Safety and Drug Regulations-Chapter 1
These are the federally approved requirements for the specified strength, quality and purity of drugs
What are drug standards?
The abbreviation OTC means:
What is over the counter?
The FDA and DEA both enforce regulations to ensure general food and drug safety.
False: The DEA is concerned with only controlled substances (including illegal drugs)
The agency that enforces the Controlled Substances Act
What is the Drug Enforcement Administration (DEA)
These drugs are controlled by prescription requirement due to the danger of addiction or abuse
What are controlled substances?
True or False: A DEA number is required for a provider to prescribe a controlled substance.
What is true?
The most dangerous or addictive quality is schedule ___________ for controlled substances. The least dangerous is schedule ___________.
What is I and V?
True or False: Warning labels are required on controlled substances only
What is false?
True or False: All drugs made in the United States are made in federally approved laboratories.
What is false?
This Act required all drugs in the USA to meet minimal standards of purity, strength and quality
What is the 1906 Pure Food and Drug Act?
True or False: Controlled substances are labeled with the letter "D" for dangerous and a roman numeral.
What is false? They are labeled "C" with a roman numeral I-V.
How long must healthcare workers keep records of controlled substances?
What is at least 2 years?
List 3 guidelines for the Healthcare workers related to drugs
Keep a drug reference book on hand at all times
Keep controlled drugs locked accordingly (double locked)
Keep prescription pads in a designated area
Keep accurate records of all controlled substances records are kept on hand for at least two years
Stay current with FDA and DEA regulations
Establish a working rapport with the pharmacist
Establish a working rapport with the pharmaceutical representatives
This department of Health and Welfare enforces the provisions of the Federal Food, Drug and Cosmetic Act and amendments of 1951 and 1965
What is the Food and Drug Administration (FDA)?
This law established these references for approved drugs:
USP — United States Pharmacopeia
NF — National Formulary
What is 1906 Pure Food and Drug Act?