Definitions

Question 1

Agent

Answer 1

An individual designated by a prescriber to act on behalf of or at the discretion of that prescriber

Question 2

Automated Device

Answer 2

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

Question 3

Biological Drug Product

Answer 3

biological product

Question 4

Brand Name

Answer 4

the registered trademark name given to a drug product by its manufacturer

Question 5

Compounding

Answer 5

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

Question 6

Compounding Pharmacy

Answer 6

pharmacy tha is licensed under this part and is authorized to offer compounding services

Question 7

Current Selling Price

Answer 7

the retail price for a prescription drug that is available for sale from a pharmacy

Question 8

Deliver/Delivery

Answer 8

actual, constructive, or attempted transfer of a drug or device from 1 person to another

Question 9

Device

Answer 9

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

Question 10

Dispense

Answer 10

the preparation, compounding, packaging, or labeling of a drug pursuant to a prescription or other authorization issued by a prescriber

Question 11

Dispensing Prescriber

Answer 11

prescriber, other than a veterinarian, who dispenses prescription drugs

Question 12

Distribute/Distribution

Answer 12

sell, offer for sale, deliver, offer to deliver, broker, give away, or transfer a drug, whether by passage of title or physical movement

Question 13

Drug

Answer 13

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

Question 14

Electronic Signature

Answer 14

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

Question 15

Electronically Transmitted Prescription

Answer 15

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

Question 16

Federal Act

Answer 16

the federal food, drug, and cosmetic act

Question 17

Food ad Drug Administration (FDA)

Answer 17

the United Stated Food and Drug Administration

Question 18

Generic Name

Answer 18

the established or official name of a drug or drug product

Question 19

Harmful Drug

Answer 19

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

Question 20

Interchangeable Biological Drug Product

Answer 20

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”

Question 21

Internship

Answer 21

educational program of professional and practical experience for an intern

Question 22

Label

Answer 22

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

Question 23

Labeling

Answer 23

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

Question 24

License

Answer 24

a pharmacy license, drug control license, or a manufactuere, wholesale distributor, or wholesale distributor-broker of drugs or devices license

Question 25

Manufacturer

Answer 25

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.

Question 26

Official Compendium

Answer 26

the USP and the NF, or the Homeopathic Pharmacopoeia of the US, as applicable.

Question 27

Parent Pharmacy

Answer 27

a pharmacy that operates a remote pharmacy through a telepharmacy system

Question 28

Personal Charge

Answer 28

the immediate physical presence of a pharmacist or dispensing prescriber

Question 29

Pharmacist

Answer 29

an individual licensed under this artical to engage in the practice of pharmacy

Question 30

PIC

Answer 30

the pharmacist who is designated by a pharmacy, manufacturer, wholesale distributor, or wholesale distributor-broker as its pharmacist in charge

Question 31

Pharmacist Intern

Answer 31

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

Question 32

Pharmacy

Answer 32

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.

Question 33

Pharmacy Technician

Answer 33

an individual who is required to hold a health profession subfield license under this part to serve as a pharmacy technician

Question 34

Practice of Pharmacy

Answer 34

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.

Question 35

Preceptor

Answer 35

pharmacist approved by the board to direct the training of an intern in an approved pharmacy

Question 36

Prescriber

Answer 36

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

Question 37

Prescription

Answer 37

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

Question 38

Prescription Drug

Answer 38

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

Question 39

Sign

Answer 39

to affix one's signature manually to a document or to use an electronic signature when transmitting a prescription electronically

Question 40

Sterile Pharmaceutical

Answer 40

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

Question 41

Substitute

Answer 41

to dispense, without the prescriber's authorization, a different drug in place of the drug prescribed

Question 42

Surveillance System

Answer 42

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

Question 43

Telepharmacy System

Answer 43

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

Question 44

USP Standards

Answer 44

the pharmacopeial standards for drug substances, dosage forms, and compounded preparations based on designated levels of risk as published in the official compendium

Question 45

Wholesale Distributor

Answer 45

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.

Question 46

Wholesale Distributor-Broker

Answer 46

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