California Assembly Bill AB1045 Amended / Bill

 BILL NUMBER: AB 1045AMENDED BILL TEXT AMENDED IN SENATE JUNE 6, 2013 AMENDED IN ASSEMBLY APRIL 22, 2013 INTRODUCED BY Assembly Member Quirk-Silva FEBRUARY 22, 2013 An act to amend  Sections 4112 and 4127.2   Section 4303  of, and to add Section 4127.9 to, the Business and Professions Code, relating to pharmacy. LEGISLATIVE COUNSEL'S DIGEST AB 1045, as amended, Quirk-Silva. Sterile compounding  and nonresident  pharmacies. Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacies in this state by the California State Board of Pharmacy. A violation of these provisions is a crime. Existing law provides that a pharmacy located outside this state that ships, mails, or delivers, in any manner, controlled substances, dangerous drugs, or dangerous devices into this state shall be considered a nonresident pharmacy. Existing law prohibits a person from acting as a nonresident pharmacy unless he or she has obtained a license from the board, and authorizes the board to register a nonresident pharmacy that is organized as a limited liability company in the state in which it is licensed. The law also prohibits a resident or nonresident pharmacy from compounding injectable sterile drug products for shipment into this state without a license issued by the board, and authorizes a license to compound injectable sterile drug products to be issued only for a location that is licensed as a  resident or  nonresident pharmacy.  This bill would provide that if the home state pharmacy license of a nonresident pharmacy is revoked or suspended for any reason, any license issued pursuant to provisions governing the licensing and registration of nonresident pharmacies and authorizing a nonresident pharmacy to compound injectable sterile drug products shall be immediately revoked or suspended by operation of law.   The   This  bill would  also  require a resident or a nonresident pharmacy that issues a recall notice regarding a sterile compounded drug to contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 24 hours of the recall notice if use of or exposure to the recalled drug may cause serious adverse health consequences or death and if the recalled drug was dispensed or is intended for use in this state. Because a violation of these requirements would be a crime, the bill would impose a state-mandated local program.  The bill would also provide that if the home state pharmacy license of a nonresident pharmacy is revoked or suspended for any reason, any license issued pursuant to the provisions governing the licensing and registration of nonresident pharmacies or authorizing a nonresident pharmacy to compound injectable sterile drug products shall be immediately revoked or suspended by operation of law.  The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:  SECTION 1.   Section 4112 of the Business and Professions Code is amended to read: 4112. (a) Any pharmacy located outside this state that ships, mails, or delivers, in any manner, controlled substances, dangerous drugs, or dangerous devices into this state shall be considered a nonresident pharmacy. (b) A person may not act as a nonresident pharmacy unless he or she has obtained a license from the board. The board may register a nonresident pharmacy that is organized as a limited liability company in the state in which it is licensed. (c) A nonresident pharmacy shall disclose to the board the location, names, and titles of (1) its agent for service of process in this state, (2) all principal corporate officers, if any, (3) all general partners, if any, and (4) all pharmacists who are dispensing controlled substances, dangerous drugs, or dangerous devices to residents of this state. A report containing this information shall be made on an annual basis and within 30 days after any change of office, corporate officer, partner, or pharmacist. (d) All nonresident pharmacies shall comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is licensed as well as with all requests for information made by the board pursuant to this section. The nonresident pharmacy shall maintain, at all times, a valid unexpired license, permit, or registration to conduct the pharmacy in compliance with the laws of the state in which it is a resident. As a prerequisite to registering with the board, the nonresident pharmacy shall submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which it is located. If the home state pharmacy license of a nonresident pharmacy is revoked or suspended for any reason, any license issued pursuant to this section shall be immediately revoked or suspended by operation of law. (e) All nonresident pharmacies shall maintain records of controlled substances, dangerous drugs, or dangerous devices dispensed to patients in this state so that the records are readily retrievable from the records of other drugs dispensed. (f) Any pharmacy subject to this section shall, during its regular hours of operation, but not less than six days per week, and for a minimum of 40 hours per week, provide a toll-free telephone service to facilitate communication between patients in this state and a pharmacist at the pharmacy who has access to the patient's records. This toll-free telephone number shall be disclosed on a label affixed to each container of drugs dispensed to patients in this state. (g) A nonresident pharmacy shall not permit a pharmacist whose license has been revoked by the board to manufacture, compound, furnish, sell, dispense, or initiate the prescription of a dangerous drug or dangerous device, or to provide any pharmacy-related service, to a person residing in California. (h) The board shall adopt regulations that apply the same requirements or standards for oral consultation to a nonresident pharmacy that operates pursuant to this section and ships, mails, or delivers any controlled substances, dangerous drugs, or dangerous devices to residents of this state, as are applied to an in-state pharmacy that operates pursuant to Section 4037 when the pharmacy ships, mails, or delivers any controlled substances, dangerous drugs, or dangerous devices to residents of this state. The board shall not adopt any regulations that require face-to-face consultation for a prescription that is shipped, mailed, or delivered to the patient. The regulations adopted pursuant to this subdivision shall not result in any unnecessary delay in patients receiving their medication. (i) The registration fee shall be the fee specified in subdivision (a) of Section 4400. (j) The registration requirements of this section shall apply only to a nonresident pharmacy that ships, mails, or delivers controlled substances, dangerous drugs, and dangerous devices into this state pursuant to a prescription. (k) Nothing in this section shall be construed to authorize the dispensing of contact lenses by nonresident pharmacists except as provided by Section 4124.   SEC. 2.   Section 4127.2 of the Business and Professions Code is amended to read: 4127.2. (a) A nonresident pharmacy may not compound injectable sterile drug products for shipment into the State of California without a license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable. (b) A license to compound injectable sterile drug products may only be issued for a location that is licensed as a nonresident pharmacy. Furthermore, the license to compound injectable sterile drug products may only be issued to the owner of the nonresident pharmacy license at that location. If the home state pharmacy license of a nonresident pharmacy is revoked or suspended for any reason, any license issued pursuant to Section 4112 or this section shall be immediately revoked or suspended by operation of law. A license to compound injectable sterile drug products may not be issued or renewed until the board receives the following from the nonresident pharmacy: (1) A copy of an inspection report issued by the pharmacy's licensing agency, or a report from a private accrediting agency approved by the board, in the prior 12 months documenting the pharmacy's compliance with board regulations regarding the compounding of injectable sterile drug products. (2) A copy of the nonresident pharmacy's proposed policies and procedures for sterile compounding. (c) Nonresident pharmacies operated by entities that are licensed as a hospital, home health agency, or a skilled nursing facility and have current accreditation from the Joint Commission on Accreditation of Healthcare Organizations, or other private accreditation agencies approved by the board, are exempt from the requirement to obtain a license pursuant to this section. (d) This section shall become effective on the earlier of July 1, 2003, or the effective date of regulations adopted by the board pursuant to Section 4127.   SEC. 3.   SECTION 1. Section 4127.9 is added to the Business and Professions Code, to read: 4127.9. (a) A pharmacy licensed pursuant to Section 4127.1 or 4127.2, including a pharmacy that is exempt from licensure pursuant to subdivision (d) of Section 4127.1 and subdivision (c) of Section 4127.2, that issues a recall notice regarding a sterile compounded drug shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 24 hours of the recall notice if both of the following apply: (1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death. (2) The recalled drug was dispensed, or is intended for use, in this state. (b) A recall notice issued pursuant to subdivision (a) shall be made as follows: (1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient. (2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified. (3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, who shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.  SEC.   2.   Section 4303 of the   Business and Professions Code   is amended to read:  4303. (a) The board may report any violation by a nonresident pharmacy of the laws and regulations of this state, any other state, or of the United States, including, but not limited to, any violation of this chapter or of the regulations established by the board, to any appropriate state or federal regulatory or licensing agency, including, but not limited to, the regulatory or licensing agency of the state in which the nonresident pharmacy is a resident or in which the pharmacist is licensed. (b) The board may deny, revoke, or suspend a nonresident pharmacy registration, issue a citation or letter of admonishment to a nonresident pharmacy, or take any other action against a nonresident pharmacy that the board may take against a resident pharmacy license, on any of the same grounds upon which such action might be taken against a resident pharmacy, provided that the grounds for the action are also grounds for action in the state in which the nonresident pharmacy is permanently located.  (c) If the home state pharmacy license of a nonresident pharmacy is revoked or suspended for any reason, any license issued pursuant to Section 4112 or 4127.2 shall be immediately revoked or suspended by operation of law.   SEC. 4.   SEC. 3.  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.