Pharmacy Technician Certification (PTCB) Review - Federal Pharmacy Law

1906 - Federal Food and Drug Act correct answer: This act prohibits the sale of adulterated or mislabeled food, drinksand drugs 1914 - Harrison Narcotic Act correct answer: This act limits the transport of opium. In order to purchase opium, a prescription is required. 1938 - Food Drug and Cosmetic Act correct answer: This act made the food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal, This act requires drug companies to provide package inserts,requires that habit-forming drugs be labeled "may be habit forming" , requires that a new drug has to be proven safe under FDA guidelines before marketing 1951 - Durham Humphrey Amendment correct answer: This act distinguishes legend drugs(prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs "Caution:Federal law prohibits dispensing without a prescrition", requires physician supervision for the purchase of legend drugs. Also, over the counter drugs without medical supervision are required to have on the label: Product Name, Name and Address of manufacturer, Active ingredients, quantities of all other ingredients whether active or not 1962 - Kefauver-Harris Amendment correct answer: All drugs made from 1938 forward must be proven save and effective. Also the FTC now handles drug advertisement. Stricter requirements for drug approval. Manufacturersmust now register annually, be inspected ever 2 years, and report adverse effects of drugs. 1970 - Comprehensive Drug Abuse Prevention and Control Act (Controlled substance Act - CSA) correct answer: Drug enforcement agency (DEA) was formed. Also controlled substanced were placed in schedules I-V based on abuse potential.Schedule I drugs have the highest abuse potential and schedule V drugs have the lowest abuse potential. 1970 - Poison Prevention packaging act correct answer: This act required childproof packaging on most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs used in emergency situations, such as dispensing nitroglycerin, or if a drug is packaged in such a small quantity it would not hard a child under 5 years old. 1983 - Orphan Drug Act correct answer: This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases. 1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman Amendment) correct answer: This act streamlines the process for granting approval of generic drugs. It also give manufacturers incentives to develop new drugs by giving patent extensions. This act allows generic drug companies the ability to rely on safety and ef