Definitions Flashcards
Agent
An individual designated by a prescriber to act on behalf of or at the discretion of that prescriber
Automated Device
mechanical system that performs an operation or activity, other than compounding or administration, relating to the storage, packaging, dispensing or delivery of a drug and that collects, controls, and maintains transaction information
Biological Drug Product
biological product
Brand Name
the registered trademark name given to a drug product by its manufacturer
Compounding
the preparation, mixing, assembling, packaging, and labeling of a drug or device by a pharmacist under the following circumstances:
- Upon the receipt of a prescription for a specific patient
- Upon the receipt of a medical or dental order from a prescriber or agent for use in the treatment of patients within the course of the prescriber’s professional practice
- In anticipation of the receipt of a prescription or medical or dental order based on routine, regularly observed prescription or medical or dental order patterns
- For the purpose of or incidental to research, teaching, or chemical analysis and not for the purpose of sale or dispensing
Compounding Pharmacy
pharmacy tha is licensed under this part and is authorized to offer compounding services
Current Selling Price
the retail price for a prescription drug that is available for sale from a pharmacy
Deliver/Delivery
actual, constructive, or attempted transfer of a drug or device from 1 person to another
Device
instrument, apparatus, or contrivance, including its components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or other animals, or to affect the structure or function of the body of human beings or other animals
Dispense
the preparation, compounding, packaging, or labeling of a drug pursuant to a prescription or other authorization issued by a prescriber
Dispensing Prescriber
prescriber, other than a veterinarian, who dispenses prescription drugs
Distribute/Distribution
sell, offer for sale, deliver, offer to deliver, broker, give away, or transfer a drug, whether by passage of title or physical movement
Drug
Any of the following:
- a substance recognized or for which the standards or specifications are prescribed in the official compendium
- a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or other animals
- a substance, other than food, intended to affect the structure or a function of the body of human beings or other animals
- a substance intended for use as a component of a substance specificed in above, but not including a device or its componenets, parts, or accessories
Electronic Signature
an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record
Electronically Transmitted Prescription
the communication of an original prescription or refill authorization by electronic means including computer to computer, computer to fax machine, or email transmission that contains the same information it contained when the prescriber or his or her agent transmitted the prescription
Federal Act
the federal food, drug, and cosmetic act
Food ad Drug Administration (FDA)
the United Stated Food and Drug Administration
Generic Name
the established or official name of a drug or drug product
Harmful Drug
a drug intended for use by human beings that is harmful because of its toxicity, habit-forming nature, or other potential adverse effect; the method of its use; or the collateral measures necessary to its safe and effective use and that is designated as harmful by a rule promulgated under this part
Interchangeable Biological Drug Product
Either of the following:
- a biological drug product that is licensed by the FDA and that the FDA has determined meets the standards for interchangeability
- Until March 23, 2021, a biological drug product that the FDA has determined to be therapeutically equivalent as set fort in “Approved Drug Products with Therapeutic Equivalence Evaluations”, an FDA publication that is commonly referred to as the “Orange Book”
Internship
educational program of professional and practical experience for an intern
Label
a display of written, printed, or graphic matter on the immediate container of a drug or device, but does not include package liners. A requirement made by or under authority of this part that a word, statement, or other information appear on the label is not complied with unless the word, statement, or other information appears on the outside container or wrapper of the retail package of the drug or device as displayed for sale or is easily legible through and outside container or wrapper
Labeling
the labels and other written, printed, or graphic matter on a drug or device or its container or wrapper, or accompanying the drug or device
License
a pharmacy license, drug control license, or a manufactuere, wholesale distributor, or wholesale distributor-broker of drugs or devices license
Manufacturer
a person that prepares, produces, derives, propagates, compounds, processes, packages, or repackages a drug or device salable on prescription only, or otherwise changes the container or the labeling of a drug or device salable on prescription only, and that supplies, distributes, sells, offers for sale, barters, or otherwise disposes of that drug or device and any other drug or device salable on prescription only, to another person for resale, compounding, or dispensing.
Official Compendium
the USP and the NF, or the Homeopathic Pharmacopoeia of the US, as applicable.
Parent Pharmacy
a pharmacy that operates a remote pharmacy through a telepharmacy system
Personal Charge
the immediate physical presence of a pharmacist or dispensing prescriber
Pharmacist
an individual licensed under this artical to engage in the practice of pharmacy
PIC
the pharmacist who is designated by a pharmacy, manufacturer, wholesale distributor, or wholesale distributor-broker as its pharmacist in charge
Pharmacist Intern
an individual who satisfactorily completes the requirements set forth in rules promulgated by the department in consultation with the board and is licensed by the board for the purpose of obtaining instruction in the practice of pharmacy from a preceptor approved by the board
Pharmacy
a facility or part of a facility that is licensed under this part to dispense prescription drugs or prepare prescription drugs for delivery or distribution.
Pharmacy Technician
an individual who is required to hold a health profession subfield license under this part to serve as a pharmacy technician
Practice of Pharmacy
a health service, the clinical application of which includes the encouragement of safety and efficacy in the prescribing, dispensing, administering, and use of drugs and related articles for the prevention of illness, and the maintenance and management of health.
Preceptor
pharmacist approved by the board to direct the training of an intern in an approved pharmacy
Prescriber
a licensed dentist; a licensed doctor of medicine; a licensed doctor of osteopathic medicine and surgery; a licensed doctor of podiatric medicine and surgery; a licensed physician’s assistant; a licensed optometrist; an advanced practice registered nurse; a licensed veterinarean; a registered professional nurse who holds a specialty certification as a nurse anesthetist when he or she is engaging in the practice of nursing and providing the anesthesia and analgesia services; any other licensed health professional acting under the delegation and using, recording, or otherwise indicating the name of the delegating licensed doctor of medicine or licensed doctor of osteopathic medicine and surgery
Prescription
an order by a prescriber to fill, compound, or dispense a drug or device written and signed; written or created in an electronic format, signed, and transmitted by facsimile; or transmitted electronically or by other means of communication
Prescription Drug
One or more of the following:
- dispensed pursuant to a prescription
- bears the federal legend “CAUTION: federal law prohibits dispensing without prescription” or “Rx only”
- designated by the board as a drug that may only be dispensed pursuant to a prescription
Sign
to affix one’s signature manually to a document or to use an electronic signature when transmitting a prescription electronically
Sterile Pharmaceutical
a dosage form of a drug that is essentially free from living microbes and chemical or physical contamination to the point at which it poses no present risk to the patient, in accordance with USP standards
Substitute
to dispense, without the prescriber’s authorization, a different drug in place of the drug prescribed
Surveillance System
a real-time, continuous audio and visual camera system that connects a pharmacist at a parent pharmacy with a remote pharmacy for the purpose of providing oversight and security surveillance
Telepharmacy System
an interoperable computer system that meets all of the following requirements:
- shares real-time data and uses a real-time audio and video link to connect a pharmacist at a parent pharmacy with a remote pharmacy operated by the parent pharmacy
- uses a camera that is of sufficient quality and resolution to allow a pharmacist at a parent pharmacy who is reviewing a prescription to visually identify the markings on tablets and capsules at the remote pharmacy
USP Standards
the pharmacopeial standards for drug substances, dosage forms, and compounded preparations based on designated levels of risk as published in the official compendium
Wholesale Distributor
a person, other than a manufacturer or wholesale distributor-broker, that supplies, distributes, sells, offers for sale, barters, or otherwise disposes of, to other persons for resale, compounding, or dispensing, a drug or device salable on prescription only that the distributor has not prepared, produced, derived, propagated, compounded, processed, packaged, or repackaged, or otherwise changed the container or the labeling of the drug or device.
Wholesale Distributor-Broker
Meets both of the following:
- the person facilitates the delivery or trade of a drug or device salable on prescription only, other than a controlled substance between pharmacies, or between a pharmacy and a qualified pharmacy for the purpose of filling a prescription for an identified patient
- the person does not take possession or ownership of a drug or device salable on prescription only or coordinate warehousing of the drug or device
