Pharmacy Tech: Drug Regulation

failure to follow accepted protocols

What OTC meds are now kept behind the counter due to Combat Methamphetamine Epidemic Act?

Status of medications that are both OTC and prescription

monthly limits for ephedrine and pseudoephedrine

drugs with identical active ingredients that have the exact same use in the body

Fatal poisoning from liquid sulfanilamide began the___

the non-proprietary name for a drug

Drug recalls issued when a product may cause serious side effects or death are class___ recalls

drugs that do not require a prescription

after an expired drug patent, other manufacturers may release the drug under the ____ name

the need for larger doses to get the same effect is

patient in clinical trial is not told if in control or treatment group

an inactive substance given in place of a medication

additional information about an OTC product that is not on the label

Drugs that contain identical amounts of the same active ingredient/same dosage form

Required child-proof packaging for most prescription drugs

FDA requires ___phases of testing in humans

the proprietary name for a drug

neither the doctor nor the patient are told if in the control group or treatment group

FDA reporting system for adverse effects from approved drugs is called

All drugs marketed in the US must be approved by ___ before marketing

A patent for a new drug usually lasts __years from the drug's discovery

gives a manufacturer exclusive rights to market a drug for a specific period of time

An unintended negative side effect of a medication

Any drug that requires a prescription

Phase 3 clinical trials generally have ___ participants

action taken to remove a drug from the market

series of numbers on a drug stock label that indicates the manufacturer and product info