Law - Exam 1 Flashcards
Class 1, 2, or 3 devices are most dangerous
3
T or F: Class 1, 2 and 3 devices require pre-market approval
false!! only class 3 Class 2 "require special controls" but do not need pre approval
what is the only banned device in the US
prosthetic hair fibers
Example of Class 1, 2, or 3 Device?
tampons
2
Example of Class 1, 2, or 3 Device?
stethoscope
1
Example of Class 1, 2, or 3 Device?
condoms
2
Drug recalls are ________
Device recalls are ________
drug: voluntary
device: mandatory
Example of Class 1, 2, or 3 Device?
syringes
2
Example of Class 1, 2, or 3 Device?
Ventilator tubing
1
Example of Class 1, 2, or 3 Device?
pacemakers
3
Example of Class 1, 2, or 3 Device?
replacement heart valves
3
Example of Class 1, 2, or 3 Device?
soft contact lenses
3
T or F: FDA can request, but NOT order manufacturers to recall a drug
true
if FDA requests for a drug recall and manufacturer refuses – the FDA has to file a lawsuit called ____________
libel for information and condemnation
Class 1, 2 or 3 recalls are worse?
1
Class 1, 2 or 3 recalls?
- Exposure to or use of product may cause temporary or medically reversible adverse health consequences
- Chance of severe consequences is remote
2
Class 1, 2 or 3 recalls?
Use of or exposure to product may cause serious consequences or death
1
Class 1, 2 or 3 recalls?
Use of or exposure to product is not likely to cause adverse health consequences
3
what is the Durham-Humphrey Amendment?
- Passed in 1951
- Gave us information for what drugs required prescriptions!!
- Allowed refills on prescriptions for the first time
- Previously one and done
- Allowed written or oral (telephone) prescriptions
what four practitioners are recognized as prescribers in all states? The big four
Physicians (MD/DO)
Dentists (DDS/DMD)
Podiatrists (DPM)
Veterinarians (DVM)
Physicians: scope of practice?
whole body practice
Dentists: scope of practice?
Mouth, oral cavity, maxillary area
Podiatrists: scope of practice?
Feet, ankles, and associated structures
(*May include hands in some states
**^Only a few states, not Indiana)
Veterinarians: scope of practice?
- Responsible for animals
- No restriction on the type of animal they can prescribe for (small, large, exotic)
- Can prescribe animal drugs or human drugs for conditions in animals
who is responsible for PPPA
pharmacist and manufacturer
manufacturer is hen 30 or 90 unit dose containers
what pregnancy info is needed in the package insert now (as of 6/30/15)
- Pregnancy
- Lactation
- Females and males of reproductive potential
Lactation Section of Package Insert:
If the drug is absorbed systemically must include information on the drug in human milk and its effects of ___________
effects of the drug on the child/milk production
Generic name = _________ name
established
Statute vs Regulation:
Statute: written law enacted by legislature
Regulation: rule having the force of law issued by an administrative agency
Statute vs. Regulation:
T or F: both are enacted by elected officials
FALSE
only statute is elected officials
regulation: is non-elected officials (ex: board of pharmacy, FDA, DEA)
The following is a definition for ________:
article recognized in the official compendium or any supplement of the official compendium
AND
article is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animal
AND
an article (other than food) intended to affect the structure or any function of the body in man or other animal
(AND steps 1 - 3 above…)
Drug
what are examples of official compendiums
USP
NF
HPUS
USP stands for?
united states pharmacopeia
NF stands for?
national formulary
HPUS stands for?
homeopathic pharmacopeia of the U.S
The following is a definition for ________
Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance AND articles that intended for use as a component of any article
(but not soap…)
Cosmetics
other names for prescription drugs?
Rx-Only
or
Legend Drug
The following are definitions for _______:
Drugs used by humans
Require supervision for safe/effective use
Are unavoidably unsafe but not unreasonably dangerous
Prescription drug/ Rx-Only/ Legend Drug
The following is a definition of _______:
Drugs that are safe and effective for use without a prescribers supervision
OTC Drug
The following is a definition of _________:
An unofficial class of drugs
State or proposal specific
certain drugs sold only by a pharmacist - but not needing a prescription
behind the counter drugs (BTC)
The following is a definition for _______:
A drug that has a dependence liability and/or potential for abuse
controlled substance
The following is a definition for _______:
used for a condition that affects less than 200,000 persons in the US
OR
affects more than 200,000 in the US but the cost of developing and making the drug will not be recovered from sales in the US
orphan drug (sometimes called Drugs for Rare Diseases)
T or F:
If an orphan drug later gains another use after first approved it does not lose its orphan drug status
TRUE
The following is a definition for _______:
A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
- vitamin
- mineral
- herb/other botanical
- an amino acid
- dietary substance for use by man to supplement the diet by increasing total dietary intake
OR
- concentrate/metabolite, constituent, extract or combo of any ingredient described above
Dietary supplement
GRAE and GRAS stand for?
GRAE: generally recognized as effective
GRAS: generally recognized as safe
T or F:
To be FDA approved you only need one (GRAE or GRAS) *don’t need both
FALSE:
need to be GRAE AND GRAS to get FDA approval
The following is a definition for _______:
Not generally recognized as GRAE or GRAS
For a new condition or in a new dosage form
Has not been used in the condition/dosage form long enough
Must go through New drug application for FDA approval
New Drug
what does DESI stand for
drug efficacy study implementation
The following is a definition for _______:
drugs introduced onto the market between 1938 and 1962
(known to be safe but not proved to be effective)
thus they had to prove efficacy or pull drug from market
DESI Drugs
NDA stands for? vs IND stands for? vs ANDA stands for?
NDA: new drug application
IND: Investigational new drug application
ANDA: Abbreviated New Drug Application
The following is a definition for _______:
Application sent to FDA once all clinical trials and ata have been collected on a new drug in order to have the drug approved for marketing
NDA: new drug application
The following is a definition for _______:
Application sent to FDA asking them for exemption to the NDA requirements in order to investigate and conduct clinical trials on the new drug
IND: Investigational New Drug application
The following is a definition for _______:
Application used by generic manufacturers to show proof of bioequivalence and proof of acceptable manufacturing practices and controls
ANDA: Abbrev. New Drug Application
The following is a definition for _______:
Official name
or
Official title thereof in the official compendium
or
common or usual name
Established Name
The following is a definition for _______:
display of written, printed, or graphic matter upon the immediate container or any article
Label
The following is a definition for _______:
All labels and other written, printed, graphic matter:
[- Upon any article or any of its containers or wrappers
OR
-Accompanying such article (papers assoc. with paper]
Labeling
T or F:
Label is part of labeling (but not the other way around)
True
The following is a definition for _______:
-Significantly difficult for kids under 5 years of age to…
open or obtain a toxic/harmful amount of substance contained therein, within a reasonable amount of time, and not difficult for NORMAL ADULTS to use properly BUT does not mean packaging cannot be opened by kids in a reasonable time completely
special packaging
Special packaging: deterring kids of ages \_\_\_\_\_\_: A) 4 and Under B) 5 and under C) 0 - 5
A
age five cannot be included!!
The following is a definition for _______:
Products with the same active ingredient, same dosage form, same strength
may differ in look, release mechanism, expiration times, and have minor variations in labeling
Pharmaceutical Equivalent
Ex: ProAir vs Ventolin
The following is a definition for _______:
Pharmaceutical equivalents that are likely to have the same clinical and safety profiles
Therapeutic Equivalents
Pharmaceutical or Therapeutic Equivalents are substitutable?
Therapeutic
The following is a definition for _______:
An instrument or related article which is recognized in USP, NF, or any supplement
AND
Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in man or other animal
AND
intended to affect the structure or any function of the body in man or other animal, which does not achieve its primary intended purposes through chemical action and which is not dependent upon being metabolized for the achievement of its primary intended purpose
Device
The following is a definition for _______:
can mean individual, partnership, corporation, and association
Person
plural in law is persons
3 recognized classes of devices?
Class 1, 2, or 3
what are the other types of devices? (outside of 1,2 or 3)
Restricted
Custom
Banned
T or F:
FDA can order/require manufacturers to recall a drug
false!!
they can request, not order
what did the Durham-Humphrey Amendment do?
- gave us info on what drugs needed an rx
- allowed refills on prescriptions for the first time
- allowed written/telephone rxs
Federal government or States decide who has authority to prescribe?
states
Federal Requirements for a Label:
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