BILL NUMBER: AB 30 CHAPTERED 09/18/04 CHAPTER 573 FILED WITH SECRETARY OF STATE SEPTEMBER 18, 2004 APPROVED BY GOVERNOR SEPTEMBER 18, 2004 PASSED THE ASSEMBLY AUGUST 24, 2004 PASSED THE SENATE AUGUST 18, 2004 AMENDED IN SENATE AUGUST 17, 2004 AMENDED IN SENATE JULY 8, 2003 AMENDED IN ASSEMBLY APRIL 24, 2003 INTRODUCED BY Assembly Member Richman (Principal coauthor: Senator Burton) DECEMBER 2, 2002 An act to amend Sections 11161, 11162.1, and 11190 of the Health and Safety Code, relating to controlled substances, and declaring the urgency thereof, to take effect immediately. LEGISLATIVE COUNSEL'S DIGEST AB 30, Richman. Controlled substances: Schedule II. (1) Existing law provides that no person shall prescribe a controlled substance, nor shall any person fill, compound, or dispense such a prescription unless it complies with specified requirements, one of which is to issue prescriptions for Schedule II controlled substances on either triplicate prescription blanks issued by the Department of Justice or prescription forms for controlled substance prescriptions obtained from security printers approved by the Board of Pharmacy. Existing law provides that the provision requiring the Department of Justice to issue triplicate prescription blanks to practitioners shall remain operative until July 1, 2004, and shall be repealed on January 1, 2005. This bill would provide that the provision requiring the Department of Justice to issue triplicate prescription blanks to practitioners shall instead remain operative until November 1, 2004. (2) Existing law provides that a prescriber designated by a licensed health care facility who orders controlled substance prescription forms for use by prescribers when treating patients in that facility shall maintain in that facility for 3 years a record containing specified information of the prescribers to whom controlled substance prescription forms are issued. This bill would provide that forms printed by a computerized prescription generation system shall not be subject to these recordkeeping provisions and may, but are not required to, contain specified information. (3) Existing law provides that for each prescription for a Schedule II controlled substance that is dispensed by a practitioner in his or her office or place of practice, the prescriber shall record and maintain specified information, including the pharmacy prescription number, license number, and federal controlled substance registration number. This bill would no longer require the practitioner who dispenses a Schedule II controlled substance in his or her office or place of practice to record and maintain the pharmacy prescription number, license number, and federal controlled substance registration number. (4) The bill would declare that it is to take effect immediately as an urgency statute. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 11161 of the Health and Safety Code, as amended by Section 4 of Chapter 406 of the Statutes of 2003, is amended to read: 11161. (a) Prescription blanks shall be issued by the Department of Justice in serially numbered groups of not more than 100 forms each in triplicate unless a practitioner orally, electronically, or in writing requests a larger amount, and shall be furnished to any practitioner authorized to write a prescription for controlled substances classified in Schedule II. The Department of Justice may charge a fee for the prescription blanks sufficient to reimburse the department for the actual costs associated with the preparation, processing, and filing of any forms issued pursuant to this section. The prescription blanks shall not be transferable. Any person possessing a triplicate prescription blank otherwise than as provided in this section is guilty of a misdemeanor. (b) When a practitioner is named in a warrant of arrest or is charged in an accusatory pleading with a felony violation of Section 11153, 11154, 11156, 11157, 11170, 11173, 11350, 11351, 11352, 11353, 11353.5, 11377, 11378, 11378.5, 11379, 11379.5, or 11379.6, the court in which the accusatory pleading is filed or the magistrate who issued the warrant of arrest shall, upon the motion of a law enforcement agency which is supported by reasonable cause, issue an order which requires the practitioner to surrender to the clerk of the court all triplicate prescription blanks in the practitioner's possession at a time set in the order and shall direct the Department of Justice to withhold prescription blanks from the practitioner. The law enforcement agency obtaining the order shall notify the Department of Justice of this order. Except as provided in subdivisions (c) and (f) of this section, the order shall remain in effect until further order of the court. Any practitioner possessing prescription blanks in violation of the order is guilty of a misdemeanor. (c) The order provided by subdivision (b) shall be vacated if the court or magistrate finds that the underlying violation or violations are not supported by reasonable cause at a hearing held within two court days after the practitioner files and personally serves upon the prosecuting attorney and the law enforcement agency that obtained the order, a notice of motion to vacate the order with any affidavits on which the practitioner relies. At the hearing, the burden of proof, by a preponderance of the evidence, is on the prosecution. Evidence presented at the hearing shall be limited to the warrant of arrest with supporting affidavits, the motion to require the defendant to surrender all triplicate prescription blanks with supporting affidavits, the sworn complaint together with any documents or reports incorporated by reference thereto which, if based on information and belief, state the basis for the information, or any other documents of similar reliability as well as affidavits and counter affidavits submitted by the prosecution and defense. Granting of the motion to vacate the order is no bar to prosecution of the alleged violation or violations. (d) The defendant may elect to challenge the order issued under subdivision (b) at the preliminary examination. At that hearing, the evidence shall be limited to that set forth in subdivision (c) and any other evidence otherwise admissible at the preliminary examination. (e) If the practitioner has not moved to vacate the order issued under subdivision (b) by the time of the preliminary examination and he or she is held to answer on the underlying violation or violations, the practitioner shall be precluded from afterwards moving to vacate the order. If the defendant is not held to answer on the underlying charge or charges at the conclusion of the preliminary examination, the order issued under subdivision (b) shall be vacated. (f) Notwithstanding subdivision (e), any practitioner who is diverted pursuant to Chapter 2.5 (commencing with Section 1000) of Title 7 of Part 2 of the Penal Code may file a motion to vacate the order issued under subdivision (b). (g) This section shall become inoperative on November 1, 2004, and, as of January 1, 2005, is repealed. SEC. 2. Section 11161 of the Health and Safety Code, as added by Section 5 of Chapter 406 of the Statutes of 2003, is amended to read: 11161. (a) When a practitioner is named in a warrant of arrest or is charged in an accusatory pleading with a felony violation of Section 11153, 11154, 11156, 11157, 11170, 11173, 11350, 11351, 11352, 11353, 11353.5, 11377, 11378, 11378.5, 11379, 11379.5, or 11379.6, the court in which the accusatory pleading is filed or the magistrate who issued the warrant of arrest shall, upon the motion of a law enforcement agency which is supported by reasonable cause, issue an order which requires the practitioner to surrender to the clerk of the court all triplicate prescription blanks or controlled substance prescription forms in the practitioner's possession at a time set in the order. Except as provided in subdivisions (b) and (e) of this section, the order shall remain in effect until further order of the court. Any practitioner possessing prescription blanks in violation of the order is guilty of a misdemeanor. (b) The order provided by subdivision (a) shall be vacated if the court or magistrate finds that the underlying violation or violations are not supported by reasonable cause at a hearing held within two court days after the practitioner files and personally serves upon the prosecuting attorney and the law enforcement agency that obtained the order, a notice of motion to vacate the order with any affidavits on which the practitioner relies. At the hearing, the burden of proof, by a preponderance of the evidence, is on the prosecution. Evidence presented at the hearing shall be limited to the warrant of arrest with supporting affidavits, the motion to require the defendant to surrender all triplicate prescription blanks or controlled substance prescription forms with supporting affidavits, the sworn complaint together with any documents or reports incorporated by reference thereto which, if based on information and belief, state the basis for the information, or any other documents of similar reliability as well as affidavits and counter affidavits submitted by the prosecution and defense. Granting of the motion to vacate the order is no bar to prosecution of the alleged violation or violations. (c) The defendant may elect to challenge the order issued under subdivision (a) at the preliminary examination. At that hearing, the evidence shall be limited to that set forth in subdivision (b) and any other evidence otherwise admissible at the preliminary examination. (d) If the practitioner has not moved to vacate the order issued under subdivision (a) by the time of the preliminary examination and he or she is held to answer on the underlying violation or violations, the practitioner shall be precluded from afterwards moving to vacate the order. If the defendant is not held to answer on the underlying charge or charges at the conclusion of the preliminary examination, the order issued under subdivision (a) shall be vacated. (e) Notwithstanding subdivision (d), any practitioner who is diverted pursuant to Chapter 2.5 (commencing with Section 1000) of Title 7 of Part 2 of the Penal Code may file a motion to vacate the order issued under subdivision (a). (f) This section shall become operative on November 1, 2004. SEC. 3. 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 checkoff 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 either (A) contain a statement printed on the bottom of the prescription blank that the "Prescription is void if more than one controlled substance prescription is written per blank" or (B) contain a space for the prescriber to specify the number of drugs prescribed on the prescription and 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, and federal controlled substance registration number of the prescribing practitioner. (10) A check box indicating the prescriber's order not to substitute. (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 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). (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 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 controlled substance prescription forms are issued, which record 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 shall 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. 4. Section 11190 of the Health and Safety Code, as added by Section 28 of Chapter 406 of the Statutes of 2003, 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 is administered or prescribed. (c) (1) For each prescription for a Schedule II 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, 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) Date of dispensing of the prescription. (2) Each prescriber that dispenses controlled substances shall provide the Department of Justice the information required by this subdivision on a monthly basis in either hardcopy or electronic form. (d) This section shall become operative on July 1, 2004, and shall remain in effect only until January 1, 2005, and as of that date is repealed. SEC. 5. Section 11190 of the Health and Safety Code, as added by Section 29 of Chapter 406 of the Statutes of 2003, 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 or Schedule III 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, 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) Date of dispensing of the prescription. (2) Each prescriber that dispenses controlled substances shall provide the Department of Justice the information required by this subdivision on a monthly basis in either hardcopy or electronic form. (d) This section shall become operative on January 1, 2005. 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: In order to effectuate the smooth transition by prescribers of Schedule II controlled substances from the use of triplicate prescription forms to the use of controlled substance prescription forms issued by security printers, and to make related changes, it is necessary for this act to take effect immediately.