Chapter 3 Drug Regulation & Control

Front 1

Legend Drug

Back 1

Any drug that requires a prescription and either of these legends on the label: "Caution: Federal law prohibits dispensing without a prescription," or "Rx only."

Front 2

Pediatric

Back 2

Having to do with the treatment of children.

Front 3

Placebo

Back 3

An inactive substance given in place of a medication.

Front 4

Pharmaceutical Equivalent

Back 4

Drug products that contain identical amounts of the same active ingredients in the same dosage form

Front 5

Product Labeling

Back 5

Important associated information that is not on the label of a drug product itself, but is provided with the product in the he firm of an insert, brochure, or other document

Front 6

Therapeutic Equivalent

Back 6

Pharmaceutical equivalents that produce the same effects in patients

Front 7

Combat Methamphetamine Epidemic Act (CMEA)

Back 7

Federal law that sets daily and monthly limits on OTC sale of psuedoephedrine and ephedrine

Front 8

Dual Marketing

Back 8

Status of medications like Plan B that are classified as both prescription drugs and OTC drugs

Front 9

Exempt Narcotics

Back 9

Medications with habit forming ingredients that could be dispensed by a pharmacist without a prescription to persons at least 18 years of age

Front 10

Controlled Substance Mark

Back 10

The mark (CII-CV) that indicates the control category of a drug with a potential for abuse

Front 11

Controlled Substances

Back 11

Five groups of drugs identified by the 197 of Controlled Substances Act (CSA) as having the potential for abuse and whose distribution is therefore strictly controlled by dive control schedules sec forth in the CSA.

Front 12

Adverse Effect

Back 12

An unintended side effect of a medication that is negative or in some way injurious to a patient's health

Front 13

Injunction

Back 13

A court order preventing a specific action, such as the distribution of a potentially dangerous drug

Front 14

Recall

Back 14

The action taken to remove a drug from the market and have it returned to the manufacturer

Front 15

Compliance

Back 15

What is required

Front 16

Protocol

Back 16

Specific guideline for practice

Front 17

Liability

Back 17

Legal responsibility for costs or damages arising from misconduct or negligence

Front 18

Negligence

Back 18

Failing to do something that sh I understand or must be done

Front 19

Ethics

Back 19

A branch of philosophy that helps determine what should be done in a principled sense

Front 20

Poison Prevention Packaging Act

Back 20

Required child proof packaging for most prescription drugs

Front 21

There are limits to how many dosage units of an exempt narcotic can be sold in a ______-hour period.

Back 21

48

Front 22

What age is Plan B prescription only?

Back 22

under 17

Front 23

_______ drug recalls are issued by manufacturers when there is a strong likelihood that the product will cause serious adverse effects or death.

Back 23

Class I

Front 24

Pharmacies located in health-care institutions (hospitals, ect.) are r we quoted to follow regulations of what organization?

Back 24

TJC

Front 25

Child proof packaging was required by the Fair Packaging and Labeling Act.

Back 25

False

Front 26

All controlled substances must be ordered using a DEA controlled substance order form

Back 26

False

Front 27

A need for tighter drug regulations for the thalidomide lesson led to the

Back 27

Kefauver-Harris Amendment

Front 28

Ethical value that patients have the right to treatment:

Back 28

Autonomy