511 - Pharm Law - Exam I - Fdca And Definitions

Front 1

Define: "FDCA"

Back 1

Food, Drug and Cosmetic Act

Regulates all drugs introduced into inter-state commerce as well as purity of products and labeling

Front 2

What must be required before a drug may be marketed and sold?

Back 2

1) Proven safe
2) Proven effective for its intended use
3) Approved by the FDA

Front 3

Define: "FDA"

Back 3

Food and Drug Administration

Front 4

How did the Durham-Humphrey Amendment alter the FDCA?

Back 4

Required drugs be labeled with "adequate directions for use" while creating two distinct classes of drugs, prescription and OTC.

It also authorized oral prescriptions and refills for the first time.

Front 5

What must appear on every prescription stock bottle to signify that it is prescription only?

Back 5

Rx Only

Front 6

How did the Kefauver-Harris Amendment alter the FDCA?

Back 6

Related to the thalidomide disaster

Required that drugs be proven to be safe and effective. Also transferred advertising jurisdiction from the FTC to the FDA, established the Good Manufacturing Practices requirements and added requirements better informing research subjects

Front 7

How did the Medical Device Amendment of 1976 alter the FDCA?

Back 7

Gave the FDA the authority to regulate such devices. It requires:
1) Classification of devices according to function
2) Premarket approval
3) Establishment of performance standards
4) Conformance with GMP
5) Adherence to record and reporting requirements

Front 8

What FDCA amendment created a fast-track process for serious or life-threatening diseases?

Back 8

The Food and Drug Administration Modernization Act of 1997

Front 9

What FDCA amendment gave the FDA authority over OTC drugs?

Back 9

The Food and Drug Administration Modernization Act of 1997

Front 10

What FDCA amendment established labeling requirements for inactive ingredients?

Back 10

The Food and Drug Administration Modernization Act of 1997

Front 11

What is another name for the Waxman-Hatch Amendment?

Back 11

The Drug Price Competition and Patent Term Restoration Act of 1984

Front 12

What FDCA amendment gave rise to the proliferation of generic drugs while establishing extended patent rights for innovator drugs?

Back 12

The Drug Price Competition and Patent Term Restoration Act of 1984

Front 13

Name the six centers housed under the FDA

Back 13

1) Center for Biologics Evaluation and Research
2) Center for Food Safety and Applied Nutrition
3) Center for Drug Evaluation and Research
4) Center for Veterinary Medicine
5) Center for Devices and Radiological Health
6) Center for Tobacco Products

Front 14

What is the legal definition of "food"?

Back 14

1) Articles used for food or drink for man or other animals
2) Chewing gum
3) Articles used for components of any such article

Front 15

What is the legal definition of "drug"?

Back 15

1) Recognized in USP, Homeopathic Pharmacopoeia of the US or official National Formulary
2) Use in diagnosis, cure, mitigation, treatment or prevention of disease
3) Intended to affected the structure of any function of the body of man or other animals (and is not food)
4) Any components related to the first three descriptors

Front 16

What is the legal definition of "device"?

Back 16

An instrument et al
1) recognized in the official National Formulary or the USP or supplement to either
2) Intended to diagnosis, cure, mitigate, treat or prevent disease
3) Intended to affected the structure or any function of the body of man or animals which does not achieve any of its principal intended purposes through chemical action

Front 17

What is the legal definition of "cosmetic"?

Back 17

1) Articles intended to be rubbed, poured, sprinkled or sprayed on for the purpose of cleaning, beautifying, promoting attractiveness or altering appearance
2) Articles intended for use as a component of any such articles (except soap)

Front 18

What is the difference been drugs and food?

Back 18

Food is used primarily for taste, aroma or nutritional value.

To be a food it must be consumed for ordinary purposes, despite the fact it technically alters the structure and function of the body.

Front 19

What are the three sub-groups of legal "foods"?

Back 19

Medicinal Foods, Nutraceuticals & Functional Foods and Special Dietary Foods

Front 20

Define: "Special Dietary Foods"

Back 20

Used in people who have a hypersensitivity to food, are underweight or overweight, need to control sodium intake, who may pregnant or have any other condition which may require a special diet

Front 21

What are some examples of "Special Dietary Foods"?

Back 21

Infant formula, Artificial Sweetners

Front 22

Define: "Medical Foods"

Back 22

Foods intended for use under the car of a physician for a specific dietary management of a disease or condition

Front 23

What was the purpose of the Dietary Supplement Health and Education Act of 1994?

Back 23

Amended the FDCA by creating a separate category, and giving regulatory authority, over dietary supplements

Front 24

What is the legal definition of a "Dietary Supplement"?

Back 24

A product intended for ingestion to supplement the diet and contains one or more of the following
1) A vitamin
2) A mineral
3) An herb or other botanical
4) An amino acid
5) A supplement which increases total dietary intake
6) A concentrate, extract, etc of one of the previous items

Front 25

What four statements to the FDA allow on dietary supplements lest it be called a drug?

Back 25

1) Will benefit a classicial nutrient deficiency disease while disclosing prevalence
2) Describe the role in affecting the structure or function of the body
3) Documented mechanism by which a nutrient or dietary supplement acts to maintain said structure or function
4) Explanation of general well-being from consumption (energizer, relaxant, etc)

Front 26

What disclaimer must be found on all dietary supplement packaging?

Back 26

“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”

Front 27

Describe the three classes of Medical Devices

Back 27

Class I - Present minimal potential for harm to users, simpler in design

Class II - Most medical devices

Class III - Usually sustain or support life, are implanted or present potential unreasonable risk of illness or injury

Front 28

Give an example of a Class I Medical Device

Back 28

Toothbrushes, elastic bandages, kinetics... (okay not really)

Front 29

Give an example of a Class II Medical Device

Back 29

Syringes, Infusion Pumps, Tampons

Front 30

Give an example of a Class III Medical Device

Back 30

Pacemakers, Soft Contact Lenses

Front 31

Define: "Biologic"

Back 31

Products derived form living organisms ranging from viruses to toxins to blood components, for the prevention, treatment or cure of a disease or condition

Front 32

Why are there no generic Biologics?

Back 32

Questions exist over the safety and efficacy of generics as the process is much more complex and there exists little legal precedent for it.

Front 33

Define: "Label"

Back 33

To display a written, printed or graphic material directly upon the immediate container of any article.

Essentially, all the required information must be clearly printed on the packaging

Front 34

Define: "Labeling"

Back 34

All labels and other written, printed or graphic materials upon any of its containers or wrappers and accompanying such article.

Best example, the package insert to go along with the required "label"

Front 35

What are the official compendia?

Back 35

1) USP
2) National Formulary (NF)
3) Homeopathic Pharmacopeia of the US (HPUS)

Front 36

What is the purpose of the USP?

Back 36

Contains monographs of active ingredients

Now combined with the NF

Front 37

What is the purpose of the NF?

Back 37

Contains monographs of inactive ingredients

Now combined with the USP