CPJE (California) California Practice Standards and Jurisprudence Examination

Correct: Under California Business and Professions Code and the federal Drug Quality and Security Act, compounding must be for a specific patient based on a valid prescription. Distributing compounded preparations to other pharmacies for the purpose of resale is classified as manufacturing. This activity requires the pharmacy to be licensed as a manufacturer by the California Department of Public Health Food and Drug Branch and to register with the FDA as a manufacturer.

Incorrect: The 5 percent rule typically applies to the transfer of existing manufactured dangerous drugs between pharmacies to alleviate a temporary shortage, not to the distribution of compounded products for retail sale. While master formula records and potency testing are essential for compounding standards under California Code of Regulations Title 16 Section 1735.2, they do not authorize a pharmacy to act as a wholesaler of compounded goods. Providing products for office use is restricted to a prescriber for administration to their own patients and does not permit a pharmacy to supply another pharmacy for resale purposes, regardless of accreditation status.

Takeaway: Compounding for the purpose of wholesale distribution or resale to other pharmacies is legally defined as manufacturing and requires appropriate state and federal manufacturing licenses.

Correct: Under California Business and Professions Code Section 4052.03, a pharmacist is authorized to furnish a complete 28-day course of HIV post-exposure prophylaxis (PEP). The pharmacist must ensure the patient has had a negative HIV test within the previous seven days or must order or perform an HIV test. Mandatory counseling must be provided, and the pharmacist is legally required to notify the patient’s primary care provider of the treatment, or provide the patient with a list of providers if they do not have one.

Incorrect: Furnishing only a 7-day starter supply is incorrect because California law specifically allows for the provision of the full 28-day course to facilitate adherence and completion of the regimen. Requiring a waiver for HIV testing is incorrect because the pharmacist is legally mandated to ensure testing occurs; the patient cannot waive this regulatory requirement for the pharmacist to furnish the medication. Withholding notification to the primary care provider is incorrect because the statute mandates notification to ensure continuity of care, regardless of the patient’s preference for total anonymity from their existing medical team.

Takeaway: California pharmacists must furnish a full 28-day course of PEP, ensure HIV testing is conducted, provide counseling, and satisfy primary care notification requirements.

Correct: California Business and Professions Code Section 4115 specifies that in a community pharmacy setting, the ratio of pharmacists to pharmacy technicians is strictly regulated to ensure public safety. For the first pharmacist on duty, the law permits only one pharmacy technician. For each additional pharmacist working at the same time, the ratio increases to two pharmacy technicians for each of those additional pharmacists. This tiered approach ensures that the initial supervision remains focused while allowing for greater operational scale as more licensed supervisors are present.

Incorrect: Maintaining a consistent two-to-one ratio for all pharmacists on duty is incorrect because it ignores the specific restriction placed on the first pharmacist, who is limited to a one-to-one ratio. Utilizing a one-to-one ratio for all pharmacists regardless of the total number of staff is an overly restrictive interpretation that does not take advantage of the legal allowance for additional technicians per subsequent pharmacist. Increasing the ratio to three technicians for every two pharmacists during peak hours is a miscalculation of the statutory limit, as the law does not allow for a three-to-two aggregate ratio for the first two pharmacists; the limit for two pharmacists would be three technicians total.

Takeaway: In California community pharmacies, the maximum allowable technician-to-pharmacist ratio is 1:1 for the first pharmacist and 2:1 for each additional pharmacist.

Correct: Under California law, pharmacy permits are not transferable between entities or persons. When a change of ownership occurs, the prospective owner must submit a full application for a new pharmacy permit. To ensure that patient care is not interrupted during the transition, California Business and Professions Code allows the Board of Pharmacy to issue a temporary permit to the new owner. This temporary permit is valid for a period not to exceed 180 days and allows the pharmacy to operate while the permanent license application is being reviewed and processed.

Incorrect: Suggesting that a permit can be transferred by filing an affidavit or updating the name on an existing license is incorrect because California law explicitly states that licenses are non-transferable. Proposing a grace period where the pharmacy operates under the seller’s license is a regulatory violation, as the new owner must have their own legal authority to possess dangerous drugs and devices immediately upon the transfer of the business. Claiming that a new application is only necessary if the Pharmacist-in-Charge changes is a misconception; the license is tied to the ownership entity, and any change in the majority interest or the legal owner requires a new permit regardless of the professional staff.

Takeaway: Pharmacy permits in California are non-transferable and require a new application, though a temporary permit may be issued for up to 180 days to maintain continuity of operations.

Correct: Under California Code of Regulations Title 16, Section 1711, once a medication error is discovered, the pharmacist is legally mandated to immediately communicate the error to both the patient or their agent and the prescriber. The communication to the patient must include specific steps to avoid or mitigate any adverse reactions. This prioritization ensures patient safety is addressed before administrative tasks like formal Quality Assurance documentation are finalized.

Incorrect: Delaying notification to prioritize the completion of an internal Quality Assurance record is incorrect because California law requires immediate communication upon discovery, whereas the Quality Assurance report has a two-business-day window for completion. Deferring the decision to notify the patient based on a prescriber assessment of clinical significance is incorrect because the duty to inform the patient and prescriber is mandatory under California law once an error is identified. Instructing the patient to contact the prescriber themselves without the pharmacist also making direct contact with the prescriber fails to meet the regulatory requirement that the pharmacist must inform the prescriber of the error.

Takeaway: California law requires immediate notification of both the patient and the prescriber when a medication error is discovered, prioritizing patient safety and mitigation over administrative documentation.

Correct: Maintaining a current reference library that includes the latest edition of the California Pharmacy Law Book and other references necessary for the pharmacy’s specific scope of practice, while ensuring the facility has a sink with hot and cold running water. This approach is mandated by California Code of Regulations Title 16, Sections 1707.1 and 1714(b). Section 1707.1 specifically requires the latest edition of the state Law Book and other references tailored to the pharmacy’s services, while Section 1714(b) requires a sink with hot and cold running water to ensure sanitary conditions for drug preparation and dispensing.

Incorrect: Relying exclusively on a corporate-provided digital database and the USP as the sole legal reference is incorrect because California law specifically mandates the inclusion of the California Pharmacy Law Book in the reference library. Ensuring the pharmacy has a dedicated clean room for all medication preparation and a subscription to the Merck Manual is an incorrect application of the law, as clean rooms are not required for all types of medication preparation and the Merck Manual is not a specifically mandated reference. Maintaining a physical scale capable of weighing to 0.1mg and a printed copy of the Orange Book regardless of the pharmacy’s scope of practice is not required, as equipment must be appropriate for the specific services provided and the Orange Book is not the primary mandated reference under CCR 1707.1.

Takeaway: California pharmacies must maintain a current state Law Book and provide a sink with hot and cold running water to meet minimum practice standards.

Correct: Under California Business and Professions Code Section 4115 and California Code of Regulations Title 16, Section 1793.7, a pharmacy that provides services to a health facility licensed pursuant to Section 1250 of the Health and Safety Code, such as a hospital, is permitted a ratio of one pharmacist to two pharmacy technicians. This specific ratio applies to the inpatient setting and is intended to accommodate the unique workflow and medication distribution systems found in institutional environments. This ratio applies to all pharmacists on duty in the hospital setting, unlike the tiered ratio used in community pharmacy.

Incorrect: Applying a ratio of one pharmacist to one technician for the first pharmacist and one pharmacist to two technicians for each additional pharmacist is the standard for community or outpatient pharmacies, not inpatient hospital pharmacies. Maintaining a strict one-to-one ratio for all pharmacists is an overly restrictive interpretation that does not reflect the maximum allowance granted by California law for hospital settings. Permitting the pharmacist-in-charge or a hospital committee to determine a flexible ratio based on technician competency or patient acuity is incorrect, as the California Board of Pharmacy sets specific statutory limits that must be followed regardless of internal hospital policies or professional judgment regarding task complexity.

Takeaway: The maximum pharmacist-to-pharmacy technician ratio in a California licensed hospital pharmacy is one pharmacist to two pharmacy technicians.

Correct: Implementing a quality assurance program that requires semi-annual gloved fingertip testing and daily pressure differential monitoring is the correct approach. Under USP 797 standards and California Code of Regulations (CCR) Title 16, Section 1751.7, personnel involved in the preparation of Category 2 sterile preparations must undergo competency evaluations, including gloved fingertip and thumb sampling, at least every six months. Furthermore, CCR 1751.4 requires that the pressure differential between the buffer area and the ante-area be monitored and recorded at least daily when compounding is occurring to ensure the integrity of the ISO-classified environments.

Incorrect: The approach involving a Segregated Compounding Area (SCA) is incorrect because Category 2 compounded sterile preparations (CSPs) must be prepared in a cleanroom suite consisting of a buffer room and an ante-room; preparations made in an SCA are limited to Category 1 requirements and beyond-use dates. The approach suggesting annual media-fill testing is incorrect because USP 797 and California standards require this validation to be performed semi-annually (every six months) for personnel preparing Category 2 CSPs. The approach involving annual air sampling and higher room temperatures is incorrect because viable air sampling must be conducted at least every six months, and a room temperature of 24 degrees Celsius (75 degrees Fahrenheit) exceeds the recommended threshold for maintaining a controlled sterile environment and ensuring operator comfort during garbing.

Takeaway: California sterile compounding compliance for Category 2 preparations requires adhering to semi-annual personnel competency evaluations and daily documentation of environmental pressure differentials.

Correct: California Code of Regulations Section 1707.1 mandates that a pharmacy maintain a patient medication record for at least one year from the date when the last prescription was filled. This profile must include the patient’s full name, address, telephone number, age or date of birth, gender, and a comprehensive list of all known allergies, drug reactions, and idiosyncrasies to allow the pharmacist to perform a meaningful prospective drug utilization review.

Incorrect: One approach suggests retaining the profile for three years from the date of the first fill while relying on physicians for allergy data; however, California law requires retention for one year from the last fill and places the responsibility on the pharmacy to collect allergy information. Another approach focuses on updating profiles only when providers change or requiring height and weight for all adults; this is incorrect because profiles must be maintained for every patient regardless of provider changes, and height/weight are not universal requirements for the medication record under Section 1707.1. A third approach proposes a two-year retention period based on the expiration of the prescription; this is inconsistent with the specific one-year post-last-fill requirement and emphasizes non-mandatory information like emergency contacts over required clinical data.

Takeaway: California law requires pharmacies to maintain patient medication profiles containing specific demographic and clinical data for at least one year from the date of the last fill to ensure patient safety.

Correct: Under California Business and Professions Code Sections 4008 and 4081, the Board of Pharmacy has the authority to inspect any establishment holding a pharmacy permit during business hours. This includes the right to examine and copy all records of manufacture, sale, acquisition, or disposition of dangerous drugs. The pharmacist-in-charge or the pharmacist on duty must provide immediate access to these records without requiring a warrant or subpoena, as the power to inspect is a condition of maintaining a professional license in the state of California.

Incorrect: Requesting that the inspector return with a formal administrative subpoena or warrant is incorrect because the Board’s inspection authority is granted by statute, and BPC 4081 specifically mandates that records be open to inspection during business hours without such legal hurdles. Informing the inspector that records older than one year are stored off-site and will be available within 72 hours is incorrect because California law requires records to be maintained for at least three years, and while off-site storage is permitted with a Board-approved waiver, the records must be produced within 48 hours of a request. Restricting the removal of documents until a legal representative is present is incorrect because the Board has the statutory right to copy or remove records as part of their investigative and enforcement duties under the Pharmacy Law, and delaying an inspection can be considered a violation of the law.

Takeaway: California Board of Pharmacy inspectors have the legal authority to access, inspect, and copy all drug-related records during business hours without a warrant or prior notice.

Correct: Under California Business and Professions Code Section 4052.2, a pharmacist practicing in a non-health facility setting (such as a community pharmacy) who adjusts a drug regimen pursuant to a collaborative protocol must notify the initiating prescriber of the change within 24 hours. This regulatory requirement ensures that the primary care provider is kept current on the patient’s treatment plan while allowing the pharmacist to utilize their clinical expertise to optimize therapy efficiently.

Incorrect: Providing a written summary only at the end of the month fails to meet the strict 24-hour notification requirement mandated by California law for outpatient drug therapy management. Requiring verbal confirmation for every specific adjustment is the standard for a traditional prescription but is not required under a collaborative practice agreement, which is designed to streamline care by allowing the pharmacist to act independently within the protocol’s scope. Adjusting the regimen and updating the profile without notifying the physician at all is a violation of the collaborative practice standards, which require timely communication to maintain the integrated care model and patient safety.

Takeaway: In a California community pharmacy setting, pharmacists must notify the authorizing prescriber within 24 hours of making any adjustments to a patient’s drug regimen under a collaborative practice agreement.

Correct: Ceasing all operations within 48 hours after the termination of the declared state of emergency is a mandatory requirement under California Business and Professions Code Section 4110. This ensures that the temporary mobile unit is used strictly for the duration of the crisis and that standard pharmacy practice environments are restored as soon as the emergency status is lifted.

Incorrect: Operating indefinitely while a permanent structure is damaged is incorrect because the legal authority for a mobile pharmacy is tied specifically to the Governor’s declaration of emergency, not just the physical state of a building. Requiring a separate, independent license for the mobile unit is incorrect because California law allows a currently licensed pharmacy to operate the mobile unit as an extension of its existing license during the emergency. Requiring a Board inspector to be physically present for the dispensing of controlled substances is an unnecessary regulatory hurdle not found in the law; the mobile pharmacy must simply be under the control and management of a pharmacist who ensures security and record-keeping.

Takeaway: Mobile pharmacies in California must be operated by a licensed pharmacy and must conclude all activities within 48 hours of the emergency declaration’s end.

Correct: California law, specifically Business and Professions Code sections 4081 and 4333, requires that all records of manufacture, sale, acquisition, or disposition of dangerous drugs and devices, including controlled substances, be maintained for at least three years. Additionally, California Code of Regulations section 1707 requires that these records be kept on the licensed premises for at least one year from the date of the last entry. After this one-year period, a pharmacy may apply for a waiver to store records off-site, provided they remain retrievable within 48 hours.

Incorrect: Maintaining records for five years to align with Medicare Part D is a common administrative practice for reimbursement audits, but it does not accurately reflect the specific California pharmacy law mandate of three years for acquisition and disposition records. Maintaining records for only two years follows federal Drug Enforcement Administration (DEA) regulations under the Controlled Substances Act, but California law is stricter and takes precedence by requiring a three-year retention period. Moving records to off-site storage immediately upon receipt is a violation of California regulations, which mandate that records must remain on the licensed premises for at least one year before they are eligible for off-site storage.

Takeaway: California law requires pharmacies to retain controlled substance records for three years, with the first year of those records mandatory to be stored on the licensed premises.

Correct: Under California Business and Professions Code Section 4053, an applicant for a Designated Representative license must demonstrate at least one year of paid work experience in a capacity related to the distribution or dispensing of dangerous drugs or devices. This ensures the individual has practical knowledge of the supply chain and regulatory requirements before overseeing wholesale operations.

Incorrect: Requiring an Associate degree in a science-related field exceeds the minimum educational requirement, which is a high school diploma or its equivalent. Limiting a representative to three locations is incorrect because California law generally requires a designated representative to be at the licensed premises during operation and typically limits them to one site to ensure adequate supervision. Requiring a pharmacy technician license is incorrect as the Designated Representative is a distinct license category with its own qualifying criteria, and holding a technician license is not a prerequisite.

Takeaway: A Designated Representative must have a high school education and at least one year of relevant paid experience to qualify for licensure in California.

Correct: In California, pharmacy clerks are permitted to perform non-discretionary tasks such as data entry, requesting refill authorizations, and handling sales, but they are strictly prohibited from pulling drugs from stock or counting medications. Pharmacy technicians are authorized to perform these additional non-discretionary tasks, including pulling stock and counting or pouring medications, provided they are under the direct supervision of a pharmacist. This division ensures that only those with specific registration and training handle the physical drug product during the filling process.

Incorrect: One approach suggests a clerk may pull stock bottles from the shelf to assist with workflow, which is prohibited under California law as clerks cannot handle the actual medication containers for the purpose of filling. This same approach incorrectly allows a technician to perform a final check, which is a discretionary task reserved solely for the pharmacist. Another approach allows a clerk to count medications or a technician to provide counseling; however, counting is restricted to technicians, interns, or pharmacists, and counseling is a professional judgment task reserved strictly for pharmacists or supervised interns. Finally, an approach suggests a clerk can take a new oral prescription or a technician can transfer a prescription; California law requires a pharmacist or pharmacist intern to receive new oral prescriptions and perform prescription transfers.

Takeaway: While both clerks and technicians perform non-discretionary tasks in California, only technicians are permitted to pull, count, and pour medications, while tasks involving professional judgment or clinical communication remain restricted to pharmacists.

Correct: Ensuring the label contains the name of the authorized entity, the designation Section 1797.197a of the Health and Safety Code, and providing the required product information sheet. According to California Business and Professions Code Section 4119.4, a pharmacy is permitted to dispense epinephrine auto-injectors to an authorized entity based on a valid prescription. The law specifically mandates that the label must include the name of the entity, the specific reference to Section 1797.197a of the Health and Safety Code, and the instructions Use as directed. Furthermore, the pharmacist is legally required to provide the authorized entity with a standardized product information sheet as part of the dispensing process.

Incorrect: Maintaining a registry of all employees at the authorized entity who have completed the required training program is not a duty assigned to the pharmacist or the pharmacy under California law; the authorized entity itself is responsible for maintaining its own training records and certifications. Restricting the total quantity dispensed to a single twin-pack per location is not a legal requirement, as the pharmacist should dispense the quantity authorized by the prescribing physician to meet the specific emergency needs of the entity. Verifying that the authorized entity has a medical director or physician physically present at the facility during all hours of operation is not required, as the legislative intent of the authorized entity provision is to allow trained laypeople to administer the medication in emergencies when medical professionals are not immediately available.

Takeaway: When dispensing epinephrine auto-injectors to authorized entities in California, pharmacists must ensure the label includes the entity name, the specific Health and Safety Code reference, and provide a product information sheet.

Correct: Under California Health and Safety Code Section 11165, pharmacies are required to report the dispensing of Schedule II, III, and IV controlled substances to the CURES database as soon as reasonably possible, but not more than one working day after the date the controlled substance is released to the patient or their representative. This ensures the database remains current for prescribers and pharmacists performing mandatory lookups and helps prevent prescription drug abuse and diversion.

Incorrect: Including Schedule V medications in the mandatory reporting requirement is incorrect as California law specifically mandates reporting for Schedules II, III, and IV. Reporting within three business days or at the end of the work week fails to meet the strict one-working-day deadline established to provide real-time data to healthcare providers. Differentiating reporting timelines based on the specific schedule, such as allowing monthly reporting for Schedule IV medications, is not permitted under current California regulations, which apply a uniform one-working-day standard to all covered schedules.

Takeaway: California pharmacies must report dispensed Schedule II, III, and IV controlled substances to the CURES database no later than one working day after the medication is released to the patient.

Correct: Segregating RCRA hazardous waste into black containers, non-RCRA pharmaceutical waste into blue containers, and trace chemotherapy waste into yellow containers for off-site incineration. Under the California Medical Waste Management Act and Title 22 of the California Code of Regulations, pharmacies must strictly segregate waste streams based on their chemical and biological hazards. RCRA-regulated hazardous waste (such as P-listed or U-listed drugs) requires black bins, while non-RCRA pharmaceutical waste is typically placed in blue bins. Trace chemotherapy waste, defined as containing less than 3 percent of the original contents, must be placed in yellow containers for specialized incineration.

Incorrect: Combining all non-controlled pharmaceutical waste into red biohazard sharps containers to streamline the disposal process is incorrect because red containers are reserved for biohazardous waste and sharps; they are often processed via autoclaving, which is insufficient for the chemical destruction of pharmaceuticals. Utilizing a single white container for all expired medications and disposing of them in municipal trash after using a chemical deactivation system is a violation of California law, as hazardous waste must be managed through authorized waste haulers and cannot be discarded in the regular trash. Returning all hazardous pharmaceutical waste to a reverse distributor under the assumption of a total generator exemption is incorrect; while reverse distributors handle creditable products, the pharmacy remains responsible for the proper segregation and disposal of all non-creditable waste generated on-site according to generator status.

Takeaway: California pharmacies must utilize specific color-coded waste streams to ensure that hazardous and non-hazardous pharmaceutical wastes are treated according to the Medical Waste Management Act and Title 22.

Correct: The pharmacy must maintain all records of acquisition and disposition on the licensed premises for at least three years unless a specific waiver for off-site storage has been granted by the Board. According to California Business and Professions Code sections 4081 and 4105, these records must be preserved for at least three years from the date of making and must be kept on the licensed premises to ensure they are available for inspection by authorized officers during business hours. A pharmacy may only store these records off-site if they apply for and receive a waiver from the California Board of Pharmacy, which typically requires the records to be retrievable within 48 hours.

Incorrect: Moving records off-site without a Board-approved waiver is a regulatory violation, even if the records are stored nearby or are easily retrievable. The distance of the storage unit or the speed of delivery does not bypass the requirement for on-site maintenance. While electronic backups are useful, they do not exempt the pharmacy from the requirement to maintain the primary records on the licensed premises for the full three-year duration. Relying on a wholesaler portal for acquisition records is insufficient because the pharmacy is independently responsible for maintaining its own records of receipt and disposition on-site.

Takeaway: California law requires all dangerous drug records to be maintained on the licensed premises for three years unless the Board of Pharmacy has granted a specific waiver for off-site storage.

Correct: California Business and Professions Code 4070 and California Code of Regulations Title 16, Section 1717 require that an oral prescription be reduced to writing immediately by the pharmacist. The resulting record must include the date of the order, the name of the patient, the name and quantity of the drug or device prescribed, the directions for use, and the name of the prescriber. If the prescription is transmitted by an agent of the prescriber, the name of that transmitter must be recorded. Furthermore, the pharmacist who receives the oral order and reduces it to writing must initial the prescription to document accountability for the transcription.

Incorrect: Requiring the prescriber’s National Provider Identifier (NPI) and a full pharmacist signature is incorrect because while an NPI is used for billing and identification, California law specifically emphasizes the name of the transmitter and the pharmacist’s initials for the oral reduction record. Recording the name of the clinic rather than the specific individual transmitting the order is insufficient, as the law requires the identity of the person who is the transmitter to be documented. Including the prescriber’s license number or DEA number for a non-controlled substance like Lisinopril is not a specific legal requirement for the documentation of an oral prescription reduction under California practice standards.

Takeaway: California law requires that oral prescriptions reduced to writing include the transmitter’s name and the receiving pharmacist’s initials.

Correct: Under California Health and Safety Code Section 11167, when a pharmacist dispenses a Schedule II controlled substance pursuant to an emergency oral authorization, the prescriber must provide a follow-up prescription (electronic or on a California security form) within 7 days. If the prescriber fails to provide this documentation, the pharmacist is legally required to notify the California Department of Justice in writing within 144 hours of the prescriber’s failure to comply. This reporting mechanism is a critical risk assessment tool used by the state to monitor potential diversion or inappropriate prescribing habits.

Incorrect: Reporting the incident to the local Drug Enforcement Administration field office within 72 hours of the initial dispensing date is incorrect because California law specifically mandates reporting to the state Department of Justice and defines the timeline based on the expiration of the 7-day grace period, not the date of dispensing. Maintaining internal records and refusing future emergency fills for the practitioner is a reasonable internal risk management strategy but does not fulfill the mandatory statutory reporting requirement to state authorities. Accepting a standard written prescription on a non-security form is prohibited for Schedule II substances in California, as the follow-up prescription must be either a valid electronic prescription or written on a California-approved security prescription form to be legally valid.

Takeaway: California law requires pharmacists to report a prescriber’s failure to provide a covering Schedule II prescription to the Department of Justice within 144 hours of the deadline.

Correct: Under California Business and Professions Code Section 4100 and 16 CCR Section 1704, any licensee, including pharmacists, interns, and technicians, must notify the Board of Pharmacy within 30 days of a change in name or address. This notification must be submitted in writing and include both the previous and the new information to ensure the Board’s records remain accurate for service of process, official correspondence, and public verification.

Incorrect: Requiring notification within 10 days is an incorrect timeframe, as California law specifically grants a 30-day window for personal address or name changes, which differs from the shorter windows required for reporting certain drug losses or changes in a Pharmacist-in-Charge. Waiting until the biennial renewal period is insufficient and violates the requirement for timely updates, potentially leading to disciplinary action or missed regulatory notices. Limiting the notification requirement only to those moving to a different county or out of state ignores the mandate that all licensees must maintain a current address of record with the Board regardless of the distance moved.

Takeaway: California licensees are legally mandated to report any change of name or residence address to the Board of Pharmacy within 30 days of the change.

Correct: Under California Business and Professions Code Section 4052.4, a pharmacist is authorized to perform procedures such as ordering and interpreting drug therapy-related laboratory tests to monitor and manage the efficacy and toxicity of drug therapies. A critical component of this authority is the requirement for the pharmacist to coordinate with the patient’s prescriber. This ensures that the healthcare team is aligned, and the prescriber is informed of any findings or subsequent adjustments made to the patient’s medication regimen based on the laboratory data.

Incorrect: Requiring a Clinical Laboratory Improvement Amendments (CLIA) waiver is only necessary if the pharmacy intends to actually perform the laboratory tests on-site (point-of-care testing). It is not a legal requirement for the act of ordering a test to be performed at an outside reference laboratory. Suggesting that a patient must provide a written power of attorney for clinical monitoring is an incorrect interpretation of consent laws; while pharmacists must act within a collaborative framework, a power of attorney is a legal instrument for decision-making that exceeds the requirements for standard clinical pharmacy services. Limiting the interpretation of results to only those performed in a hospital setting is inconsistent with California law, which allows pharmacists in various practice settings, including community and specialized clinics, to order and interpret tests for the purpose of drug therapy management.

Takeaway: California pharmacists may order and interpret laboratory tests for drug therapy management but must maintain coordination and communication with the patient’s prescriber regarding the results and clinical actions.

Correct: Under California Code of Regulations Title 16, Section 1711, a pharmacist who discovers a medication error must immediately communicate to the patient and the prescriber. This communication must include the fact that an error occurred and provide necessary instructions to mitigate any potential harm. This immediate action is required regardless of whether the patient has already experienced an adverse reaction.

Incorrect: Delaying prescriber notification until an adverse effect is observed is incorrect because the law requires notification of the prescriber as soon as the error is discovered to ensure clinical oversight. Prioritizing the completion of the internal Quality Assurance record before contacting the patient is incorrect because the safety communication must be immediate, whereas the written Quality Assurance record can be completed within two days. Contacting the prescriber for a new prescription before informing the patient is incorrect because it delays the patient’s awareness of the error, potentially leading to further ingestion of the incorrect medication.

Takeaway: California pharmacists must prioritize immediate communication to both the patient and prescriber upon discovery of a medication error to facilitate harm mitigation.

Correct: Under California Business and Professions Code sections 4081 and 4333, all records of manufacture and sale or disposition of dangerous drugs must be at all times during business hours open to inspection by authorized officers of the law. The Board of Pharmacy has the authority to inspect any establishment holding a pharmacy permit. This authority is not contingent upon the presence of the Pharmacist-in-Charge; the pharmacist on duty must provide immediate access to all areas where drugs are stored and all required records to ensure public safety and regulatory compliance.

Incorrect: Delaying the inspection until the Pharmacist-in-Charge returns is a violation of the requirement that records be open for inspection at all times during business hours. Restricting access to specific areas or requiring a formal written request for records that are legally required to be maintained on the premises obstructs the Board’s oversight authority. Scheduling a follow-up for records older than two years is incorrect because California law requires all records to be maintained and available for at least three years.

Takeaway: California law mandates that all pharmacy records and drug storage areas must be immediately accessible to Board inspectors during business hours, regardless of whether the Pharmacist-in-Charge is present.