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1 FDA (Food and Drug Administration) 2 Nephr/Nephro means:
How much pseudoephedrine can a Food, Drug, and Cosmetic Act of
3 4
person purchase in 30 days? 1938
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Terms in this set (128)
In charge of
FDA (Food and Drug -Approval of Prescription and OTC drugs
Administration) -Drug labeling
-Manufacturing standards
In charge of:
CDC (Center for Disease
-Requirements for vaccines and immunizations
Control)
-National Health Issues
, Food, Drug, and Cosmetic Requires new drugs must be proven safe before
Act of 1938 marketing by the FDA
Durham-Humphrey Created the 2 classes of drugs (OTC and Prescription)
Amendment of 1951
Legend Drugs are: Prescription only
-Active and inactive ingredients
OTC's must have what
-What its intended use is
according to the Durham-
-Warnings
Humphrey Act?
-Dosage instructions
Introduced Child Resistant Packaging (safety caps)
PDDA (Poison Prevention
Can NOT be opened by 80% of children under 5
packaging Act of 1970)
years old but CAN be opened by 90% of adults
What can Techs Topical, Oral, and Irrigation Solutions
Compound?
What is the Tech to 2 techs per 1 pharmacist
Pharmacist Ratio?
REM Risk Evaluation and Mitigation Stratagy
How much 9 grams in store and 7.5 grams for mail order (No
pseudoephedrine can a restrictions for RX)
person purchase in 30
days?
How much 3.6 Grams (no restriction for RX)
Pseudoephedrine can
someone purchase in 1
day?
Which Rems Program is TIRF (Transmucosal Immediate Release Fentanyl)
needed for Actiq, REMs program
Lazanda, Subsys, and
Fentora (Types of
Fentanyl)
-Must have a Pre-dispense Authorization Code
-Prescriber, Pharmacy, and Patient enrollment in a
Requirements for filling
REMs program
Clozapine
-ANC (Absolute Neutrophil Count) up to date
-Good ANC or prescribers explanation
Weekly- new patients