California Assembly Bill AB467 Amended / Bill

 BILL NUMBER: AB 467AMENDED BILL TEXT AMENDED IN SENATE SEPTEMBER 6, 2013 AMENDED IN SENATE AUGUST 19, 2013 AMENDED IN SENATE AUGUST 12, 2013 AMENDED IN ASSEMBLY APRIL 11, 2013 AMENDED IN ASSEMBLY MARCH 19, 2013 INTRODUCED BY Assembly Member Stone (Principal coauthor: Senator Hill) FEBRUARY 19, 2013 An act to  amend Section 150201 of,   add Section 4046 to, and to add Article 11.5 (commencing with Section 4169.5) to, Chapter 9 of Division 2 of, the Business and Professions Code,  and  to amend Section 150205 of, and  to add Section 150208 to, the Health and Safety Code, relating to pharmaceuticals,  making an appropriation therefor,  and declaring the urgency thereof, to take effect immediately. LEGISLATIVE COUNSEL'S DIGEST AB 467, as amended, Stone. Prescription drugs: collection and distribution program. Existing law authorizes a county to establish, by ordinance, a repository and distribution program under which specified pharmacies and primary care clinics may distribute surplus unused medications, as defined, to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Existing law authorizes specified health and care facilities, pharmacies, drug manufacturers, and pharmacy wholesalers to donate unused medications to the program. Existing law requires a county that has established a program to establish procedures to, among other things, ensure proper safety and management of any medications collected and maintained by a participating entity.  Existing la  w exempts specified persons and entities, including prescription drug manufacturers and pharmacists and   physicians who accept or dispense prescription drugs, from criminal and civil liability for injury caused when donating, accepting, or dispensing prescription drugs in compliance with these provisions.   This bill would provide that activities relating to the donation or distribution of medications under the program are not wholesaling activities, and any person, as defined, that is not otherwise a wholesaler shall not be deemed a wholesaler or required to be licensed as a wholesaler when performing those activities.   Existing law, the Pharmacy Law, governs the scope and practice of pharmacy, including dispensing dangerous drugs and devices. Existing law establishes in the Department of Consumer Affairs the California State Board of Pharmacy to exercise licensing, regulatory, and disciplinary functions with respect to the practice of pharmacy. Existing law provides that fees collected on behalf of the board are credited to the Pharmacy Board Contingent Fund, a continuously appropriated fund. A violation of the Pharmacy Law is a crime.   This bill would require the California State Board of Pharmacy to license a surplus medication collection and distribution intermediary, as defined, established for the purpose of facilitating the connection of eligible and participating entities under the unused medication repository and distribution program described above. Among other things, the bill would prohibit that intermediary from taking possession, custody, or control of dangerous drugs and devices, but would authorize the intermediary to charge specified fees for the reasonable costs of the services provided. The bill would require that a surplus medication collection and distribution intermediary be licensed by the board, as specified, and would require the payment of a fee in the amount of $300 to obtain the license. The bill would provide that the fees collected would be deposited in the Pharmacy Board Contingent Fund. By providing a new source of funds for a continuously appropriated fund, the bill would make an appropriation. Because a violation of the provision governing licensing would be a crime, the bill would impose a state-mandated local program. The bill would exempt a surplus medication collection and distribution intermediary from criminal or civil liability for injury caused when facilitating the donation of prescription drugs.   The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.   This bill would provide that no reimbursement is required by this act for a specified reason.  This bill would declare that it is to take effect immediately as an urgency statute. Vote: 2/3. Appropriation:  no   yes  . Fiscal committee:  no   yes  . State-mandated local program:  no   yes  . THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:  SECTION 1.   Section 150201 of the Health and Safety Code is amended to read: 150201. For purposes of this division: (a) "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. (b) "Medication" or "medications" means a dangerous drug, as defined in Section 4022 of the Business and Professions Code. (c) "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. (d) "Person" includes a firm, association, partnership, corporation, limited liability company, state governmental agency, or political subdivision.   SECTION 1.   Section 4046 is added to the   Business and Professions Code   , to read:   4046. "Surplus medication collection and distribution intermediary" means a firm, association, partnership, corporation, limited liability company, state governmental agency or political subdivision that performs the functions specified in Section 4169.5 for the purpose of a program established pursuant to Division 116 (commencing with Section 150200) of the Health and Safety Code.   SEC. 2.   Article 11.5 (commencing with Section 4169.5) is added to Chapter 9 of Division 2 of the   Business and Professions Code   , to read:   Article 11.5. Surplus Medication Collection and Distribution Intermediaries 4169.5. (a) A surplus medication collection and distribution intermediary established for the purpose of facilitating the connection of eligible and participating entities under a program established pursuant to Division 116 (commencing with Section 150200) of the Health and Safety Code shall be licensed by the board. The board shall enforce the requirements set forth in Section 150208 of the Health and Safety Code. (b) An application for licensure as a surplus medication collection and distribution intermediary shall be made on a form furnished by the board, and shall state the name, address, usual occupation, and professional qualifications, if any, of the applicant. If the applicant is an entity other than a natural person, the application shall state the information as to each person beneficially interested in that entity. (c) As used in this section, and subject to subdivision (e), the term "person beneficially interested" means and includes: (1) If the applicant is a partnership or other unincorporated association, each partner or member. (2) If the applicant is a corporation, each of its officers, directors, and stockholders, provided that no natural person shall be deemed to be beneficially interested in a nonprofit corporation. (3) If the applicant is a limited liability company, each officer, manager, or member. (d) In any case where the applicant is a charitable organization described in Section 501 (c) (3) of the Internal Revenue Code, the applicant shall furnish the board with organizations the articles of incorporation. The applicant shall also furnish the board with the names of the controlling members. (e) In any case where the applicant is a partnership or other unincorporated association, is a limited liability company, or is a corporation, and where the number of partners, members, or stockholders, as the case may be, exceeds five, the application shall so state, and shall further state the information required by subdivision (a) as to each of the five partners, members, or stockholders who own the five largest interests in the applicant's entity. Upon request by the executive officer of the board, the applicant shall furnish the board with the information required by subdivision (a) as to partners, members, or stockholders not named in the application, or shall refer the board to an appropriate source of that information. (f) The application shall contain a statement to the effect that the applicant or persons beneficially interested have not been convicted of a felony and have not violated any of the provisions of this chapter. If the applicant cannot make this statement, the application shall contain a statement of the violation, if any, or reasons which will prevent the applicant from being able to comply with the requirements with respect to the statement. (g) Upon the approval of the application by the board and payment of a fee in the amount of three hundred dollars ($300), the executive officer of the board shall issue a license to operate as a surplus medication collection and distribution intermediary, if all of the provisions of this chapter have been complied with. Fees received by the board pursuant to this section shall be deposited into the Pharmacy Board Contingent Fund. An applicant for licensure as a surplus medication collection and distribution intermediary that is a nonprofit organization pursuant to subdivision (d) is exempt from the fee requirement. (h) A surplus medication collection and distribution intermediary licensed pursuant to this section is exempt from licensure as a wholesaler.   SEC. 3.   Section 150205 of the   Health and Safety Code  is amended to read:  150205.  (a)    The following persons and entities shall not be subject to criminal or civil liability for injury caused when donating, accepting, or dispensing prescription drugs in compliance with this division:  (a)   (1)  A prescription drug manufacturer, wholesaler, governmental entity, or participating entity.  (b)   (2)  A pharmacist or physician who accepts or dispenses prescription drugs.  (c)   (3)  A licensed health or care 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 prescription drugs in compliance with this division.   SEC. 2.   SEC. 4.  Section 150208 is added to the Health and Safety Code, to read:  150208. Activities relating to the donation or distribution of medications, including, but not limited to, facilitating or negotiating the donation or distribution of medications, pursuant to this division shall not be deemed wholesaling activities. Any person that is not otherwise a wholesaler, as defined in Section 4043 of the Business and Professions Code, shall not be deemed a wholesaler or required to be licensed as a wholesaler under the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code) when performing those activities pursuant to this division.   150208.   (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 connection of eligible and 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 or provided logistical support to facilitate a shipment directly from an eligible entity to a participating entity.   (3) It shall not select, or direct an eligible entity 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) Contract directly with a county to connect eligible entities with participating entities and provide general support in a county's implementation of a program established pursuant to this division.   (2) Charge membership, administrative, or overhead fees sufficient to cover the reasonable costs of the services provided.   (d) No participating entities shall receive donated medication directly from the surplus medication collection and distribution intermediary.   SEC. 5.   No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.  SEC. 3.   SEC. 6.  This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the Constitution and shall go into immediate effect. The facts constituting the necessity are: To ensure that California's medication donation program is allowed to continue to operate to facilitate the distribution of medications to the indigent population which would not otherwise have access to these medications, it is necessary that this act take effect immediately.