Pharm Tech Chapter 3 (Drug Regulation & Control)

44 Questions | By Ashleycream | Last updated: Mar 19, 2022 | Total Attempts: 480

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Drug Regulation & Control -Drug Regulations -New Drug Approval -Marketed Drugs -OTC Meds -Sample Labels -Controlled Substances -Additional DEA Forms -Public Safety -Law and the Technician

Questions and Answers

1.

Medications with habit-forming ingredients that can be dispensed by a pharmacist without a prescription to persons at least 18 yeasrs of age
- A.
  
  Controlled substance
- B.
  
  Controlled substances
- C.
  
  Exempt narcotics
- D.
  
  Compliance
2.

Any drug which requires a prescription and this "legend" on the lable: Rx only
- A.
  
  Injunction
- B.
  
  Legend drug
- C.
  
  Pharmaceutical equivalent
- D.
  
  Protocol
3.

Failing to do something you should have done
- A.
  
  Liability
- B.
  
  Negligence
- C.
  
  Protocol
- D.
  
  Recall
4.

Important associated information that is not on the label of a drug product itself
- A.
  
  Combat Methamphetamine Epidemic Act (CMEA)
- B.
  
  DUAL MARKETING
- C.
  
  NDC (National Drug Code)
- D.
  
  Product labeling
5.

Legal responsibility for costs or damages arising from misconduct or negligence.
- A.
  
  Liability
- B.
  
  Negligence
- C.
  
  Protocol
- D.
  
  Adverse effect
6.

Status of medications like Plan B that are classified as both prescritpion and OTC drugs
- A.
  
  Exempt narcotics
- B.
  
  Placebo
- C.
  
  Dual marketing
- D.
  
  Product labeling
7.

The action taken to remove a drug from the market and have it returned to the manufacturer
- A.
  
  Liability
- B.
  
  Recall
- C.
  
  Controlled substance mark
- D.
  
  Liability
8.

The mark (CII-CV) which indicates the control category of a drug with a potential for abuse
- A.
  
  NDC (National Drug Code)
- B.
  
  Combat Methamphetamine Epidemic Act (CMEA)
- C.
  
  Controlled Substances
- D.
  
  Controlled substance mark
9.

The number on a manufacturer's label indicating the manufacturer and product information
- A.
  
  Controlled substance mark
- B.
  
  NDC (National Drug Code)
- C.
  
  Combat Methamphetamine Epidemic Act (CMEA)
- D.
  
  Roman Numbers
10.

Federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine
- A.
  
  Compliance
- B.
  
  NDC (National Drug Code)
- C.
  
  Legend drug
- D.
  
  Combat Methamphetamine Epidemic Act (CMEA)
11.

An inactive substance given inplace of a medication
- A.
  
  Juice
- B.
  
  Vitamins
- C.
  
  Placebo
- D.
  
  Distilled water
12.

Having to do with the treament of children
- A.
  
  Therapeutic equivalent
- B.
  
  Compliance
- C.
  
  Negligence
- D.
  
  Pediatric
13.

Drug products that contain identical amounts of the same active ingredients in the same dosage form
- A.
  
  Therapeutic equivalent
- B.
  
  Pharmaceutical equivalent
- C.
  
  Medical equivalent
- D.
  
  Good and equivalent
14.

Pharmaceutical equivalents that produce the same effects in a patients
- A.
  
  Therapeutic equivalent
- B.
  
  Medical equivalent
- C.
  
  Good and equivalent
- D.
  
  Pharmaceutical equivalent
15.

Five groups of drugs identified by the 1970 Controlled Substances Act (CSA) as having the potential for abuse and whose distribution is therefore strictly controlled by five control schedules set forth in the CSA
- A.
  
  Controlled substance mark
- B.
  
  Controlled substances
- C.
  
  Weed
- D.
  
  Controlled marketing
16.

An unintended side effect of a medication that is negative or in someway injurious to a patients health
- A.
  
  Adverse effect
- B.
  
  Regrets
- C.
  
  Negligence
- D.
  
  Placebo
17.

A court order preventing a specific action, such as the distribution of a potentially dangerous drug
- A.
  
  Recall
- B.
  
  Indictment
- C.
  
  Warrant
- D.
  
  Injunction
18.

Specific guideline for practice
- A.
  
  Protocol
- B.
  
  Nagging
- C.
  
  Personal inventory
- D.
  
  Eat on lunch break
19.

Doing what is required
- A.
  
  Compliance
- B.
  
  Being obedient
- C.
  
  The good son
- D.
  
  Goody two shoes
20.

Both domestic and imported drugs require approval by (a/the) ___ before they can be marketed in the United States
- A.
  
  FDA
- B.
  
  US Marshal
- C.
  
  DEA
- D.
  
  US Customs
21.

The ____ prohibited interstate commerce in adulterated or misbranded food, drinks and drugs.
- A.
  
  1938 Food, Drug and Cosmetic (FDC) Act
- B.
  
  Food and Drug Act of 1906
- C.
  
  Harrison Act
- D.
  
  1990 Omnibus Budget Reconciliation Act (OBRA)
22.

In response to growing addiction to opiates and cocaine-containing medicines, the Harrison Narcotic Act of 1914 required that all manufacturers, importers and physicians prescribing narcotics be
- A.
  
  Licensed
- B.
  
  Taxed
- C.
  
  Licensed and taxed
- D.
  
  Fined
23.

The Food And Drug Administration was initially named the
- A.
  
  Food, Drug, and Alcohol Commission
- B.
  
  Food, Drug, and Weapons Administration
- C.
  
  Food, Drug, and Hazardous Substance Regulatory Agency
- D.
  
  Food, Drug, and Insecticide Administration
24.

Because of fatal poisoning from liquid sulfanilamide, the ______ required new drugs be shown to be safe before marketing
- A.
  
  Food and Drug Act of 1906
- B.
  
  1938 Food, Drug and Cosmetic Act
- C.
  
  1951 Durham Humphrey Amendment
- D.
  
  1990 Omnibus Budget Reconciliation Act (OBRA)
25.

The 1984 Hatch-Watchman Act allowed for
- A.
  
  Quicker introduction of generic drugs only
- B.
  
  Extension of drug patent terms only
- C.
  
  Quicker introduction of drugs and extension of drug patent terms
- D.
  
  Introduciton of generic versions of trade drugs regardless of patent terms