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16 Cards in this Set

  • Front
  • Back
Who manages the FDCA?
FDA
When was Opium Int'l Convention held?
1912
What information did the Federal Narcotic Drug act (1914) require to be on all CS containers?
Must have a tax stamp.

Would verify that it had entered the country through the proper channels.
What govt group manages the CSA?
DEA manages the Controlled Substance Act (1970)
What does the DEA stand for?
Drug Enforcement Agency
What did the Kefauver-Harris amendment require?
a. Required manufacturers to prove effectiveness of their products before marketing them. Safety laws were also expanded.

b. Required levels of cleanliness, storage and purity.
What did the Durham-Humphrey amendment do in regards to drugs?
Required that drugs be separated into 2 categories:
a.) Legend Drugs
b.) OTC Drugs
Opium Int'l Convention: what happened w/ this convention that had to do with the United States?
a. Federal Narcotic Drug act of 1914.

b. Teddy Roosevelt: "Opium is the greatest threat to the safety of the United States."
i.) Many nations came together in hopes of controlling narcotics through int'l agreements and treaties.
Name of drug that caused malformed babies.
Thalidomide
How did the Federal Comprehensive Drug Abuse & Prevention Control Act (more commonly known as CONTROLLED SUBSTANCE ACT) create methods to control drugs that were deemed dangerous? (Cheryl is looking for 2 things)
a. Attempt to prevent persons who are unauthorized to take narcotic medications (controlled substance).

b. Method to control drugs that were deemed dangerous through their potential for abuse and addiction.
Medical term that is used when referring to deformed limbs (1962)
Phocomelia (pneumonics: focal, or "foco-melia")

Thalidomide caused it.
Legend that is placed on all prescription containers:
"Caution: Federal law prohibits dispensing without a prescription."
First countries that had laws regulating drug purity?
USA and all over Europe.
FDCA
federal Food, Drug, and Cosmetic Act
2 reasons why the FDA act of 1906 was inadequate:
a. Untrue statements made by the manufacturer weren't considered misbranding by the courts.

b. Medications' contents were still not required to be identified on the labels.

c. Law included legislation regarding food and drink, but not cosmetics.
"miracle drug" that killed 107 people.
Sulfanilamide (had Diethylene glycol) ANTIFREEZE!!!