ARTICLE 7. Pharmacies [4110 - 4126.10]
( Article 7 added by Stats. 1996, Ch. 890, Sec. 3. )
(a) No person shall conduct a pharmacy in the State of California unless they have obtained a license from the board. A license shall be required for each pharmacy owned or operated by a specific person. A separate license shall be required for each of the premises of any person operating a pharmacy in more than one location. The license shall be renewed annually. The license shall not be renewed unless the applicant includes necessary matters identified by the board in the renewal application, including, but not limited to, notification to the board regarding compounding practices, including compounded human drug preparations distributed outside of the state. The board may, by regulation, determine the circumstances under which a license may be transferred.
(b) The
board may, at its discretion, issue a temporary permit upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary permit fee shall be required in an amount established by the board as specified in subdivision (a) of Section 4400. When needed to protect public safety, a temporary permit may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary permit was issued by mistake or denies the application for a permanent license or registration, the temporary license or registration shall terminate upon either personal service of the notice of termination upon the permitholder or service by certified mail, return receipt requested, at the permitholder’s address of record with the board, whichever comes first. Neither for purposes of retaining a temporary permit nor for purposes of any disciplinary or license denial proceeding before the board shall the
temporary permitholder be deemed to have a vested property right or interest in the permit.
(c) The board may allow the temporary use of a mobile pharmacy when a pharmacy is destroyed or damaged, the mobile pharmacy is necessary to protect the health and safety of the public, and the following conditions are met:
(1) The mobile pharmacy shall provide services only on or immediately contiguous to the site of the damaged or destroyed pharmacy.
(2) The mobile pharmacy is under the control and management of the pharmacist-in-charge of the pharmacy that was destroyed or damaged.
(3) A licensed pharmacist is on the premises while drugs are being dispensed.
(4) Reasonable security measures are
taken to safeguard the drug supply maintained in the mobile pharmacy.
(5) The pharmacy operating the mobile pharmacy provides the board with records of the destruction of, or damage to, the pharmacy and an expected restoration date.
(6) Within three calendar days of restoration of the pharmacy services, the board is provided with notice of the restoration of the permanent pharmacy.
(7) The mobile pharmacy is not operated for more than 48 hours following the restoration of the permanent pharmacy.
(Amended by Stats. 2021, Ch. 629, Sec. 16. (AB 1533) Effective January 1, 2022.)
Notwithstanding any other provision of this article, a county, city and county, or special hospital authority described in Chapter 5 (commencing with Section 101850) or Chapter 5.5 (commencing with Section 101852) of Part 4 of Division 101 of the Health and Safety Code may operate one or more mobile units to provide prescription medication within its jurisdiction to those individuals without fixed addresses, individuals living in county-owned or city-and-county-owned or operated housing facilities, and those enrolled in Medi-Cal plans operated by the county or a city and county, a health district, or a joint powers authority pursuant to Chapter 7 (commencing with Section 14000) or Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code. The mobile unit shall be operated as an extension of a pharmacy
license held by the county, city and county, or special hospital authority. The pharmacist-in-charge shall determine the number of mobile units that are appropriate for a particular pharmacy license. The mobile unit may dispense prescription medication pursuant to a valid prescription, including a prescription of a physician who practices in the mobile unit, if the county, city and county, or special hospital authority meets all of the following requirements:
(a) A licensed pharmacist is on the premises and the mobile unit is under the control and management of a pharmacist while prescription medications are being dispensed.
(b) All activities of the pharmacist, including the furnishing of medication by the pharmacist, are consistent with Article 3 (commencing with Section 4050).
(c) If a physician is practicing in
the mobile unit, all prescribing by the physician meets the requirements of the Medical Practice Act (Chapter 5 (commencing with Section 2000)).
(d) (1) The mobile unit does not carry or dispense controlled substances.
(2) Paragraph (1) does not apply to Schedule III, Schedule IV, or Schedule V controlled substances approved by the United States Food and Drug Administration for the treatment of opioid use disorder. Any controlled substance for the treatment of opioid use disorder carried or dispensed in accordance with this paragraph shall be carried in reasonable quantities based on prescription volume and stored securely in the mobile pharmacy unit.
(e) Dangerous drugs shall not be left in the mobile unit during the hours that the mobile unit is not in operation.
(f) A county, city and county, or special hospital authority shall notify the board of its intention to operate a mobile unit as soon as possible, and no later than five business days after commencing operation of a mobile unit. A county, city and county, or special hospital authority shall also notify the board of its intention to discontinue operation of a mobile unit as soon as possible, and at least one business day before discontinuing operation of a mobile unit.
(Amended by Stats. 2023, Ch. 539, Sec. 1. (AB 663) Effective January 1, 2024.)
(a) Except as otherwise provided in subdivision (b), (d), or (e), the board shall not issue or renew a license to conduct a pharmacy to any of the following:
(1) A person or persons authorized to prescribe or write a prescription, as specified in Section 4040, in the State of California.
(2) A person or persons with whom a person or persons specified in paragraph (1) shares a community or other financial interest in the permit sought.
(3) Any corporation that is controlled by, or in which 10 percent or more of the stock is owned by a person or persons prohibited from
pharmacy ownership by paragraph (1) or (2).
(b) Subdivision (a) shall not preclude the issuance of a permit for an inpatient hospital pharmacy to the owner of the hospital in which it is located.
(c) The board may require any information the board deems is reasonably necessary for the enforcement of this section.
(d) Subdivision (a) shall not preclude the issuance of a new or renewal license for a pharmacy to be owned or owned and operated by a person licensed on or before August 1, 1981, under the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code) and qualified on or before August 1, 1981, under subsection (d) of Section 1310 of Title XIII
of the federal Public Health Service Act, as amended, whose ownership includes persons defined pursuant to paragraphs (1) and (2) of subdivision (a).
(e) Subdivision (a) shall not preclude the issuance of a new or renewal license for a pharmacy to be owned or owned and operated by a pharmacist authorized to issue a drug order pursuant to Section 4052.1, 4052.2, or 4052.6.
(Amended by Stats. 2013, Ch. 469, Sec. 13. (SB 493) Effective January 1, 2014.)
(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.
(Amended by Stats. 2011, Ch. 646, Sec. 3. (SB 431) Effective January 1, 2012.)
(a) Every pharmacy shall designate a pharmacist-in-charge and, within 30 days thereof, shall notify the board in writing of the identity and license number of that pharmacist and the date they were designated.
(b) The proposed pharmacist-in-charge shall be subject to approval by the board. The board shall not issue or renew a pharmacy license without identification of an approved pharmacist-in-charge for the pharmacy.
(c) (1) The pharmacist-in-charge shall be responsible for a pharmacy’s compliance with all state
and federal laws and regulations pertaining to the practice of pharmacy.
(2) The pharmacist-in-charge may make staffing decisions to ensure sufficient personnel are present in the pharmacy to prevent fatigue, distraction, or other conditions that may interfere with a pharmacist’s ability to practice competently and safely. If the pharmacist-in-charge is not available, a pharmacist on duty may adjust staffing according to workload if needed.
This paragraph does not apply to facilities of the Department of Corrections and Rehabilitation.
(d) (1) The pharmacist-in-charge or pharmacist on duty shall immediately notify store management of any conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. Store management shall take immediate and reasonable steps to address and resolve the conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. If the conditions are not resolved within 24 hours, the
pharmacist-in-charge or pharmacist on duty shall ensure the board is timely notified.
(2) Nothing in this subdivision shall be construed as presenting, limiting, or restraining a pharmacist-in-charge, pharmacy technician, or member of the public from communication with the board, including filing a complaint.
(3) The conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff may include, but are not limited to, any of the following:
(A) Workplace safety and health hazards that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff.
(B) Sustained temperatures that could impact ambient temperature drug stability according to manufacturer data on acceptable drug storage conditions.
(C) Vermin infestation that poses a risk to the safety or efficacy of medicine.
(4) If, after receipt of a notice described in paragraph (1) and an evaluation and assessment of the relevant evidence, the executive officer has a reasonable belief that conditions within a pharmacy exist that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff, the executive officer may, in conformance with the processes set forth in subdivisions (b) and (c) of Section 4127.3, issue an order to the pharmacy to immediately cease and desist those pharmacy operations that are affected by
the conditions at issue. The cease and desist order shall remain in effect until either the executive officer determines the conditions that presented an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff have been abated or for no more than 30 days, whichever is earlier. Evidence of corrective actions taken shall be submitted by the pharmacy to correct the conditions at issue. Failure to comply with a cease and desist order issued pursuant to this section shall be unprofessional conduct pursuant to Section 4156.
(5) Nothing in this paragraph shall prevent the owner of the licensed premises from closing a pharmacy
to mitigate against a perceived immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff.
(6) Facilities of the Department of Corrections and Rehabilitation shall be exempt from this subdivision.
(e) Every pharmacy shall notify the board in writing, on a form designed by the board, within 30 days of the date when a pharmacist-in-charge ceases to act as the pharmacist-in-charge, and shall on the same form propose another pharmacist to take over as the pharmacist-in-charge. The proposed replacement pharmacist-in-charge shall be subject to approval by the board. If disapproved, the pharmacy shall propose another replacement within 15 days of the date of
disapproval and shall continue to name proposed replacements until a pharmacist-in-charge is approved by the board.
(f) If a pharmacy is unable, in the exercise of reasonable diligence, to identify within 30 days a permanent replacement pharmacist-in-charge to propose to the board on the notification form, the pharmacy may instead provide on that form the name of any pharmacist who is an employee, officer, or administrator of the pharmacy or the entity that owns the pharmacy and who is actively involved in the management of the pharmacy on a daily basis, to act as the interim pharmacist-in-charge for a period not to exceed 120 days. The pharmacy, or the entity that owns the pharmacy, shall be prepared during normal business hours to provide a representative of the board with the name of the interim pharmacist-in-charge with
documentation of the active involvement of the interim pharmacist-in-charge in the daily management of the pharmacy, and with documentation of the pharmacy’s good faith efforts prior to naming the interim pharmacist-in-charge to obtain a permanent pharmacist-in-charge. By no later than 120 days following the identification of the interim pharmacist-in-charge, the pharmacy shall propose to the board the name of a pharmacist to serve as the permanent pharmacist-in-charge. The proposed permanent pharmacist-in-charge shall be subject to approval by the board. If disapproved, the pharmacy shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a pharmacist-in-charge is approved by the board.
(Amended by Stats. 2023, Ch. 470, Sec. 1. (AB 1286) Effective January 1, 2024.)
(a) Except as specified in subdivision (e), a community pharmacy licensed pursuant to this article shall report, either directly or through a designated third party, including a component patient safety organization as defined in Section 3.20 of Title 42 of the Code of Federal Regulations, all medication errors to an entity approved by the board. A community pharmacy shall submit the report no later than
14 days following the date of discovery of the error. These reports are deemed confidential and are not subject to discovery, subpoena, or disclosure pursuant to the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code), except that the board may publish deidentified case summary information compiled from the data in the reports so long as deidentification is done in accordance with the requirements set forth in Section 164.514(b)(2) of Title 45 of the Code of Federal Regulations, and includes omitting the name of the reporting pharmacy. The community pharmacy shall maintain records demonstrating compliance
with this requirement for three years and shall make these records immediately available at the request of an inspector. A medication error report made pursuant to this section shall not be subject to investigation, discipline, or other enforcement action by the board based solely on a report received pursuant to this section. However, if the board receives other information regarding the medication
error independent of the medication error report, that information may serve as basis for discipline or other enforcement by the board.
(b) Any entity approved by the board shall have experience with the analysis of medication errors that occur in the outpatient setting.
(c) For purposes of this section, “community pharmacy” includes any pharmacy that dispenses medication to an
outpatient, but does not include facilities of the Department of Corrections and Rehabilitation.
(d) For purposes of this section, “medication error” includes any variation from a prescription drug order not authorized by the prescriber, including, but not limited to, errors involving the wrong drug, the wrong dose, the wrong patient, the wrong directions, the wrong preparation, or the wrong route of administration. A medication error does not include any variation that is corrected prior to dispensing to the patient or patient’s agent or any variation allowed by law.
(e) An outpatient hospital pharmacy shall not be required to report a medication
error that meets the requirements of an adverse event, as specified in subdivision (a), that has been reported to the State Department of Public Health pursuant to Section 1279.1 of the Health and Safety Code. The State Department of Public Health may share a report with the California State Board of Pharmacy.
(Added by Stats. 2023, Ch. 470, Sec. 2. (AB 1286) Effective January 1, 2024.)
(a) A community pharmacy shall not require a pharmacist employee to engage in the practice of pharmacy at any time the pharmacy is open to the public, unless either another employee of the pharmacy or, if the pharmacy is located within another establishment, an employee of the establishment within which the pharmacy is located, is made available to assist the pharmacist at all times.
(b) This section shall not apply to any of the following:
(1) A hospital pharmacy, as defined in Section 4029 or 4056.
(2) A pharmacy located in a hospital
facility, including, but not limited to, a building where outpatient services are provided in accordance with the hospital’s license.
(3) A pharmacy owned or operated by a federal, state, local, or tribal government entity, including, but not limited to, a correctional pharmacy, a University of California pharmacy, or a pharmacy operated by the State Department of State Hospitals.
(4) A pharmacy owned by a person or persons who, collectively, control the majority of the beneficial interest in no more than four pharmacies in California.
(5) A pharmacy entirely owned and operated by a health care service plan that exclusively contracts with no more than two medical groups in the state to provide, or arrange for the provision of, professional medical services to the enrollees of the plan.
(6) A pharmacy that permits patients to receive
medications at a drive-through window when both of the following conditions are met:
(A) A pharmacist is working during the times when patients may receive medication only at the drive-through window.
(B) The pharmacist’s employer does not require the pharmacist to retrieve items for sale to patients if the items are located outside the pharmacy. These items include, but are not limited to, items for which a prescription is not required.
(7) Any other pharmacy from which controlled substances, dangerous drugs, or dangerous devices are not furnished, sold, or dispensed at retail.
(c) A violation of subdivision (a) is not subject to subdivision (a)
of Section 4321.
(d) The board shall not take action against a pharmacy for a violation of this section if both of the following apply:
(1) Another employee is unavailable to assist the pharmacist due to reasonably unanticipated circumstances, including, but not limited to, illness, injury, family emergency, or the employee’s termination or resignation.
(2) The pharmacy takes all reasonable action to make another employee available to assist the pharmacist.
(e) This section shall not be construed to permit an employee who is not licensed under this chapter to engage in any act for which a license is required under this chapter.
(Added by Stats. 2018, Ch. 569, Sec. 2. (SB 1442) Effective January 1, 2019.)
(a) A chain community pharmacy subject to Section 4113.5 shall be staffed at all times with at least one clerk or pharmacy technician fully dedicated to performing pharmacy-related services. The board shall not take action against a pharmacy for a violation of this subdivision if any of the following conditions apply:
(1) The pharmacist on duty waives the requirement in writing during specified hours based on workload need.
(2) The pharmacy is open beyond normal business hours, which is before 8:00 a.m. and after 7:00 p.m. During the hours before 8:00 a.m. and after 7:00 p.m., the requirement shall not apply.
(3) The pharmacy’s prescription volume per day on average is less than 75 prescriptions per day based on the average daily prescription volume for the past calendar year. However, if the pharmacist is also expected to provide additional pharmacy services such as immunizations, tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a), or any other ancillary services provided by law, this paragraph does not apply.
(b) Where staffing of pharmacist hours within a chain community pharmacy does not overlap sufficiently, scheduled closures for lunch time for all pharmacy staff shall be established and publicly posted and included on the outgoing telephone message.
(Amended by Stats. 2024, Ch. 80, Sec. 4. (SB 1525) Effective January 1, 2025.)
(a) A chain community pharmacy, as defined in subdivision (c) of Section 4001, shall not establish a quota related to the duties for which a pharmacist or pharmacy technician license is required.
(b) A chain community pharmacy shall not, through employees, contractors, or third parties, communicate the existence of
quotas, that are illegal pursuant to this section, to pharmacists or pharmacy technicians who are employees of the chain community pharmacy or with whom the chain community pharmacy contracts.
(c) (1) For purposes of this section, “quota” means a fixed number or formula related to the duties for which a pharmacist or pharmacy technician license is required, against which the chain
community pharmacy or its agent measures or evaluates the number of times either an individual pharmacist or pharmacy technician performs tasks or provides services while on duty. “Quota” includes a fixed number or formula related to any of the following:
(A) Prescriptions filled.
(B) Services rendered to patients.
(C) Programs offered to patients.
(D) Revenue obtained.
(2) For purposes of this section, “quota” does not mean any of the following:
(A) A measurement of the revenue earned by a particular licensed chain community pharmacy not calculated in relation to, or measured by, the tasks performed, or services provided by, individual pharmacists or pharmacy technicians.
(B) Any evaluation or measurement of the competence, performance, or quality of care provided to patients of a pharmacist or pharmacy technician if the evaluation does not use quotas, as defined in paragraph (1).
(C) Any performance metric required by state or federal regulators that does not use quotas, as defined in paragraph (1).
(d) This section does not prohibit a chain community pharmacy from establishing policies and procedures that assist in assessing the competency and performance of a pharmacist or pharmacy technician in providing care to patients if the measurements used are not, or do not include, quotas, as defined in subdivision (c).
(Added by Stats. 2021, Ch. 334, Sec. 2. (SB 362) Effective January 1, 2022.)
(a) An intern pharmacist may perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist whose license is in good standing with the board.
(b) A pharmacist may not supervise more than two intern pharmacists at any one time.
(Amended by Stats. 2005, Ch. 621, Sec. 52. Effective January 1, 2006.)
(a) A pharmacy technician may perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist. The pharmacist shall be responsible for the duties performed under their supervision by a technician.
(b) (1) In addition to the tasks specified in subdivision (a) a pharmacy technician may, under the direct supervision and control of a pharmacist, prepare and administer influenza and COVID-19 vaccines via injection or intranasally,
prepare and administer epinephrine, perform specimen collection for tests that are classified as waived under CLIA, receive prescription transfers, and accept clarification on prescriptions under the following conditions:
(A) The pharmacy has scheduled another pharmacy technician to assist the pharmacist by performing the tasks provided in subdivision (a).
(B) The pharmacy technician is certified pursuant to paragraph (4) of subdivision (a) of Section 4202 and maintains that certification.
(C) The pharmacy technician has successfully completed at least six hours of practical training approved by the Accreditation Council for Pharmacy Education and includes hands-on injection technique,
the recognition and treatment of emergency reactions to vaccines, and an assessment of the pharmacy technician’s injection technique.
(D) The pharmacy technician is certified in basic life support.
(2) “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; Public Law 100-578).
(c) This section does not authorize the performance of any tasks specified in subdivisions (a) and (b) by a pharmacy technician without a pharmacist on duty.
(d) This section does not authorize a pharmacy technician to perform any act requiring the exercise of professional judgment by a pharmacist.
(e) The board shall adopt regulations to specify tasks pursuant to subdivision (a) that a pharmacy technician may perform under the supervision of a pharmacist. Any pharmacy that employs a pharmacy technician shall do so in conformity with the regulations adopted by the board.
(f) A person shall not act as a pharmacy technician without first being licensed by the board as a pharmacy technician.
(g) (1) A pharmacy with only one pharmacist shall have no more than one pharmacy technician performing the tasks specified in subdivision (a). A pharmacy with only one pharmacist shall have no more than one pharmacy technician performing the tasks specified in subdivision (b). If a pharmacy technician is performing the tasks specified in subdivision (b), a
second pharmacy technician shall be assisting a pharmacist with performing tasks specified in subdivision (a). The ratio of pharmacy technicians performing the tasks specified in subdivision (a) to any additional pharmacist shall not exceed 2:1, except that this ratio shall not apply to personnel
performing clerical functions pursuant to Section 4116 or 4117. This ratio is applicable to all practice settings, except for an inpatient of a licensed health facility, a patient of a licensed home health agency, as specified in paragraph (2), an inmate of a correctional facility of the Department of Corrections and Rehabilitation, and for a person receiving treatment in a facility operated by the State Department of State Hospitals, the State Department of Developmental Services, or the Department of Veterans Affairs.
(2) The board may adopt regulations establishing the ratio of pharmacy technicians performing the tasks specified in subdivision (a) to pharmacists applicable to the filling of prescriptions of an inpatient of a licensed health facility and for a patient of a licensed home health agency. Any ratio established by
the board pursuant to this subdivision shall allow, at a minimum, at least one pharmacy technician for a single pharmacist in a pharmacy and two pharmacy
technicians for each additional pharmacist, except that this ratio shall not apply to personnel performing clerical functions pursuant to Section 4116 or 4117.
(3) A pharmacist scheduled to supervise a second pharmacy technician may refuse to supervise a second pharmacy technician if the pharmacist determines, in the exercise of their professional judgment, that permitting the second pharmacy technician to be on duty would interfere with the effective performance of the pharmacist’s responsibilities under this chapter. A pharmacist assigned to supervise a second pharmacy technician shall notify the pharmacist-in-charge in writing of their determination, specifying the circumstances of concern with respect to the pharmacy or the pharmacy technician that have led to the determination, within a reasonable period, but not to
exceed 24 hours, after the posting of the relevant schedule. An entity employing a pharmacist shall not discharge, discipline, or otherwise discriminate against any pharmacist in the terms and conditions of employment for exercising or attempting to exercise in good faith the right established pursuant to this paragraph.
(h) Notwithstanding subdivisions (a) to (c), inclusive, the board shall by regulation establish conditions to permit the temporary absence of a pharmacist for breaks and lunch periods pursuant to Section 512 of the Labor Code and the orders of the Industrial Welfare Commission without closing the pharmacy. During these temporary absences, a pharmacy technician may, at the discretion of the pharmacist, remain in the pharmacy but may only perform nondiscretionary tasks. The pharmacist shall be responsible for a pharmacy
technician and shall review any task performed by a pharmacy technician during the pharmacist’s temporary absence. This subdivision shall not be construed to authorize a pharmacist to supervise pharmacy technicians in greater ratios than those described in subdivision (g).
(i) The pharmacist on duty shall be directly responsible for the conduct of a pharmacy technician supervised by that pharmacist.
(j) In a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code, a pharmacy technician’s duties may include any of the following:
(1) Packaging emergency supplies for use in the health care facility and the hospital’s emergency medical system or as authorized under Section 4119.
(2) Sealing emergency containers for use in the health care facility.
(3) Performing monthly checks of the drug supplies stored throughout the health care facility. Irregularities shall be reported within 24 hours to the pharmacist-in-charge and the director or chief executive officer of the health care facility in accordance with the health care facility’s policies and procedures.
(Amended by Stats. 2023, Ch. 470, Sec. 4. (AB 1286) Effective January 1, 2024.)
(a) Notwithstanding any other law, a pharmacy technician trainee may be placed in a pharmacy to complete an externship for the purpose of obtaining practical training required to become licensed as a pharmacy technician.
(b) (1) A pharmacy technician trainee participating in an externship as described in subdivision (a) may perform the duties described in subdivision (a) of Section 4115 only under the direct supervision and control of a pharmacist.
(2) A pharmacist supervising a pharmacy technician trainee participating in an externship as described in subdivision (a) shall be
directly responsible for the conduct of the trainee.
(3) A pharmacist supervising a pharmacy technician trainee participating in an externship as described in subdivision (a) shall verify any prescription prepared by the trainee under supervision of the pharmacist by initialing the prescription label before the medication is disbursed to a patient or by engaging in other verification procedures that are specifically approved by board regulations.
(4) A pharmacist may only supervise one pharmacy technician trainee at any given time.
(5) A pharmacist supervising a pharmacy technician trainee participating in an externship as described in subdivision (a) shall certify attendance for the pharmacy technician trainee and certify
that the pharmacy technician trainee has met the educational objectives established by a California public postsecondary education institution or the private postsecondary vocational institution in which the trainee is enrolled, as established by the institution.
(c) (1) Except as described in paragraph (2), an externship in which a pharmacy technician trainee is participating as described in subdivision (a) shall be for a period of no fewer than 120 hours and no more than 140 hours.
(2) When an externship in which a pharmacy technician trainee is participating as described in subdivision (a) involves rotation between a community and hospital pharmacy for the purpose of training the student in distinct practice settings, the externship may be
for a period of up to 340 hours.
(d) An externship in which a pharmacy technician trainee may participate as described in subdivision (a) shall be for a period of no more than six consecutive months in a community pharmacy and for a total of no more than 12 months if the externship involves rotation between a community and hospital pharmacy. The externship shall be completed while the trainee is enrolled in a course of instruction at the institution.
(e) A pharmacy technician trainee participating in an externship as described in subdivision (a) shall wear identification that indicates the pharmacy technician trainee’s status as a trainee.
(Amended by Stats. 2019, Ch. 213, Sec. 1. (SB 655) Effective January 1, 2020.)
(a) No person other than a pharmacist, an intern pharmacist, an authorized officer of the law, or a person authorized to prescribe shall be permitted in that area, place, or premises described in the license issued by the board wherein controlled substances or dangerous drugs or dangerous devices are stored, possessed, prepared, manufactured, derived, compounded, dispensed, or repackaged. However, a pharmacist shall be responsible for any individual who enters the pharmacy for the purposes of receiving consultation from the pharmacist or performing clerical, inventory control, housekeeping, delivery, maintenance, or similar functions relating to the pharmacy if the pharmacist remains present in the pharmacy during all times as the authorized individual is present.
(b) (1) The board may, by regulation, establish reasonable security measures consistent with this section in order to prevent unauthorized persons from gaining access to the area, place, or premises or to the controlled substances or dangerous drugs or dangerous devices therein.
(2) The board shall, by regulation, establish conditions for the temporary absence of a pharmacist for breaks and lunch periods pursuant to Section 512 of the Labor Code and the orders of the Industrial Welfare Commission without closing the pharmacy and removing authorized personnel from the pharmacy. These conditions shall ensure the security of the pharmacy and its operations during the temporary absence of the pharmacist and shall allow, at the discretion of the pharmacist, nonpharmacist personnel to remain and perform any lawful activities during the pharmacist’s temporary absence.
(Amended by Stats. 1999, Ch. 900, Sec. 4. Effective October 10, 1999.)
No person other than a pharmacist, an intern pharmacist, a pharmacy technician, an authorized officer of the law, a person authorized to prescribe, a registered nurse, a licensed vocational nurse, a person who enters the pharmacy for purposes of receiving consultation from a pharmacist, or a person authorized by the pharmacist in charge to perform clerical, inventory control, housekeeping, delivery, maintenance, or similar functions relating to the pharmacy shall be permitted in that area, place, or premises described in the license issued by the board to a licensed hospital wherein controlled substances, dangerous drugs, or dangerous devices are stored, possessed, prepared, manufactured, derived, compounded, dispensed, or repackaged.
(Amended by Stats. 1997, Ch. 549, Sec. 69. Effective January 1, 1998.)
(a) When, in the opinion of the board, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a pharmacy that does not meet all of the requirements for licensure as a pharmacy, the board may waive any licensing requirements.
(b) When, in the opinion of the board, a high standard of patient safety, consistent with good patient care, can be provided by the licensure of a hospital pharmacy, as defined by subdivision (a) of Section 4029, that does not meet all of the requirements for licensure as a hospital pharmacy, the board may waive any licensing requirements. However, when a waiver of any requirements is granted by the board, the pharmaceutical services to be rendered by this pharmacy shall be limited to patients registered for treatment in the hospital, whether or not they are actually staying in the hospital, or to emergency cases under treatment in the hospital.
(Amended by Stats. 1997, Ch. 549, Sec. 70. Effective January 1, 1998.)
(a) A pharmacist at a hospital pharmacy shall obtain an accurate medication profile or list for each high-risk patient upon admission of the high-risk patient under the following conditions:
(1) The hospital has more than 100 beds.
(2) The accurate medication profile or list may be acquired by the pharmacist during the hospital pharmacy’s hours of operation.
(b) Notwithstanding any other law, a pharmacy technician or an intern pharmacist may perform the task of obtaining an accurate medication profile or list for a high-risk patient if both of the following conditions are satisfied:
(1) The hospital pharmacy has a quality assurance program to monitor competency.
(2) The hospital has established policies and procedures for training and proctoring pharmacy technicians or intern pharmacists by the hospital pharmacy department and the pharmacy technician or intern pharmacist has completed that training and proctoring.
(c) The hospital shall establish criteria regarding who is a high-risk patient for purposes of this section, and shall determine the timeframe for completion of the medication profile or list, based on the patient populations served by the hospital.
(d) The board may adopt rules and regulations to carry out the purposes and objectives of this section.
(e) This
section shall not apply to the State Department of State Hospitals.
(f) Nothing in this section shall be construed to prohibit a healing arts licensee licensed pursuant to this division from obtaining an accurate medication profile or list.
(Added by Stats. 2018, Ch. 697, Sec. 1. (SB 1254) Effective January 1, 2019.)
(a) Notwithstanding any other law, a pharmacy may furnish a dangerous drug or dangerous device to a licensed health care facility for storage in a secured emergency pharmaceutical supplies container maintained within the facility in accordance with facility regulations of the State Department of Public Health set forth in Title 22 of the California Code of Regulations and the requirements set forth in Section 1261.5 of the Health and Safety Code. These emergency supplies shall be approved by the facility’s patient care policy committee or pharmaceutical service committee and shall be readily available to each nursing station. Section 1261.5 of the Health and Safety Code limits the number of oral dosage form or suppository form drugs in these
emergency supplies to 48.
(b) Notwithstanding any other law, a pharmacy may furnish a dangerous drug or a dangerous device to an approved service provider within an emergency medical services system for storage in a secured emergency pharmaceutical supplies container, in accordance with the policies and procedures of the local emergency medical services agency, if all of the following are met:
(1) The dangerous drug or dangerous device is furnished exclusively for use in conjunction with services provided in an ambulance, or other approved emergency medical services service provider, that provides prehospital emergency medical services.
(2) The requested dangerous drug or dangerous device is within the licensed or
certified emergency medical technician’s scope of practice as established by the Emergency Medical Services Authority and set forth in Title 22 of the California Code of Regulations.
(3) The approved service provider within an emergency medical services system provides a written request that specifies the name and quantity of dangerous drugs or dangerous devices.
(4) The approved emergency medical services provider administers dangerous drugs and dangerous devices in accordance with the policies and procedures of the local emergency medical services agency.
(5) The approved emergency medical services provider documents, stores, and restocks dangerous drugs and dangerous devices in accordance with the policies and
procedures of the local emergency medical services agency.
Records of each request by, and dangerous drugs or dangerous devices furnished to, an approved service provider within an emergency medical services system, shall be maintained by both the approved service provider and the dispensing pharmacy for a period of at least three years.
The furnishing of controlled substances to an approved emergency medical services provider shall be in accordance with the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code).
(Amended by Stats. 2017, Ch. 647, Sec. 2. (SB 443) Effective January 1, 2018.)
(a) Notwithstanding any other law, a pharmacy, or a licensed wholesaler that is also an emergency medical services provider agency, may restock dangerous drugs or dangerous devices into an emergency medical services automated drug delivery system (EMSADDS) that is licensed by the board under this section. Dangerous drugs and dangerous devices stored or maintained in an EMSADDS shall be used for the sole purpose of restocking a secured emergency pharmaceutical supplies container as authorized in subdivision (b) of Section 4119. The EMSADDS may be used only if all of the following conditions are met:
(1) The emergency medical services provider agency obtains a license
from the board to operate the EMSADDS. As a requirement for licensure, the EMSADDS shall be located on the premises of a fire department headquarters, a fire station, or at an emergency medical services provider agency’s location. A separate license shall be required for each location. As part of its license application, the emergency medical services provider agency shall provide: the address where the EMSADDS will be located; the name of the medical director responsible for overseeing the emergency medical services provider agency; the name of any designated pharmacist or licensed designated paramedic who is responsible for performing the duties as required under this section; the policies and procedures detailing the provisions under which the EMSADDS will operate; and the name and license number of the pharmacy or emergency medical services provider agency wholesaler that will furnish the
dangerous drugs and dangerous devices through the EMSADDS.
(2) Each EMSADDS shall collect, control, and maintain all
transaction information necessary to accurately track the movement of drugs into and out of the system for purposes of security, accuracy, and accountability.
(3) The medical director and designated pharmacist, or the medical director and the licensed designated paramedic, shall develop, adopt, and maintain policies and procedures detailing the provisions under which the EMSADDS will operate. At a minimum, the policies and procedures shall address (A) inventory controls, (B) training, (C) storage and security of the dangerous drugs and dangerous devices, and (D) safeguards to limit access to the EMSADDS to authorized staff only.
(4) The licensed EMSADDS operator shall limit access to the EMSADDS only to employees of the operator who are licensed by the state
and as authorized in this section.
(A) An EMSADDS may only be restocked by the medical director, a pharmacist, or a licensed designated paramedic, each of whom may possess and transport dangerous drugs or dangerous devices for that purpose. The transport of dangerous drugs or dangerous devices for restocking into an EMSADDS shall be done in a secured manner to prevent theft or unauthorized access, and shall be done under conditions appropriate to meet storage and handling requirements of the dangerous drugs or dangerous devices. While the dangerous drugs or dangerous devices may be transported, representatives shall not store a dangerous drug or dangerous device at an unlicensed location.
(B) Only a medical director, a pharmacist, or a paramedic may remove dangerous drugs or
dangerous devices from an EMSADDS to fill a secured emergency pharmaceutical supplies container. This access shall be observed by a second person who is also a paramedic, a pharmacist, or a medical director. Both the individual who removes dangerous drugs or dangerous devices from the EMSADDS and the observer shall record their participation in the removal of the dangerous drugs or dangerous devices via their signatures or use of biometric identifiers. The restocking of the secured emergency pharmaceutical supplies container from the EMSADDS shall occur at the licensed location of the EMSADDS.
(C) A medical director, a pharmacist, or a licensed designated paramedic may remove outdated dangerous drugs or dangerous devices from an EMSADDS. Any outdated dangerous drugs or dangerous devices shall be provided to a licensed reverse distributor
for destruction.
(5) Every EMSADDS operator shall perform monthly inventory and inventory reconciliation functions. The medical director, designated pharmacist, or licensed designated paramedic shall perform a reconciliation and prepare a written report based on written policies and procedures developed to maintain the security and quality of the dangerous drugs and dangerous devices. The written inventory reconciliation report shall include all of the following:
(A) A physical count of all quantities of dangerous drugs and dangerous devices stored in the EMSADDS.
(B) A review of all dangerous drugs and dangerous devices added into and removed from each EMSADDS since the last monthly inventory.
(C) A comparison of subparagraphs (A) and (B), and identification of any variances.
(D) A review of all individuals who accessed the EMSADDS since the last inventory and identification of unauthorized individuals accessing the EMSADDS or suspicious activity.
(E) Identification of possible causes of shortages and overages.
(6) The medical director and designated pharmacist, or medical director and licensed designated paramedic, shall be jointly responsible for monthly review of the inventory reconciliation report, the training, storage, and security of dangerous drugs and dangerous devices, and the restocking of the EMSADDS. Any inventory losses from an EMSADDS
shall be reported to the board within seven days from identification of the loss.
(7) In order for an individual to perform the functions of a licensed designated paramedic described in this section, that individual shall be licensed by the board pursuant to Section 4202.5. A paramedic who only restocks a secured emergency pharmaceutical supplies container from an EMSADDS need not be licensed with the board.
(8) A record of each access to the EMSADDS, as well as all records used to compile an inventory reconciliation report, shall be maintained at the operator’s location for at least three years in a readily retrievable form. The records shall include the identity of every individual who accessed the system or witnessed such access; the date of each access; and the drug, dosage,
form, strength, and quantity of dangerous drugs or dangerous devices added or removed.
(b) A violation of any of the provisions of this section shall constitute unprofessional conduct and provides the board the authority to take action against the EMSADDS operator’s license.
(c) This section shall become operative on January 1, 2025.
(Repealed (in Sec. 4) and added by Stats. 2023, Ch. 723, Sec. 5. (SB 816) Effective January 1, 2024. Operative January 1, 2025, by its own provisions.)
A pharmacy located in the state may use pharmacists to perform FDA-approved or -authorized tests that are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, under all of the following conditions:
(a) The pharmacy is appropriately licensed as a laboratory under Section 1265.
(b) The pharmacy maintains policies and procedures that do all of the following:
(1) Establish the initial training requirements,
including specimen collection techniques relevant to a test being performed at the pharmacy, and ongoing training.
(2) Establish safety precautions necessary to protect pharmacy staff and consumers and to reduce the risk of transmission, consistent with Cal-OSHA and CDC requirements, including, but not limited to, provisions for the use of personal protective equipment, cleaning and sanitizing procedures, appropriate biohazard waste requirements, and space requirements for pharmacy staff and consumers.
(3) Ensure the availability of dedicated physically distanced space or other segregated space that provides for privacy during the testing process and private consultation with the pharmacist, and limits potential contamination of other consumers in the pharmacy.
(4) Establish requirements for providing test results to the patient in a nonverbal manner, complying with mandatory reporting requirements to local and state reporting systems, and notifying the patient’s health care providers if consent is provided, and referral to licensed sources of care for confirmation, diagnosis, and treatment as appropriate for followup to positive test results. A health care provider shall not be held personally liable for test results, or for any actions or inactions related to test results they
did not receive, have knowledge of, or otherwise have access to.
(5) Establish requirements for the pharmacist-in-charge serving as the pharmacy laboratory director to report any reportable disease or condition identified in Section 120130 of the Health and Safety Code or the regulations adopted under that section.
(6) Ensure documentation of testing equipment maintenance and calibration.
(7) Ensure appropriate storage and handling of specimens, testing reagents, and other supplies or equipment that require specialized storage or handling. Specimen collection shall not include vaginal swab, venipuncture, or the collection of seminal fluid.
(c) The test is authorized to be administered by a pharmacist pursuant to paragraph (1) of subdivision (b) of Section 4052.4.
(d) The pharmacist-in-charge does both of the following:
(1) Annually reviews the policies and procedures maintained pursuant to subdivision (b), assesses the pharmacy’s compliance with its
policies, and documents corrective actions to be taken when noncompliance is found.
(2) Maintains documentation of the annual review and assessment in a readily retrievable format for a period of three years from the date of completion.
(e) The pharmacy maintains documentation related to performing tests that demonstrates compliance with this section, which shall include the name of the pharmacist performing the test, the results of the test, and communication of results to a patient’s primary medical provider, and is maintained in a readily retrievable format for a period of three years from the date of creation.
(Added by Stats. 2021, Ch. 604, Sec. 4. (SB 409) Effective January 1, 2022.)
(a) A pharmacy located in the state may provide pharmacy services to the patients of a “covered entity,” as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:
(1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the
pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license.
(2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system.
(3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity
and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy.
(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records.
(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.
(6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system.
(7) The operation of the automated patient
dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may
supervise the system electronically.
(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license.
(9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days.
(10) The automated patient dispensing system license shall be canceled
by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board.
(11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued.
(b) For purposes of this section, the following definitions shall apply:
(1) An “automated drug delivery system” (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or
distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.
(2) An “automated patient dispensing system” (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist.
(3) An “automated unit dose system” (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions.
(c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the
movement of drugs into and out of the system for security, accuracy, and accountability.
(2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.
(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient, if all of the following requirements are met:
(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:
(A) Maintaining the security of the automated patient dispensing system and
the dangerous drugs and devices within that automated patient dispensing system.
(B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.
(C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system.
(D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the
automated patient dispensing system.
(E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices.
(F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system if the automated patient dispensing system is disabled or malfunctions.
(2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to
receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1).
(3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patient’s drugs and devices to the patient or the patient’s agent.
(4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.
(5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patient’s profile
for potential contraindications and adverse drug reactions.
(6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.
(7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system.
(8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section
4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations.
(9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacy’s quality assurance program pursuant to Section 4125.
(10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy.
(11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to
paragraph (1) for three years after the last date of use of that automated patient dispensing system.
(e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days.
(f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.
(g) The stocking of an automated patient dispensing system shall be
performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility, if all of the following conditions are met:
(1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.
(2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a
secure tamper-evident container.
(3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system.
(h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. A pharmacist shall conduct the review on a monthly basis, which shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction
records in order to verify the security and accountability of the system.
(i) A pharmacy holding an automated patient dispensing system license shall complete a self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment.
(j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system
license and separately from other pharmacy records.
(k) This section shall become operative on January 1, 2025.
(Repealed (in Sec. 6) and added by Stats. 2023, Ch. 723, Sec. 7. (SB 816) Effective January 1, 2024. Operative January 1, 2025, by its own provisions.)
(a) Notwithstanding any other law, a pharmacy may furnish epinephrine auto-injectors to a school district, county office of education, or charter school pursuant to Section 49414 of the Education Code if all of the following are met:
(1) The epinephrine auto-injectors are furnished exclusively for use at a school district site, county office of education, or charter school.
(2) A physician and surgeon provides a written order that specifies the quantity of epinephrine auto-injectors to be furnished.
(b) Records regarding the acquisition and disposition of
epinephrine auto-injectors furnished pursuant to subdivision (a) shall be maintained by the school district, county office of education, or charter school for a period of three years from the date the records were created. The school district, county office of education, or charter school shall be responsible for monitoring the supply of epinephrine auto-injectors and ensuring the destruction of expired epinephrine auto-injectors.
(Amended by Stats. 2014, Ch. 321, Sec. 1. (SB 1266) Effective January 1, 2015.)
(a) Notwithstanding any other law, a pharmacy may dispense epinephrine auto-injectors to a prehospital emergency medical care person or lay rescuer for the purpose of rendering emergency care in accordance with Section 1797.197a of the Health and Safety Code, if both of the following requirements are met:
(1) A physician and surgeon provides a written order that specifies the quantity of epinephrine auto-injectors to be dispensed to a person described in subdivision (b) of
Section 1797.197a of the Health and Safety Code. The physician and surgeon may issue the prescription only upon presentation of a current certificate demonstrating that the person is trained and qualified under Section 1797.197a of the Health and Safety Code to administer an epinephrine auto-injector to another person in an emergency situation. The prescription shall specify that the dispensed epinephrine auto-injector is for “First Aid Purposes Only” and that the named recipient is a “Section 1797.197a Responder.” A new prescription shall be written for any additional epinephrine auto-injectors required.
(2) (A) The pharmacy shall label each
epinephrine auto-injector dispensed with all of the following:
(i) The name of the person to whom the prescription was issued.
(ii) The designations “Section 1797.197a Responder” and “First Aid Purposes Only.”
(iii) The dosage, use, and expiration date.
(B) Each dispensed prescription shall include the manufacturer’s product information sheet for the epinephrine auto-injector.
(b) The person described in subdivision (b) of
Section 1797.197a of the Health and Safety Code receiving epinephrine auto-injectors pursuant to this section shall make and maintain a record for five years reflecting dates of receipt, use, and destruction of each auto-injector dispensed, the name of any person to whom epinephrine was administered using an auto-injector, and the circumstances and manner of destruction of any auto-injectors.
(c) The epinephrine auto-injectors dispensed pursuant to this section may be used only for the purpose, and under the circumstances, described in Section 1797.197a of the Health and Safety Code.
(Added by Stats. 2013, Ch. 725, Sec. 1. (SB 669) Effective January 1, 2014.)
(a) Notwithstanding any other law, a pharmacy may furnish epinephrine auto-injectors to an authorized entity, for the purpose of rendering emergency care in accordance with Section 1797.197a of the Health and Safety Code, if both of the following requirements are met:
(1) The epinephrine auto-injectors are furnished exclusively for use by, or in connection with, an authorized entity.
(2) An authorized health care provider provides a prescription that specifies the quantity of epinephrine auto-injectors to be furnished to an authorized entity described in subdivision (a) of Section 1797.197a of the Health and Safety Code. A new prescription
shall be written for any additional epinephrine auto-injectors required for use.
(b) The pharmacy shall label each epinephrine auto-injector dispensed with all of the following:
(1) The name of the person or entity to whom the prescription was issued.
(2) The designations “Section 1797.197a Responder” and “First Aid Purposes Only.”
(3) The dosage, use, and expiration date.
(c) Each dispensed prescription shall include the manufacturer’s product information sheet for the epinephrine auto-injector.
(d) Records regarding the acquisition and disposition of epinephrine auto-injectors furnished pursuant to subdivision (a) shall be
maintained by the authorized entity for a period of three years from the date the records were created. The authorized entity shall be responsible for monitoring the supply of epinephrine auto-injectors and ensuring the destruction of expired epinephrine auto-injectors.
(e) The epinephrine auto-injector dispensed pursuant to this section may be used only for the purpose, and under the circumstances, described in Section 1797.197a of the Health and Safety Code.
(f) For purposes of this section, “epinephrine auto-injector” means a disposable delivery device designed for the automatic injection of a premeasured dose of epinephrine into the human body to prevent or treat a life-threatening allergic reaction.
(Added by Stats. 2016, Ch. 374, Sec. 1. (AB 1386) Effective January 1, 2017.)
(a) A pharmacy can transfer a reasonable supply of dangerous drugs to another pharmacy.
(b) A pharmacy may repackage and furnish to a prescriber a reasonable quantity of dangerous drugs and dangerous devices for prescriber office use.
(Added by Stats. 1997, Ch. 549, Sec. 72. Effective January 1, 1998.)
An intern pharmacist under the direct supervision and control, as defined in Section 4023.5, of a pharmacist may stock, replenish, and inspect the emergency pharmaceutical supplies container and the emergency medical system supplies of a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code.
(Added by Stats. 2014, Ch. 319, Sec. 2. (SB 1039) Effective January 1, 2015.)
(a) Notwithstanding any other law, a hospital pharmacy serving a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code may furnish a dangerous drug or dangerous device pursuant to preprinted or electronic standing orders, order sets, and protocols established under the policies and procedures of the health
care facility,
as approved according to the policies of the health care facility’s governing body, if the order is dated, timed, and authenticated in the medical record of the patient to whom the dangerous drug or dangerous device will be provided.
(b) A health care facility shall store and maintain drugs in accordance with national standards regarding the storage area and refrigerator or freezer temperature, and otherwise pursuant to the manufacturer’s guidelines. The health care facility’s policies and procedures shall specify these storage parameters.
(c) An intern pharmacist under the direct
supervision and control, as defined in Section 4023.5, of a pharmacist, may inspect the drugs maintained in the health care facility at least once per month. The health care facility shall establish specific written policies and procedures for inspections pursuant to this subdivision.
(d) For purposes of this section, “health care facility” means a health facility licensed under subdivision (a) of Section 1250 of the Health and Safety
Code.
(Added by Stats. 2014, Ch. 319, Sec. 3. (SB 1039) Effective January 1, 2015.)
(a) Notwithstanding any other law, a pharmacy may furnish naloxone hydrochloride or another opioid antagonist to a school district, county office of education, or charter school pursuant to Section 49414.3 of the Education Code if all of the following are met:
(1) The naloxone hydrochloride or another opioid antagonist is furnished exclusively for use at a school district schoolsite, county office of education schoolsite, or charter school.
(2) A physician and surgeon provides a written order that specifies the quantity of naloxone hydrochloride or another opioid antagonist to be furnished.
(b) Records regarding the acquisition and disposition of naloxone hydrochloride or another opioid antagonist furnished pursuant to subdivision (a) shall be maintained by the school district, county office of education, or charter school for a period of three years from the date the records were created. The school district, county office of education, or charter school shall be responsible for monitoring the supply of naloxone hydrochloride or another opioid antagonist and ensuring the destruction of expired naloxone hydrochloride or another opioid antagonist.
(Added by Stats. 2016, Ch. 557, Sec. 1. (AB 1748) Effective January 1, 2017.)
Notwithstanding any other law, a pharmacy, wholesaler, or manufacturer may furnish naloxone hydrochloride or other opioid
antagonists to a law enforcement agency if both of the following are met:
(a) The naloxone hydrochloride or other opioid antagonist is furnished exclusively for use by employees of the law enforcement agency who have completed training, provided by the law enforcement agency, in administering naloxone hydrochloride or other opioid
antagonists.
(b) Records regarding the acquisition and disposition of naloxone hydrochloride or other opioid antagonists furnished pursuant to this section shall be maintained by the law enforcement agency for a period of three years from the date the records were created. The law enforcement agency shall be responsible for monitoring the supply of naloxone hydrochloride or
other opioid antagonists and ensuring the destruction of expired naloxone hydrochloride or other opioid antagonists.
(Added by Stats. 2018, Ch. 259, Sec. 1. (AB 2256) Effective January 1, 2019.)
(a) A nonresident pharmacy shall not sell or distribute dangerous drugs or dangerous devices in this state through any person or media, other than a wholesaler or third-party logistics provider who has obtained a license pursuant to this chapter or through a selling or distribution outlet that is licensed as a wholesaler or third-party logistics provider pursuant to this chapter, without registering as a nonresident pharmacy.
(b) Applications for a nonresident pharmacy registration shall be made on a form furnished by the board. The board may require any information the board deems reasonably necessary to carry out the purposes of this section.
(c) The
Legislature, by enacting this section, does not intend a license issued to any nonresident pharmacy pursuant to this section to change or affect the tax liability imposed by Chapter 3 (commencing with Section 23501) of Part 11 of Division 2 of the Revenue and Taxation Code on any nonresident pharmacy.
(d) The Legislature, by enacting this section, does not intend a license issued to any nonresident pharmacy pursuant to this section to serve as any evidence that the nonresident pharmacy is doing business within this state.
(Amended by Stats. 2015, Ch. 303, Sec. 6. (AB 731) Effective January 1, 2016.)
(a) Notwithstanding Section 651, an advertisement of the retail price for a drug that requires a prescription shall be limited to quantities of the drug that are consistent with good medical practice and shall include the strength, dosage form, and the exact dates during which the advertised price will be in effect.
(b) This section shall not apply to a pharmacy that is located in a licensed hospital and that is accessible only to hospital medical staff and personnel.
(Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
(a) In every pharmacy there shall be prominently posted in a place conspicuous to, and readable by, prescription drug consumers a notice provided by the board concerning the availability of prescription price information, the possibility of generic drug product selection, the type of services provided by pharmacies, and a statement describing patients’ rights relative to the requirements imposed on pharmacists pursuant to Section 733. The format and wording of the notice shall be adopted by the board by regulation. A written receipt that contains the required information on the notice may be provided to consumers as an alternative to posting the notice in the pharmacy.
(b) A pharmacist, or a pharmacist’s employee, shall give the current retail price for any drug sold at the pharmacy upon request from a consumer, however that request is communicated to the pharmacist or employee.
(c) If a requester requests price information on more than five prescription drugs and does not have valid prescriptions for all of the drugs for which price information is requested, a pharmacist may require the requester to meet any or all of the following requirements:
(1) The request shall be in writing.
(2) The pharmacist shall respond to the written request within a reasonable period of time. A reasonable period of time is deemed to be 10 days, or the time period stated in the written request, whichever is later.
(3) A pharmacy may charge a reasonable fee for each price quotation, as long as the requester is informed that there will be a fee charged.
(4) No pharmacy shall be required to respond to more than three requests as described in this subdivision from any one person or entity in a six-month period.
(d) This section shall not apply to a pharmacy that is located in a licensed hospital and that is accessible only to hospital medical staff and personnel.
(e) Notwithstanding any other provision of this section, no pharmacy shall be required to do any of the following:
(1) Provide the price of any controlled substance in response to a telephone request.
(2) Respond to a request from a competitor.
(3) Respond to a request from an out-of-state requester.
(Amended by Stats. 2007, Ch. 130, Sec. 11. Effective January 1, 2008.)
Any pharmacy that contracts to compound a drug for parenteral therapy, pursuant to a prescription, for delivery to another pharmacy shall report that contractual arrangement to the board. That information shall be reported by the pharmacy performing the compounding services within 30 days of commencing that compounding.
(Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
(a) Notwithstanding Section 2543, a pharmacist may dispense replacement contact lenses pursuant to a valid prescription of a physician or optometrist. Nothing in this section authorizes a pharmacist to conduct an examination of the eyes or to fit or adjust contact lenses. For purposes of this section, “replacement contact lenses” means soft contact lenses that require no fitting or adjustment, and that are dispensed as packaged and sealed by the manufacturer.
(b) No replacement contact lenses may be sold or dispensed except pursuant to a prescription that meets all of the following requirements:
(1) Conforms to state and federal statutes and regulations governing those prescriptions and includes the name, address, and state license number of the prescribing practitioner.
(2) Explicitly states an expiration date of not more than one year from the date of the last prescribing examination.
(3) Explicitly states that the prescription is for contact lenses and includes the lens brand name, type, and tint, including all specifications necessary for the ordering of lenses.
(c) The contact lenses that are dispensed shall be the exact contact lenses that have been prescribed, and no substitutions shall be made.
(d) Any pharmacist and pharmacy that dispenses replacement contact lenses shall direct the patient to confer with his or her eyecare practitioner in the event of any eye problem or reaction to the lenses.
(e) Any pharmacist and pharmacy that sells replacement contact lenses shall provide the following or substantially equivalent written notification to the patient whenever contact lenses are supplied:
WARNING: IF YOU ARE HAVING ANY UNEXPLAINED EYE DISCOMFORT, WATERING, VISION CHANGE, OR REDNESS, REMOVE YOUR LENSES IMMEDIATELY AND CONSULT YOUR EYE CARE PRACTITIONER BEFORE WEARING YOUR LENSES AGAIN.
(f) Any pharmacy and pharmacist dispensing replacement contact lenses shall be subject to all statutes, regulations, and ordinances governing the advertisement of contact lenses. In addition, any advertisement by a pharmacy or pharmacist that mentions replacement contact lenses shall include within the advertisement all fees, charges, and costs associated with the purchase of the lenses from that pharmacy and pharmacist.
(g) Any pharmacy dispensing replacement contact lenses shall register with the Medical Board of California at the time of initial application for a license or at the time of annual renewal of that license.
(h) All nonresident pharmacies shall maintain records of replacement contact lenses shipped, mailed, or delivered to persons in California for a period of at least three years. The records shall be available for inspection upon request by the board or the Division of Licensing of the Medical Board of California.
(i) The requirements of this section are applicable to nonresident pharmacies as defined in subdivision (a) of Section 4112. A nonresident pharmacy may dispense contact lenses only as provided in this section.
(Repealed and added by Stats. 1996, Ch. 890, Sec. 3. Effective January 1, 1997.)
(a) Every pharmacy shall establish a quality assurance program that shall, at a minimum, document medication errors attributable, in whole or in part, to the pharmacy or its personnel. The purpose of the quality assurance program shall be to assess errors that occur in the pharmacy in dispensing or furnishing prescription medications so that the pharmacy may take appropriate action to prevent a recurrence.
(b) Records generated for and maintained as a component of a pharmacy’s ongoing quality assurance program shall be considered peer review documents and not subject to discovery in any arbitration, civil, or other proceeding, except as provided hereafter. That privilege shall not prevent review of a pharmacy’s quality assurance program and records maintained as part of that system by the board as necessary to protect the public health and safety or if fraud is alleged by a government agency with jurisdiction over the pharmacy. Nothing in this section shall be construed to prohibit a patient from accessing his or her own prescription records. Nothing in this section shall affect the discoverability of any records not solely generated for and maintained as a component of a pharmacy’s ongoing quality assurance program.
(c) This section shall become operative on January 1, 2002.
(Added by Stats. 2000, Ch. 677, Sec. 1. Effective January 1, 2001. Section operative January 1, 2002, by its own provisions.)
(a) Notwithstanding any other provision of law, a covered entity may contract with a pharmacy to provide pharmacy services to patients of the covered entity, as defined in Section 256b of Title 42 of the United States Code, including dispensing preferentially priced drugs obtained pursuant to Section 256b of Title 42 of the United States Code. Contracts between those covered entities and pharmacies shall comply with guidelines published by the Health Resources and Services Administration and shall be available for inspection by board staff during normal business hours.
(b) Drugs purchased pursuant to Section 256b of Title 42 of the United States Code and received by a pharmacy shall be segregated from the pharmacy’s other drug stock by either physical or electronic means. All records of acquisition and disposition of these drugs shall be readily retrievable in a form separate from the pharmacy’s other records.
(c) Drugs obtained by a pharmacy to be dispensed to patients of a covered entity pursuant to Section 256b of Title 42 of the United States Code that cannot be distributed because of a change in circumstances for the covered entity or the pharmacy shall be returned to the distributor from which they were obtained. For the purposes of this section, a change in circumstances includes, but is not limited to, the termination or expiration of the contract between the pharmacy and the covered entity, the closure of a pharmacy, disciplinary action against the pharmacy, or closure of the covered entity.
(d) A licensee that participates in a contract to dispense preferentially priced drugs pursuant to this section shall not have both a pharmacy and a wholesaler license.
(e) Neither a covered entity nor a pharmacy shall be required to obtain a license as a wholesaler based on acts reasonably necessary to fully participate in the drug purchase program established by Section 256b of Title 42 of the United States Code.
(Added by Stats. 2001, Ch. 631, Sec. 2. Effective January 1, 2002.)
(a) A pharmacy may furnish dangerous drugs only to the following:
(1) A wholesaler owned or under common control by the wholesaler from whom the dangerous drug was acquired.
(2) The pharmaceutical manufacturer from whom the dangerous drug was acquired.
(3) A licensed wholesaler acting as a reverse distributor.
(4) Another pharmacy or wholesaler to alleviate a temporary shortage of a dangerous drug that could result in the denial of health care. A pharmacy furnishing dangerous drugs pursuant to this
paragraph may only furnish a quantity sufficient to alleviate the temporary shortage.
(5) A patient or to another pharmacy pursuant to a prescription or as otherwise authorized by law.
(6) A health care provider that is not a pharmacy but that is authorized to purchase dangerous drugs.
(7) To another pharmacy under common control. During a proclaimed state of emergency, “another pharmacy” as used in this paragraph shall include a mobile pharmacy, as described in subdivision (c) of Section 4062.
(b) Notwithstanding subdivision (a), or any other law, a clinic licensed under Section 4180 may furnish dangerous drugs to any of the following during a proclaimed
state of emergency:
(1) Another clinic or wholesaler to alleviate a temporary shortage of a dangerous drug that could result in the denial of health care. A clinic furnishing dangerous drugs pursuant to this paragraph may only furnish a quantity sufficient to alleviate the temporary shortage.
(2) A patient pursuant to a prescription or as otherwise authorized by law.
(3) A health care provider that is not a clinic but that is authorized to purchase dangerous drugs.
(4) To another clinic under common control, including a mobile clinic, as described in subdivision (c) of Section 4062.
(c) Notwithstanding any other law, a violation of this section may subject the person or persons who committed the violation to a fine not to exceed the amount specified in Section 125.9 for each occurrence pursuant to a citation issued by the board.
(d) Amounts due from any person under this section on or after January 1, 2005, shall be offset as provided under Section 12419.5 of the Government Code. Amounts received by the board under this section shall be deposited into the Pharmacy Board Contingent Fund.
(e) For purposes of this section, “common control” means the power to direct or cause the direction of the management and policies of another person whether by ownership, by voting rights, by contract, or by other means.
(Amended by Stats. 2018, Ch. 716, Sec. 4. (AB 2576) Effective January 1, 2019.)
The compounding of drug preparations by a pharmacy for furnishing, distribution, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.
(Added by Stats. 2019, Ch. 184, Sec. 1. (AB 973) Effective January 1, 2020.)
(a) A pharmacy that issues a recall notice regarding a nonsterile compounded drug product shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board within 12 hours of the recall notice if both of the following apply:
(1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death.
(2) The recalled drug was dispensed, or is intended for use, in this state.
(b) A recall notice issued pursuant to subdivision (a) shall be made as follows:
(1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient.
(2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified.
(3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, which shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.
(c) A pharmacy that has been advised that a patient has been harmed by using a nonsterile compounded product potentially attributable to the pharmacy shall report the event to MedWatch within 72 hours of the pharmacy being
advised.
(Added by Stats. 2016, Ch. 484, Sec. 22. (SB 1193) Effective January 1, 2017.)
(a) A pharmacy located in California may distribute compounded human drug preparations interstate only if all of the following conditions are met:
(1) Between January 1 and March 31 of each year, the pharmacy reports all required data for the previous calendar year into the Information Sharing Network established by the National Association of Boards of Pharmacy in conjunction with the United States Food and Drug Administration (FDA) to implement the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products.
(2) On an annual basis, in connection with and as a condition of renewal
of the pharmacy’s license, the pharmacist-in-charge of the pharmacy certifies that the reporting requirements of paragraph (1) have been satisfied.
(3) The pharmacy reports any adverse drug experience and product quality issue for any compounded product to the board within 12 hours after the pharmacy receives notice of the adverse drug experience or product quality issue.
(b) Information reported by the board to the FDA directly or through the Information Sharing Network established by the National Association of Boards of Pharmacy in conjunction with the FDA to implement the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products shall not be subject to public disclosure under the California Public Records Act (Division 10 (commencing with
Section 7920.000) of Title 1 of the Government Code).
(Amended by Stats. 2022, Ch. 28, Sec. 5. (SB 1380) Effective January 1, 2023.)