BILL NUMBER: AB 1545 CHAPTERED 10/10/99 CHAPTER 914 FILED WITH SECRETARY OF STATE OCTOBER 10, 1999 APPROVED BY GOVERNOR OCTOBER 9, 1999 PASSED THE ASSEMBLY SEPTEMBER 9, 1999 PASSED THE SENATE SEPTEMBER 8, 1999 AMENDED IN SENATE SEPTEMBER 3, 1999 AMENDED IN SENATE AUGUST 16, 1999 AMENDED IN SENATE JULY 6, 1999 AMENDED IN ASSEMBLY MAY 17, 1999 AMENDED IN ASSEMBLY APRIL 15, 1999 INTRODUCED BY Assembly Member Correa (Coauthor: Assembly Member Honda) FEBRUARY 26, 1999 An act to amend Sections 2725.1, 4061, 4076, 4170, and 4175 of the Business and Professions Code, relating to health practitioners. LEGISLATIVE COUNSEL'S DIGEST AB 1545, Correa. Health practitioners. Under existing law, a nurse practitioner may not sign for delivery of a complimentary sample of a dangerous drug or dangerous device; may not direct a pharmacist to dispense a trade name or generic drug; use a dispensing device; or hand drugs or dangerous devices to patients in his or her office or place of practice, as specified. This bill would authorize a nurse practitioner or, in some instances, a physician assistant, to perform the above services, and would make corresponding changes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 2725.1 of the Business and Professions Code is amended to read: 2725.1. Notwithstanding any other provision of law, a registered nurse may dispense drugs or devices upon an order by a licensed physician and surgeon when the nurse is functioning within a licensed clinic as defined in paragraphs (1) and (2) of subdivision (a) of Section 1204 of, or within a clinic as defined in subdivision (b) or (c) of Section 1206, of the Health and Safety Code. No clinic shall employ a registered nurse to perform dispensing duties exclusively. No registered nurse shall dispense drugs in a pharmacy, keep a pharmacy, open shop, or drugstore for the retailing of drugs or poisons. No registered nurse shall compound drugs. Dispensing of drugs by a registered nurse, except a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, shall not include substances included in the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code). Nothing in this section shall exempt a clinic from the provisions of Article 3.5 (commencing with Section 4063) of Chapter 9. SEC. 2. Section 4061 of the Business and Professions Code is amended to read: 4061. No manufacturer's sales representative shall distribute any dangerous drug or dangerous device as a complimentary sample without the written request of a physician, dentist, podiatrist, or veterinarian. However, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, or physician assistant who functions pursuant to Section 3502.1 may sign for the delivery or receipt of complimentary samples of a dangerous drug or dangerous device that has been requested in writing by his or her supervising physician. Each written request shall contain the names and addresses of the supplier and the requester, the name and quantity of the specific dangerous drug desired, the name of the nurse practitioner or physician assistant, if applicable, receiving the samples pursuant to this section, the date of receipt, and the name and quantity of the dangerous drugs or dangerous devices provided. These records shall be preserved by the supplier with the records required by Section 4059. SEC. 3. Section 4076 of the Business and Professions Code is amended to read: 4076. (a) A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following: (1) Except where the prescriber or nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, or physician assistant who functions pursuant to Section 3502.1 orders otherwise, either the manufacturer's trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturer's trade name or the commonly used name or the principal active ingredients. (2) The directions for the use of the drug. (3) The name of the patient or patients. (4) The name of the prescriber and, if applicable, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, or physician assistant who functions pursuant to Section 3502.1. (5) The date of issue. (6) The name and address of the pharmacy, and prescription number or other means of identifying the prescription. (7) The strength of the drug or drugs dispensed. (8) The quantity of the drug or drugs dispensed. (9) The expiration date of the effectiveness of the drug dispensed. (10) The condition for which the drug was prescribed if requested by the patient and the condition is indicated on the prescription. (b) If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration. (c) If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, or physician assistant who functions pursuant to Section 3502.1. SEC. 4. Section 4170 of the Business and Professions Code is amended to read: 4170. (a) No prescriber shall dispense drugs or dangerous devices to patients in his or her office or place of practice unless all of the following conditions are met: (1) The dangerous drugs or dangerous devices are dispensed to the prescriber's own patient and the drugs or dangerous devices are not furnished by a nurse or physician attendant. (2) The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient. (3) The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons. (4) The prescriber fulfills all of the labeling requirements imposed upon pharmacists by Section 4076, all of the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers. (5) The prescriber does not use a dispensing device unless he or she personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded in accordance with paragraph (4). (6) The prescriber, prior to dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy. (7) The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patient's choice. (8) A nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, or a physician assistant who functions pursuant to Section 3502.1, may hand to a patient of the supervising physician and surgeon a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist. (b) The Medical Board of California, the State Board of Optometry, the Board of Dental Examiners of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, and the Physician Assistant Committee shall have authority with the California State Board of Pharmacy to ensure compliance with this section, and those boards are specifically charged with the enforcement of this chapter with respect to their respective licensees. (c) "Prescriber," as used in this section, means a person, who holds a physician's and surgeon's certificate, a license to practice optometry, a license to practice dentistry, or a certificate to practice podiatry, and who is duly registered as such by the Medical Board of California, the State Board of Optometry, the Board of Dental Examiners of California, or the Board of Osteopathic Examiners of this state. SEC. 5. Section 4175 of the Business and Professions Code is amended to read: 4175. (a) The California State Board of Pharmacy shall promptly forward to the appropriate licensing entity, including the Medical Board of California, the Board of Dental Examiners of California, the State Board of Optometry, the Osteopathic Medical Board of California, the Board of Registered Nursing, or the Physician Assistant Committee, all complaints received related to dangerous drugs or dangerous devices dispensed by a prescriber, nurse practitioner, or physician assistant pursuant to Section 4170. (b) All complaints involving serious bodily injury due to dangerous drugs or dangerous devices dispensed by prescribers, nurse practitioners, or physician assistants pursuant to Section 4170 shall be handled by the Medical Board of California, the Board of Dental Examiners of California, the State Board of Optometry, the Osteopathic Medical Board of California, the Board of Registered Nursing, or the Physician Assistant Committee as a case of greatest potential harm to a patient.