Reading 2

Question 1

Four criteria to meet to be legally classified as a drug

Answer 1

1. Recognized in the official compendium or any supplement of the official compendium
2. Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal
3. Intended to affect the structure or any function of the body in man or other animal
4. Intended for use as a component of any article specified in 1, 2, or 3

Question 2

Official compendia

Answer 2

Books that provide standards for products/practice that are used by manufacturers and practitioners

Question 3

Books in the official compendia

Answer 3

United States Pharmacopeia (USP), National Formulary (NF), and Homeopathic Pharmacopeia of the United States (HPUS)

Question 4

Purpose of USP

Answer 4

Establishes the approved titles, definitions, descriptions, and standards for identity quality, strength, purity, packaging, stability, and labeling for a drug, as well as how to prepare sterile and nonsterile pharmaceuticals

Question 5

USP-NF

Answer 5

Single publication of the USP and NF that serves as the official compendium for drug standards in the United States

Question 6

Purpose of USPNF

Answer 6

Develop and publish standards for drug substances, drug products, excipients, and dietary supplements

Question 7

Purpose of HPUS

Answer 7

Provides standards for homeopathy products

Question 8

T/F: Homeopathic products are drugs

Answer 8

True

Question 9

FDA regulations on homeopathic drug products

Answer 9

Regulates these products based on their potential risk to patients

Question 10

Prescription drug

Answer 10

Drug intended for use by man which (A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or (B) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug (new drug)

Question 11

Necessary symbol or statement required on the label of all prescription drugs

Answer 11

“Rx only”, “prescription only”, or “caution: federal law prohibits dispensing without prescription”

Question 12

Over-the-counter drug (nonprescription drugs)

Answer 12

Drug that is (A) not subject to section 353(b) and (B) not subject to approval in an application submitted under section 355; drugs safe and effective for use without a prescriber’s supervision for certain conditions (those that don’t require medical diagnosis and monitoring)

Question 13

2022 FDA rule: “Nonprescription Drug Product With an Additional Condition for Nonprescription Use”

Answer 13

Establishes requirements for making certain drugs available OTC when labeling alone isn’t enough to ensure that a consumer can use the drug appropriately (may require a questionnaire be completed before selling/conversation with pharmacist)

Question 14

New drug

Answer 14

Drug that is not generally recognized as safe and effective for the condition(s), in the dosage form it would be prescribed under, or a drug that has been recognized as safe and effective but has not been used in the condition(s) or dosage form for a sufficient amount of time (not yet comleted the pre-market approval process)

Question 15

Categories that new drugs fall into

Answer 15

New molecular entities or new active pharmaceutical ingredients, new dosage forms, new indiciations, new combinations of previously approved products, or articles that contain a new substance (excipient, carrier, coating not previously used)

Question 16

GRAS

Answer 16

Generally recognizes as safe

Question 17

GRAE

Answer 17

Generally recognized as effective

Question 18

GRASE

Answer 18

Generally recognized as safe and effective

Question 19

Brand name

Answer 19

Proprietary name given to the drug by the manufacturer

Question 20

Generic name

Answer 20

Established name in the law (name we use for the specific drug or molecular entity)

Question 21

Established name

Answer 21

Applicable official name designated pursuant to section 358 of this title; or if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium, the common or usual name, if any, of such drug or of such ingredient

Question 22

Section 358

Answer 22

Section granting authority to designate official names that covers naming requirements and grants authority to change established names if necessary

Question 23

United States Adopted Names (USAN)

Answer 23

Group that selects simple, informative, and unique nonproprietary (generic) names

Question 24

Members of USAN council

Answer 24

FDA liaison, at-large member, AMA representative, USP representative, and APhA representative

Question 25

Device

Answer 25

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, inlcuding any component, part, or accessory, which is (1) recognized in the USP, NF, or any supplement of them, and (2) intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in man or other animal, and (3) intended to affect the structure or any function of the body in man or other animal, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purpose

Question 26

Main difference between a device and a drug

Answer 26

A device doesn't use chemical action or doesn't need to be metabolized by the body to achieve its primary intended purpose (also definition doesn't include official compendium - only listed in USP-NF / no homeopathic devices exist)

Question 27

Orphan drug

Answer 27

A drug intended for use in a rare disease or condition as defined in section 526 of the Food, Drug, and Cosmetic Act

Question 28

Conditions for orphan drugs

Answer 28

Affects <200,000 U.S. individuals or affects >200,000 U.S. individuals but drug companies don't expect to recover development costs from sales of treatment

Question 29

Benefits of manufacturing orphan drugs

Answer 29

Tax benefits

Question 30

Grandfathered drug

Answer 30

Drug introduced before 1938 and still on the market in 1962 that were assumed to be safe and effective given their longevity on the market (did not need to prove safety or efficacy)

Question 31

Examples of grandfathered drugs

Answer 31

Digoxin, codeine, and phenobarbital

Question 32

DESI drug

Answer 32

Drug that entered the market between 1938 and 1962 that were assumed to be safe but were not considered effective

Question 33

DESI program

Answer 33

Drug efficacy study implementation program that requires drug companies to complete efficacy studies on DESI drugs

Question 34

New drug application (NDA)

Answer 34

Application sent to the FDA once all clinical trials and data have been collected on a new drug to have the drug approved for marketing

Question 35

Investigational new drug (IND) application

Answer 35

Application sent to the FDA asking them for an exemption to the NDA requirements to investigate and conduct clinical trials on a new drug

Question 36

Abbreviated new drug application (ANDA)

Answer 36

Application used by generic manufacturers to show therapeutic equivalence (both bioequivalence and pharmaceutical equivalence) and provide proof of acceptable manufacturing practices and controls

Question 37

Supplemental new drug application (SNDA)

Answer 37

Application used when a company needs to change a label, market a new dosage or strength of a drug, or change how the company manufactures a drug

Question 38

Label

Answer 38

Any printed, written, or graphic material on the product container (only sticker or printed material on container)

Question 39

Labeling

Answer 39

All labels and written, printed, or graphic material on the container, container wrapper, or accompanying the product (all printed and other information accompanying a product)

Question 40

T/F: Spoken words from a drug rep or advertisements is labeling

Answer 40

True

Question 41

Special packing

Answer 41

Packaging that is designed or constructed to be significantly difficult for children <5 years old to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time

Question 42

General idea of special packing

Answer 42

Kids <5 should struggle opening the packaging or be prevented from obtaining a toxic/harmful amount in a reasonable time, while normal adults should not struggle

Question 43

Dietary supplement

Answer 43

Product (other than tobacco) intended to supplement the diet that bears or contains a vitamin, mineral, herb or other botanical, amino acid, dietary substance to supplement the diet by increasing total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the before-mentioned ingredients

Question 44

Are dietary supplements drugs?

Answer 44

No

Question 45

Person

Answer 45

Individual, partnership, corporation, and association

Question 46

State

Answer 46

Any state or territory of the U.S., the District of Columbia, and the Commonwealth of Puerto Rico

Question 47

Territory

Answer 47

Any territory or possession of the U.S., including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone

Question 48

5 major U.S. territories

Answer 48

Puerto Rico, Guam, U.S. Virgin Islands, American Samoa, and the Northern Mariana Islands