PharmacyPharmacies
Section § 4110
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.
Section § 4110.5
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.
Section § 4111
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.
Section § 4112
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.
Section § 4113
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.
Section § 4113.1
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.
Section § 4113.5
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.
Section § 4113.6
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.
Section § 4113.7
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.
Section § 4114
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.
Section § 4115
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.
Section § 4115.5
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.
Section § 4116
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.
Section § 4117
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.
Section § 4118
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.
Section § 4118.5
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.
Section § 4119
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.
Section § 4119.01
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.
Section § 4119.10
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.
Section § 4119.11
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.
Section § 4119.2
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.
Section § 4119.3
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.
Section § 4119.4
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.
Section § 4119.5
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.
Section § 4119.6
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.
Section § 4119.7
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.
Section § 4119.8
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.
Section § 4119.9
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.
Section § 4120
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.
Section § 4121
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.
Section § 4122
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.
Section § 4123
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.
Section § 4124
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.
Section § 4125
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.
Section § 4126
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.
Section § 4126.10
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.
Section § 4126.5
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.
Section § 4126.8
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.
Section § 4126.9
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.