Federal Drug Acts Flashcards
What was the aim of the Sherman Antitrust ACT of 1890
Block monopolies that used deceptive marketing and price fixing to exclude competion
What was the aim of the Pure Food and Drug Acto of 1906 (Wiley Act)
No misbranded or adulterated drugs can be sent through interstate commerce
Drugs must meet standards by the USP and National Formulary
What was the aim Food, Drug, Comestic Act FDCA of 1938
Prove drug safety prior to marketing, prohibits adulterated and misbranded, Ingredients must be clearly listed on label (must be truthful), Comply with CGMPs
T/F: Pharmacies are restricted from receiving or distributing drug samples from manufacturers
True
What are the the three circumstances that require a drug to have a prescription
HABIT FORMING, UNSAFE without EXPERT SUPERVISION, Manufacturer’s New Drug Application
What act classified drugs as prescription “Legend” or OTC drugs
Durham-Humphrey Amendment of 1951
T/F: Durham-Humphrey act legalized verbal transmission or prescriptions and legalized refill authorizations
True
What act required drugs to not only be proven safe but also effective
Kefauver-Harris Amendment 1962
T/F: The Kefauver-Harris Amendment required manufacturers to report adverse effects events to the FDA and and created the NDA and supplmental NDA
True
T/F: The Poison Prevention Packaging ACT (PPPA) of 1970 requires requires prescription and OTC drugs to have child resistant containers
True
T/F: New bottle/vial and cap with each prescription filled
True
What did the Federal Anti-Tampering Act of 1982 due
Required OTC products to have tamper-resistant features
What are OTC drugs that are exempt from anti tampering features
Skin products, lozenges, insulin, dentrifice
In order to bypass the PPPA who can authorize easy open containers
Patient can request for particular prescriptions OR a blanket waiver for all prescriptions
Prescribers may request for one prescription at a time
