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3 Cards in this Set
- Front
- Back
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Describe the details of each law in the pharmacy timeline.
(1906) federal food & drug act (1912) federal food & drug act (amendment) (1918) harrison narcotic act (1938) federal, food, drug, & cosmetic act |
(1906) federal food & drug act ensures purity of products labels reflect package contects (not misbranded) no contamination is present (pure, not adulterated)
(1912) federal food & drug act (amendment) requires manufacturers & distributors to provide scientific evidence for product claims (1918) harrison narcotic act controlled illegal narcotic trafficking employed tax stamps on legal selling of narcotics (1938) federal, food, drug, & cosmetic act legislation replaces the federal food & drug act clarification & expansion of misbranding & adulteration demands safety of product via certification from the food & drug administration |
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Describe the details of each law in the pharmacy timeline.
(1951) durham-humphrey amendment (1962) kefauver-harris amendment (1965) drug abuse control amendment (1968) bureau of narcotics & dangerous drugs |
(1951) durham-humphrey amendment requires instructions printed clearly on package labels new class of drugs called legend drugs (rx drugs) rx drugs are used under supervision with the label "rx only"
(1962) kefauver-harris amendment requires proof of effectiveness fda regulates rx drug advertising (1965) drug abuse control amendment expands harrison act to include barbituates & stimulant drugs enforcement no longer via tax levy (stamps), but via Congress to regulate interstate commerce (1968) bureau of narcotics & dangerous drugs harrison act & DACA combined to form the bureau of narcotics & dangerous drugs |
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Describe the details of each law in the pharmacy timeline.
(1970) comprehensive drug abuse prevention & control act (1970) poison prevention packaging act (1973) drug enforcement administration (1976) medical device amendment |
(1970) comprehensive drug abuse prevention & control act (CSA) aka controlled substances act replaces the harrison act & DACA amendment defines a controlled substance record keeping & registration requirements to keep track of transactions between manufacturers, suppliers, practitioners, consumers
(1970) poison prevention packaging act decrease poisonings from rx medications requires locking cap on all rx bottles except nitroglycerin, isosorbide sublingual products except when requested by patient/prescriber (1973) drug enforcement administration bureau of narcotics & dangerous drugs renamed as the DEA (1976) medical device amendment manufacturers of medical devices are required to get pre-market approvel from the FDA |
