PPLE MODULE 2 EXAM STUDY GUIDE SOLUTIONS

PPLE MODULE 2 EXAM STUDY GUIDE SOLUTIONS Pure Food and Drug Act - ANSWER-1906- LABELING Food Drug and Cosmetic Act - ANSWER-1938- SAFETY Kefauver-Harris Amendment to FD&C - ANSWER-1962- SAFETY AND EFFICACY, SUBSTANTIAL EVIDENCE ORPHAN DRUG ACT - ANSWER-1983 SUBPART H - ANSWER-1992- ACCELERATED APPROVAL FDAAA - ANSWER-2007- POST-MARKETING SAFETY AND CLINICAL TRIAL DATABASES FDASIA - ANSWER-2012- BREAKTHROUGH DESIGNATION Harvey Wiley, physician and chemist, was a key figure for enacting a national _______ and _______ statute. - ANSWER-food; drug Journalistic "____________" wrote exposes on the shocking conditions in food processing and the dangerous ingredients and fraudulent advertising of drugs. - ANSWER-mudrakers Copyright ©SOPHIABENNETT 2025 ACADEMIC YEARALL RIGHTS RESERVED. Page 2/11 Federal Pure Food and Drug Act of 1906 - ANSWER--Drugs (as well as foods) could be considered INTERSTATE COMMERCE (BETWEEN STATES) -Could exact penalties for certain types of MISBRANDING AND ADULTERATION -Helped lead to states enacting more strict food and drugs standards for intrastate (within the state) commerce -USP AND NF WERE MADE THE OFFICIAL STANDARDS FOR THE DEFINITION OF "ADULTERATION" OF A DRUG 1912 Congress ______________ the Pure Food and Drug Act to prohibit _________ and _________ ________ _________. (Supreme Court decision; U.S. vs. Johnson) - ANSWER-amended; false; fraudulent efficacy claims What tragedy helped point out the inadequacies of the Federal Pure Food and Drug Act of 1906? - ANSWER-Elixir Sulfanilamide- over 100 deaths. It was labeled as an "elixir" vs. a "solution", but did NOT contain alcohol-CONSIDERED MISBRANDING (if this would not have been true, the FDA would have had no legal authority for charges). This formulation contained "diethylene glycol" which is antifreeze. TESTED FOR FLAVOR, APPEARANCE, AND FRAGRANCE, BUT NOT FOR SAFETY Food, Drug, and Cosmetic Act of 1938 (21 USC 301 .52 Stat. 1040) - ANSWER-- Basis of ALL subsequent amendments Copyright ©SOPHIABENNETT 2025 ACADEMIC YEARALL RIGHTS RESERVED. Page 3/11 -Required that NO NEW DRUG COULD BE MARKETED UNTIL IT WAS PROVEN SAFE TO BE USED UNDER THE CONDITIONS DESCRIBED ON THE LABEL AND APPROVED BY THE FDA -It applied to cosmetics and devices as well as drugs -DRUGS MARKETED PRIOR TO 1938 WERE EXEMPT FROM BEING PROVEN SAFE BEFORE MARKETING -APPLIES NOT ONLY TO INTERSTATE COMMERCE BUT ALSO TO TRANSACTIONS BETWEEN PHARMACISTS AND PATIENTS -It required that laws contain adequate directions for use, warnings (particularly about the habit-forming nature of certain drugs) -Gives more authority to the FDA In 1941, the FDCA was amended to require batch certification of ___________ and _________ of insulin and penicillin in 1945, although these requirements were eliminated in 1997. - ANSWER-safety; efficacy Durham Humphrey Amendment of 1951 (Prescription Drug Amendment) - ANSWER--Many drugs were unsafe for use without medical supervision -DURHAM-HUMPHREY ESTABLISHED TWO CLASSES OF DRUGS, PRESCRIPTION, AND OTC Copyright ©SOPHIABENNETT 2025 ACADEMIC YEARALL RIGHTS RESERVED. Page 4/11 -Durham-Humphrey provided that labels of prescription drugs do not require adequate directions for use, if they contain the legend, "CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION." -If dispensed by a pharmacist, directions from prescriber on the label satisfies "adequate directions for use requirement." -Durham-Humphrey also authorizes ORAL PRESCRIPTIONS and REFILLS OF PRESCRIPTION DRUGS Food Additives Amendment of 1958 - ANSWER--Required that COMPONENTS ADDED TO FOOD PRODUCTS receive PREMARKET