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2016 Fed Pharm Law
federal laws applying to pharmacy law
| Question | Answer |
|---|---|
| what is a dea form 41? | indicates loss of a controlled substance by breaking or damaging a container. |
| otc category 1? | generally recognized as safe and effective (GRASE) for the claimed therapeutic indication |
| define otc category 2 | not generally recognized as safe and effective or having unacceptable indications |
| define otc category 3 | insufficient data available to permit final classification |
| Pure food and drug act of 1906 | prohibited adulterated or misbranded drugs in interstate commerce. did not require ingredients or directions for use |
| 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 |
| Did drugs marketed prior to 1938 require labeling or safety testing? | nope |
| 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 |
| 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 |
| medical device amendment of 1976 | required GMP, adverse reporting, and classification for medical devices. |
| drug price competition and patent term restoration act | created abbreviated NDA (ANDA). brand name manufacturers got 5 years of additional patent protection |
| Prescription drug marketing act of 1987 | created more stringent controls on distribution of samples. banned reimportation of rx drugs made in the US. |
| 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 |
| usp di vol 1 | drug info for the healthcare professional |
| usp di vol 2 | advice for the patient - lay language info for the general public |
| usp di vol 3 | info from the orange book, usp/nf definitions, controlled substance regulations |
| 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. |
Created by:
nickh88
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