Reading 2

Question 1

Define “drug”.

Answer 1

1. An article recognized in the official compendium or any supplement of the official compendium; and
2. An article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal; and
3. An article (other than food) intended to affect the structure or any function of the body in man or other animal; and
4. Articles intended for use as a component of any article specified in (1), (2), or (3)

Question 2

What are the official compendium?

Answer 2

• US Pharmacopeia (USP)
• National Formulary (NF)
• Homeopathic Pharmacopeia of the United States (HPUS)

Question 3

Define “prescription drug”.

Answer 3

Drug intended for use by man, which:

• 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
• Is limited by an approved application….to use under the professional supervision of a practitioner licensed by law to administer such drug

Question 4

What MUST be included on a prescription drug’s product label?

Answer 4

“Rx Only”

Question 5

Define “over-the-counter drug”.

Answer 5

a drug that is safe and effective for use without a prescriber’s supervision for certain conditions.

Question 6

Give an example of a drug that is OTC for one condition but not another.

Answer 6

meclizine is OTC for motion sickness, but prescription-only for vertigo

Question 7

Define “behind-the-counter drug”.

Answer 7

an unofficial third class of drugs that are available to patients without a prescription, but only after consultation with pharmacists

Question 8

Give an example of a behind-the-counter drug.

Answer 8

Sudafed, or birth control in some states

Question 9

Define “controlled substance”.

Answer 9

a drug that has dependence liability or the potential for abuse

Question 10

What are the schedules for controlled substances?

Answer 10

I - V

Question 11

Define “orphan drug”.

Answer 11

Used for:

• A condition that affects less than 200,000 persons in the United States; or
• A condition that affects more than 200,000 persons in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug (not making money off of these products)

Question 12

True or false: once an orphan drug is discovered to work for more than just a rare population, its manufacturer must give up the tax benefits.

Answer 12

false

Question 13

Define “dietary supplement”.

Answer 13

A product (other than tobacco) intended to supplement the diet that bears/contains one or more of the following dietary ingredients:

• a vitamin;
• a mineral;
• an herb or other botanical;
• an amino acid;
• a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
• A concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E)

Question 14

Define “new drug”.

Answer 14

• not generally recognized as safe and effective (GRAS, GRAE) for the condition(s) or in the dosage form it would be prescribed under; or
• drugs that have been recognized as safe and effective, but haven’t been used in the condition(s) or dosage form for a sufficient amount of time

Question 15

Define “pre-‘38” or “grandfathered drug”.

Answer 15

a drug that was on the market before 1938 and still on the market in 1962, which was assumed safe and effective based on its longevity on the market

Question 16

Define “Drug Efficacy Study Implementation (DESI) drug”.

Answer 16

drugs that entered the market between 1938-62 that had to prove their efficacy for an indication to stay on the market.

Question 17

What application do you send to the FDA once all clinical trials and data have been collected on a new drug, in order to have the drug approved for marketing?

Answer 17

New Drug Application (NDA)

Question 18

What application do you send to the FDA in order to ask for an exemption to the NDA requirements, in order to investigate and conduct clinical trials?

Answer 18

Investigational New Drug Application (IND)

AKA “Notice of Claimed Investigational Exemption for a New Drug”

Question 19

What application do generic manufacturers use to show proof of bioequivalence and proof of acceptable manufacturing practices and controls?

Answer 19

Abbreviated New Drug Application (ANDA)

Question 20

What is the “established name” or a product?

Answer 20

its generic name

Question 21

What’s the difference between “label” and “labeling”?

Answer 21

labels are the printed, written, or graphic material on the actual container, but labeling can include the container, wrapper, or materials accompanying the product (includes a label)

Question 22

Define “special packaging”.

Answer 22

• designed to be difficult for children <5 to open or obtain a toxic/harmful amount of substance within a reasonable time
• not difficult for normal adults to use properly
• does NOT mean packaging which all such children cannot open/obtain a harmful amount within a reasonable time frame

Question 23

Define “pharmaceutical equivalent”.

Answer 23

products with the same active ingredient, same dosage form, and same strength

Question 24

Define “therapeutic equivalent”.

Answer 24

pharmaceutical equivalents that are likely to have the same clinical and safety profile

Question 25

Define “device”.

Answer 25

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 1. Recognized **in the United States Pharmacopeia, National Formulary, 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

True or false: in legal jargon, the term “person” can include an entire corporation or association.

Answer 26

true

Question 27

Define “state”.

Answer 27

any **state or territory** in the US (including DC and Puerto Rico)

Question 28

Define “territory”.

Answer 28

any **territory or possession** of the US (includes DC, but _excludes Puerto Rico_ and the Canal Zone)