BILL NUMBER: AB 2986 CHAPTERED 09/14/06 CHAPTER 286 FILED WITH SECRETARY OF STATE SEPTEMBER 14, 2006 APPROVED BY GOVERNOR SEPTEMBER 14, 2006 PASSED THE ASSEMBLY AUGUST 22, 2006 PASSED THE SENATE AUGUST 21, 2006 AMENDED IN SENATE JUNE 22, 2006 AMENDED IN SENATE JUNE 20, 2006 AMENDED IN ASSEMBLY MAY 26, 2006 AMENDED IN ASSEMBLY APRIL 5, 2006 INTRODUCED BY Assembly Member Mullin FEBRUARY 24, 2006 An act to amend Sections 11162.1, 11164, 11165, 11165.1, and 11190 of the Health and Safety Code, relating to controlled substances. LEGISLATIVE COUNSEL'S DIGEST AB 2986, Mullin Controlled substances: prescription requirements. (1) Existing law provides that no person shall prescribe a controlled substance, nor shall any person fill, compound, or dispense such a prescription unless the prescription complies with specified requirements; the prescription must be printed with specified features and must set forth specified information. Unless otherwise specified, a violation of any of these provisions is a misdemeanor, punishable as specified. This bill would require the prescription forms to also include the name of the ultimate user or research subject, or the contact information as determined by the U.S. Secretary of Health and Human Services; check boxes so that the prescriber may indicate the number of refills ordered. (2) Existing law provides for the electronic monitoring and reporting of the prescribing and dispensing of Schedule II and Schedule III controlled substances pursuant to the Controlled Substance Utilization Review and Evaluation System (CURES) program. This bill would provide that the CURES program shall also monitor and report on the prescribing and dispensing of Schedule IV controlled substances. (3) Existing law provides that every practitioner, other than a pharmacist, who prescribes or administers a Schedule II controlled substance shall make a record of the transaction and shall provide the Department of Justice with information relating to the transaction on a monthly basis, as specified. This bill would provide that every practitioner other than a pharmacist, who prescribes or administers a Schedule II, Schedule III, or Schedule IV controlled substance shall make a record of the transaction and would require the information to be provided to the Department of Justice, as specified. (4) The bill would make conforming changes to related provisions. By revising existing crimes, this bill would impose a state-mandated local program. 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. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 11162.1 of the Health and Safety Code is amended to read: 11162.1. (a) The prescription forms for controlled substances shall be printed with the following features: (1) A latent, repetitive "void" pattern shall be printed across the entire front of the prescription blank; if a prescription is scanned or photocopied, the word "void" shall appear in a pattern across the entire front of the prescription. (2) A watermark shall be printed on the backside of the prescription blank; the watermark shall consist of the words "California Security Prescription." (3) A chemical void protection that prevents alteration by chemical washing. (4) A feature printed in thermo-chromic ink. (5) An area of opaque writing so that the writing disappears if the prescription is lightened. (6) A description of the security features included on each prescription form. (7) (A) Six quantity check off boxes shall be printed on the form and the following quantities shall appear: 1-24 25-49 50-74 75-100 101-150 151 and over. (B) In conjunction with the quantity boxes, a space shall be provided to designate the units referenced in the quantity boxes when the drug is not in tablet or capsule form. (8) Prescription blanks shall contain a statement printed on the bottom of the prescription blank that the "Prescription is void if the number of drugs prescribed is not noted." (9) The preprinted name, category of licensure, license number, federal controlled substance registration number of the prescribing practitioner. (10) Check boxes shall be printed on the form so that the prescriber may indicate the number of refills ordered. (11) The date of origin of the prescription. (12) A check box indicating the prescriber's order not to substitute. (13) An identifying number assigned to the approved security printer by the Department of Justice. (14) (A) A check box by the name of each prescriber when a prescription form lists multiple prescribers. (B) Each prescriber who signs the prescription form shall identify himself or herself as the prescriber by checking the box by their name. (b) Each batch of controlled substance prescription forms shall have the lot number printed on the form and each form within that batch shall be numbered sequentially beginning with the numeral one. (c) (1) A prescriber designated by a licensed health care facility, a clinic specified in Section 1200, or a clinic specified in subdivision (a) of Section 1206 that has 25 or more physicians or surgeons may order controlled substance prescription forms for use by prescribers when treating patients in that facility without the information required in paragraph (9) of subdivision (a) or paragraph (3) of this subdivision. (2) Forms ordered pursuant to this subdivision shall have the name, category of licensure, license number, and federal controlled substance registration number of the designated prescriber and the name, address, category of licensure, and license number of the licensed health care facility the clinic specified in Section 1200, or the clinic specified in subdivision (a) of Section 1206 that has 25 or more physicians or surgeons preprinted on the form. (3) Forms ordered pursuant to this section shall not be valid prescriptions without the name, category of licensure, license number, and federal controlled substance registration number of the prescriber on the form. (4) (A) Except as provided in subparagraph (B), the designated prescriber shall maintain a record of the prescribers to whom the controlled substance prescription forms are issued, that shall include the name, category of licensure, license number, federal controlled substance registration number, and the quantity of controlled substance prescription forms issued to each prescriber and be maintained in the health facility for three years. (B) Forms ordered pursuant to this subdivision that are printed by a computerized prescription generation system shall not be subject to the requirements set forth in subparagraph (A) or paragraph (7) of subdivision (a). Forms printed pursuant to this subdivision that are printed by a computerized prescription generation system may contain the prescriber's name, category of professional licensure, license number, federal controlled substance registration number, and the date of the prescription. (d) This section shall become operative on July 1, 2004. SEC. 2. Section 11164 of the Health and Safety Code is amended to read: 11164. Except as provided in Section 11167, no person shall prescribe a controlled substance, nor shall any person fill, compound, or dispense a prescription for a controlled substance, unless it complies with the requirements of this section. (a) Each prescription for a controlled substance classified in Schedule II, III, IV, or V, except as authorized by subdivision (b), shall be made on a controlled substance prescription form as specified in Section 11162.1 and shall meet the following requirements: (1) The prescription shall be signed and dated by the prescriber in ink and shall contain the prescriber's address and telephone number; the name of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services; refill information, such as the number of refills ordered and whether the prescription is a first-time request or a refill; and the name, quantity, strength, and directions for use of the controlled substance prescribed. (2) The prescription shall also contain the address of the person for whom the controlled substance is prescribed. If the prescriber does not specify this address on the prescription, the pharmacist filling the prescription or an employee acting under the direction of the pharmacist shall write or type the address on the prescription or maintain this information in a readily retrievable form in the pharmacy. (b) (1) Notwithstanding paragraph (1) of subdivision (a) of Section 11162.1, any controlled substance classified in Schedule III, IV, or V may be dispensed upon an oral or electronically transmitted prescription, which shall be produced in hard copy form and signed and dated by the pharmacist filling the prescription or by any other person expressly authorized by provisions of the Business and Professions Code. Any person who transmits, maintains, or receives any electronically transmitted prescription shall ensure the security, integrity, authority, and confidentiality of the prescription. (2) The date of issue of the prescription and all the information required for a written prescription by subdivision (a) shall be included in the written record of the prescription; the pharmacist need not include the address, telephone number, license classification, or federal registry number of the prescriber or the address of the patient on the hard copy, if that information is readily retrievable in the pharmacy. (3) Pursuant to an authorization of the prescriber, any agent of the prescriber on behalf of the prescriber may orally or electronically transmit a prescription for a controlled substance classified in Schedule III, IV, or V, if in these cases the written record of the prescription required by this subdivision specifies the name of the agent of the prescriber transmitting the prescription. (c) The use of commonly used abbreviations shall not invalidate an otherwise valid prescription. (d) Notwithstanding any provision of subdivisions (a) and (b), prescriptions for a controlled substance classified in Schedule V may be for more than one person in the same family with the same medical need. (e) This section shall become operative on January 1, 2005. SEC. 3. Section 11165 of the Health and Safety Code is amended to read: 11165. (a) To assist law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, and Schedule IV controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds from the Contingent Fund of the Medical Board of California, the Pharmacy Board Contingent Fund, the State Dentistry Fund, the Board of Registered Nursing Fund, and the Osteopathic Medical Board of California Contingent Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. (b) The reporting of Schedule III and Schedule IV controlled substance prescriptions to CURES shall be contingent upon the availability of adequate funds from the Department of Justice. The Department of Justice may seek and use grant funds to pay the costs incurred from the reporting of controlled substance prescriptions to CURES. Funds shall not be appropriated from the Contingent Fund of the Medical Board of California, the Pharmacy Board Contingent Fund, the State Dentistry Fund, the Board of Registered Nursing Fund, the Naturopathic Doctor's Fund, or the Osteopathic Medical Board of California Contingent Fund to pay the costs of reporting Schedule III and Schedule IV controlled substance prescriptions to CURES. (c) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal persons or public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the Department of Justice, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the Department of Justice, for educational, peer review, statistical, or research purposes, provided that patient information, including any information that may identify the patient, is not compromised. Further, data disclosed to any individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to any third party. (d) For each prescription for a Schedule II, Schedule III, or Schedule IV controlled substance, the dispensing pharmacy shall provide the following information to the Department of Justice on a weekly basis and in a format specified by the Department of Justice: (1) Full name, address, and the telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender, and date of birth of the ultimate user. (2) The prescriber's category of licensure and license number; federal controlled substance registration number; and the state medical license number of any prescriber using the federal controlled substance registration number of a government-exempt facility. (3) Pharmacy prescription number, license number, and federal controlled substance registration number. (4) NDC (National Drug Code) number of the controlled substance dispensed. (5) Quantity of the controlled substance dispensed. (6) ICD-9 (diagnosis code), if available. (7) Number of refills ordered. (8) Whether the drug was dispensed as a refill of a prescription or as a first-time request. (9) Date of origin of the prescription. (10) Date of dispensing of the prescription. (e) This section shall become operative on January 1, 2005. SEC. 4. Section 11165.1 of the Health and Safety Code is amended to read: 11165.1. (a) (1) A licensed health care practitioner eligible to prescribe Schedule II, Schedule III, or Schedule IV controlled substances or a pharmacist may make a written request for, and the Department of Justice may release to that practitioner or pharmacist, the history of controlled substances dispensed to an individual under his or her care based on data contained in CURES. (2) Any request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the Department of Justice. (b) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, or Schedule IV controlled substances, the Department of Justice may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual. (c) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the Department of Justice pursuant to this section shall be considered medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code. SEC. 5. Section 11190 of the Health and Safety Code is amended to read: 11190. (a) Every practitioner, other than a pharmacist, who prescribes or administers a controlled substance classified in Schedule II shall make a record that, as to the transaction, shows all of the following: (1) The name and address of the patient. (2) The date. (3) The character, including the name and strength, and quantity of controlled substances involved. (b) The prescriber's record shall show the pathology and purpose for which the controlled substance was administered or prescribed. (c) (1) For each prescription for a Schedule II, Schedule III, or Schedule IV controlled substance that is dispensed by a prescriber pursuant to Section 4170 of the Business and Professions Code, the prescriber shall record and maintain the following information: (A) Full name, address, and the telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender, and date of birth of the patient. (B) The prescriber's category of licensure and license number; federal controlled substance registration number; and the state medical license number of any prescriber using the federal controlled substance registration number of a government-exempt facility. (C) NDC (National Drug Code) number of the controlled substance dispensed. (D) Quantity of the controlled substance dispensed. (E) ICD-9 (diagnosis code), if available. (F) Number of refills ordered. (G) Whether the drug was dispensed as a refill of a prescription or as a first-time request. (H) Date of origin of the prescription. (2) (A) Each prescriber that dispenses controlled substances shall provide the Department of Justice the information required by this subdivision on a weekly basis in a format set by the Department of Justice pursuant to regulation. (B) The reporting requirement in this section shall not apply to the direct administration of a controlled substance to the body of an ultimate user. (d) This section shall become operative on January 1, 2005. (e) The reporting requirement in this section for Schedule IV controlled substances shall not apply to any of the following: (1) The dispensing of a controlled substance in a quantity limited to an amount adequate to treat the ultimate user involved for 48 hours or less. (2) The administration or dispensing of a controlled substance in accordance with any other exclusion identified by the United States Health and Human Service Secretary for the National All Schedules Prescription Electronic Reporting Act of 2005. (f) Notwithstanding paragraph (2) of subdivision (c), the reporting requirement of the information required by this section for a Schedule II or Schedule III controlled substance, in a format set by the Department of Justice pursuant to regulation, shall be on a monthly basis for all of the following: (1) The dispensing of a controlled substance in a quantity limited to an amount adequate to treat the ultimate user involved for 48 hours or less. (2) The administration or dispensing of a controlled substance in accordance with any other exclusion identified by the United States Health and Human Service Secretary for the National All Schedules Prescription Electronic Reporting Act of 2005. SEC. 6. 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.