Name that Act
• Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate information about side effects
What is
The Kefauver-Harris Amendment of 1962
ProAIR Proventil
What is albuterol
NORVASC
What is amlodipine
Brand FLONASE
fluticasone
Corticosteroid
Allergic Rhinitis
Legend
ropinirole
What is REQUIP
Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription.. • Required Legend Drugs to carry the statement:
Caution: Federal law prohibits dispensing without a prescription.". • Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
What is
The Durham-Humphrey Amendment of 1951
COMBIVENT
What is albuterol + ipratropium
Cardizem
What is diltiazem
Brand SOLU-MEDROL
methylprednisolone
Corticosteroid
Inflammation
cefuroxime
What is Ceftin
Known as FDCA 1938.
• Replaced the Food and Drug act of 1906.
• Provided better clarification about misbranding definitions.
• Provided better clarification about adulteration definitions.
• Gave the FDA authority to require adequate testing of new drugs for safety.
What is
Federal Food, Drug and Cosmetic Act of 1938
Glucophage
What is metformin
Omnicef
What is cefdinir
Brand DELTASONE
prednisone
Corticosteroid
Inflammation
ezetimibe + simvastatin
What is Vytorin
Known as the Harrison Narcotic Act.
• Provided authority for Internal Revenue Service to collect tax on Opiates thru Tax Stamps.
• Required that any entity which produced, distributed, dispensed or sold opiates be registered with the IRS.
• Emphasis was on attempting to control the massive flow of opiates in order to protect the public from rising addiction.
What is
Narcotic Tax Act of 1914
Fosamax
What is alendronate
Procardia
What is nifedipine
Brand NASACORT
triamcinolone
Corticosteroid
Allergic Rhinitis
conjugated estrogen
What is PREMARIN
Known as the Pure Food and Drug Act.
• Provided authority for federal inspection of meat products and prohibited the sale of adulterated foods.
• Required that "Secret Elixirs" containing ingredients like: Cocaine, Heroin, Morphine and Alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages.
What is
Federal Food and Drug Act of 1906
Actonel
What is risedronate
Rocephin
What is ceftriaxone
Brand ADVAIR
fluticasone + salmeterol
Corticosteroid + Asthma
COPD
clobetasol
What is TEMOVATE