Sources Of Law Flashcards
What regulates non prescription drug advertising?
FTC
Federal Trade Commission
What act established two drug classes?
Durham Humphrey Amendment of 1951
What act provided for oral prescriptions and prescription refills?
Durham Humphrey amendment of 1951
What was adopted in response to thalidomide?
Kefauver Harris amendment of 1962
What required that all drugs marketed had to be not only safe, but effective?
Kefauver Harris amendment of 1962
What prohibited foods and drugs that were distributed thru interstate commerce from being misbranded or adulterated?
Pure food and drug act of 1906
What required for meds to be proven safe?
Food Drug and Cosmetic act of 1938
The Food Drug and Cosmetic Act of 1938 also required what two other things?
Labels include adequate directions for use
Warnings about habit forming drugs
What regulates prescription drug advertising?
FDA
What drug application is filled out for generic products?
ANDA
ANDAs require proof of what with its brand name counterpart?
Bioequivalence
What placed more strict controls on distribution of prescriptions and samples?
Prescription Drug Marketing Act of 1987
What are the three official compendia of the U.S.?
USP/NF
HPUS
Drugs@FDA
What jurisdiction is the DEA under?
U.S. Department of Justice
What department is the FDA under?
Department of Health and Human Services
DHHS
What does FDCA stand for?
Food Drug and Cosmetic Act
What act only prohibited adulteration and misbranding?
Pure Food and Drug Act
What did sulfanilamide elixir lead to?
Food Drug and Cosmetic Act of 1938
The Food Drug and Cosmetic Act said a drug cannot me marketed until it’s proven what?
Safe
What established two classes of drugs?
Durham Humphrey amendment
What gave authorization for oral prescriptions and prescription refills?
Durham Humphrey amendment
What was made because of thalidomide?
Kefauver Harris amendment
What amendment streamlined generic approval?
Wax man- Hatch Amendment
What required informed decisions by patients?
Omnibus Budget Reconciliation Act
OBRA
What said drugs had to be both safe and effective?
Kefauver Harris Amendment
What act regulated certain health and disease prevention claims on nutritional products?
Nutrition Labeling Education Act (NLEA)
A dietary supplement must include what statement?
This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.
Who only can remove dietary supplements from the market?
FDA
Why would the FDA remove a dietary supplement from the market?
Basis of public safety
What act requires that prescription only drug products and CS can dispensed in child resistant packaging?
Poison prevention packaging Act of 1970
What kind of packaging can be reused?
Glass bottles with plastic child resistant lids if replace the lids each time
What dealt with the marketing and movement of sampling drugs?
Prescription drug marketing act of 1987
The prescription drug marketing act (PDMA) stopped pharmacists from doing what?
Dispensing samples
What class of medical devices have a low potential for causing harm?
Class 1
Do class 1 medical devices have to get approval from FDA before marketing?
No only premarket notification
What class of medical devices have specific performance standards that are fixed by panels of experts?
Class 2
Do class 2 medical devices have to get FDA approval?
Yes and give pre-market notification
What class of medical devices are usually used in serious life supporting situations?
Class 3
Do class 3 medical devices have to have FDA approval?
Yes
What medical devices have to have FDA approval?
Class 2 and 3
When is a recall mandatory?
When it’s a device
Recalls of what two products are voluntary?
Drugs and cosmetics
Which recall is the most serious?
1
What made it required for a pharmacist to offer counseling at the point of purchase?
OBRA 90
What law provided for oral prescriptions and prescription refills?
Durham Humphrey amendment
What created GMP?
Kefauver Harris Amendment
Who oversees Medicare and Medicaid?
CMS
DEA is part of what department?
Department of Justice
