• 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
Prescriptions are good for 28 days no refills
What is
Schedule II
C-II MEDICATIONS
PRESCRIPTIONS ARE GOOD FOR 28 DAYS
O REFILLS
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 volume required for an injection if 1000mg is ordered and the stock ampules contain 500mg/ML
What is
2 mL
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
Heroin, Cocaine, Peyote
What is
C - l drugs
C-III -V MEDICATIONS
PRESCRIPTIONS ARE GOOD FOR 6 MONTHS
1 FILL AND 5 REFILLS
Known as the Harrison Narcotic Act.
• Provided authority for Internal Revenue Service to collect tax on Opiates thru Tax Stamps.
WHAT IS
Narcotic Tax Act of 1914
What volume is required for an injection if 750mg are ordered and stock ampules contain 125mg/ml?
What is
6mL
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
Prescriptions are good for 6 months from the date the Doctor writes
What is
C-III - V
LEGEND PRESCRIPTIONS
PRESCRIPTIONS ARE GOOD FOR 1 YEAR FROM THE DATE WRITTEN
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 safet
What is
Federal Food, Drug and Cosmetic Act of 1938
A script calls for 25 grams of Hydrocortisone cream 15%. Your Pharmacy stocks both 5% and 20% formulations. How much of the 20% will you use in this order ?
What is
16.75 grams of the 20%
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
Prescriptions are good for 1 year from the date the doctor writes
What is
A Legend drug
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 Drug
What is
The Durham-Humphrey Amendment of 1951
Let’s say that a nurse will be administering a 300 mL SVP (small volume parenteral) over 3 hours (the rate of administration) using an 11-drop set (the drop factor). What is the drip rate?
What is 18.33 gttmin
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
XANAX,KLONIPIN,VALIUM,ATIVAN,RESTORIL
C-IV
Benzodiazepines
XANAX(ALPRAZOLAM) ANXIETY
KLONIPIN(CLONAZEPAM)
VALIUM ( DIAZEPAM)
ATIVAN(LORAZEPAM)
RESTORIL ( TEMAZEPAM) SLEEP
This medication is used in some medical practices but it is still considered a C-I drug
What is
Marijuana
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)
Convert 5.5 kgs to lbs
What is
12.1 lbs