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pharmacy law Flashcards

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0
Q

This act limits the transport of opium. In order to purchase opium, a prescription is required

A

1914 Harrison Narcotic Act

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1
Q

This act prohibits the sale of adulterated or mislabeled food, drinks, and drugs

A

1906 Federal Food and Drug Act

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2
Q

This act made the Food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal

A

1938 Food Drug and Cosmetic Act

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3
Q

-requires drug companies to provide package inserts

A

1938 Food Drug and Cosmetic Act

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4
Q

-requires that a habit-forming drug to be labeled “may be habit forming”

A

1938 Food Drug and Cosmetic Act

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5
Q

-requires that a new drug has to be proven safe under FDA guidelines before marketing

A

1938 Food Drug and Cosmetic Act

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6
Q

This act distinguishes legend drugs(prescription) from over the counter drugs (otc)

A

1951 Durham Humphrey Amendment

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7
Q

Requires companies to label legend drugs “Caution: Federal law prohibits dispensing without a prescription”

A

1951 Durham Humphrey Amendment

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8
Q

Requires physician supervision for the purchase of legend drugs

A

1951 Durham Humphrey Amendment

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9
Q

over the counter drugs without medical supervision are required to have certain information on box

A

1951 Durham Humphrey Amendment

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10
Q
  • product name
  • name and address of manufacturer and/or distributor
  • active ingredients
  • quantities of all other ingredients whether active or not
A

1951 Durham Humphrey Agreement

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11
Q

All drugs made from 1938 forward have to be proven safe and effective

A

1962 Kefauver-Harris Amendment

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12
Q

Requires “good manufacturing practices” gmp

A

1962 Kefauver-Harris Amendment

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13
Q

Stricter requirements are now placed on drug manufacturers seeking drug approval; manufacturers have to prove their drug to be safe and effective before marketing it

A

1962 Kefauver-Harris Amendment

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14
Q

FTC(Federal Trade Commission), not the FDA, now handles drug advertisement

A

1962 Kefauver-Harris Amendment

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15
Q

Requires that a manufacturer must:

  • Register annually
  • Report any adverse reactions
  • Be inspected every two years
A

1962 Kefauver-Harris Amendment

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16
Q

Drug Enforcement Agency(DEA) was formed which is a unit of the Justice Department. The controlled substances are now placed into schedules I-V which are based on abuse potential.

A

1970 Comprehensive Drug Abuse Prevention and Control Act(Controlled Substance Act)

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17
Q

This act requires childproof packaging on most drugs dispensed in a pharmacy

A

1970 Poison Prevention Packaging Act

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18
Q

This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases

A

1983 Orphan Drug Act

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19
Q

These drugs are made for such a small percentage of the population that the drug’s demand does not make marketing and manufacturing in large quantities economically feasible

A

1983 Orphan Drug Act

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20
Q

This act streamlines the process for granting approval of generic drugs

A

1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendment)

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21
Q

Gives manufacturers incentives to develop new drugs by giving patent extensions

A

1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendement)

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22
Q

This act allows generic drug companies the ability to rely on safety and efficacy findings of an innovator’s drug after the expiration of the patent

A

1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendment)

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23
Q

This act established the FDA as an agency of the Department of Health and Human Services

A

1988 Food and Drug Administration Act

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24
Q

Banned the sale, trade, or purchase of drug samples

A

1988 Prescription Drug Marketing Act

25
Q

This act requires a pharmacist to attempt or offer to counsel patients on all new prescriptions

A

1990 Omnibus Budget Reconcilliation Act (OBRA)

26
Q

This act requires pharmacists to provide information on any drug being dispensed such as: name and description of the medication, and how much of the medication should be taken, side effects, contraindications, interactions, adverse effects of the medication, storage, refill information and what to do if a dose is missed

A

1990 Omnibus Budget Reconcilliation Act (OBRA)

27
Q

This act created rules and regulations regarding the privacy and security of patient health information

A

1996 Health Insurance Portablility and Accountability (HIPAA)

28
Q

This act provides limitations stating who can access, distribute and receive patient health information

A

1996 Health Insurance Portability and Accountability Act (HIPAA)

29
Q

This act makes health insurance portable for employees switching jobs.

A

1996 Health Insurance Portability and Accountability Act (HIPAA)

30
Q

This act includes provisions that make health care information more cost effective and efficient by requiring standardized electronic transmissions of claim information

A

1996 Health Insurance Portability and Accountability Act (HIPAA)

31
Q

This act limits the purchase of pseudoephedrine products to 3.6g of pseudoephedrine per day or 9g per 30 days

A

2006 Combat Methamphetamine Epidemic Act (CMEA)

32
Q

An attempt must be made to notify the patient that the drug they may be taking could cause serious harm or death

A

Class I Recall

33
Q

The probability of serious harm is not likely and the effects may be temporary or reversible. This recall does not go to the customer level and is usually due to problems with consistency of potency

A

Class II recall

34
Q

Not likely to cause any serious adverse effects and does not go to the customer level

A

Class III recall

35
Q
  • Description of the drug
  • Clinical Pharmacology
  • Indications and usage
  • Contraindications, precautions, warnings and adverse reactions
  • Drug abuse, dependence and overdosage information
  • Dosage, administration and how the drug is supplied
  • The date of the most recent labeling revision
A

Package inserts must contain

36
Q
  • Oral contraceptives
  • Estrogen-containing and progestational drugs
  • Intrauterine contraceptive devices
  • Diethylstillbestrol products
  • Accutane
  • Metered-Dose inhalers
A

Package inserts must be distributed with the following drug classes:

37
Q

The first five numbers of an NDC identify:

A

the manufacturer

38
Q

The next four numbers identify:

A

a specific drug made by the manufacturer

39
Q

The last two numbers of NDC identify

A

the package size

40
Q
  • These drugs have no accepted medicinal use in US

- These drugs have the highest abuse potential

A

Schedule I Drugs

41
Q
  • these drugs may not be refilled
  • the ordering of these drugs require a DEA 222 form
  • the returning of out of date drugs require a DEA 222 form
  • these drugs have a high abuse potential that may lead to severe physical or psychological dependence
A

Schedule II drugs

42
Q
  • these drugs may be refilled 5 times in a 6 month period

- these drugs have less potential for abuse or dependence than a Schedule I or II drugs

A

Schedule III drugs

43
Q
  • These drugs may be refilled 5 times in a 6 month period

- these drugs have less potential for abuse or dependence than Schedule II or III drugs

A

Schedule IV drugs

44
Q

-these drugs have less potential for abuse or dependence than Schedule II, III, or IV drugs

A

Schedule V drugs

45
Q

Used for the purchasing and returning of outdated CII drugs.

A

DEA form 222

46
Q

Used to report lost or stolen controlled substances.

A

DEA 106 form

47
Q

Used to document the destruction of controlled substances.

A

DEA form 41

48
Q

This form is needed for a pharmacy to dispense controlled substances

A

DEA form 224

49
Q

This form is needed to operate a controlled substance treatment program or compound controlled substances

A

DEA form 363

50
Q

This form is needed to manufacture or distribute controlled substances

A

DEA form 225

51
Q

compares therapeutic equivalency of drugs using an alphabetical rating system. This book determines if drugs can be substituted in place of others. A can be-B cannot

A

Orange book(FDA’s approved drug products publication)

52
Q

This book contains a comprehensive listing of drugs and comparative drugs. Drugs are organized by therapeutic class and provide general information with a list of monographs.

A

Drug Facts and Comparisons

53
Q

This book gives a listing of drugs by pricing, strengths, sizes, manufacturers, brands, and generics

A

Drug Topics Red Book

54
Q

This book lists injectable drug information such as compatability, storage and dosages

A

Handbook on Injectable Drugs

55
Q

This book contains packet insert drug information intended for physicians and is published annually. It contains color pictures with a list of drug manufacturers including their addresses and phone numbers.

A

Physician’s Desk Reference(PDR)

56
Q

This book lists generic drugs in alphabetical order. It also contains additional drug info

A

Mosby’s Complete Drug Reference

57
Q

Drugs are listed alphabetically and provide brand, generic and the chemical names of the drugs. It gives a list of manufacturers, strengths and dosage forms of the drugs listed

A

American Drug Index

58
Q

This book is used to determine the compatibility of medications that will be used in an IV bag. This book shows the compatability, solubility and stabililty of medications

A

The Handbook of Injectable Drugs

59
Q

Provides information on hazardous materials that may be in the pharmacy and also provides information on disposal, storage, safe use and clean-up of the medications

A

Material Safety Data Sheets (MSDS)

Pharmacy Law (1 decks)

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