California Senate Bill SB431 Amended / Bill

 BILL NUMBER: SB 431AMENDED BILL TEXT AMENDED IN ASSEMBLY AUGUST 23, 2011 AMENDED IN SENATE MAY 10, 2011 AMENDED IN SENATE APRIL 11, 2011 INTRODUCED BY Senator Emmerson  (   Coauthor:   Assembly Member   Fuentes   )  FEBRUARY 16, 2011 An act to amend Sections 4081, 4104, 4105, and 4112 of  , and to add Section 4126.7 to,  the Business and Professions Code, relating to pharmacies. LEGISLATIVE COUNSEL'S DIGEST SB 431, as amended, Emmerson. Pharmacies: regulation. Existing law, the Pharmacy Law, creates the California State Board of Pharmacy and makes it responsible for administering and enforcing the provisions of that law, including the licensure of pharmacies, as defined, and nonresident pharmacies that ship, mail, or deliver controlled substances or dangerous drugs or devices, as defined, into this state.  Under existing law, a reverse distributor is any person who acts as an agent for a pharmacy, drug wholesaler, manufacturer, or other entity by receiving, inventorying, and managing the disposition of outdated or nonsalable dangerous drugs.  A knowing violation of the Pharmacy Law is a crime.  This bill would, except as specified, prohibit a reverse distributor from accepting the return of dangerous drugs that have been dispensed to a patient that are later returned by the patient or patient's agent to a pharmacy, as specified.  Existing law requires that each pharmacy establish procedures for addressing the theft, diversion, or self-use of dangerous drugs by a licensed individual employed by or with the pharmacy, and that every pharmacy report to the board within 30 days of the receipt or development of certain information affecting the ability of those individuals to practice the profession or occupation authorized by their license, as specified. Existing law requires an entity licensed by the board to retain records of the acquisition and disposition of dangerous drugs and devices in a specified manner. Existing federal law requires registrants distributing specified controlled substances to conduct an inventory of controlled substances every 2 years. This bill would instead require a pharmacy to report and provide to the board, within 14 days of the receipt or development thereof, the information described above regarding the ability of licensed individuals employed by or with the pharmacy to practice the profession or occupation authorized by their license. The bill would require the report to include specified detailed information, including the date of the last controlled substances inventory, and would require the pharmacy to prepare and submit an audit relating to the report upon the request of the board. The bill would also require an entity licensed by the board to provide records to designated persons within 3 business days of the time of the request, unless that timeframe is extended by the board, as specified. The bill would prohibit a pharmacist whose license was revoked by the board to perform pharmacy duties, as specified, for a nonresident pharmacy. Existing law requires all records of manufacture and of sale, acquisition, or disposition of dangerous drugs or dangerous devices to be at all times during business hours open to inspection by authorized officers of the law and preserved at least 3 years from the date of making. Existing law requires every person or entity who maintains a stock of dangerous drugs or dangerous devices to keep a current inventory. This bill would require that any record pertaining to the return of dangerous drugs to a wholesaler  , reverse distributor,  or hazardous waste hauler include specified information, including the quantity or weight of the drugs returned. Because this bill would specify additional requirements under the Pharmacy Law, a violation of which is a crime, it would impose a state-mandated local program by creating additional crimes. 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 4081 of the Business and Professions Code is amended to read: 4081. (a) All records of manufacture and of sale, acquisition, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, pharmacy, veterinary food-animal drug retailer, physician, dentist, podiatrist, veterinarian, laboratory, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices. (b) The owner, officer, and partner of a pharmacy, wholesaler, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge or designated representative-in-charge, for maintaining the records and inventory described in this section. (c) The pharmacist-in-charge or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge or designated representative-in-charge had no knowledge, or in which he or she did not knowingly participate. (d) Any record pertaining to the return of dangerous drugs to a wholesaler  or provided to a reverse distributor  shall document the quantity or weight of the drugs returned, the date the drugs were returned, and the name of the  reverse distributor or  wholesaler to whom the drugs were provided. (e) Any record pertaining to the return of dangerous drugs to a hazardous waste hauler, as described in Section 117660 of the Health and Safety Code, shall list the volume in weight or measurement of the pharmaceutical waste returned, the date the waste was returned, and the name of the hazardous waste hauler to whom the waste was provided. SEC. 2. Section 4104 of the Business and Professions Code is amended to read: 4104. (a) Every pharmacy shall have in place procedures for taking action to protect the public when a licensed individual employed by or with the pharmacy is discovered or known to be chemically, mentally, or physically impaired to the extent it affects his or her ability to practice the profession or occupation authorized by his or her license, or is discovered or known to have engaged in the theft, diversion, or self-use of dangerous drugs. (b) Every pharmacy shall have written policies and procedures for addressing chemical, mental, or physical impairment, as well as theft, diversion, or self-use of dangerous drugs, among licensed individuals employed by or with the pharmacy. (c) Every pharmacy shall report and provide to the board, within 14 days of the receipt or development thereof, the following information with regard to any licensed individual employed by or with the pharmacy: (1) Any admission by a licensed individual of chemical, mental, or physical impairment affecting his or her ability to practice. (2) Any admission by a licensed individual of theft, diversion, or self-use of dangerous drugs. (3) Any video or documentary evidence demonstrating chemical, mental, or physical impairment of a licensed individual to the extent it affects his or her ability to practice. (4) Any video or documentary evidence demonstrating theft, diversion, or self-use of dangerous drugs by a licensed individual. (5) Any termination based on chemical, mental, or physical impairment of a licensed individual to the extent it affects his or her ability to practice. (6) Any termination of a licensed individual based on theft, diversion, or self-use of dangerous drugs. (d) The report required in subdivision (c) shall include sufficient detail to inform the board of the facts upon which the report is based, including an estimate of the type and quantity of all dangerous drugs involved, the timeframe over which the losses are suspected, and the date of the last controlled substances inventory. Upon request of the board, the pharmacy shall prepare and submit an audit involving the dangerous drugs suspected to be missing. (e) Anyone making a report authorized or required by this section shall have immunity from any liability, civil or criminal, that might otherwise arise from the making of the report. Any participant shall have the same immunity with respect to participation in any administrative or judicial proceeding resulting from the report. SEC. 3. Section 4105 of the Business and Professions Code is amended to read: 4105. (a) All records or other documentation of the acquisition and disposition of dangerous drugs and dangerous devices by any entity licensed by the board shall be retained on the licensed premises in a readily retrievable form. (b) The licensee may remove the original records or documentation from the licensed premises on a temporary basis for license-related purposes. However, a duplicate set of those records or other documentation shall be retained on the licensed premises. (c) The records required by this section shall be retained on the licensed premises for a period of three years from the date of making. (d) Any records that are maintained electronically shall be maintained so that the pharmacist-in-charge, the pharmacist on duty if the pharmacist-in-charge is not on duty, or, in the case of a veterinary food-animal drug retailer or wholesaler, the designated representative on duty, shall, at all times during which the licensed premises are open for business, be able to produce a hard copy and electronic copy of all records of acquisition or disposition or other drug or dispensing-related records maintained electronically. (e) (1) Notwithstanding subdivisions (a), (b), and (c), the board, may upon written request, grant to a licensee a waiver of the requirements that the records described in subdivisions (a), (b), and (c) be kept on the licensed premises. (2) A waiver granted pursuant to this subdivision shall not affect the board's authority under this section or any other provision of this chapter. (f) When requested by an authorized officer of the law or by an authorized representative of the board, the owner, corporate officer, or manager of an entity licensed by the board shall provide the board with the requested records within three business days of the time the request was made. The entity may request in writing an extension of this timeframe for a period not to exceed 14 calendar days from the date the records were requested. A request for an extension of time is subject to the approval of the board. An extension shall be deemed approved if the board fails to deny the extension request within two business days of the time the extension request was made directly to the board. SEC. 4. 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. (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. 5.   Section 4126.7 is added to the Business and Professions Code, to read: 4126.7. (a) A reverse distributor shall not accept the return of dangerous drugs that have been dispensed to a patient and returned to the pharmacy unless the dangerous drugs were dispensed in a sealed or tamper-evident package and there is no evidence that the package was opened, damaged, or otherwise tampered with prior to its return to the pharmacy. Records of these returned dangerous drugs shall be kept by the pharmacy. (b) For purposes of this section, "dispensed" means that the dangerous drugs have been provided to the patient or patient's agent and taken from a pharmacy.   SEC. 6.   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.