15. TL:DR - Notes on Laws and Requirements Flashcards
Federal Food Drug and Cosmetic Act (FFDCA)
established the FDA
Durham-Humphrey Amendment
separated TOC and Rx
Kefauer Harris Amendment
thalidomide (made manufacturers prove effectiveness of drugs before they go on the market)
Poison Prevention Packaging Act (PPA)
child-resistant packaging requirement
Health Insurance Portability and Accountability Act (HIPAA)
privacy of identifiable health information and security of electronic PHI
Health Information Technology for Economic and Clinical Health Act (HITECH)
Electronic health record implementation
Misbranded conditions
- imitation offered for sale under another article
- contents have been removed, replaced, or if fails to bear a statement of the net contents on the label on the label of the quantity of alcohol/narcotic/habit-forming drug
- package shall bear statement, design, or device regarding the curative effect of article which is false or fraudulent
adulterated
sold by a name recognized in /USP-NF and differs from the standard of strength, quality, or purity as determined by the test laid down therin
Class I recall
situation in which there is a reasonable probability that the use of/expsoure to product will cause serious adverse health consequences or death
Class II recall
exposure to product may cause temporary or medically reversible adverse health consequences but the probability of serous health consequences is remote
Class III recall
exposure is not likely to cause adverse health consequences
Red book
drug pricing
orange book
therapeutic equivalence
yellow book
international travel vaccines
green book
animal drug products
