POP Law Quiz 3

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1

Requests to reclassify a Rx-only drug product to an OTC product may occur only by which 4 possible ways?

  1. By submitting a full NDA to the FDA requesting status change
  2. By the FDA granting an exemption if it deems that Rx-only status is unnecessary for the protection of public health
  3. By filing a supplement to the NDA
  4. By recommendation from the Nonprescription Drug Advisory Committee
2

Insufficient data available to permit final classification describes which OTC ingredient category?

Category III

3

Generally recognized as safe and effective (GRASE) for claimed therapeutic indication describes which OTC ingredient category?

Category I

4

Which law places health foods, food supplements, and herbal products in to a class different from Rx and OTC products?

DSHEA

5

What main 3 things did DSHEA do?

  1. Products to be marketed without proven efficacy
  2. Products currently on the market do not have be proven safe
  3. The USP published “Manufacturing Practices for Dietary Supplements
6

Not generally recognized as safe and effective or having unacceptable indications describes which OTC ingredient category?

Category II

7

According to DSHEA, who's responsibility was it to prove if a product is unsafe?

FDA

8

Who has to challenge the product after it has gone to market if evidence comes forth that the product is ineffective for its labeled use?

FDA or FTC

9

The final product is known as what?

Dietary Supplement

10

A vitamin, mineral, herb or botanical, amino acid, or other dietary substance used to supplement the diet is referred to as a what?

Dietary ingredient

11

An excipient or substance used to manufacture a DS is known as a what?

Non-dietary ingredient

12

Most requirements fall on whom with respect to testing and record-keeping of DS?

the manufacturer

13

True or False: GMP guidelines outline required tests that must be performed to verify identity, strength, purity, etc

False; do not outline

14

Records involving manufacturing a DS must be kept for how long?

  • 1 year past the expiration date
  • or 2 years beyond the date of distribution of the last batch
15

Violations of GMP rules results in the DS being considered what?

Adultered

16

Who has published monographs for some botanicals that appear to have therapeutic efficacy?

USP/NF

17

True or False: Herbal product must have an FDA approved use of USP DI Panel recognized use

True

18

The monographs for herbal products outline at what 3 things?

  1. the portion of the plant used
  2. its botanical characteristics
  3. appropriate assays procedures for ingredients
19

The monographs for herbals do not describe what?

Therapeutic use

20

Dietary Supplements/Herbals with monographs include:

  • Chamomile
  • Cranberry liquid preps
  • Feverfew
  • Garlic
  • Ginger
  • Gingko biloba
  • Milk Thistle
  • St. John’s wort
  • Saw Palmetto
  • Valerian
21

What describes the relationship between a food, food component or DS ingredient AND reducing the risk of a disease or health-related condition?

Health claim

22

What increases risk of bleeding (can be an ADR of a DS)?

Anticoagulation properties

23

What describes how a product may affect the organs or systems of the body AND it cannot mention any specific disease?

Structure/function claim

24

These decrease drug concentrations:

Enzyme inducers

25

What describes the relative amount of a nutrient or DS in a product?

Nutrient/content claim

26

These Increase drug concentrations:

Enzyme inhibitors

27

Labels of herbals and DS must contain standard common names listed in Herbs of Commerce, published by the who?

American Herbal Products Association

28

If the product does not have a standard common name, the manufacturer must include the herb’s what on the label?

Latin name

29

When did the FDA ban the sale of all ephedra (used for asthma) containing dietary supplements?

2004

30

The Ephedra ban does not apply to what products?

  • prescription drug products
  • non-prescription drug products
  • conventional foods (herbal teas)
  • products used for “Traditional Chinese Medicine”
31

List the 4 main resources for DS:

  • Natural Medicines Comprehensive Database(PubMed)
  • Office of Dietary Supplements (NIH)
  • The Consumer Lab
  • The U.S. Pharmacopeia (USP)
32

Incorrect or damaged composition of the product is referred to as what?

Adulteration

33

Incorrect or damage to the product label is referred to as what?

Misbranding

34

Articles to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance are known as what?

Cosmetics

35

True or False: Cosmetics do not require pre-marketing approval by the FDA

True

36

Cosmetics do not have to meet GMP requirements, but are obligated to be manufactured under what?

sanitary conditions

37

Any product (cosmetic) not manufactured under sanitary conditions will be considered what?

adultered

38

Which law does not require cosmetics to be tested for safety?

FDCA of 1938

39

Any product (cosmetic) posing a safety risk will be considered what?

Misbranded

40

Any product (cosmetic) containing an unapproved color additive will be considered what?

Adulterated

41

List some examples of cosmetics:

  • skin moisturizers
  • cleansing shampoos
  • permanent waves
  • hair colors
  • deodorants
42

Regulation of cosmetic advertising and labeling falls under the jurisdiction of the whom?

FTC

43

Cosmetic product labels must contain names of each ingredient listed in what?

descending order of predominance

44

What cosmetics may be listed by name?

  • Perfumes
  • flavoring oils
45

Which cosmetics must be accepted for cosmetic use?

Coloring agents

46

Ingredient names listed on cosmetic labels must match the generic name listed in at least 1 of what 2 resources?

  • USP/NF
  • CTFA Cosmetic Ingredient Dictionary
47

–CTFA is a book compiled by whom that contains many ingredients commonly used in cosmetics?

Cosmetic, Toiletry, and Fragrance Association (CFTA)

48

Can a product be both a cosmetic and a drug?

Yes

49

List examples of products that can be a cosmetic and a drug:

  • Anti-dandruff shampoo
  • fluoridated toothpaste
  • medicated mouthwash
  • deodorant/antiperspirant
  • moisturizers and makeup with sun-protection claims
  • essential oils with therapeutic claims
50

What are the 5 common ADRs and SE of a DS?

  1. Anticoagulation properties
  2. Enzyme inducers
  3. Enzyme inhibitors
  4. Affect electrolyte level
  5. Potentially hepatotoxic