federal laws applying to pharmacy law
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each of the black spaces below before clicking
on it to display the answer.
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| what is a dea form 41? | indicates loss of a controlled substance by breaking or damaging a container.
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| otc category 1? | generally recognized as safe and effective (GRASE) for the claimed therapeutic indication
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| define otc category 2 | not generally recognized as safe and effective or having unacceptable indications
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| define otc category 3 | insufficient data available to permit final classification
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| Pure food and drug act of 1906 | prohibited adulterated or misbranded drugs in interstate commerce. did not require ingredients or directions for use
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| Food, Drug, and Cosmetic Act of 1938 | for the first time in the US, required that a product be safe when used according to the label. required warnings about habit forming drugs. Also applied to medical devices
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| Did drugs marketed prior to 1938 require labeling or safety testing? | nope
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| Durham-humphrey Amendment of 1951 | created rx and otc classes of drugs. otc drugs required adequate directions. also created law for oral rx's and refills
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| Kefauver-Harris Amendment of 1962 | required drugs to be effective; extended to drugs between 1938 and 1962. created informed consent requirements, reporting of adverse drug events, and creation of GMP
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| medical device amendment of 1976 | required GMP, adverse reporting, and classification for medical devices.
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| drug price competition and patent term restoration act | created abbreviated NDA (ANDA). brand name manufacturers got 5 years of additional patent protection
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| Prescription drug marketing act of 1987 | created more stringent controls on distribution of samples. banned reimportation of rx drugs made in the US.
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| FDA Modernization Act of 1997 | shortened drug label to RX only. eliminated "caution-may be habit forming"; gave 6 months additional patent protection for new drugs performing pediatric studies; gave compounding pharmacies exemption from GMP
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| usp di vol 1 | drug info for the healthcare professional
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| usp di vol 2 | advice for the patient - lay language info for the general public
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| usp di vol 3 | info from the orange book, usp/nf definitions, controlled substance regulations
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| usp/nf | published by a private organization and contains info about the standards of quality. if a drug is listed by the name in this book, then it must comply with the standards in the book, per US law.
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