Study Resource Test Bank - Current Edition Solutions

Study Resource Test Bank - Current Edition Solutions Drug Standards - answer - Rules set to assure consumers that they get what they pay for The law says that all preparations called by the same drug name must me of uniform , strength,quality and purity - answer - True 1906 Pure Food and Drug Act - answer - First government attempt to establish consumer protection in the manufacture of drugs and foods Required all drugs marketed in the United States to meet minimal standards of strength,purity and quality Demanded that drug preparations containing dangerous ingredients have a labeled container indicating the ingredient. Established two references of officially approved drugs . United States pharmacopeia (USP) National formulary (NF) 1938 Federal Food, Drug, and Cosmetic Act and Amendments is 1951,1962 and 1972 - answer - Established FDA -under the department of health and human services to enforce the provisions of the act . Established more specific regulations to prevent adulteration of tampering with drugs food and cosmetics. -All labels must be accurate and must include a listing of all inactive ingredients. -All new products must be approved by the FDA before public release -warning labels must be present on certain preparations . -Certain drugs must be labeled with the legend inscription. "caution -federal law prohibits dispensing without prescription" legend drugs -such preparations . Prescription and non prescription drugs must be shown to be effective as well as safe -In 1972, the National Drug Code (NDC) Directory was established. This provided the FDA with a list of all drugs manufactured for commercial distribution. National Drug Code (NDC) Directory was established. This provided the FDA with a list of all drugs manufactured for commercial distribution. - answer - Each drug is identified by an NDC number, made up of three parts The first part is five numbers and identifies the manufacturer. The second part is four numbers and identifies the drug. The third part is two digits and identifies the package size. Example: ; note it is a common practice to omit a leading zero in the first or second part of the NDC number so this drug could also be written as . National Drug Code (NDC) Directory - answer - Example: ; note it is a common practice to omit a leading zero in the first or second part of the NDC number so this drug could also be written as . Five Schedules of Controlled Substances - answer - Schedule 1 High abuse potential Not approved for medical use in the United States EX. Heroin, LSD, mescaline( hallucinogenic effects) ecstasy Five Schedules of Controlled Substances - answer - Schedule 2 High abuse potential May lead to severe dependence Written prescription only (or electronic prescriptions that meet DEA standards) No phoning in of prescription by the office health care professional, in an emergency, physician may phone in, but handwritten prescription must go to the pharmacy within seven days No refills without new written prescription Prescription may be faxed, but original prescription must be handed in to pick up prescription EX) Morphine-It can treat moderate to severe pain) Codeine- It can treat pain and cough. Methadone- It can treat moderate to severe pain. It can also treat narcotic drug addiction. Percocet-It can treat moderate to moderately severe pain. Dilaudid-It can treat moderate to severe pain. Ritalin-t can treat ADHD and narcolepsy. Oxycontin-It can treat moderate to severe pain. meperidine (Demerol)-It can treat moderate to severe pain. Hydrocodone with Tylenol- It can treat pain. Five Schedules of Controlled Substances - answer - Schedule 3 May lead to moderate dependence Written, faxed, or verbal (phonedin) prescription, by physician only May be refilled up to five times in six months EX) Codeine and, anabolic (muscle-building) steroids Five Schedules of Controlled Substances - answer - Schedule 4 L