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30 Cards in this Set

  • Front
  • Back
Pure Food and Drug Act of 1906
1)prohibited adulteration and misbranding of food and drugs in interstate commerce
---prohibited false statements regarding drug identity (strenght, quality, purity)
Food, Drug and Cosmetic Act of 1938
1)no new drug can be marketed until proven safe for use
2)labels must contain "adequate directions for use" and warnings about potential habit forming properties
Durham-Humphrey Amendement 1951
1)established 2 classes of drugs (prescription drugs, OTC drugs)
2)authorized oral prescriptions and refills for legend drug prescriptions
Kefauver-Harris Amendment 1962
1)requires that drugs be proved not only safe but also effective
2)efficacy requirement made retroactive to all drugs marketed between 1938-1962 (DESI)
Medical Device Amendment 1976
1)allowed FDA to approve devices for safety and efficacy prior to marketing
Orphan Drug Act 1983
1)for manufacturing drugs for rare diseases or conditions that affect <200,000 people in US or
2)that affect >200,000 people in US and for which there is no reasonable expectation of recovering the developmental costs from the drugs US sales (AIDS, Alzheimers drugs, etc)
3)tax incentives
3)limited exclusive license
Prescription Drug Marketing Act 1987
1)required states to license wholesale distributors
2)banned the sale, trade or purchase of drug samples
3)mandated the storage, handling, and recordkeeping requirements for drug samples
Label
display of written, printed or graphic matter on the immediate container
Labeling
all labgels and other written, printed, or graphic matter upon the article or container OR accompanying such article (package insert)
Distinguish from advertising
which does not accompany the product (includes representations made by a detail person (manufacturer's representative)
Container Label Requirments
1)Mfr name and address
2)established product name
3)active ingredients, including quantity and proportion of active ingredient
4)inactive ingredients (w/ some exceptions) if not for oral use*
5)statement of identity (generic and brand names)
6)strength
7)net quantity
8)recommended or usual dosage or reference to package insert*
9)Caution: Federal law prohibits dispensing w/o prescription or Rx only
10)route of administration if not for oral use*
11)lot or control number
12)dispensing container directions*
13)expiration date
*this info may be placed on other labeling on or within the package due to space limitations
National Drug Code (NDC)
10 digits
XXXXX-XXXX-X
manufacturer-drug identity-package
-mfg may be 5 or 4 digits
-drug can be 4 or 3 digits
-pkg can be 2 or 1 digits
Are NDC numbers required on OTC manufacturer's label?
No
The label of OTC drugs must contain the following...
1)statement of identity (name, pharmacological category)
2)mfr name and address
3)package quantity
4)cautions, warnings
5)adequate directions for use
6)Drug Facts Panel (active ingredients, purpose, use, warnings, directions, other info, inactive ingredients, "Questions?", phone number)
Drug Facts Panel
1)normal dose for each intended use and the doses for individuals of different ages and different physical conditions
2)frequency and duration of administration or application
3)administration in relation to meals, onset of symptoms, or other time factors
4)route or method of administration/application
5)any required preparation for use
Adulteration
1)focused on flaw in the product
2)product flaw may be related to what the label purports the product to be
Misbranding
1)focused on flaw in labeling or other representation
Adulteration is most often applicable to...
manufacturers, but may apply to compounding or repackaging pharmacies
A drug is deemed adulterated if...
1)prepared, packed, or held in conditions where it may have been contaminated
2)exposed to container that may have contaminated it
3)manufactured under conditions that do not conform to current GMP (filthy, putrid, unsanitary)
4)contains unsafe color additives
5)If subject to compendial standards, it differs in strenght, quality, or purity from compendia standards (USP/NF) unless variations are stated on the label (then it is both adulterated and misbranded)
6)If not subject to compendial standards, it differs in strength, quality, or purity from the label (then it is both adulterated and misbranded)
Adulteration
-Current Good Manufacturing Practices (CGMP)
1)regulations that establish minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packaging, or holding of a drug product
2)drug is adulterated unless it is manufactured in accordance with CGMP
3)manufacturers are inspected for compliance with CGMP once every 2 years
Misbranding
1)those that are sold, dispensed, or distributed in violation of the labeling requirments of the FDCA
2)labeling must not be false or misleading
Examples of misbranding
1)dispensed w/o a prescription
2)OTC w/o proper labeling
3)improper refills
4)false advertising
5)incorrect directions for use
6)wrong drug dispensed (also adulterated)
7)wrong strength dispensed (also adulterated)
8)outdated drug (also adulterated)
1)Dispensing without a prescription or without refill authorization
misbranded only
2)contaminated product
adulterated only
3)dispensing wrong drug
adulterated and misbranded
4)dispensing outdated products
adulterated and misbranded
5)improper directions for use
misbranded only
6)container is contaminated
adulterated only
7)product is held under conditions where it may have been contaminated
adulterated only
8)dispensing drug that does not meet compendial standards or dug that differs in strength, quality, or purity from label/labeling
adulterated and misbranded