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OTC > OTC Exam 1 - Law > Flashcards

OTC Exam 1 - Law Flashcards

1
Q

1906 pure food and drug act

A

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

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2
Q

1914 harrison narcotic act

A
  • required rx only status for opium and other narcotics (previously OTC)
  • this was hard to enforce
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3
Q

1938 Food, Drug, and Cosmetic Act (FDCA)

A

Mandated food, drug, and cosmetic safety

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4
Q

Duram-humphrey amendment

A

Established rx vs OTC categories and the labeling requirements for each

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5
Q

Requirements for a drug to be OTC

A
  • low potential for abuse and misuse
  • benefits of being OTC must outweigh risks
  • state law may make it rx only
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6
Q

Snake oil

A

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

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7
Q

A ____ medication may be used without medical supervision

A

Nonprescription

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8
Q

No HCP is needed for ____ and ____ use of OTC

A

Safe and effective

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9
Q

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

A

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

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10
Q

Outcome of the Duram-Humphrey Amendment of 1951

A
  • made a clear distinction between OTC and rx drugs
  • named 3 conditions that would make a drug rx only
  • determined labeling requirements for each
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11
Q

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

A
  • 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
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12
Q

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

A

Manufacturer

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13
Q

Kefauver-harris drug amendment of 1962

A
  • 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
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14
Q

In ____ the FDA created the OTC review process

A

1972

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14
Q

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

A

Categories

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15
Q

What was the first rx to OTC switch

A

Diphenhydramine and hydrocortisone

16
Q

Category 1

A

Generally recognized as safe and effective (GRASE)

17
Q

Category 2

A

Not GRASE

18
Q

Category 3

A

Insufficient evidence to prove safety and/or efficacy

18
Q

3 phases of the nonprescription drug review process

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

(At The Fair)

19
Q

NDA

A

FDA reviews safety and efficacy of the product as a whole

20
Q

Monograph

A

FDA reviews safety and efficacy of the individual ingredient

21
Q

Can an OTC monograph be changed

A

Yes

22
Q

Poison Prevention Packaging Act (1970)

A

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

23
Q

Drug Listing Act (1972)

A
  • Established NDCs
  • each drug is required to register w/ the FDA
24
Q

Federal Anti-Tampering Act (1982)

A
  • Makes it a crime to tamper w/ OTC products
  • Requires tamper resistant features on OTC medications
25
Q

Food and Drug Modernization Act (1997)

A

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

26
Q

Exempt items from the federal anti-tampering act

A

Topicals
Toothpaste
Lozenges
Insulin

27
Q

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

A

True

27
Q

Who makes the decision on an OTC switch

A

FDA

28
Q

Dual status

A
  • Some OTC meds are also available as rx
  • certain dosages, dosage forms, or indications deemed safe OTC
29
Q

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

A

FTC

30
Q

Who regulates nonprescription drug labeling

A

FDA

OTC (21 decks)

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