Federal Pharmacy Law Ch 1 Flashcards
Harrison narcotic act
Prescription is required
Food and drug act
Prohibits the sale of adulterated or mislabeled food drinks and drugs
Food drug and cosmetic act
Requires that a new drug has to be proven safe under FDA guidelines before marketing
Durham Humphrey amendment
This act distinguishes legend drugs from over-the-counter drugs
Requires companies to label legend drugs
Kefauver-Harris amendment
Requires good Manufacturing practices
Register annually
Report any adverse reactions
Be inspected every two years
Comprehensive drug abuse prevention and control act
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.
Poison prevention packaging act
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
Orphan drug act
This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases
Drug price competition and patent term restoration act
Grants the approval of generic drugs
Food and drug administration act
This act banned the sale trade or purchase of drug samples also any adverse drug reactions and outcomes should reported to the FDA
Omnibus budget reconciliation act
OBRA
This act requires a pharmacist to attempt or offered to council patients on all new prescription
Health insurance portability and accountability act
HIPAA
This act created rules and regulations regarding the privacy and security of all patient information
Combat methamphetamine epidemic act
CMEA
This act limits the purchase of pseudoephedrine products of 3.6 g of PSE per day or 9 g per 30 days
Class one recall
An attempt must be made to notify the patient that the drug he or she may be taking could cause serious harm for death
Class 2 recall
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
Class three recall
This recall is not likely to cause any serious adverse effects
And does not go to the customer level
Accutane is also called
ISO tretinoin
National drug code for the NDC number
The NDC number is composed of three sets of numbers which identifies the manufacturer drug and package size
The first five numbers of the NDC identify the
Manufacturer
The next four numbers of the NDC identify a
Specific drug
The last two numbers of the NDC code identify the
Package size
I controlled substance inventory must be done at least once every
2 years
The records of the dangers drugs or scheduled drugs must be kept for at least
2 years
Schedule two drugs must have a What type of file
It must have a perpetual file
File system
One file for the schedule drugs 2 through 5 and an additional file for all others
Two file system
Make one file for sch 2 drugs only and another file for all others
2 file system
Make one file for the sch 2 drugs one for the other sch drugs and one for the non sch drugs
3 file system
This DEA form is used for the purchasing and returning of outdated schedule two drugs
The DEA 222 form
This copy of the DEA 222 form goes to the purchaser
The blue copy
This copy of the DEA 222 form goes to the seller. And also the local DEA
The green copy
This copy of the DEA 222 form goes to the seller
The brown copy
The DEA 106 form is used to what
To report lost or stolen controlled substances
The DEA form is used when ______ percent of the yearly product so it’s missing
5 percent
The DEA 41 form is used to document the
Destruction of controlled substances
The DEA 224 form is needed for a pharmacy to
Dispense controlled substances
What book gives the generic form for all drugs
The approved drugs product with therapeutic equivalence evaluation
For the Orange book
If the product is rated A be substituted because they are
Bioequivalent
Products rated ___ it cannot be substituted because they are not bio equivalent
B
This book contains a comprehensive listing of drugs and comparative drugs
The drug facts and comparisons
This book is updated monthly
The dugs facts and comparisons book
This book is published yearly and is also called the FDA’s approved drug products publication
The orange book
This book gives the listing of drugs by pricing
The red book
The physicians desk reference contains what
The package insert
This book is used to determine the compatibility of medications they’ll be using an IV bag
The handbook of injectable drugs
What book provides information on hazardous materials
The material safety data sheets or the MSDS
