3 - Drug Regulations & Control Flashcards
(18 cards)
status of medications that are classified as both prescription and OTC drugs
dual marketing
medications with habit-forming ingredients that can be dispensed without a prescription by a pharmacist to persons of at least 18 years of age
exempt narcotics
a court order preventing a specific action, such as the distribution of a potentially dangerous drug
injunction
drug products that contain identical amounts of the same active ingredients in the same dosage form
pharmaceutical equivalent
pharmaceutical equivalents that produce the same effects in patients
therapeutic equivalent
this prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs
Food and Drug Act of 1906
this required new drugs be shown to be safe before marketing because of fatal poisoning from liquid sulfanilamide
Food, Drug, and Cosmetic Act of 1938
this required child-proof packaging for most prescription drugs
Poison Prevention Packaging Act
this allowed quicker introduction of drugs and extension of drug patent terms
Hatch-Watchman Act of 1984
this allowed quicker introduction of drugs and extension of drug patent terms
Hatch-Watchman Act of 1984
the purpose of phase 2 clinical trials
effectiveness
the form used to order Schedule II controlled substances
DEA Form 222
drug recall that is issued by manufacturers when there is a strong likelihood that the product will cause serious adverse effects or death
Class I
drugs with a high potential for abuse and no accepted medical use in the US
Schedule I
drugs with a high potential for abuse which may lead to addiction but have accepted medical uses like amphetamines, opium, cocaine, methadone and various opiates
Schedule II
drugs with a potential for abuse that may lead to moderate to low dependencies or high psychological dependence. (i.e., anabolic steroids and various compounds containing limited quantities of narcotic substances such as codeine)
Schedule III
drugs with low potential for abuse that may lead to limited physical and psychological dependence (i.e., phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital)
Schedule IV
drugs with the lowest potential for abuse that may lead to very limited physical or psychological dependences (i.e., compounds containing limited amounts of narcotic such as codeine)
Schedule V
