PharmacyDefinitions
Section § 4015
This section states that the definitions provided in this chapter are the ones to be used throughout, unless there's a specific note or context indicating otherwise.
Section § 4016
In this context, "administer" refers to giving a drug or device directly to someone, whether by injection, inhaling, swallowing, or any other method.
Section § 4016.5
This law defines what an 'advanced practice pharmacist' is. It's a licensed pharmacist who the board has officially recognized for having advanced skills and is allowed to perform more complex pharmacy-related tasks. These tasks can be done inside or outside of a traditional pharmacy setting, as long as they follow the specific rules set by the board.
Section § 4017
This law explains that 'authorized officers of the law' include certain inspectors and investigators related to pharmacy and public health, as well as peace officers who are conducting official investigations.
Section § 4017.3
This law defines three types of automated systems related to drug handling. An 'automated drug delivery system' (ADDS) is a machine that handles storing and dispensing drugs, but not mixing or giving them to patients. It must track all drug movements for security and accuracy. An 'automated unit dose system' (AUDS) is a type of ADDS used to store and retrieve single doses of medicine for patient use by authorized people. Finally, an 'automated patient dispensing system' (APDS) is a type of ADDS that stores and gives out prescribed drugs directly to patients once a pharmacist has approved it.
Section § 4018
This section defines the term "Board" as the California State Board of Pharmacy.
Section § 4019
This law states that a drug order written in a patient's chart at a hospital counts as a prescription when the medications are given by hospital staff. It allows the hospital pharmacy to provide these drugs from their supplies based on the order by a doctor or authorized practitioner. The law requires certain details to be included in the patient's records, and orders must be signed by the prescriber or attending physician, either at the time the medication is given or on the prescriber's next hospital visit if they're absent at the time.
Section § 4021
This section indicates that a 'controlled substance' refers to any drug or chemical listed in a specific part of the Health and Safety Code that deals with the regulation of certain drugs.
Section § 4021.5
This law defines a 'correctional pharmacy' as a pharmacy licensed to provide medications and pharmaceutical care specifically to prison inmates. These pharmacies can dispense or give out medication based on a chart order or a proper prescription, following the rules of this chapter.
Section § 4022
This law defines what a 'dangerous drug' or 'dangerous device' is. It includes any drug or device that is not safe for people or animals to use by themselves. Specifically, it refers to drugs or devices that carry warnings like 'Rx only' or similar labels. Essentially, these are items that can only be dispensed or sold if there's a prescription due to federal or state law requirements.
Section § 4022.5
This law defines what a 'designated representative' and 'designated representative-in-charge' are in the context of handling certain drugs. A designated representative is someone who has been licensed specifically for this role, while a pharmacist does not need this separate license to perform the same duties. A 'designated representative-in-charge' is a person, approved by the board, who supervises and ensures that a wholesaler or animal drug retailer follows all relevant laws and regulations. This role can be filled by a designated representative, a reverse distributor, or a licensed pharmacist from the home state.
Section § 4022.6
This section clarifies who can be a 'designated representative-reverse distributor.' It's someone with a license who oversees a licensed wholesaler acting as a reverse distributor. Importantly, a pharmacist doing their typical tasks under another section doesn't need this specific license.
Section § 4022.7
This law describes the roles of two individuals involved in third-party logistics of drugs and medical devices. A 'designated representative-3PL' is someone who gets a specific license, except if they're a pharmacist doing certain duties, they don't need this separate license. A 'responsible manager' is a person picked by a logistics company to ensure its operations comply with laws about handling potentially dangerous drugs or devices.
Section § 4023
This section defines what is considered a 'device' within a specific context. A device can be anything like an instrument, machine, or implant used to diagnose, treat, or prevent diseases in humans or animals. It also includes anything that affects the body's structure or functions. However, contact lenses and certain prosthetic or orthopedic devices that don't need a prescription are not classified as devices here.
Section § 4023.5
Section § 4024
This law defines what it means to "dispense" drugs or medical devices. "Dispense" generally involves giving out drugs or devices based on a prescription from qualified medical professionals like doctors or nurse practitioners. It can also mean giving them directly to a patient by those same professionals as long as they're acting within their authorized role or area of practice.
Section § 4025
This section defines what is considered a "drug". It includes items listed in recognized official medical references, those used to diagnose or treat diseases, items meant to alter body functions (besides food), and any parts or components of these articles.
Section § 4025.1
This section defines a 'nonprescription drug' as a medication you can buy without needing a doctor's prescription, as long as it's properly labeled according to state and federal laws.
Section § 4025.2
This law section defines a 'nonprescription diabetes test device' as a glucose meter or test strip that can be bought without a prescription. These devices are used by people with prediabetes or diabetes and must have proper labels following state and federal laws.
Section § 4026
The term "furnish" refers to supplying something, whether you're selling it or giving it in another way.
Section § 4026.5
'Good standing' refers to a license that hasn't been limited or penalized due to disciplinary actions according to specific government rules.
Section § 4027
This section clarifies the definitions of various health care facilities within certain legal contexts. It explains how different types of facilities, like skilled nursing and intermediate care facilities, are defined according to specific parts of the Health and Safety Code. It details what qualifies as a 'licensed health care facility' or 'health care facility' in related sections, indicating that these are typically places licensed or managed by health care service plans. It also specifies that licensed clinics and home health agencies have particular definitions under the Health and Safety Code.
Section § 4028
A "licensed hospital" is a certified facility where people can stay overnight for the diagnosis, care, and treatment of illnesses. It must meet state health regulations and can be a general, specialized, maternity, or tuberculosis hospital. However, it specifically does not include facilities like sanitariums, rest homes, nursing or convalescent homes, maternity homes, or places that treat alcoholism.
Section § 4029
This section describes what a hospital pharmacy is in California. It's a pharmacy located within a licensed hospital where patients are diagnosed, treated, and may stay overnight. Hospital pharmacies can also operate in other buildings associated with a general acute care hospital, but they can only serve patients in that building. Additionally, there's a concept called a 'hospital satellite compounding pharmacy.' These special areas can perform sterile compounding and are also associated with a general acute care hospital, but they might be in a different location than the main hospital.
Section § 4030
An 'intern pharmacist' is someone who has been given a license as described in another section, specifically Section 4208.
Section § 4031
This law explains what qualifies as a 'laboratory' in this context. It refers to places used for research, teaching, or testing, which do not dispense drugs but use dangerous drugs or devices for scientific purposes. Laboratories must have a fixed business location, keep purchase records, and are overseen by a governing board.
Section § 4032
This section defines the term "license" as it relates to any official permit or certificate issued by a board, including the initial application and renewal process.
Section § 4033
In this section, a 'manufacturer' refers to anyone involved in making or repackaging drugs or devices, except for pharmacies that produce drugs on-site for direct sale to customers. However, pharmacies that compound drugs for parenteral therapy to be delivered to other pharmacies, or that repackage drugs for patients based on their request, are not considered manufacturers. Additionally, the term also applies to any person or entity involved in handling dangerous drugs, devices, or cosmetics, and includes those with approved drug applications or those distributing privately labeled drugs.
Section § 4034
An 'outsourcing facility' is a place in the U.S. that compounds both sterile and nonsterile drugs. It must be officially registered with the FDA as an outsourcing facility as per federal law and operate in or into California. Additionally, it needs to be licensed by the local board in California.
Section § 4034.5
This section defines an 'emergency medical services automated drug delivery system' (EMSADDS) as a system that stores and distributes drugs specifically for restocking secure emergency medical supply containers used by emergency medical services.
Section § 4035
In this section, the term "person" is defined broadly. It not only refers to an individual human being but also includes entities like companies, partnerships, government agencies, and other organized groups.
Section § 4036
A pharmacist is someone who has a valid license from the board, allowing them to practice pharmacy. This license lets them work within a pharmacy or elsewhere, as long as it's permitted by the rules in this chapter.
Section § 4036.5
A 'Pharmacist-in-charge' is a pharmacist chosen by a pharmacy and approved by the board to oversee and make sure that the pharmacy follows all related state and federal pharmacy laws and regulations.
Section § 4037
A 'pharmacy' is defined as any licensed location where pharmacy is practiced and prescriptions are made, including places where controlled substances or dangerous drugs are handled or sold. However, it does not cover areas in health facilities where drugs are stored just for patient care like wards or emergency rooms.
Section § 4038
This law defines who is considered a pharmacy technician and a pharmacy technician trainee. A pharmacy technician is someone who helps a pharmacist with their pharmacy-related tasks. On the other hand, a pharmacy technician trainee is a person undergoing training in a recognized educational program to become a pharmacy technician.
Section § 4039
This law defines which medical professionals are recognized as practicing in California with valid licenses. It specifies that individuals like physicians, dentists, and nurses need an unrevoked license to work in their field. It also clarifies what 'physician' means under California law, including those with specific certifications and, under certain conditions, those practicing without a license but within legal guidelines.
Section § 4040
This section defines what counts as a "prescription" for medications and devices. A prescription can be oral, written, or electronic and must include details like the patient's name, address, medication details, and instructions. It must also show the prescriber's details, including license number if it's for a controlled substance. Prescriptions might also say why the medication is prescribed if the patient asks. Different professionals, like doctors or pharmacists, can issue these prescriptions under certain rules. Written prescriptions for certain dangerous drugs can be accepted if they meet basic requirements, and more details can be added later by the pharmacy. Additionally, electronic prescriptions can be sent as images (like via fax) or data to pharmacies. Using common abbreviations doesn't affect the validity of a prescription.
Section § 4040.5
This section defines a "reverse distributor" as anyone who helps pharmacies and other businesses by handling old or unsellable medicine or medical devices, including tasks like receiving, storing, and managing them.
Section § 4041
Section § 4042
This section defines what "veterinary food-animal drugs" are. These include any drugs used in animals raised for food that have a label saying they're only for use under a veterinarian's guidance. It also includes other drugs that need a veterinarian's prescription, according to another specific law.
Section § 4043
This law describes what a 'wholesaler' is in the context of selling and distributing drugs or medical devices. It covers various roles like merchants, brokers, and agents involved in the wholesale distribution of these items. Wholesalers can only store or warehouse these drugs at licensed locations unless the law allows otherwise.
Section § 4044
A 'repackager' is someone or a company registered with the FDA that either packages finished drugs from bulk amounts or transfers dangerous drugs into new containers, not including shipping containers.
Section § 4044.3
This law defines what a "remote dispensing site pharmacy" is in California. It explains that such a pharmacy is a licensed pharmacy run by a supervising pharmacy and staffed with qualified pharmacy technicians. These pharmacies provide services like storing and dispensing prescription drugs and controlled substances, reviewing drug regimens, and offering patient counseling. A licensed pharmacist oversees or provides these services remotely using telepharmacy technology. Additionally, remote dispensing site pharmacies must follow all relevant state and federal pharmacy laws unless specified otherwise.
Section § 4044.5
This section defines a "reverse third-party logistics provider" as a company that helps manufacturers, wholesalers, or dispensers manage outdated or unsellable dangerous drugs or devices. However, these providers do not own or decide the sale or disposal of these drugs or devices. The same rules that apply to third-party logistics providers also apply to reverse third-party logistics providers unless stated otherwise.
Section § 4044.6
A 'supervising pharmacy' in California is a licensed pharmacy where at least one board-licensed pharmacist owns and manages it. This pharmacy is responsible for overseeing the operations of a remote dispensing site pharmacy. The supervising pharmacy is fully accountable for the remote site and its staff.
Section § 4044.7
Telepharmacy is a system used by a main pharmacy to oversee the distribution of prescription drugs at a different location. This system also allows for drug reviews and patient counseling through electronic means, like video or audio calls, and imaging technology.
Section § 4045
This section defines a 'third-party logistics provider' as a company that helps manage storage and transportation of dangerous drugs or devices for others, like manufacturers or pharmacies, without actually owning or deciding what happens to those drugs or devices.
Section § 4046
This law defines what a "surplus medication collection and distribution intermediary" is. Essentially, it's any organization or government body that handles the collection and distribution of leftover medications to be used in certain health programs.