OTC Exam 1 - Law

Question 1

1906 pure food and drug act

Answer 1

prohibited adulteration and misbranding; the reason ineffective cure-alls were taken off the market

Question 2

1914 harrison narcotic act

Answer 2

• required rx only status for opium and other narcotics (previously OTC)
• this was hard to enforce

Question 3

1938 Food, Drug, and Cosmetic Act (FDCA)

Answer 3

Mandated food, drug, and cosmetic safety

Question 4

Duram-humphrey amendment

Answer 4

Established rx vs OTC categories and the labeling requirements for each

Question 5

Requirements for a drug to be OTC

Answer 5

• low potential for abuse and misuse
• benefits of being OTC must outweigh risks
• state law may make it rx only

Question 6

Snake oil

Answer 6

Term used to describe “worthless pseudo-medical” remedies that were promoted as cures for various illnesses

Question 7

A ____ medication may be used without medical supervision

Answer 7

Nonprescription

Question 8

No HCP is needed for ____ and ____ use of OTC

Answer 8

Safe and effective

Question 9

How can a state make a drug’s access more strict

Answer 9

By making a product that is considered OTC under federal law into a prescription only product under state law

Question 10

Outcome of the Duram-Humphrey Amendment of 1951

Answer 10

• made a clear distinction between OTC and rx drugs
• named 3 conditions that would make a drug rx only
• determined labeling requirements for each

Question 11

What are the 3 conditions that would make a drug rx only

Answer 11

• habit forming
• considered unsafe for use except under expert supervision due to toxicity concerns
• rx only drugs had to undergo a new drug application w/ FDA

Question 12

Before the durahm-humphrey amendment the ___ decided what would be rx or OTC

Answer 12

Manufacturer

Question 13

Kefauver-harris drug amendment of 1962

Answer 13

• required proven efficacy of marketed products (including OTC)
• both rx and OTC must be manufactured using current good manufacturing practices (cGMPs)
• FTC regulates advertising of OTC drugs

Question 14

In ____ the FDA created the OTC review process

Answer 14

1972

Question 14

OTC review process divided products into ___ according to therapeutic effect and active ingredients

Answer 14

Categories

Question 15

What was the first rx to OTC switch

Answer 15

Diphenhydramine and hydrocortisone

Question 16

Category 1

Answer 16

Generally recognized as safe and effective (GRASE)

Question 17

Category 2

Answer 17

Not GRASE

Question 18

Category 3

Answer 18

Insufficient evidence to prove safety and/or efficacy

Question 18

3 phases of the nonprescription drug review process

Answer 18

1. Advance notice of proposed rulemaking
2. Tentative final monograph
3. Final monograph

(At The Fair)

Question 19

NDA

Answer 19

FDA reviews safety and efficacy of the product as a whole

Question 20

Monograph

Answer 20

FDA reviews safety and efficacy of the individual ingredient

Question 21

Can an OTC monograph be changed

Answer 21

Yes

Question 22

Poison Prevention Packaging Act (1970)

Answer 22

Requires drugs and specific household substances to be in child resistant packaging

Question 23

Drug Listing Act (1972)

Answer 23

• Established NDCs
• each drug is required to register w/ the FDA

Question 24

Federal Anti-Tampering Act (1982)

Answer 24

• Makes it a crime to tamper w/ OTC products
• Requires tamper resistant features on OTC medications

Question 25

Food and Drug Modernization Act (1997)

Answer 25

Expanded FDA authority over OTC drugs and established inactive ingredient labeling requirements

Question 26

Exempt items from the federal anti-tampering act

Answer 26

Topicals
Toothpaste
Lozenges
Insulin

Question 27

(T/F): pharmacists may recommend OTC drugs for a condition or a dosage NOT listed on the label

Answer 27

True

Question 27

Who makes the decision on an OTC switch

Answer 27

FDA

Question 28

Dual status

Answer 28

• Some OTC meds are also available as rx
• certain dosages, dosage forms, or indications deemed safe OTC

Question 29

Who regulates advertising of nonprescription meds, devices, and dietary supplements

Answer 29

FTC

Question 30

Who regulates nonprescription drug labeling

Answer 30

FDA