Arizona MPJE questions with correct answers

Pure Food and Drug Act - Answer 1906 - Forbade the manufacture or sale of mislabeled or adulterated food or drugs, it gave the government broad powers to ensure the safety and efficacy of drugs in order to abolish the "patent" drug trade. Still in existence as the FDA. The Food Drug and Comestic Act of 1938 - Answer Established the Food and Drug Administration (FDA). Primarily regulates drug development, manufacturing, and marketing- focus on quality. Only safe and properly labeled drugs may be introduced into interstate commerce. Defined label and labeling (Labels must contain adequate directions for use and warning if habit‐forming). Expanded the definition of misbranding and adulteration (US Supreme court ruled that FDCA applies to drugs sold by the pharmacy to the consumer. Also ruled that the outer container must tell consumers of the contents, otherwise, it is misbranded). Defines what is considered a "food," "drug," "cosmetic," "dietary supplement," and "devices" A drug is adulterated if: - Answer It consists of any filthy, putrid, or decomposed substance; it has been prepared , packed, or held under unsanitary conditions or not in conformity with current good manufacturing practices; if it's container is composed of any poisonous substance; the drug strength, quality or purity of the drug differs from that on the label; the drug strength, quality or purity of the drug differs from compendia standards (unless variations stated on the label; contains an unsafe color additive A drug is misbranded if: - Answer It's labeling is false or misleading in any way; required information is missing from the label such as: established name of drugs of both active and inactive ingredients, adequate directions for use, adequate information for use, name and place of business of the manufacturer, packer, or distributor, or Rx only is missing