, identify activities necessary to achieve those goals, and recommend legislation or other actions to advance One Health efforts.

(2) The three departments shall periodically post joint reports on their respective internet websites and shall submit the joint reports to the Legislative Analyst’s Office, containing the information described in paragraph (1).

(d) Upon the three departments’ initial development of the framework described in this section, the Legislative Analyst’s Office shall submit to the relevant policy and fiscal committees of the Legislature a single report containing both of the following:

(1) An assessment of whether the framework is a reasonable approach to meeting the purpose of the One Health Program as described in this section.

(2) Recommendations for ways in which the Legislature could conduct regular oversight of the framework’s implementation.

(e) This section shall be implemented subject to an appropriation by the Legislature for the purposes described in this section.

history: (History: Added by Stats. 2022, Ch. 990, Sec. 2. (SB 1029) Effective January 1, 2023.)

division: 118. ONE HEALTH PROGRAM

path: 118. ONE HEALTH PROGRAM


text: There is the Virtual Health Hub for Rural Communities Pilot Program.

history: (History: Added by Stats. 2025, Ch. 311, Sec. 2. (SB 338) Effective January 1, 2026. Conditionally inoperative December 31, 2030, pursuant to Section 150706.)

division: 118.5. VIRTUAL HEALTH HUB FOR RURAL COMMUNITIES PILOT PROGRAM


text:
The following definitions shall apply to this division:

(a) “Department” means the State Department of Public Health.

(b) “Program” means the Virtual Health Hub for Rural Communities Pilot Program established by this division.

(c) “Virtual health hub” means a vehicle or portable facility that is equipped with, at a minimum, computers, Wi-Fi, cubicles for virtual visits, and exam rooms for telemedicine.

path: 118.5. VIRTUAL HEALTH HUB FOR RURAL COMMUNITIES PILOT PROGRAM


text:
(a) The department shall administer the Virtual Health Hub Fund to expand access to health services for farmworkers in rural communities by providing virtual connections to health care providers, mental health services, and educational services to help improve health outcomes in underserved communities.

(b) The department shall distribute grants as described in Section 150704. The department shall provide technical assistance to the grant recipients with regard to any licensing or reporting requirements necessary to fulfill the obligations under Section 150705.


text:
(a) The Virtual Health Hub Fund is hereby created in the State Treasury.

(b) The department is authorized to administer this division with funding other than General Fund moneys, including gifts, donations, bequests, or grants of funds from private sources and public agencies, designated for any of the purposes of this division and deposited in the Virtual Health Hub Fund.

(c) This division shall be implemented only if all of the following conditions are met:

(1) No General Fund moneys are used for this division.

(2) The balance of the fund meets or exceeds two million dollars ($2,000,000).

(3) The department posts a notice to its internet website stating the minimum fund balance has been met.


text:
(a) The department shall award grants to partnerships of two separate community-based organizations to establish and deploy virtual health hubs. However, the department may award both components of a virtual health hub to a single community-based organization if it determines that doing so is necessary to ensure program effectiveness, administrative efficiency, or adequate service coverage in a particular community or region.

(b) Grant recipients shall deploy virtual health hubs in two rural communities based on farmworker population and access to health care.

(c) The grant recipients shall make space available in or around virtual health hubs that can be used for visits by professionals, including, but not limited to, medical teams, educators, and volunteers, who bring additional programming onsite to rural farms.

(d) The grant recipients shall report the information outlined in subdivision (b) of Section 150705 to the department upon request and in the manner prescribed by the department.


text:
(a) In evaluating grant proposals pursuant to this division, the department shall give priority to community-based organizations that meet one or more of the following criteria:

(1) Provide farmworker communities with mental health support, cultural resources, educational tools, advocacy, immigration litigation support, food, or basic necessities.

(2) A history of serving communities that are medically underserved or face significant barriers to accessing health care, including, but not limited to, low-income populations, rural communities, immigrants, individuals with limited English proficiency, or communities of color.

(3) Provide a benefit to farmworker communities in underserved areas as defined in Section 14076 of the Welfare and Institutions Code, to medically underserved populations determined under Sections 39711 and 39713, and vulnerable communities as defined in subdivision (d) of Section 71340 of the Public Resources Code.

(4) Are culturally and linguistically aligned with the populations served, including having multilingual staff, culturally competent service delivery models, or representation from the target community within leadership or governance structures.

(5) Have existing infrastructure, or a clearly defined plan to offer or facilitate virtual or telehealth services, including access to private consultation space, digital equipment, or partnerships with licensed providers.

(6) Have the capacity and willingness to collect and report deidentified, aggregate data as required by the department, including, but not limited to, age ranges, income brackets, race or ethnicity, language, and service type.

(7) Have demonstrated collaboration with local clinics, schools, hospitals, tribal health providers, or other public or private health entities to ensure effective referral systems and service integration.

(8) Operate or have operated within a health professional shortage area, medically underserved area, or other area designated by the department as high need.

(b) The department may assign a weighted scoring system to these criteria. To ensure transparency and equity in funding decisions, the department shall make public any application rubric or review process used to evaluate proposals.


text:
(a) Two years after the date the department posts to their internet website that the minimum fund requirement for program operation has been met pursuant to subdivision (c) of Section 150703, the department shall submit a report regarding the program to the Legislature.

(b) The report shall include information provided to the department by the grant recipients, including, but not limited to, all of the following:

(1) Age ranges of the people served.

(2) Household income brackets of the people served.

(3) Self-reported race and ethnicity of the people served, when available.

(4) Primary language spoken at home of the people served.

(5) ZIP Code or general geographic area served.

(6) Insurance status of the people served, including whether they have private insurance, are uninsured, or are covered by the Medi-Cal program.

(7) Number of individuals served, not including repeat users.

(8) Type of health services accessed, including, but not limited to, preventative, behavioral, and maternal health.

(9) General barriers to care, as identified by participants.

(c) The information shall contain only deidentified information and shall be reported only in aggregate form to ensure compliance with applicable privacy laws, including the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the California Confidentiality of Medical Information Act (CMIA).

(d) The department shall post the final report to its internet website.

(e) A report to be submitted pursuant to this section shall be submitted in compliance with Section 9795 of the Government Code.


text: Unless subsequent legislation supersedes or modifies this division to extend the program, this division shall become inoperative if the fund balance has not been met by December 31, 2030.

history: (History: Added by Stats. 2025, Ch. 311, Sec. 2. (SB 338) Effective January 1, 2026. Conditionally inoperative December 31, 2030, by its own provisions. Note: Inoperative provisions affect Division 118.5, commencing with Section 150700.)


text:
(a) The Two-Spirit, Transgender, Gender Nonconforming, and Intersex (2TGI) Wellness and Equity Fund is established in the State Treasury.

(b) The State Department of Public Health shall administer the 2TGI Wellness and Equity Fund for purposes of funding grants to create programs, or funding existing programs, focused on coordinating trans-inclusive health care for individuals who identify as Two-Spirit, transgender, gender nonconforming, or intersex.

(c) Upon appropriation by the Legislature, moneys in the 2TGI Wellness and Equity Fund may be used to fund grants for the following purposes:

(1) The grants shall be available to 2TGI-serving organizations for the purpose of increasing the capacity of health care professionals to effectively provide 2TGI health care and institute 2TGI-inclusive best practices. This includes, but is not limited to, cultural responsiveness training, the creation of educational materials, or the facilitation of capacity-building trainings.

(2) The grants shall be available to 2TGI-serving organizations for the purpose of facilitating evidence-based therapeutic arts programs.

(3) The grants shall be available to 2TGI-serving organizations for purposes of assisting, identifying, and referring 2TGI people to access supportive housing. This includes case management opportunities, financial assistance, and assisting 2TGI people in receiving and utilizing housing vouchers. If a 2TGI-serving organization has already implemented a 2TGI-specific housing program, funding may be utilized to maintain or expand existing housing programs.

(4) The grants shall be available to a hospital, health care clinic, or other medical provider that currently provides gender-affirming health care services, such as hormone therapy or gender reassignment surgery, to continue providing those services, or to a hospital, health care clinic, or other medical provider that will establish a program that offers gender-affirming health care services and has an established relationship with a 2TGI-serving organization that will lead in establishing the program.

(5) The grants shall be available to 2TGI-serving organizations for the purpose of providing workforce development training for 2TGI individuals.

(6) The grants shall be available to 2TGI-serving organizations for the purpose of providing resettlement and social integration programs for 2TGI asylees and immigrants.

(7) The grants shall be available to 2TGI-serving organizations for the purpose of providing diversion programs for, and outreach to, transitional-age 2TGI youth.

(d) (1) A hospital, health care clinic, or other medical provider that applies for a grant must apply in partnership with a 2TGI-serving organization and consult with the 2TGI-serving organization throughout the process of creating and implementing its trans-inclusive health care program.

(2) An organization that serves tribal populations is also eligible to be awarded a grant for any of the purposes described in subdivision (c) if that organization applies in partnership with a 2TGI-serving organization, as defined in paragraph (8) of subdivision (f).

(e) This section does not limit or impact payer coverage requirements of health care or other social services.

(f) For purposes of this section, the following definitions apply:

(1) “Health care” means any of the following:

(A) Medical, behavioral health, and spiritual care, which includes, but is not limited to, guided meditation and nondenominational therapy.

(B) Evidence-based therapeutic arts programs.

(C) Services related to substance use disorder or substance abuse.

(D) Supportive housing as a mechanism to support 2TGI-identified individuals in accessing other social services.

(E) Mental health services.

(2) “TGI-serving organization” means either of the following:

(A) A public or nonprofit organization with a mission statement that centers around serving transgender, gender nonconforming, and intersex people, and where at least 65 percent of the clients of the organization are TGI.

(B) A nonprofit that serves as the fiscal agent or sponsor for an organization described in subparagraph (A). A nonprofit that is serving as a fiscal agent or sponsor shall pass all funding to the organization, but may charge a reasonable or industry standard fee for administrative costs of not more than 16 percent.

(3) “Transgender” is broad and inclusive of all gender identities different from the gender that a person was assigned at birth.

(4) “Gender nonconforming” is an inclusive term used to describe individuals who may experience a gender that is neither exclusively male nor female or is in between or beyond both of those genders, including, but not limited to, nonbinary, gender fluid, agender or without gender, third gender, genderqueer, gender variant, Hijra, Kathoey, Mak nyah, Muxe, Waria, Māhū, and Fa’afafine.

(5) “Intersex” is an umbrella term referring to people whose anatomy, hormones, or chromosomes fall outside the strict male and female binary.

(6) “Two-Spirit” is a term referring to unique indigenous cultural roles that intersect with diverse sexual orientations and gender embodiments.

(7) “Transitional-age 2TGI youth” means youth between 16 to 26 years of age, inclusive, who are transgender, gender nonconforming, intersex, or Two-Spirit.

(8) “2TGI-serving organization” means a TGI-serving organization, as defined in paragraph (2), that also applies to Two-Spirit people, as follows:

(A) The public or nonprofit organization’s mission statement centers around serving Two-Spirit, transgender, gender nonconforming, or intersex people, or any combination thereof, and at least 65 percent of the clients of the organization are 2TGI.

(B) The nonprofit described in subparagraph (B) of paragraph (2) serves as the fiscal agent or sponsor for an organization described in subparagraph (A) of this paragraph, and follows the other criteria described in subparagraph (B) of paragraph (2), as applicable to this paragraph.

history: (History: Amended by Stats. 2025, Ch. 732, Sec. 3. (AB 1487) Effective January 1, 2026.)

division: 119. TRANSGENDER WELLNESS AND EQUITY

path: 119. TRANSGENDER WELLNESS AND EQUITY


text:
(a) The Transgender, Gender Variant, and Intersex (TGI) Wellness Reentry Fund is established in the State Treasury.

(b) The State Department of Public Health’s Office of Health Equity shall administer the TGI Wellness Reentry Fund for purposes of funding grants to create programs, or funding existing programs, focused on reentry programming specifically to support TGI people who have experienced carceral systems.

(c) Upon appropriation by the Legislature, moneys in the TGI Wellness Reentry Fund may be used to fund grants to existing and new TGI-specific reentry programs run by TGI-serving organizations. Reentry programs include, but are not limited to, emergency, transitional, or permanent housing, employment linkage and support, direct employment opportunities, workforce development and career development training, entrepreneurship opportunities, mental and general health care, identity document updating services, legal assistance, computer training, services navigation, case management, financial assistance and literacy, and other wraparound and comprehensive services.

(d) For purposes of this section, the following definitions apply:

(1) “Transgender” has the same meaning as defined in paragraph (3) of subdivision (f) of Section 150900.

(2) “Gender Variant” has the same meaning as “gender nonconforming” as defined in paragraph (4) of subdivision (f) of Section 150900.

(3) “Intersex” has the same meaning as defined in paragraph (5) of subdivision (f) of Section 150900.

(4) “TGI-serving organization” has the same meaning as defined in Section 150900.

history: (History: Added by Stats. 2023, Ch. 845, Sec. 2. (AB 1487) Effective January 1, 2024.)

division: 119.1. TRANSGENDER, GENDER VARIANT, AND INTERSEX WELLNESS REENTRY


text:
(a) No later than March 1, 2023, the California Health and Human Services Agency shall convene a working group of representatives from at least three TGI-serving organizations, at least three individual California residents who identify as TGI, health care providers, and one appointee representing each of the following state agencies:

(1) The Department of Managed Health Care.

(2) The Department of Insurance.

(3) The State Department of Health Care Services.

(4) The California Health Benefit Exchange.

(5) CalPERS.

(6) The State Department of Public Health.

(b) The working group shall be charged with developing a quality standard for patient experience to measure cultural competency related to the TGI community and recommend training curriculum to provide trans-inclusive health care. This shall be done with input from health care providers, experts on quality measurement, additional stakeholders, and other entities the agency deems necessary. The working group shall conduct at least four listening sessions across the state with patients from the TGI community. The quality standard and recommendations for curriculum shall be developed no later than March 1, 2024.

(c) The agency may contract with consultants to assist the working group with the implementation and administration of its duties under this section. Contracts entered into pursuant to the authority in this subdivision shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code, Section 19130 of the Government Code, and Chapter 6 (commencing with Section 14825) of Part 5.5 of Division 3 of Title 2 of the Government Code and shall be exempt from the review or approval of any division of the Department of General Services.

(d) For purposes of this section, the following definitions apply:

(1) “TGI” means transgender, gender diverse, or intersex.

(2) “TGI-serving organization” has the same meaning as set forth in paragraph (2) of subdivision (f) of Section 150900.

history: (History: Added by Stats. 2022, Ch. 822, Sec. 4. (SB 923) Effective January 1, 2023.)

division: 119.5. TRANSGENDER, GENDER DIVERSE, OR INTERSEX HEALTH CARE QUALITY STANDARDS


text: This division shall be known, and may be cited, as the Sexual Health Education Accountability Act.

history: (History: Added by Stats. 2007, Ch. 602, Sec. 1. Effective January 1, 2008.)

division: 120. SEXUAL HEALTH EDUCATION ACCOUNTABILITY ACT