Legal Lecture Flashcards

1
Q

What did the pure food and drug act do?

A

Drugs had to meet the standards for strength, quality, and purity claimed by the manufacturer
- Did not have to be safe or effective

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2
Q

What did the Federal Food, Drug, and Cosmetic Act do?

A

Drugs must be safe

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3
Q

What did the Durham-Humphrey Amendment do?

A

Drugs classified as either prescription or non-prescription

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4
Q

What did Kefauver-Harris Amendment do?

A

All new drugs must be safe and effective

- Development of the FDA and NDA

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5
Q

What is the FDA?

A

Responsible for enforcing the provisions of the FDC Act

  • Reviewing over-the-counters products (1972)
  • Responsible for labeling of OTC products
  • Decides whether prescription drugs can be switched to non-prescription status
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6
Q

What are OTC monographs?

A
Approved by the FDA for ingredients  that are "GRASE"
Established for each class of drugs 
Lists acceptable ingredients, dose, formulations and labeling
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7
Q

When can a manufacturer market a new product without FDA approval?

A

If ingredients are covered in a previous OTC monograph

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8
Q

What are the labeling requirements of OTC products?

A

Standardized content and format required by the FDA
“Drug Facts” box
- active ingredient
- uses
- warnings, directions and inactive ingredients
Expiration date

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9
Q

Define misbranded

A

Product that lacks active ingredients, uses, warnings, directions, and inactive ingredients

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10
Q

Exceptions of expiration dates include?

A

Stable for more than 3 years that do not have a dose limits

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11
Q

What are some package requirements?

A

Tamper-evident packaging is required
Nonprescription drugs must have a barrier
Packaging must state the mechanism
Patients should be educated to look for them

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12
Q

How can prescriptions switch to OTC?

A

Through the nonprescription drug review process
Manufacturer submits a supplemental NDA
Manufacturer or third party petitions the FDA
No exact standards

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13
Q

What does the Federal Trade Commission do?

A

Regulates advertising of nonprescription drugs

- Has to be honest and not deceiving (1970’s)

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14
Q

What are the code of guidelines for advertisements?

A

Urge customers to read and follow directions
No unsubstantiated claims
No curative suggestions
Point out uses and benefits
No unproven claims against competing products

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15
Q

What happens with product recalls?

A

Utilized when a product is ID as a potential risk to the public

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16
Q

What are the methods of action for product recalls?

A

If misbranded, adulterated or not approved the FDA can seize the product
Court injunction preventing further distribution
Ask the manufacturer to recall the product

17
Q

What is a class I recall?

A

Dangerous or defective products that pose serious health risks or death

18
Q

What is a class II recall?

A

May cause a temporary health risk or slight risk of serious problem

19
Q

What is a class III recall?

A

Unlikely to cause a problem but violate FDA labeling or manufacturing regulation

20
Q

Who regulates dietary supplements?

A

Dietary Supplement Health and Education Act of 1994

  • Allows the FDA to regulate under the Center for Food Safety and Applied Nutrition
  • Exempt from purity and potency standards
  • Clinical trails are not required
  • Only has to prove it is safe
21
Q

What did the Dietary Supplements and Non-Prescription Drug Consumer Protection Act do?

A

Requires manufacturers to report to the FDA any serious adverse event reports from the consumer

22
Q

What are Good Manufacturing Practices?

A

No adulterants
No impurities
Limits on the presence of bacteria, pesticides, heavy metals
Labeling requriements

Required by DSHEA in 2007

23
Q

What must the label contain for dietary supplements?

A
Name of the product
Word supplement
Net quantity
Manufacturers name and place of business
Directions
"Supplement Facts" label
24
Q

What are dietary supplements not allowed to do?

A

Make claims that the product will diagnose, cure, mitigate, prevent or treat a disease

25
Q

What are the three categories of claims?

A

Health, nutrient content, and structure-function

26
Q

What statement must supplements have on their label?

A

This statement has not been evaluated (approved) by the FDA.

This product is no intended to diagnose, treat, cure, or prevent disease

27
Q

What is a health claim?

A

The relationship between the ingredient and reduction of risk of a disease

28
Q

What is a nutrient claim?

A

Amount of a nutrient or dietary substance

29
Q

What are structure-function claims?

A

How the product helps maintain the healthy structure or function of the body

30
Q

How are homeopathic remedies regulated?

A

Regulated by the FDA via the FDC Act
( USP and HPUS and NF)
Not classified as a dietary supplements
Requires labeling standards for homeopathic drugs

31
Q

What does the HPUS labeling assure standards of?

A

Strength, quality, purity, and packaging have been met

32
Q

Who does the HPCUS work cloesly with and what do they do?

A

FDA

Approve any amendments or additions to HPUS