Name that Act
• Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate information about side effects
What is
The Kefauver-Harris Amendment of 1962
Which part of the DEA number should be multiplied by two?
What is
Step 2
2,4,6
What is the minimum amount of time a Controlled prescription should be kept on file ?
What is
2 years
Instill 1 gtts ou bid
90 days supply
10 ml
WHAT IS
1 Box
Early Pharmacist were called
What is druggist
Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription.. • Required Legend Drugs to carry the statement:
Caution: Federal law prohibits dispensing without a prescription.". • Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
What is
The Durham-Humphrey Amendment of 1951
When filing a Controlled Prescription how long should all prescriptions be retained on file ( minimum )
What is 2 years
A Pharmacy technician should recognize that otic medication are for the
What is the ear
Instill 1-2 gtts ou bid
90 days supply
10 ml
WHAT IS
3 bottles
What is
The Durham Humphreys Amendment of 1951
Known as FDCA 1938.
• Replaced the Food and Drug act of 1906.
• Provided better clarification about misbranding definitions.
• Provided better clarification about adulteration definitions.
• Gave the FDA authority to require adequate testing of new drugs for safety.
What is
Federal Food, Drug and Cosmetic Act of 1938
Enacted to regulate the OTC sales of pseudoephedrine.
• Identity and address of each purchaser to be kept for two years. • Daily sales of regulated products not to exceed 3.6 grams.
• 30 day purchase limit not to exceed 9 grams
• 30 day purchase via mail order not to exceed 7.5 grams
What is Combat Methamphetamine Epidemic Act (2005)
A Pharmacy technician receives a prescription for Ambien 10 mg , the technician should
What is
Process and fill
Instill 1-2 gtts od bid
90 days supply
2.5 ml
What is 5 boxes
Also known as Drug Efficacy Amendment
What is
Kefauver-Harris Amendment
Known as the Harrison Narcotic Act.
• Provided authority for Internal Revenue Service to collect tax on Opiates thru Tax Stamps.
• Required that any entity which produced, distributed, dispensed or sold opiates be registered with the IRS.
• Emphasis was on attempting to control the massive flow of opiates in order to protect the public from rising addiction.
What is
Narcotic Tax Act of 1914
Also known as the PPPA
• Designed to reduce the risk of children ingesting dangerous substances. • Required locking caps on most prescriptions
What is Poison Prevention Packaging Act of 1970
Fentanyl patches
What is a
C-II medication
Nurse Wendell wrote a prescription for
Instill 1 gtts ou bid
30 days supply
5 ml
What is
1 box
Also known as Controlled Substance Act
What is Drug Abuse Prevention ? Control Act of 1970
Known as the Pure Food and Drug Act.
• Provided authority for federal inspection of meat products and prohibited the sale of adulterated foods.
• Required that "Secret Elixirs" containing ingredients like: Cocaine, Heroin, Morphine and Alcohol which were available at most stores as miracle cure-alls be labeled with correct information about their ingredients as well as suggested dosages.
What is
Federal Food and Drug Act of 1906
What is the maximum amount of Sudafed that can be sold in a calendar day?
What is 3.6 grams
The publication Approved Drug Products with Therapeutic Equivalence Evaluations
What is Orange Book
Nurse Sandra writes
Instill 2-4 gtts ou bid
90 days supply
10 ml
What is 7 boxes
Replaced Food and Drug act of 1906
FDCA 1938
What is Federal Food Drug and Cosmetic Act of 1938