Federal Pharmacy Law Ch 1

Question 0

Harrison narcotic act

Answer 0

Prescription is required

Question 1

Food and drug act

Answer 1

Prohibits the sale of adulterated or mislabeled food drinks and drugs

Question 2

Food drug and cosmetic act

Answer 2

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

Question 3

Durham Humphrey amendment

Answer 3

This act distinguishes legend drugs from over-the-counter drugs
Requires companies to label legend drugs

Question 4

Kefauver-Harris amendment

Answer 4

Requires good Manufacturing practices
Register annually
Report any adverse reactions
Be inspected every two years

Question 5

Comprehensive drug abuse prevention and control act

Answer 5

Drug enforcement agency was formed which is a unit of the Justice Department. The controlled substances are now placing to schedule one through five which are based on abuse potential.

Question 6

Poison prevention packaging act

Answer 6

Requires childproof packaging on most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs used in emergency situations such as dispensing nitroglycerin

Question 7

Orphan drug act

Answer 7

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

Question 8

Drug price competition and patent term restoration act

Answer 8

Grants the approval of generic drugs

Question 9

Food and drug administration act

Answer 9

This act banned the sale trade or purchase of drug samples also any adverse drug reactions and outcomes should reported to the FDA

Question 10

Omnibus budget reconciliation act

OBRA

Answer 10

This act requires a pharmacist to attempt or offered to council patients on all new prescription

Question 11

Health insurance portability and accountability act

HIPAA

Answer 11

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

Question 12

Combat methamphetamine epidemic act

CMEA

Answer 12

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

Question 13

Class one recall

Answer 13

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

Question 14

Class 2 recall

Answer 14

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

Question 15

Class three recall

Answer 15

This recall is not likely to cause any serious adverse effects
And does not go to the customer level

Question 16

Accutane is also called

Answer 16

ISO tretinoin

Question 17

National drug code for the NDC number

Answer 17

The NDC number is composed of three sets of numbers which identifies the manufacturer drug and package size

Question 18

The first five numbers of the NDC identify the

Answer 18

Manufacturer

Question 19

The next four numbers of the NDC identify a

Answer 19

Specific drug

Question 20

The last two numbers of the NDC code identify the

Answer 20

Package size

Question 21

I controlled substance inventory must be done at least once every

Answer 21

2 years

Question 22

The records of the dangers drugs or scheduled drugs must be kept for at least

Answer 22

2 years

Question 23

Schedule two drugs must have a What type of file

Answer 23

It must have a perpetual file

Question 24

File system

One file for the schedule drugs 2 through 5 and an additional file for all others

Answer 24

Two file system

Question 25

Make one file for sch 2 drugs only and another file for all others

Answer 25

2 file system

Question 26

Make one file for the sch 2 drugs one for the other sch drugs and one for the non sch drugs

Answer 26

3 file system

Question 27

This DEA form is used for the purchasing and returning of outdated schedule two drugs

Answer 27

The DEA 222 form

Question 28

This copy of the DEA 222 form goes to the purchaser

Answer 28

The blue copy

Question 29

This copy of the DEA 222 form goes to the seller. And also the local DEA

Answer 29

The green copy

Question 30

This copy of the DEA 222 form goes to the seller

Answer 30

The brown copy

Question 31

The DEA 106 form is used to what

Answer 31

To report lost or stolen controlled substances

Question 32

The DEA form is used when ______ percent of the yearly product so it’s missing

Answer 32

5 percent

Question 33

The DEA 41 form is used to document the

Answer 33

Destruction of controlled substances

Question 34

The DEA 224 form is needed for a pharmacy to

Answer 34

Dispense controlled substances

Question 35

What book gives the generic form for all drugs

Answer 35

The approved drugs product with therapeutic equivalence evaluation
For the Orange book

Question 36

If the product is rated A be substituted because they are

Answer 36

Bioequivalent

Question 37

Products rated ___ it cannot be substituted because they are not bio equivalent

Answer 37

B

Question 38

This book contains a comprehensive listing of drugs and comparative drugs

Answer 38

The drug facts and comparisons

Question 39

This book is updated monthly

Answer 39

The dugs facts and comparisons book

Question 40

This book is published yearly and is also called the FDA’s approved drug products publication

Answer 40

The orange book

Question 41

This book gives the listing of drugs by pricing

Answer 41

The red book

Question 42

The physicians desk reference contains what

Answer 42

The package insert

Question 43

This book is used to determine the compatibility of medications they’ll be using an IV bag

Answer 43

The handbook of injectable drugs

Question 44

What book provides information on hazardous materials

Answer 44

The material safety data sheets or the MSDS