PHA 372 Law Quiz 3

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1

What are the 4 ways a request to reclassify a Rx drug to an OTC product?

  1. Submit full NDA to FDA requesting status change
  2. FDA can grant exemption if it deems Rx-only status unnecessary for protection of public health
  3. Filing a supplement to NDA
  4. Recommendation from Nonprescription Drug Advisory Committee
2

OTC ingredients are classified into one of _______ categories

3

3

Which OTC ingredient category is generally recognized as safe and effective (GRASE) for claimed therapeutic indication?

Category I

4

Which OTC ingredient category is not generally recognized as safe and effective or having unacceptable indications?

Category II

5

Which OTC ingredient category has insufficient data available to permit final classification?

Category III

6

________ places health foods, food supplements, and herbal products into a class different from Rx and OTC products.

Dietary Supplement Health Education Act (DSHEA)

7

Examples of products included in DSHEA

  • Herbals
  • Amino Acids
  • Vitamins
  • Minerals
  • Dietary Supplements
8

What did DSHEA do?

  • Products to be marketed w/o proven efficacy
  • Products currently on the market do not have to be proven safe
  • USP published "Manufacturing Practices for Dietary Supplements"
9

Who may challenge a DSHEA product after it has gone to market and when would they do so?

FDA or FTC; if evidence comes forth that the product is ineffective for its labeled use

10

Who's responsibility is it to prove DSHEA products unsafe?

FDA

11

Dietary supplement is defined as

The final product

12

Dietary ingredient is defined as

Vitamin, mineral, herb, or botanical, amino acid, or other dietary substance used to supplement the diet.

13

Non-dietary ingredient is defined as

An excipient or substance used to manufacture a DS

14

When manufacturing DS, most requirements fall on the _______________ with respect to testing and record-keeping

Manufacturer

15

True/False: For DS, GMP guidelines outline required tests that must be performed to verify identity, strength, purity, etc.

False

16

True/False: For DS, manufacturers may test every batch of finished product OR subsets of finished batches.

True

17

True/False: DS manufacturers establish their own written procedures

True

18

How long must procedural records for DS manufacturers be kept?

1 year after exp date (if there is one) OR 2 year past date of distribution of the last batch

19

Violations of GMP rules results in DS being considered ___________

Adulterated

20

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

USP/NF

21

Describes the portion of the plant used, its botanical characteristics and appropriate assay procedures for ingredients.

Mongraph

22

True/False: Monographs describe therapeutic use for botanicals

False

23

Herbal product must have an FDA approved use of _______________

USP DI Panel recognized use

24

DS/Herbals with monograph examples

  • Chamomile
  • Feverfew
  • Ginger
  • Milk thistle
  • Saw Palmetto
25

Chamomile

Cranberry liquid preps

26

Feverfew

Garlic

27

Ginger

Ginko biloba

28

Milk Thistle

St. John's Wort

29

Saw Palmetto

Valerian

30

What are the 3 types of claims DS manufacturers can make?

  • Health Claim
  • Nutrient content claim
  • Structure/Fxn claim
31

Describes relationship b/w food, food component, or DS ingredient AND reducing risk of a disease or health-related condition

Health Claim

32

Describes the relative amount of a nutrient or DS in a product

Nutrient content claim

33

Describes how a product may affect the organs / systems of the body AND it cannot mention any specific disease

Structure/Fxn claim

34

What are some common ADRs and SE of DS?

  • Anticoagulation properties -- Increase risk of bleeding
  • Enzyme inducers -- Decrease drug concentrations
  • Enzyme inhibitors -- Increase drug concentrations
  • Affect electrolyte levels
  • Potentially hepatotoxic
35

Herbal and DS labels must contain what kind of names listed in Herbs of Commerce, published by the American Herbal Products Association

Standard common names

36

What should a manufacturer do if the herbal/DS product does not have a standard common name to include on the label?

Include the herb's Latin name on the label

37

True/False: Claimes about structure/fxn must be truthful and not misleading.

True

38

True/False: Herbal/DS products may make claims that the product will diagnose, cure, treat, or prevent a disease

False

39

In 2004, the FDA banned the sale of all ________ (used for asthma) containing DS bc the use presented an unreasonable risk of illness/injury.

Ephedra

40

What did the 2004 ban on Ephedra by the FDA not apply to?

  • Prescription/non prescription products
  • Conventional foods (herbal teas)
  • Products used for "Traditional Chinese Medicine"
  • (Product labels cannot have an indication that the product is a DS)
41

Resources for DS include:

  • Natural Medicines Comprehensive Database (PubMed)
  • Office of Dietary Supplements (NIH)
  • The Consumer Lab
  • The US Pharmacopeia (USP)
42

Adulteration involves ___________ of the product

composition

43

Misbranding involves ________ of the product

labeling

44

Atricles 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.

Cosmetics

45

Do cosmetics require premarket approval by the FDA?

No

46

Cosmetics do not have to meet GMP requirements, but are obligated to be manufactured under ____________ conditions

Sanitary

47

If a cosmetic is not manufactured under sanitary conditions, it is considered ______________

Adulterated

48

True/False: FDCA of 1938 required cosmetics to be tested for safety.

False

49

Any cosmetic product posing a safety risk will be considered ___________

Misbranded

50

Any cosmetic product containing an unapproved color additive will be considered ____________

Adulterated

51

Regulation of cosmetic advertising and labeling falls under the jurisdiction of ____________

FTC

52

True/False: Cosmetic product labels must contain names of each ingredient listed in ascending order of predominance.

False

53

Perfumes and flavoring oils in cosmetics may be listed by _______

name

54

Ingredient names listed on cosmetic labels must match the generic name listed int eh USP/NF or ___________

CTFA Cosmetic Ingredient Dictionary

55

Can a product be both a cosmetic and a drug?

Yes

56

What is the basis for distinction between cosmetics and drugs?

Claims made for the product