Chapter 4

Question 1

What is the Pure Food and Drug Act?

Answer 1

1906, meets standards for strength, quality, and purity; no safety for safety/efficacy

Question 2

What is the Federal Food Drug and Cosmetic Act?

Answer 2

1938, Mandated safety

Question 3

What is the Durham-Humphry Amendment?

Answer 3

1951, established Rx and non-Rx; established that OTC are safe w/o medical supervision and labeled for safe use

Question 4

What is the Kevaufer-Harris Amendment?

Answer 4

1962, All new drugs had to be safe and effective; review of older drugs; drug efficacy study implementation

Question 5

When was the Combat Meth Act enacted?

Answer 5

2010

Question 6

What is GRASE?

Answer 6

Generally recognized as safe and effective

Question 7

Which OTC dont have expiration dates?

Answer 7

OTC products that do not have a dose limit and are stable for 3 years are exempt (e.g. topicals, lotions)

Question 8

Describe the three levels of recall.

Answer 8

Level 1: Dangerous
Level 2: Slight risk
Level 3: Unlikely to cause any adverse health reaction but violates labeling/manufacturing regulations

Question 9

What is Implied warranty for fitness?

Answer 9

Product is fit for that purpose/use

Question 10

What is Implied warranty for merchantability ?

Answer 10

Product is fit for it’s general purpose under typical conditions

Question 11

To prove negligence you must show all 4 elements which are:

Answer 11

1. Duty of care: decided by the court. Provider failed to exercise a certain degree of care reasonable and prudent.
2. Breach of duty – jury decides after court decision.
3. Breach caused injury complaint.
4. Plaintiff sustained some injury/damage.

Question 12

What are homeopathic remedies recognized as by the FDA?

Answer 12

Drugs

Question 13

Homeopathic remedies are governed by whom?

Answer 13

Homeopathic Pharmacopoeia of the Unites States

Question 14

Dietary supplementation is regulated by:

Answer 14

FDA under the Dietary Supplement Health and Education Act of 1994