Term
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Definition
| Passed in 1906 to protect people from unsanitary and poorly labeled food. |
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Term
| Food, drug and cosmetic act |
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Definition
| Passed in 1938. Suggests that no new drug can be marketed until proven safe by the FDA. |
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Term
| Durham Humphrey Amendment |
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Definition
Passed in 1951.
Also known as the "Prescription Drug Amendment"
Differentiates between prescription and OTC drugs.
Suggest each drug should be labeled:
"Catuion: Federal Law prohibits dispensing without a prescription." |
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Term
| Kefauver Harris Amendment |
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Definition
Passed in 1962.
Also known as "Drug Efficacy Amendment."
Indicateds that new approved drugs must be safe as well as effective. |
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Term
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Definition
Passed in 1976.
States the classification of devices as well as safety and efficacy of medical devices. |
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Term
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Definition
Passed in 1983.
Congress passed to provide tax relief to manufacturers that develop and market drugs for orphan diseases (diseases that affect very few people). |
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Term
| Drug price competition and patent term restoration act |
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Definition
Passed in 1984.
Make generic drugs more readily available to the public. |
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Term
| National Drug Code Number (NDC) |
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Definition
10 letters long
First four: The name of the manufacturer
Middle four: Identify drug name and strength
Last two: Identify the package |
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Term
Over the Counter Drug (OTC)
Category I |
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Definition
| Includes ingredients generally considered safe, effective and not misbranded |
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Term
Over the Counter Drug (OTC)
Category II |
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Definition
| Includes ingredients that are not considered safe, effective, and are misbranded |
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Term
Over the Counter Drug (OTC)
Category III |
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Definition
| Includes ingredients for which data are insufficient to permit the classification |
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Term
| Patient Package Inserts (PPIs) |
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Definition
Passed in 1970.
States certain drugs require instructions indicating use, risks, and precautions. |
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Term
Obra Act
(Omnibus Budget Reconciliation Act) |
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Definition
Passed in 1990.
Requires that pharmacists may have to offer counseling to patients. |
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