ADV Self Care Final Flashcards
Pure Food and Drug Act
Strength and purity
Product labeling
Food, Drug, and Cosmetic Act
Safety, GRAS/E
Labeled with adequate directions for safe use
Durham Humphry
Prescription vs non-prescription drugs
Kefauver Harris
Efficacy
Retroactive - Rx and OTC since 1938
OTC FInal Monograph
Recipe book for manufacturers
Regulation of Rx advertising
FDA
Regulation of OTC drug advertising
FTC
DSHEA
Established official definition of a dietary supplement
Intended for ingestion
Disease/therapeutic claims on OTC
not allowed
Nutrient content claims on OTC
allowed
Health claims on OTC
allowed
Structure/Function claims on OTC
allowed with disclaimer
Dietary Supplement and Nonprescription Drug Consumer Act
Manufacturers of dietary supplements and OTC drugs required to report serious ADRs to MedWatch
FDA Clearance
product is similar to a predicate device on market, not FDA tested to have clinical value
MOA of Pregnancy Tests
Human Chronionic Gonadotropin (hCG)
hCG Detectability
1-2 weeks after fertilization
hCG still detectable for __ after a pregnancy
8 weeks
Infertility in Female <35
1 yr of trying to get pregnant
Infertility in female >35
6 months of trying to get pregnant
Ovulation surge occurs __ after LH surge
24-48 hours
SAliva Electrolyte microscopes
For ovulation testing
Fern-like pattern 3-5 days before ovulation, persists 2-3 days after
UTI testing MOA
nitrite and/or leukocyte esterase
HIV testing time period
> 3 months after a high risk event
Urine based drug testing is better for __ drug use
casual