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Pharmacy Law > Federal Regulation of Medications: Development, Production, and Marketing > Flashcards

Federal Regulation of Medications: Development, Production, and Marketing Flashcards

1
Q

What is the Pure Food and Drug Act of 1906?

A

Impure food
False efficacy claims 1912

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2
Q

What is the Food, Drug, and Cosmetic Act of 1938?

A

SAFETY of drugs, labeling/approval

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3
Q

What is the Durham-Humphrey Amendment of 1951?

A

Rx and OTC separation
Refills, Oral Rx
Instructions for use

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4
Q

What is the Kefauver-Harris Amendment of 1962?

A

Pregnancy safety
EFFICACY
Rx ads, GMP, and research

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5
Q

What is the Orphan Drug Act of 1983?

A

Tax incentives for manufacturers to drive research, Rare diseases

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6
Q

What is the Drug Price Competition Act of 1984?

A

GENERIC Approval process

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7
Q

What is the Prescription Drug User Fee Act of 1992?

A

Manufacturers have to pay FEES to support regulation from FDA

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8
Q

What is the Dietary Supplement Health and Education Act?

A

Dietary supplements falling under food category and the claims that can be included on the labels

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9
Q

What is the Food and Drug Administration Modernization Act of 1997?

A

Fast-Track Approval Option
OTC products have inactive and active ingredients on label

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10
Q

What is the Food and Drug Administration Amendments Act of 2007?

A

Improve Prescription labeling (DUE TO VIOXX), post-marketing surveillance, and REMS program established

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11
Q

What is the Patient Protection and Affordable Care Act of 2010?

A

Added provisions to FDCA

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12
Q

What is the FDA Safety and Innovation Act of 2012?

A

Safety mechanism for counterfeits/imports, detect and decrease drug shortages, and foreign inspections

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13
Q

What is the Drug Quality and Security Act of 2013?

A

Oversight of sterile compounding and distribution
Outsourcing facilities, CGMP regulation
Track and trace for distribution chain
(DUE to NECC tragedy)

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14
Q

What is the 21st Century Cures Act of 2016?

A

Add flexibility/innovation to drug development/approval process
Increase funding to address mental health and substance abuse issues

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15
Q

What is the Rationale for Federal Drug Regulation?

A

Protection of public against adulterer and misbranded drug products.
Necessity of balancing direction and indirect regulation.

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16
Q

The FDA falls under what U.S. department?

A

Department of Health and Human Services (DHHS)

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17
Q

What are the functions of the FDA?

A

Rule-Making
Issue Guidance Documents
Incorporate advice from standing advisory committees of outside experts

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18
Q

What is Drug Defined Part A?

A

Articles recognized in the USP, homeopathic pharmacopeia or National Formulary NF

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19
Q

What is Drug Defined Part B?

A

Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease (therapeutic/health claim)

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20
Q

What is Drug Defined Part C?

A

Articles other than food intended to affect the structure or function of the body (structure/function claim)

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21
Q

Why is the drug definition broad?

A

To include almost anything with an intended therapeutic purpose or purpose of altering the structure or function of the body

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22
Q

What are the 3 points of evidence that a product is a drug?

A

Labeling, advertising, and nature of product

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23
Q

What is the intended meaning of food in Part C drug definition?

A

Meaning of food to apply to food used for its ordinary purpose and in an ordinary manner

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24
Q

What are the Legal Food Categories?

A

Special dietary foods and medical foods

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25
Q

What are special dietary foods?

A

Formula, sweetners

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26
Q

What are medical foods?

A

Under physician supervision, require special formulation

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27
Q

What are the Publicly Conceived Food Categories?

A

Nutraceuticals and Functional Foods

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28
Q

What are the 2 special food categories?

A

Legal and Publicly Conceived

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29
Q

What are Nutraceuticals?

A

Product with specific nutrients

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30
Q

What are Functional Foods?

A

Products or nutraceuticals with fortification/enhancement

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31
Q

If there is a health claim for a food, what could result?

A

The product could be considered a drug

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32
Q

What Acts allow foods to contain health claims if approved by the FDA regulation or by the significant scientific agreement test?

A

Nutrition Labeling and Education of 1990 and DSHEA of 1994

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33
Q

What is the DSHEA 1994?

A

Dietary Supplement Health Education Act 1994

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34
Q

What are does DSHEA entitle?

A

Created a new category of food called dietary supplements DS
DS do not require premarket approval

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35
Q

What are dietary supplements that do not require premarket approval?

A

Vitamins, minerals, herbs, botanicals, amino acids, and substance used to supplement the diet by increasing total dietary intake

36
Q

What are the safety issues with dietary supplements?

A

FDA can remove a DS on the bases of the product being adulterated
Manufacturers required to report serious adverse events

37
Q

What is the definition of a DS being adulterated?

A

Significant or Unreasonable Risk of illness or injury under the conditions of use recommended or suggested in the labeling

38
Q

What are the DSHEA 4 types of nutritional support claims to AVOID consideration as a DRUG?

A
  1. Benefiting a classical nutrient deficiency disease
  2. Describing role of the supplement in affecting the structure/function of the body
  3. Characterizing the mechanism by which a DS acts to maintain the structure of function
  4. Statements of general well being
39
Q

What do DS labels MUST contain?

A

Claims that are substantial, truthful, and not misleading
Labels MUST contain disclaimer: not approved by FDA

40
Q

DSHEA only permits DS manufacturers to make health claims if what?

A

Either the FDA approves the claim by regulation or by the significant scientific agreement test
(unqualified, no disclaimer)

41
Q

What case allowed for DS manufacturers could make health claims not approved by the FDA provided they are not false or misleading and accompanied by a disclaimer (qualified)?

A

Pearson vs. Shalala

42
Q

FDA now allows what for DS labels?

A

Allows Unqualified and Qualified health claims adhering to specific criteria

43
Q

What are the implications of DSHEA for Pharmacists?

A
  1. Product selection
  2. Education of patients as opposed to promotion of products
  3. Restrictions regarding the display of DS publications
44
Q

What is the main purpose of the FDCA?

A

Protect the public, the FDA interprets the FDCA

45
Q

What is the main purpose of the Durham Humphrey?

A

Rx/OTC, labeling, and refills

46
Q

What is the main purpose of the Kefauver-Harris?

A

Efficacy requirement

47
Q

What does the term labeling include?

A

Labels on the container or wrapper (article)

48
Q

What is the definition of labeling?

A

Written or printed or graphic matter ACCOMPANYING the article

49
Q

What is the USP?

A

United States Pharmacopeia

50
Q

What does the USP do?

A

Published by the USPC, sets uniform standards

51
Q

What does the Homeopathic Pharmacopoeia of the US (HPUS) do?

A

Publishes standards for homeopathy product by the HPCUS, a private organization

52
Q

If a drug is recognized in USP or HPUS the product must meet ALL standard of the compendia or what?

A

Be considered misbranded or adulterated

53
Q

Adulteration focus on what two aspects?

A

Product and Facility

54
Q

How can a ‘pure’ drug still be considered adulterated?

A

Due to the Facility’s conditions and handling/storage

55
Q

A drug is adulterated if what 3 qualities differ from compendia standards

A

Strength, Quality, or Purity

56
Q

What is CGMP?

A

An exhaustive set of standards directed at manufacturers

57
Q

Failure to manufacture a product in a tamper resistant container is required by the law, and is considered what if not done?

A

Adulteration and Misbranding

58
Q

What is considered Misbranding (502) Part (a)?

A
  1. Labeling must not be false or misleading, including healthcare economic information.
59
Q

What is considered Misbranding (502) Part (e)?

A
  1. Labeling must include a listing of active ingredients and inactive ingredients in alpha order.
60
Q

What is considered Misbranding (502) Part (f)?

A
  1. Labeling must contain “adequate directions for use” and “adequate warnings against use” by children and others for whom use might be dangerous (directed at consumers OTC)
61
Q

What is an example of Indirect Regulation?

A

Consumer must have all the information needed to take this product safely

62
Q

What is an example of Non-Prescription?

A

Must contain adequate instructions

63
Q

What is an example of a Prescription?

A

Must contain adequate information, patients need a pharmacist to interpret this information for them

64
Q

What are 4 components of Nonprescription Drug Labeling?

A
  1. Pharmacological category or principal intended use
  2. Cautions and warnings
  3. Adequate directions for use
  4. Drug facts panel
65
Q

If a pharmacy re-labels or repackages, what must the label contain?

A

Must conform to the same labeling requirements as manufacturers

66
Q

Labels for prescription drugs, must include what?

A

Adequate Information for Use

67
Q

What are 4 components required for new package inserts?

A
  1. Highlights section at the beginning
  2. Table of Contents
  3. Full prescribing information, organized from most to least important
  4. Patient counseling information
68
Q

When are Black Box Warnings required?

A

Required in labeling when use of a drug may lead to death or serious injury

69
Q

What is a Pregnancy Warning System?

A

Drugs potentially risky during pregnancy will be placed into categories: A, B, C, D, X

70
Q

Labels will require inclusion of what 3 subsections to describe risks of pregnancy?

A
  1. Pregnancy
  2. Lactation
  3. Females and Males of Reproductive Potential
71
Q

When can a the FDA issue a drug recall?

A

The FDA cannot issue a drug recall, the manufacturer must do it voluntarily

72
Q

What happens if the manufacturer does not issue a drug recall?

A

FDA will file an Injunction, that ceases manufacturing of products period

73
Q

What are the three classes of recalls and their probability/outcome?

A

I: reasonable, serious ADE/death
II: maybe/remote, temporary/reversible
III: unlikely, no adverse health

74
Q

Are manufacturers responsible for notifying sellers of a recall?

A

YES

75
Q

What are most prohibited acts consistent of?

A

Misbranding or Adulteration

76
Q

What is 301c and why is it applicable to a pharmacy?

A

The receipt and subsequent delivery of an adulterated or misbranded drug

77
Q

What is 301i3 and why is it applicable to a pharmacy?

A

The doing of any act which causes a drug to be counterfeit

78
Q

What is 301k and why is it applicable to a pharmacy?

A

The alteration, mutilation, etc of labeling

79
Q

What is an injunction?

A

Court order to refrain from doing a specific act

80
Q

What is the seizure of products?

A

To remove adulterated/misbranded product

81
Q

What are warning letters?

A

Request written response of steps which will be taken to correct violations

82
Q

How many numbers are there in the NDC?

A

10

83
Q

What does the 1st three segment of NDC mean?

A

Manufacturer/Distributor (where)

84
Q

What does the 2nd three segment of NDC mean?

A

Strength, dosage form, and formulation (what)

85
Q

What does the 3rd three segment of NDC mean?

A

Package size and type (how)

Pharmacy Law (13 decks)

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