Section § 4110

Explanation

You can't run a pharmacy in California without a license from the board, and you need a separate one for each location. Each license must be renewed every year, and you have to include specific information like your compounding practices in the renewal application. The board can also issue temporary permits if they think it's in the public interest, but these aren't permanent and don't guarantee a permanent license. In emergencies, like if a pharmacy is damaged, a mobile pharmacy can be used temporarily, but there are strict rules—like security measures and specific conditions for operation—before the permanent site is back up and running.

(a)CA Business & Professions Code § 4110(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)CA Business & Professions Code § 4110(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)CA Business & Professions Code § 4110(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)CA Business & Professions Code § 4110(c)(1) The mobile pharmacy shall provide services only on or immediately contiguous to the site of the damaged or destroyed pharmacy.
(2)CA Business & Professions Code § 4110(c)(2) The mobile pharmacy is under the control and management of the pharmacist-in-charge of the pharmacy that was destroyed or damaged.
(3)CA Business & Professions Code § 4110(c)(3) A licensed pharmacist is on the premises while drugs are being dispensed.
(4)CA Business & Professions Code § 4110(c)(4) Reasonable security measures are taken to safeguard the drug supply maintained in the mobile pharmacy.
(5)CA Business & Professions Code § 4110(c)(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)CA Business & Professions Code § 4110(c)(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)CA Business & Professions Code § 4110(c)(7) The mobile pharmacy is not operated for more than 48 hours following the restoration of the permanent pharmacy.

Section § 4110.5

Explanation

This law allows counties, cities, or special hospital authorities in California to run mobile units providing prescription meds to people without fixed addresses, those in government-owned housing, or on specific Medi-Cal plans. These mobile units are extensions of licensed pharmacies and must have a licensed pharmacist present when dispensing medications. Though they can't dispense controlled substances generally, exceptions are made for approved opioid treatment drugs. Prescriptions must comply with the Medical Practice Act. Additionally, mobile units must securely store drugs and notify the board when they start or stop operations.

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)CA Business & Professions Code § 4110.5(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)CA Business & Professions Code § 4110.5(b) All activities of the pharmacist, including the furnishing of medication by the pharmacist, are consistent with Article 3 (commencing with Section 4050).
(c)CA Business & Professions Code § 4110.5(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)Copy CA Business & Professions Code § 4110.5(d)
(1)Copy CA Business & Professions Code § 4110.5(d)(1) The mobile unit does not carry or dispense controlled substances.
(2)CA Business & Professions Code § 4110.5(d)(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)CA Business & Professions Code § 4110.5(e) Dangerous drugs shall not be left in the mobile unit during the hours that the mobile unit is not in operation.
(f)CA Business & Professions Code § 4110.5(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.

Section § 4111

Explanation

This law generally prevents issuing or renewing licenses for pharmacies to people who can write prescriptions or have financial ties to such people. Companies with significant ownership by these individuals are also restricted. However, there are exceptions, such as hospital pharmacies, certain long-standing organizations, and specific pharmacists authorized to prescribe under other sections. The board can request necessary information to enforce these rules.

(a)CA Business & Professions Code § 4111(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)CA Business & Professions Code § 4111(a)(1) A person or persons authorized to prescribe or write a prescription, as specified in Section 4040, in the State of California.
(2)CA Business & Professions Code § 4111(a)(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)CA Business & Professions Code § 4111(a)(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)CA Business & Professions Code § 4111(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)CA Business & Professions Code § 4111(c) The board may require any information the board deems is reasonably necessary for the enforcement of this section.
(d)CA Business & Professions Code § 4111(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)CA Business & Professions Code § 4111(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.

Section § 4112

Explanation

If a pharmacy outside California sends prescription drugs or medical devices into the state, it's called a nonresident pharmacy. These pharmacies must get a license from the California board to operate and follow specific rules. They need to provide the board with information about their staff and operations, keep up-to-date licenses from their home state, and be inspected. They also must keep easily retrievable records of all prescriptions sent to California and have a toll-free number available for patients to talk to pharmacists. Nonresident pharmacies cannot let pharmacists with revoked licenses work in California, and they must follow California's consultation standards for prescriptions. However, they don't need to provide in-person consultations for mailed prescriptions. Lastly, this law doesn't allow these pharmacies to sell contact lenses unless specified elsewhere.

(a)CA Business & Professions Code § 4112(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)CA Business & Professions Code § 4112(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)CA Business & Professions Code § 4112(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)CA Business & Professions Code § 4112(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)CA Business & Professions Code § 4112(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)CA Business & Professions Code § 4112(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)CA Business & Professions Code § 4112(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)CA Business & Professions Code § 4112(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)CA Business & Professions Code § 4112(i) The registration fee shall be the fee specified in subdivision (a) of Section 4400.
(j)CA Business & Professions Code § 4112(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)CA Business & Professions Code § 4112(k) Nothing in this section shall be construed to authorize the dispensing of contact lenses by nonresident pharmacists except as provided by Section 4124.

Section § 4113

Explanation

Every pharmacy must name a lead pharmacist called the pharmacist-in-charge and inform the board, in writing, of this decision within 30 days. The board needs to approve this pharmacist-in-charge as no pharmacy can function without one. This pharmacist is responsible for ensuring the pharmacy follows all laws and regulations. They can also manage staffing to maintain safe working conditions. If any serious health risks are present in the pharmacy, the pharmacist must report them to management and, if unresolved within 24 hours, notify the board. In extreme cases, operations may be halted until issues are fixed. If a pharmacist-in-charge leaves, the pharmacy must inform the board and suggest a replacement quickly. In certain cases, an interim pharmacist can be appointed for up to 120 days while searching for a permanent replacement. Hospitals and correctional facilities have some exemptions from these rules.

(a)CA Business & Professions Code § 4113(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)CA Business & Professions Code § 4113(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)Copy CA Business & Professions Code § 4113(c)
(1)Copy CA Business & Professions Code § 4113(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)CA Business & Professions Code § 4113(c)(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)Copy CA Business & Professions Code § 4113(d)
(1)Copy CA Business & Professions Code § 4113(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)CA Business & Professions Code § 4113(d)(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)CA Business & Professions Code § 4113(d)(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)CA Business & Professions Code § 4113(d)(3)(A) Workplace safety and health hazards that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff.
(B)CA Business & Professions Code § 4113(d)(3)(B) Sustained temperatures that could impact ambient temperature drug stability according to manufacturer data on acceptable drug storage conditions.
(C)CA Business & Professions Code § 4113(d)(3)(C) Vermin infestation that poses a risk to the safety or efficacy of medicine.
(4)CA Business & Professions Code § 4113(d)(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)CA Business & Professions Code § 4113(d)(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)CA Business & Professions Code § 4113(d)(6) Facilities of the Department of Corrections and Rehabilitation shall be exempt from this subdivision.
(e)CA Business & Professions Code § 4113(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)CA Business & Professions Code § 4113(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.

Section § 4113.1

Explanation

This law requires community pharmacies to report any medication errors to an approved organization within 14 days of discovering the error. These reports are confidential and cannot be disclosed publicly, but the board can publish summaries without identifying details. Pharmacies must keep records for three years and make them available for inspection. Importantly, a medication error report alone won't lead to investigation or penalties unless there's more information indicating issues. The approved entity for analysis must have experience with outpatient medication errors. Community pharmacies cover those serving individuals outside of institutions, but prisons are exempt. Medication errors involve any deviation from a prescribed order, like wrong drug or dose, unless fixed before dispensing. Hospital outpatient pharmacies aren't required to report if they've already reported an adverse event to the health department.

(a)CA Business & Professions Code § 4113.1(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)CA Business & Professions Code § 4113.1(b) Any entity approved by the board shall have experience with the analysis of medication errors that occur in the outpatient setting.
(c)CA Business & Professions Code § 4113.1(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)CA Business & Professions Code § 4113.1(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)CA Business & Professions Code § 4113.1(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.

Section § 4113.5

Explanation

This law says that community pharmacies must have another employee available to help a pharmacist whenever the pharmacy is open to the public. If something unexpected happens and no employees are available, but the pharmacy tries hard to find someone, the pharmacy won't be penalized. There are exceptions, such as pharmacies in hospitals, government pharmacies, and some small or specialized pharmacies, that do not have to follow this rule. The law also ensures that unlicensed employees can't do tasks that require a pharmacy license.

(a)CA Business & Professions Code § 4113.5(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)CA Business & Professions Code § 4113.5(b) This section shall not apply to any of the following:
(1)CA Business & Professions Code § 4113.5(b)(1) A hospital pharmacy, as defined in Section 4029 or 4056.
(2)CA Business & Professions Code § 4113.5(b)(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)CA Business & Professions Code § 4113.5(b)(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)CA Business & Professions Code § 4113.5(b)(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)CA Business & Professions Code § 4113.5(b)(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)CA Business & Professions Code § 4113.5(b)(6) A pharmacy that permits patients to receive medications at a drive-through window when both of the following conditions are met:
(A)CA Business & Professions Code § 4113.5(b)(6)(A) A pharmacist is working during the times when patients may receive medication only at the drive-through window.
(B)CA Business & Professions Code § 4113.5(b)(6)(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)CA Business & Professions Code § 4113.5(b)(7) Any other pharmacy from which controlled substances, dangerous drugs, or dangerous devices are not furnished, sold, or dispensed at retail.
(c)CA Business & Professions Code § 4113.5(c) A violation of subdivision (a) is not subject to subdivision (a) of Section 4321.
(d)CA Business & Professions Code § 4113.5(d) The board shall not take action against a pharmacy for a violation of this section if both of the following apply:
(1)CA Business & Professions Code § 4113.5(d)(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)CA Business & Professions Code § 4113.5(d)(2) The pharmacy takes all reasonable action to make another employee available to assist the pharmacist.
(e)CA Business & Professions Code § 4113.5(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.

Section § 4113.6

Explanation

In California, chain community pharmacies must have at least one clerk or pharmacy technician on duty at all times to handle pharmacy services. However, there are exceptions where this is not required. These include situations where the pharmacist waives the requirement, if the pharmacy is operating outside normal hours (before 8:00 a.m. and after 7:00 p.m.), or if the pharmacy handles fewer than 75 prescriptions daily, unless additional services like vaccinations are also provided. Additionally, if a pharmacy doesn't have overlapping pharmacist hours, it must establish and publicize a lunch break for all staff.

(a)CA Business & Professions Code § 4113.6(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)CA Business & Professions Code § 4113.6(a)(1) The pharmacist on duty waives the requirement in writing during specified hours based on workload need.
(2)CA Business & Professions Code § 4113.6(a)(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)CA Business & Professions Code § 4113.6(a)(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)CA Business & Professions Code § 4113.6(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.

Section § 4113.7

Explanation

This law prohibits chain community pharmacies from setting quotas for pharmacists and pharmacy technicians on tasks that require a professional license, like filling prescriptions or providing patient services. It also bans communicating these quotas, if they exist, to their pharmacists or technicians. A quota is generally a set number or formula, such as prescriptions filled or revenue generated. However, the law allows for other ways to evaluate staff performance, as long as they don't rely on quotas. Chain pharmacies can have policies to assess staff competency, but these must not involve quotas.

(a)CA Business & Professions Code § 4113.7(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)CA Business & Professions Code § 4113.7(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)Copy CA Business & Professions Code § 4113.7(c)
(1)Copy CA Business & Professions Code § 4113.7(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)CA Business & Professions Code § 4113.7(c)(1)(A) Prescriptions filled.
(B)CA Business & Professions Code § 4113.7(c)(1)(B) Services rendered to patients.
(C)CA Business & Professions Code § 4113.7(c)(1)(C) Programs offered to patients.
(D)CA Business & Professions Code § 4113.7(c)(1)(D) Revenue obtained.
(2)CA Business & Professions Code § 4113.7(c)(2) For purposes of this section, “quota” does not mean any of the following:
(A)CA Business & Professions Code § 4113.7(c)(2)(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)CA Business & Professions Code § 4113.7(c)(2)(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)CA Business & Professions Code § 4113.7(c)(2)(C) Any performance metric required by state or federal regulators that does not use quotas, as defined in paragraph (1).
(d)CA Business & Professions Code § 4113.7(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).

Section § 4114

Explanation

This law allows intern pharmacists to do everything a licensed pharmacist can, but only if a licensed pharmacist closely supervises them. However, one pharmacist can supervise no more than two intern pharmacists at a time.

(a)CA Business & Professions Code § 4114(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)CA Business & Professions Code § 4114(b) A pharmacist may not supervise more than two intern pharmacists at any one time.

Section § 4115

Explanation

This law outlines what pharmacy technicians are allowed to do and under what conditions. They can perform basic, non-judgmental tasks like packaging under a pharmacist's supervision. They can also give flu and COVID-19 vaccines, handle emergencies, and help with certain tests if specific requirements are met, such as having extra training and certifications. A pharmacist must always be on duty and oversee the technician's work. Additionally, specific rules about how many technicians can work under a single pharmacist are detailed, varying by setting like hospitals or corrections facilities. The law ensures pharmacists retain overall responsibility for tasks and can refuse to supervise if they feel it affects their job performance.

(a)CA Business & Professions Code § 4115(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)Copy CA Business & Professions Code § 4115(b)
(1)Copy CA Business & Professions Code § 4115(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)CA Business & Professions Code § 4115(b)(1)(A) The pharmacy has scheduled another pharmacy technician to assist the pharmacist by performing the tasks provided in subdivision (a).
(B)CA Business & Professions Code § 4115(b)(1)(B) The pharmacy technician is certified pursuant to paragraph (4) of subdivision (a) of Section 4202 and maintains that certification.
(C)CA Business & Professions Code § 4115(b)(1)(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)CA Business & Professions Code § 4115(b)(1)(D) The pharmacy technician is certified in basic life support.
(2)CA Business & Professions Code § 4115(b)(2) “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; Public Law 100-578).
(c)CA Business & Professions Code § 4115(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)CA Business & Professions Code § 4115(d) This section does not authorize a pharmacy technician to perform any act requiring the exercise of professional judgment by a pharmacist.
(e)CA Business & Professions Code § 4115(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)CA Business & Professions Code § 4115(f) A person shall not act as a pharmacy technician without first being licensed by the board as a pharmacy technician.
(g)Copy CA Business & Professions Code § 4115(g)
(1)Copy CA Business & Professions Code § 4115(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)CA Business & Professions Code § 4115(g)(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)CA Business & Professions Code § 4115(g)(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)CA Business & Professions Code § 4115(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)CA Business & Professions Code § 4115(i) The pharmacist on duty shall be directly responsible for the conduct of a pharmacy technician supervised by that pharmacist.
(j)CA Business & Professions Code § 4115(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)CA Business & Professions Code § 4115(j)(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)CA Business & Professions Code § 4115(j)(2) Sealing emergency containers for use in the health care facility.
(3)CA Business & Professions Code § 4115(j)(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.

Section § 4115.5

Explanation

This law allows pharmacy technician trainees to gain practical experience through externships in pharmacies as part of their training to become licensed. The trainees can only work under the direct supervision of a pharmacist, who is responsible for their actions and must verify any prescriptions they prepare. Each pharmacist can supervise only one trainee at a time. The externship must last between 120 to 140 hours, but can go up to 340 hours if it includes rotations between community and hospital pharmacies. These training periods need to fit within a specific timeframe: up to six months in a community pharmacy or a total of 12 months if there are rotations. Trainees must also wear an ID that shows their status as a trainee.

(a)CA Business & Professions Code § 4115.5(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)Copy CA Business & Professions Code § 4115.5(b)
(1)Copy CA Business & Professions Code § 4115.5(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)CA Business & Professions Code § 4115.5(b)(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)CA Business & Professions Code § 4115.5(b)(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)CA Business & Professions Code § 4115.5(b)(4) A pharmacist may only supervise one pharmacy technician trainee at any given time.
(5)CA Business & Professions Code § 4115.5(b)(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)Copy CA Business & Professions Code § 4115.5(c)
(1)Copy CA Business & Professions Code § 4115.5(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)CA Business & Professions Code § 4115.5(c)(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)CA Business & Professions Code § 4115.5(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)CA Business & Professions Code § 4115.5(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.

Section § 4116

Explanation

Only certain individuals, like pharmacists and those authorized by law, are allowed in areas where controlled substances or dangerous drugs are handled. While pharmacists can let others enter for tasks like delivery or cleaning, the pharmacist must be present. The law also allows regulations for security measures to prevent unauthorized access, even detailing how security should be maintained when a pharmacist is on a short break without having to close the pharmacy. These rules allow nonpharmacist staff to continue certain duties during the pharmacist's brief absence, as long as security is maintained.

(a)CA Business & Professions Code § 4116(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)Copy CA Business & Professions Code § 4116(b)
(1)Copy CA Business & Professions Code § 4116(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)CA Business & Professions Code § 4116(b)(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.

Section § 4117

Explanation

This law specifies who can be present in certain areas of a licensed hospital where controlled or dangerous drugs and devices are handled. Only a limited group, including pharmacists, pharmacy interns, pharmacy technicians, specific medical staff, law enforcement, and those performing specific authorized tasks, are allowed in these areas.

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.

Section § 4118

Explanation

This law allows the board to waive certain pharmacy licensing requirements if a pharmacy or hospital pharmacy can still provide high-quality and safe patient care. For hospital pharmacies, any granted waiver means their pharmaceutical services can only be for patients being treated in the hospital, including emergency cases, regardless of whether they are staying in the hospital.

(a)CA Business & Professions Code § 4118(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)CA Business & Professions Code § 4118(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.

Section § 4118.5

Explanation

This law requires hospital pharmacists to get a detailed list of medications for high-risk patients when they are admitted to hospitals with more than 100 beds. Pharmacy technicians or interns can also perform this task if the hospital pharmacy has a quality assurance program and proper training is provided to them. The hospital must define high-risk patients and set timelines for completing these medication lists. This rule does not apply to state mental hospitals, and it doesn't prevent other licensed health professionals from obtaining medication lists.

(a)CA Business & Professions Code § 4118.5(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)CA Business & Professions Code § 4118.5(a)(1) The hospital has more than 100 beds.
(2)CA Business & Professions Code § 4118.5(a)(2) The accurate medication profile or list may be acquired by the pharmacist during the hospital pharmacy’s hours of operation.
(b)CA Business & Professions Code § 4118.5(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)CA Business & Professions Code § 4118.5(b)(1) The hospital pharmacy has a quality assurance program to monitor competency.
(2)CA Business & Professions Code § 4118.5(b)(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)CA Business & Professions Code § 4118.5(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)CA Business & Professions Code § 4118.5(d) The board may adopt rules and regulations to carry out the purposes and objectives of this section.
(e)CA Business & Professions Code § 4118.5(e) This section shall not apply to the State Department of State Hospitals.
(f)CA Business & Professions Code § 4118.5(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.

Section § 4119

Explanation

This law allows pharmacies to provide certain dangerous drugs or devices to health care facilities and emergency services for emergency use. For health care facilities, these supplies must be kept in a secure emergency container and approved by specific committees. They also must comply with state health regulations, and can include up to 48 drugs in oral or suppository forms. For emergency services like ambulances, the drugs and devices must be within the scope of practice for emergency medical technicians and only used for prehospital emergency care. The emergency providers need to submit a written request, keep accurate records, and follow local agency procedures for storing and restocking these supplies. Both the providers and pharmacies must keep records for at least three years. Additionally, the handling of controlled substances for emergencies must follow specific state laws.

(a)CA Business & Professions Code § 4119(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)CA Business & Professions Code § 4119(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)CA Business & Professions Code § 4119(b)(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)CA Business & Professions Code § 4119(b)(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)CA Business & Professions Code § 4119(b)(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)CA Business & Professions Code § 4119(b)(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)CA Business & Professions Code § 4119(b)(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).

Section § 4119.01

Explanation

This law allows certain pharmacies and licensed wholesalers that are emergency medical services (EMS) agencies to restock their emergency medical supplies using an automated drug delivery system (EMSADDS). The system must be located at an EMS provider's facility, such as a fire station. The EMSADDS must be licensed and have strict controls and policies in place for inventory, security, and handling of drugs. Authorized personnel such as a medical director, pharmacists, or licensed paramedics are responsible for maintaining the system, tracking drug movements, and conducting monthly inventories to ensure accuracy and security. Any shortages or suspicious activities must be reported. Unauthorized access is prohibited and any violations are considered unprofessional conduct, which can result in disciplinary action.

(a)CA Business & Professions Code § 4119.01(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)CA Business & Professions Code § 4119.01(a)(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)CA Business & Professions Code § 4119.01(a)(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)CA Business & Professions Code § 4119.01(a)(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)CA Business & Professions Code § 4119.01(a)(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)CA Business & Professions Code § 4119.01(a)(4)(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)CA Business & Professions Code § 4119.01(a)(4)(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)CA Business & Professions Code § 4119.01(a)(4)(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)CA Business & Professions Code § 4119.01(a)(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)CA Business & Professions Code § 4119.01(a)(5)(A) A physical count of all quantities of dangerous drugs and dangerous devices stored in the EMSADDS.
(B)CA Business & Professions Code § 4119.01(a)(5)(B) A review of all dangerous drugs and dangerous devices added into and removed from each EMSADDS since the last monthly inventory.
(C)CA Business & Professions Code § 4119.01(a)(5)(C) A comparison of subparagraphs (A) and (B), and identification of any variances.
(D)CA Business & Professions Code § 4119.01(a)(5)(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)CA Business & Professions Code § 4119.01(a)(5)(E) Identification of possible causes of shortages and overages.
(6)CA Business & Professions Code § 4119.01(a)(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)CA Business & Professions Code § 4119.01(a)(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)CA Business & Professions Code § 4119.01(a)(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)CA Business & Professions Code § 4119.01(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)CA Business & Professions Code § 4119.01(c) This section shall become operative on January 1, 2025.

Section § 4119.10

Explanation

This law allows pharmacies in California to use pharmacists to conduct certain low-risk tests that are approved by the FDA, as long as they follow specific guidelines. Pharmacies must have a lab license and maintain detailed procedures for training and safety, including protecting both staff and consumers. They must provide results in writing, adhere to reporting requirements, and have a system for following up on positive results. The pharmacist in charge is also responsible for annual policy reviews and ensuring proper documentation for at least three years. Some kinds of specimen collections are not allowed, like vaginal swabs and blood draws. Tests administered must be authorized for pharmacists to perform.

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)CA Business & Professions Code § 4119.10(a) The pharmacy is appropriately licensed as a laboratory under Section 1265.
(b)CA Business & Professions Code § 4119.10(b) The pharmacy maintains policies and procedures that do all of the following:
(1)CA Business & Professions Code § 4119.10(b)(1) Establish the initial training requirements, including specimen collection techniques relevant to a test being performed at the pharmacy, and ongoing training.
(2)CA Business & Professions Code § 4119.10(b)(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)CA Business & Professions Code § 4119.10(b)(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)CA Business & Professions Code § 4119.10(b)(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)CA Business & Professions Code § 4119.10(b)(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)CA Business & Professions Code § 4119.10(b)(6) Ensure documentation of testing equipment maintenance and calibration.
(7)CA Business & Professions Code § 4119.10(b)(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)CA Business & Professions Code § 4119.10(c) The test is authorized to be administered by a pharmacist pursuant to paragraph (1) of subdivision (b) of Section 4052.4.
(d)CA Business & Professions Code § 4119.10(d) The pharmacist-in-charge does both of the following:
(1)CA Business & Professions Code § 4119.10(d)(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)CA Business & Professions Code § 4119.10(d)(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)CA Business & Professions Code § 4119.10(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.

Section § 4119.11

Explanation

This law allows certain pharmacies in the state to use automated systems to dispense drugs to patients of specific health organizations (covered entities). To do this, pharmacies must get a special license for each location and follow strict rules. For example, they must be responsible for security, train staff, and maintain accurate transaction records. Patients must provide informed consent, and pharmacists must supervise the systems even if they're not on-site. Each machine requires a separate license, and there are limits on how many licenses a pharmacy can hold. The law covers everything from how the systems are stocked to keeping records of their use.

(a)CA Business & Professions Code § 4119.11(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)CA Business & Professions Code § 4119.11(a)(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)CA Business & Professions Code § 4119.11(a)(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)CA Business & Professions Code § 4119.11(a)(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)CA Business & Professions Code § 4119.11(a)(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)CA Business & Professions Code § 4119.11(a)(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.
(6)CA Business & Professions Code § 4119.11(a)(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)CA Business & Professions Code § 4119.11(a)(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)CA Business & Professions Code § 4119.11(a)(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)CA Business & Professions Code § 4119.11(a)(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)CA Business & Professions Code § 4119.11(a)(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)CA Business & Professions Code § 4119.11(a)(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)CA Business & Professions Code § 4119.11(b) For purposes of this section, the following definitions shall apply:
(1)CA Business & Professions Code § 4119.11(b)(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)CA Business & Professions Code § 4119.11(b)(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)CA Business & Professions Code § 4119.11(b)(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)Copy CA Business & Professions Code § 4119.11(c)
(1)Copy CA Business & Professions Code § 4119.11(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)CA Business & Professions Code § 4119.11(c)(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)CA Business & Professions Code § 4119.11(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient, if all of the following requirements are met:
(1)CA Business & Professions Code § 4119.11(d)(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:
(A)CA Business & Professions Code § 4119.11(d)(1)(A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system.
(B)CA Business & Professions Code § 4119.11(d)(1)(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)CA Business & Professions Code § 4119.11(d)(1)(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)CA Business & Professions Code § 4119.11(d)(1)(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)CA Business & Professions Code § 4119.11(d)(1)(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)CA Business & Professions Code § 4119.11(d)(1)(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)CA Business & Professions Code § 4119.11(d)(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)CA Business & Professions Code § 4119.11(d)(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)CA Business & Professions Code § 4119.11(d)(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)CA Business & Professions Code § 4119.11(d)(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)CA Business & Professions Code § 4119.11(d)(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)CA Business & Professions Code § 4119.11(d)(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)CA Business & Professions Code § 4119.11(d)(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)CA Business & Professions Code § 4119.11(d)(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)CA Business & Professions Code § 4119.11(d)(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)CA Business & Professions Code § 4119.11(d)(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)CA Business & Professions Code § 4119.11(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)CA Business & Professions Code § 4119.11(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)CA Business & Professions Code § 4119.11(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)CA Business & Professions Code § 4119.11(g)(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)CA Business & Professions Code § 4119.11(g)(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)CA Business & Professions Code § 4119.11(g)(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)CA Business & Professions Code § 4119.11(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)CA Business & Professions Code § 4119.11(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)CA Business & Professions Code § 4119.11(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)CA Business & Professions Code § 4119.11(k) This section shall become operative on January 1, 2025.

Section § 4119.2

Explanation

This law allows pharmacies to provide epinephrine auto-injectors to schools, including school districts, county education offices, and charter schools, but there are conditions. These auto-injectors must be specifically for use at the school location and come with a doctor's written order detailing how many are needed. Schools have to keep track of these supplies for three years and make sure expired ones are disposed of properly.

(a)CA Business & Professions Code § 4119.2(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)CA Business & Professions Code § 4119.2(a)(1) The epinephrine auto-injectors are furnished exclusively for use at a school district site, county office of education, or charter school.
(2)CA Business & Professions Code § 4119.2(a)(2) A physician and surgeon provides a written order that specifies the quantity of epinephrine auto-injectors to be furnished.
(b)CA Business & Professions Code § 4119.2(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.

Section § 4119.3

Explanation

This law allows pharmacies to give epinephrine auto-injectors to emergency medical workers or trained civilians for emergency situations. A doctor must write a special prescription that confirms the person is trained to handle such emergencies. The epinephrine must be labeled with specific details like the recipient's name and usage instructions. The people receiving these must keep records for five years detailing their use, and the auto-injectors can only be used as described in the law.

(a)CA Business & Professions Code § 4119.3(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)CA Business & Professions Code § 4119.3(a)(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)Copy CA Business & Professions Code § 4119.3(a)(2)
(A)Copy CA Business & Professions Code § 4119.3(a)(2)(A) The pharmacy shall label each epinephrine auto-injector dispensed with all of the following:
(i)CA Business & Professions Code § 4119.3(a)(2)(A)(i) The name of the person to whom the prescription was issued.
(ii)CA Business & Professions Code § 4119.3(a)(2)(A)(ii) The designations “Section 1797.197a Responder” and “First Aid Purposes Only.”
(iii)CA Business & Professions Code § 4119.3(a)(2)(A)(iii) The dosage, use, and expiration date.
(B)CA Business & Professions Code § 4119.3(a)(2)(A)(B) Each dispensed prescription shall include the manufacturer’s product information sheet for the epinephrine auto-injector.
(b)CA Business & Professions Code § 4119.3(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)CA Business & Professions Code § 4119.3(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.

Section § 4119.4

Explanation

This law allows pharmacies to provide epinephrine auto-injectors to authorized entities, like schools or businesses, for emergency use following specific guidelines. An authorized healthcare provider must write a prescription stating how many are needed. Each auto-injector must be labeled with the recipient's name, a specific emergency designation, dosage, usage, and expiration details. Pharmacies must include the manufacturer's information sheet with each injector. Entities receiving them must keep detailed records for three years and ensure expired injectors are destroyed. These auto-injectors are strictly for emergency allergic reactions as per the related health code.

(a)CA Business & Professions Code § 4119.4(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)CA Business & Professions Code § 4119.4(a)(1) The epinephrine auto-injectors are furnished exclusively for use by, or in connection with, an authorized entity.
(2)CA Business & Professions Code § 4119.4(a)(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)CA Business & Professions Code § 4119.4(b) The pharmacy shall label each epinephrine auto-injector dispensed with all of the following:
(1)CA Business & Professions Code § 4119.4(b)(1) The name of the person or entity to whom the prescription was issued.
(2)CA Business & Professions Code § 4119.4(b)(2) The designations “Section 1797.197a Responder” and “First Aid Purposes Only.”
(3)CA Business & Professions Code § 4119.4(b)(3) The dosage, use, and expiration date.
(c)CA Business & Professions Code § 4119.4(c) Each dispensed prescription shall include the manufacturer’s product information sheet for the epinephrine auto-injector.
(d)CA Business & Professions Code § 4119.4(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)CA Business & Professions Code § 4119.4(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)CA Business & Professions Code § 4119.4(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.

Section § 4119.5

Explanation

This law allows a pharmacy to give a limited amount of certain drugs, called 'dangerous drugs,' to another pharmacy. It also lets pharmacies repackage these drugs or devices and provide them to doctors for use in their offices.

(a)CA Business & Professions Code § 4119.5(a) A pharmacy can transfer a reasonable supply of dangerous drugs to another pharmacy.
(b)CA Business & Professions Code § 4119.5(b) A pharmacy may repackage and furnish to a prescriber a reasonable quantity of dangerous drugs and dangerous devices for prescriber office use.

Section § 4119.6

Explanation

This law allows intern pharmacists, who are supervised directly by a licensed pharmacist, to manage the emergency pharmaceutical supplies and emergency medical system supplies at certain healthcare facilities.

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.

Section § 4119.7

Explanation

This law allows hospital pharmacies serving certain licensed healthcare facilities to provide dangerous drugs and devices through prewritten or electronic orders, as long as these orders are dated, timed, and recorded in the patient's medical records. Facilities must store drugs according to national standards and manufacturer guidelines. Pharmacist interns can inspect the stored drugs monthly under supervision, and specific policies must be in place for these tasks. A 'health care facility' here specifically refers to those licensed under a particular section of the Health and Safety Code.

(a)CA Business & Professions Code § 4119.7(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)CA Business & Professions Code § 4119.7(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)CA Business & Professions Code § 4119.7(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)CA Business & Professions Code § 4119.7(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.

Section § 4119.8

Explanation

This law allows pharmacies to provide naloxone or other opioid antidotes to schools, but only for use on school premises. A doctor must specify how much can be provided. Schools must keep these antidotes for three years, ensure they don't run out, and dispose of any that expire.

(a)CA Business & Professions Code § 4119.8(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)CA Business & Professions Code § 4119.8(a)(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)CA Business & Professions Code § 4119.8(a)(2) A physician and surgeon provides a written order that specifies the quantity of naloxone hydrochloride or another opioid antagonist to be furnished.
(b)CA Business & Professions Code § 4119.8(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.

Section § 4119.9

Explanation

This law allows pharmacies, wholesalers, or manufacturers to provide naloxone, a drug that can reverse opioid overdoses, to law enforcement agencies. The agencies can use it if they train their employees on how to administer it. Agencies must keep records of naloxone supplies for three years and monitor and properly discard expired doses.

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)CA Business & Professions Code § 4119.9(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)CA Business & Professions Code § 4119.9(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.

Section § 4120

Explanation

This law states that pharmacies located outside of California must register with the state if they want to sell or distribute dangerous drugs or devices in California, unless they do so through a licensed wholesaler or logistics provider. The registration process involves an application provided by the board, which may request pertinent information. The law clarifies that this registration does not affect the pharmacy's state tax obligations or imply that the pharmacy is conducting business in the state.

(a)CA Business & Professions Code § 4120(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)CA Business & Professions Code § 4120(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)CA Business & Professions Code § 4120(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)CA Business & Professions Code § 4120(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.

Section § 4121

Explanation

This law specifies how pharmacies can advertise the retail prices of prescription drugs. They must only advertise prices for amounts of the drug that align with good medical practice, and they must include details like the drug's strength, dosage form, and the exact dates the price will be valid. However, this rule does not apply to pharmacies within hospitals that are only accessible to hospital staff.

(a)CA Business & Professions Code § 4121(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)CA Business & Professions Code § 4121(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.

Section § 4122

Explanation

This law requires every pharmacy to display a notice about the availability of prescription price information, the option to choose generic drugs, the services offered, and patient rights. Pharmacists must provide a drug's current price when asked. If someone requests prices for more than five drugs without valid prescriptions, the pharmacy can make them submit the request in writing and may charge a fee. Pharmacies don't have to provide drug prices over the phone for controlled substances, respond to competitors, or out-of-state requests. Hospital-only pharmacies are exempt from these rules.

(a)CA Business & Professions Code § 4122(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)CA Business & Professions Code § 4122(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)CA Business & Professions Code § 4122(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)CA Business & Professions Code § 4122(c)(1) The request shall be in writing.
(2)CA Business & Professions Code § 4122(c)(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)CA Business & Professions Code § 4122(c)(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)CA Business & Professions Code § 4122(c)(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)CA Business & Professions Code § 4122(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)CA Business & Professions Code § 4122(e) Notwithstanding any other provision of this section, no pharmacy shall be required to do any of the following:
(1)CA Business & Professions Code § 4122(e)(1) Provide the price of any controlled substance in response to a telephone request.
(2)CA Business & Professions Code § 4122(e)(2) Respond to a request from a competitor.
(3)CA Business & Professions Code § 4122(e)(3) Respond to a request from an out-of-state requester.

Section § 4123

Explanation

If a pharmacy makes a special drug mixture for injection or IV use and sends it to another pharmacy, they must inform the pharmacy board within 30 days of starting this service.

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.

Section § 4124

Explanation

This law allows pharmacists to dispense replacement contact lenses if they have a valid prescription from a doctor or optometrist, but pharmacists can't fit or adjust the lenses. The lenses must be packaged as sold by the manufacturer and can only be sold with a prescription that includes specific details and is valid for no more than a year after the last exam. The exact lenses prescribed must be dispensed. Pharmacists must warn patients about potential eye issues and direct them to see an eye care professional if problems occur. Pharmacies must also register with the Medical Board of California and keep records for three years, including any contact lenses sent into California.

(a)CA Business & Professions Code § 4124(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)CA Business & Professions Code § 4124(b) No replacement contact lenses may be sold or dispensed except pursuant to a prescription that meets all of the following requirements:
(1)CA Business & Professions Code § 4124(b)(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)CA Business & Professions Code § 4124(b)(2) Explicitly states an expiration date of not more than one year from the date of the last prescribing examination.
(3)CA Business & Professions Code § 4124(b)(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)CA Business & Professions Code § 4124(c) The contact lenses that are dispensed shall be the exact contact lenses that have been prescribed, and no substitutions shall be made.
(d)CA Business & Professions Code § 4124(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)CA Business & Professions Code § 4124(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)CA Business & Professions Code § 4124(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)CA Business & Professions Code § 4124(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)CA Business & Professions Code § 4124(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)CA Business & Professions Code § 4124(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.

Section § 4125

Explanation

Pharmacies must have a quality assurance program to document and assess medication errors related to their staff or operations, aiming to prevent future mistakes. Records from this program are protected as peer review documents and are generally not accessible in legal proceedings unless needed for public health safety checks or when fraud is involved. Patients can still access their own prescription records. This rule has been in effect since January 1, 2002.

(a)CA Business & Professions Code § 4125(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)CA Business & Professions Code § 4125(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)CA Business & Professions Code § 4125(c) This section shall become operative on January 1, 2002.

Section § 4126

Explanation

This section allows certain healthcare entities to make contracts with pharmacies to provide discounted medications to patients. These special-priced drugs must be kept separate from other drugs at the pharmacy, and records of these transactions should be easily accessible. If circumstances change and the pharmacy can't distribute these drugs, they must return them to the supplier. Pharmacies involved in such contracts can’t hold both pharmacy and wholesaler licenses. Additionally, neither healthcare entities nor pharmacies need a wholesaler license to participate in this drug program.

(a)CA Business & Professions Code § 4126(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)CA Business & Professions Code § 4126(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)CA Business & Professions Code § 4126(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)CA Business & Professions Code § 4126(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)CA Business & Professions Code § 4126(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.

Section § 4126.10

Explanation

This law states that pharmacies in California can send out their custom-made drugs to other states if they follow specific rules. They have to submit certain reports between January 1 and March 31 about the previous year’s activities through a network set up by the national association and the FDA. Every year, when renewing their license, they need to formally confirm they’ve done this reporting. If any problems with the drug or its quality happen, they must tell the board within 12 hours. Also, the information submitted is not open to public access as it’s protected under public record laws.

(a)CA Business & Professions Code § 4126.10(a) A pharmacy located in California may distribute compounded human drug preparations interstate only if all of the following conditions are met:
(1)CA Business & Professions Code § 4126.10(a)(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)CA Business & Professions Code § 4126.10(a)(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)CA Business & Professions Code § 4126.10(a)(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)CA Business & Professions Code § 4126.10(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).

Section § 4126.5

Explanation

This law explains when a pharmacy or clinic can supply dangerous drugs, essentially controlling how these drugs are distributed to ensure safety and continuity of care. Pharmacies are allowed to distribute drugs back to their suppliers, to licensed wholesalers, other pharmacies, or directly to patients, especially during shortages or emergencies. Clinics have similar allowances and can distribute medications to other clinics or patients during emergencies. Violations of these rules can lead to financial penalties. The law also describes "common control" as having the power to manage or influence a company’s actions and decisions through ownership or contracts. Fines collected from violations go into a specific fund for the Pharmacy Board.

(a)CA Business & Professions Code § 4126.5(a) A pharmacy may furnish dangerous drugs only to the following:
(1)CA Business & Professions Code § 4126.5(a)(1) A wholesaler owned or under common control by the wholesaler from whom the dangerous drug was acquired.
(2)CA Business & Professions Code § 4126.5(a)(2) The pharmaceutical manufacturer from whom the dangerous drug was acquired.
(3)CA Business & Professions Code § 4126.5(a)(3) A licensed wholesaler acting as a reverse distributor.
(4)CA Business & Professions Code § 4126.5(a)(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)CA Business & Professions Code § 4126.5(a)(5) A patient or to another pharmacy pursuant to a prescription or as otherwise authorized by law.
(6)CA Business & Professions Code § 4126.5(a)(6) A health care provider that is not a pharmacy but that is authorized to purchase dangerous drugs.
(7)CA Business & Professions Code § 4126.5(a)(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)CA Business & Professions Code § 4126.5(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)CA Business & Professions Code § 4126.5(b)(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)CA Business & Professions Code § 4126.5(b)(2) A patient pursuant to a prescription or as otherwise authorized by law.
(3)CA Business & Professions Code § 4126.5(b)(3) A health care provider that is not a clinic but that is authorized to purchase dangerous drugs.
(4)CA Business & Professions Code § 4126.5(b)(4) To another clinic under common control, including a mobile clinic, as described in subdivision (c) of Section 4062.
(c)CA Business & Professions Code § 4126.5(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)CA Business & Professions Code § 4126.5(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)CA Business & Professions Code § 4126.5(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.

Section § 4126.8

Explanation

This law states that when pharmacies in the state mix or prepare drugs, they must follow the standards set in the United States Pharmacopeia-National Formulary. This includes following testing and quality checks. Additionally, the governing board has the authority to create more rules if needed to ensure the safe mixing of drugs.

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.

Section § 4126.9

Explanation

This law says that if a pharmacy finds out one of their nonsterile compounded drugs has been recalled due to serious health risks or being life-threatening, they need to contact the patient, doctor, or pharmacy that received it within 12 hours. If the patient got the drug directly, the pharmacy must tell the patient. If a doctor got it, the pharmacy should tell the doctor, and the doctor must inform the patient. If a pharmacy received it, they should tell the doctor or patient, and if the doctor is told, they need to inform the patient. Additionally, if a patient is harmed due to these drugs, the pharmacy must report it to MedWatch within 72 hours.

(a)CA Business & Professions Code § 4126.9(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)CA Business & Professions Code § 4126.9(a)(1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death.
(2)CA Business & Professions Code § 4126.9(a)(2) The recalled drug was dispensed, or is intended for use, in this state.
(b)CA Business & Professions Code § 4126.9(b) A recall notice issued pursuant to subdivision (a) shall be made as follows:
(1)CA Business & Professions Code § 4126.9(b)(1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient.
(2)CA Business & Professions Code § 4126.9(b)(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)CA Business & Professions Code § 4126.9(b)(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)CA Business & Professions Code § 4126.9(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.