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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
What are special dietary foods?
Formula, sweetners
26
What are medical foods?
Under physician supervision, require special formulation
27
What are the Publicly Conceived Food Categories?
Nutraceuticals and Functional Foods
28
What are the 2 special food categories?
Legal and Publicly Conceived
29
What are Nutraceuticals?
Product with specific nutrients
30
What are Functional Foods?
Products or nutraceuticals with fortification/enhancement
31
If there is a health claim for a food, what could result?
The product could be considered a drug
32
What Acts allow foods to contain health claims if approved by the FDA regulation or by the significant scientific agreement test?
Nutrition Labeling and Education of 1990 and DSHEA of 1994
33
What is the DSHEA 1994?
Dietary Supplement Health Education Act 1994
34
What are does DSHEA entitle?
Created a new category of food called dietary supplements DS DS do not require premarket approval
35
What are dietary supplements that do not require premarket approval?
Vitamins, minerals, herbs, botanicals, amino acids, and substance used to supplement the diet by increasing total dietary intake
36
What are the safety issues with dietary supplements?
FDA can remove a DS on the bases of the product being adulterated Manufacturers required to report serious adverse events
37
What is the definition of a DS being adulterated?
Significant or Unreasonable Risk of illness or injury under the conditions of use recommended or suggested in the labeling
38
What are the DSHEA 4 types of nutritional support claims to AVOID consideration as a DRUG?
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
What do DS labels MUST contain?
Claims that are substantial, truthful, and not misleading Labels MUST contain disclaimer: not approved by FDA
40
DSHEA only permits DS manufacturers to make health claims if what?
Either the FDA approves the claim by regulation or by the significant scientific agreement test (unqualified, no disclaimer)
41
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)?
Pearson vs. Shalala
42
FDA now allows what for DS labels?
Allows Unqualified and Qualified health claims adhering to specific criteria
43
What are the implications of DSHEA for Pharmacists?
1. Product selection 2. Education of patients as opposed to promotion of products 3. Restrictions regarding the display of DS publications
44
What is the main purpose of the FDCA?
Protect the public, the FDA interprets the FDCA
45
What is the main purpose of the Durham Humphrey?
Rx/OTC, labeling, and refills
46
What is the main purpose of the Kefauver-Harris?
Efficacy requirement
47
What does the term labeling include?
Labels on the container or wrapper (article)
48
What is the definition of labeling?
Written or printed or graphic matter ACCOMPANYING the article
49
What is the USP?
United States Pharmacopeia
50
What does the USP do?
Published by the USPC, sets uniform standards
51
What does the Homeopathic Pharmacopoeia of the US (HPUS) do?
Publishes standards for homeopathy product by the HPCUS, a private organization
52
If a drug is recognized in USP or HPUS the product must meet ALL standard of the compendia or what?
Be considered misbranded or adulterated
53
Adulteration focus on what two aspects?
Product and Facility
54
How can a 'pure' drug still be considered adulterated?
Due to the Facility's conditions and handling/storage
55
A drug is adulterated if what 3 qualities differ from compendia standards
Strength, Quality, or Purity
56
What is CGMP?
An exhaustive set of standards directed at manufacturers
57
Failure to manufacture a product in a tamper resistant container is required by the law, and is considered what if not done?
Adulteration and Misbranding
58
What is considered Misbranding (502) Part (a)?
1. Labeling must not be false or misleading, including healthcare economic information.
59
What is considered Misbranding (502) Part (e)?
2. Labeling must include a listing of active ingredients and inactive ingredients in alpha order.
60
What is considered Misbranding (502) Part (f)?
3. 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
What is an example of Indirect Regulation?
Consumer must have all the information needed to take this product safely
62
What is an example of Non-Prescription?
Must contain adequate instructions
63
What is an example of a Prescription?
Must contain adequate information, patients need a pharmacist to interpret this information for them
64
What are 4 components of Nonprescription Drug Labeling?
1. Pharmacological category or principal intended use 2. Cautions and warnings 3. Adequate directions for use 4. Drug facts panel
65
If a pharmacy re-labels or repackages, what must the label contain?
Must conform to the same labeling requirements as manufacturers
66
Labels for prescription drugs, must include what?
Adequate Information for Use
67
What are 4 components required for new package inserts?
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
When are Black Box Warnings required?
Required in labeling when use of a drug may lead to death or serious injury
69
What is a Pregnancy Warning System?
Drugs potentially risky during pregnancy will be placed into categories: A, B, C, D, X
70
Labels will require inclusion of what 3 subsections to describe risks of pregnancy?
1. Pregnancy 2. Lactation 3. Females and Males of Reproductive Potential
71
When can a the FDA issue a drug recall?
The FDA cannot issue a drug recall, the manufacturer must do it voluntarily
72
What happens if the manufacturer does not issue a drug recall?
FDA will file an Injunction, that ceases manufacturing of products period
73
What are the three classes of recalls and their probability/outcome?
I: reasonable, serious ADE/death II: maybe/remote, temporary/reversible III: unlikely, no adverse health
74
Are manufacturers responsible for notifying sellers of a recall?
YES
75
What are most prohibited acts consistent of?
Misbranding or Adulteration
76
What is 301c and why is it applicable to a pharmacy?
The receipt and subsequent delivery of an adulterated or misbranded drug
77
What is 301i3 and why is it applicable to a pharmacy?
The doing of any act which causes a drug to be counterfeit
78
What is 301k and why is it applicable to a pharmacy?
The alteration, mutilation, etc of labeling
79
What is an injunction?
Court order to refrain from doing a specific act
80
What is the seizure of products?
To remove adulterated/misbranded product
81
What are warning letters?
Request written response of steps which will be taken to correct violations
82
How many numbers are there in the NDC?
10
83
What does the 1st three segment of NDC mean?
Manufacturer/Distributor (where)
84
What does the 2nd three segment of NDC mean?
Strength, dosage form, and formulation (what)
85
What does the 3rd three segment of NDC mean?
Package size and type (how)

Pharmacy Law (13 decks)

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