California Code of Regulations
Title 22 - Social Security
Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies
Chapter 1 - General Acute Care Hospitals
Article 3 - Basic Services
Section 70263 - Pharmaceutical Service General Requirements
Current through Register 2024 Notice Reg. No. 38, September 20, 2024
(a) All hospitals having a licensed bed capacity of 100 or more beds shall have a pharmacy on the premises licensed by the California Board of Pharmacy. Those hospitals having fewer than 100 licensed beds shall have a pharmacy license issued by the Board of Pharmacy pursuant to Section 4029 or 4056 of the Business and Professions Code.
(b) The responsibility and the accountability of the pharmaceutical service to the medical staff and administration shall be defined.
(c) A pharmacy and therapeutics committee, or a committee of equivalent composition, shall be established. The committee shall consist of at least one physician, one pharmacist, the director of nursing service or his or her representative and the administrator or his or her representative.
(d) There shall be a system maintained whereby no person other than a pharmacist or an individual under the direct supervision of a pharmacist shall dispense medications for use beyond the immediate needs of the patients.
(e) There shall be a system assuring the availability of prescribed medications 24 hours a day.
(f) Supplies of drugs for use in medical emergencies only shall be immediately available at each nursing unit or service area as required.
(g) No drugs shall be administered except by licensed personnel authorized to administer drugs and upon the order of a person lawfully authorized to prescribe or furnish. This shall not preclude the administration of aerosol drugs by respiratory care practitioners. The order shall include the name of the drug, the dosage and the frequency of administration, the route of administration, if other than oral, and the date, time and signature of the prescriber or furnisher. Orders for drugs should be written or transmitted by the prescriber or furnisher. Verbal orders for drugs shall be given only by a person lawfully authorized to prescribe or furnish and shall be recorded promptly in the patient's medical record, noting the name of the person giving the verbal order and the signature of the individual receiving the order. The prescriber or furnisher shall countersign the order within 48 hours.
(h) Standing orders for drugs may be used for specified patents when authorized by a person licensed to prescribe. A copy of standing orders for a specific patient shall be dated, promptly signed by the prescriber and included in the patient's medical record. These standing orders shall:
(i) An individual prescriber may notify the hospital in writing of his or her own standing orders, the use of which is subject to prior approval and periodic review by the pharmacy and therapeutics committee or its equivalent.
(j) The hospital shall develop policies limiting the duration of drug therapy in the absence of the prescriber's specific indication of duration of drug therapy or under other circumstances recommended by the pharmacy and therapeutics committee or its equivalent and approved by the executive committee of the medical staff. The limitations shall be established for classes of drugs and/or individual drug entities.
(k) If drugs are supplied through a pharmacy, orders for drugs shall be transmitted to the pharmacy either by written prescription of the prescriber, by an order form which produces a direct copy of the order or by an electronically reproduced facsimile. When drugs are not supplied through a pharmacy, such information shall be made available to the hospital pharmacist.
(l) Medications shall not be left at the patient's bedside unless the prescriber so orders. Such bedside medications shall be kept in a cabinet, drawer or in possession of the patient. Drugs shall not be left at the bedside which are listed in Schedules II, III and IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 as amended. If the hospital permits bedside storage of medications, written policies and procedures shall be established for the dispensing, storage and records of use, of such medications.
(m) Medications brought by or with the patient to the hospital shall not be administered to the patient unless all of the following conditions are met:
(n) The hospital shall establish a supply of medications which is accessible without entering either the pharmacy or drug storage room during hours when the pharmacist is not available. Access to the supply shall be limited to designated registered nurses. Records of drugs taken from the supply shall be maintained and the pharmacist shall be notified of such use. The records shall include the name and strength of the drug, the amount taken, the date and time, the name of the patient to whom the drug was administered and the signature of the registered nurse. The pharmacist shall be responsible for maintenance of the supply and assuring that all drugs are properly labeled and stored. The drug supply shall contain that type and quantity of drugs necessary to meet the immediate needs of patients as determined by the pharmacy and therapeutics committee.
(o) Investigational drug use shall be in accordance with applicable state and federal laws and regulations and policies adopted by the hospital. Such drugs shall be used only under the direct supervision of the principal investigator, who shall be a member of the medical staff and be responsible for assuring that informed consent is secured from the patient. Basic information concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of investigational drugs shall be available at the nursing station where such drugs are being administered and in the pharmacy. The pharmacist shall be responsible for the proper labeling, storage and distribution of such drugs pursuant to the written order of the investigator.
(p) No drugs supplied by the hospital shall be taken from the hospital unless a prescription or medical record order has been written for the medication and the medication has been properly labeled and prepared by the pharmacist in accordance with state and federal laws, for use outside of the hospital.
(q) Labeling and storage of drugs shall be accomplished to meet the following requirements:
(r) The pharmacist shall develop and implement written quality control procedures for all drugs which are prepackaged or compounded in the hospital including intravenous solution additives. He or she shall develop and conduct an in-service training program for the professional staff to assure compliance therewith.
(s) The pharmacist shall be consulted on proper methods for repackaging and labeling of bulk cleaning agents, solvents, chemicals and poisons used throughout the hospital.
(t) Periodically, the pharmacy and therapeutics committee, or its equivalent, shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.
1. Amendment of subsection (m) filed 3-13-80; effective thirtieth day thereafter (Register 80, No. 11).
2. Amendment of subsection (g), new subsections (g)(1) and (g)(2), and amendment of NOTE filed 11-26-96; operative 12-26-96 (Register 96, No. 48).
3. Change without regulatory effect amending subsection (a) and NOTE filed 6-16-2000 pursuant to section 100, title 1, California Code of Regulations (Register 2000, No. 24).
4. Change without regulatory effect amending subsections (c), (g), (i), (q)(8) and (r) and amending NOTE filed 3-12-2013 pursuant to section 100, title 1, California Code of Regulations (Register 2013, No. 11).
Note: Authority cited: Sections 1275 and 131200, Health and Safety Code. Reference: Sections 1276, 131050, 131051 and 131052, Health and Safety Code.