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2016 Fed Pharm Law

federal laws applying to pharmacy law

QuestionAnswer
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