NY MPJE || All Questions Answered Correctly.

CSA correct answers Controlled Substances Act (enforced by the DEA) Poison Prevention Packaging Act correct answers Sets child-resistant drug packaging requirements, under US Consumer Product Safety Commission HIPAA correct answers set by the department of health and human services CMEA correct answers Control Methamphetamine Epidemic Act (CMEA)- pseudoephedrine containing product requirements Hatch-Waxman Act correct answers included the ANDA approval process for generic drugs includes review of product's chemistry, manufacturing controls, labeling (does not include pre-clinical animal studies and clinical studies with human subjects; uses bioequivalency analysis instead of bioavailability data) FDC Act correct answers Food Drugs and Cosmetics Act (1938) The Orange Book correct answers FDA's Approved Drug Products with Therapeutic Equivalence Evaluations contains approved drugs ONLY (unapproved drugs will have NDC but will not be listed) Prescription Drug advertising correct answers monitored by the FDA OTC Drug advertising correct answers monitored by the COnsumer PRoduct Safety Commission (under the e FDA AD minimum requirements correct answers - min. one approved use - generic name - brief summary, major statement, or 'adequate provision' of drug risks Sherman Antitrust act of 1890 correct answers outlawed monopolies Pure Food and Drug Act of 1906 correct answers Also known as the Wiley Act - mandated accurate labeling -ingredients must meet standards of strength, quality, and purity in the USP And NF - must list dangerous ingredients - no adulterated or misbranded drugs could be sent through interstate commerce Food Drug and Cosmetic act 1938 correct answers enacted due to the sulfanilamide incident