BCPS Exam Questions With Complete Solutions

BCPS Exam Questions With Complete Solutions Drug Importation Act of 1848 - ANSWER Prohibited importation of unsafe/adulterated drugs Pure Food and Drug Act of 1906 - ANSWER Identified USP/NF as official drug standard; prohibited commerce of adulterated/misbranded drugs Food, Drug, and Cosmetic Act of 1938 - ANSWER Required evidence of safety to the FDA before marketing; advertising under Federal Trade Commission Durham-Humphrey Amendment, 1951 - ANSWER Amended the FD&C Act to differentiate prescription and nonprescription drugs Kefauver-Harris Amendments, 1962 - ANSWER Required evidence of efficacy as well as safety; authorized FDA to regulate advertising and establish GMP The Comprehensive Drug Abuse Prevention and Control Act, 1970 - ANSWER Controlled Substance Act regulated and scheduled controlled substances The Orphan Drug Act, 1983 - ANSWER Assistance and incentives for drugs targeting a patient population of less than 200,000. Drug Price Competition and Patent Term Restoration Act, 1984 (Hatch-Waxman) - ANSWER Expedites the availability of generic drugs The Food and Drug Administration Act, 1988 - ANSWER Established FDA in DHHS Prescription Drug User Fee Act (PDUFA), 1992 - ANSWER Requires drug, biologics, and medical device manufacturers to pay fees for product applications, supplements, and other services; sunsets every 5 years. The Dietary Supplement Health and Education Act, 1994 - ANSWER Regulation of nutritional supplements and vitamins FDA Modernization Act, 1997 - ANSWER Streamline clinical research; exclusivity provision for pediatric drugs; creating of ClinicalT Food and Drug Administration Amendments Act, 2007 - ANSWER Risk Evaluation Mitigation Strategies (REMS) The Family Smoking Prevention and Tobacco Control Act, 2009 - ANSWER FDA Center for Tobacco Products established to regulate tobacco products Patient Protection and Affordable Care Act, 2010 (BCPI Act) - ANSWER Established a regulatory approval pathway for biosimilars FDA Safety & Innovation Act, 2012 - ANSWER Reauthorizes PDUFA and authorizes user fees for generic and biosimilar drugs MedWatch Form 3500 - ANSWER Healthcare provider voluntary reporting MedWatch Form 3500A - ANSWER Mandatory reporting for clinical studies (IND, BLA), in regulated industry and in device-user facilities such as hospitals and nursing homes MedWatch Form 3500B - ANSWER Consumer reporting Exempt from GMP - ANSWER 503A (Traditional Compounder) Must follow GMP - ANSWER 503B (Outsourcing Facility) Exempt from specific labeling requirements - ANSWER 503A and 503B Exempt from FDA approval before marketing - ANSWER 503A and 503B Must compound for identified individual patient - ANSWER 503A May or may not be for individual patients - ANSWER 503B Follows USP guidance - ANSWER 503A Sterile compounding - ANSWER 503B No registration or reporting; regulated by state - ANSWER 503A FDA registration and inspection - ANSWER 503B Reports of products and ingredients every 6 months - ANSWER 503B Must follow track-and-trace - ANSWER 503A Exempt from track-and-trace - ANSWER 503B OR 1.5 - ANSWER 50% increase in the likelihood that person experienced the outcome