Laws and Regulations
An overall rule that is passed by the legislative branches of federal, state, and local governments to guide conduct.
What is a law?
This act prohibited the sale or interstate transportation of adulterated or misbranded food and drugs.
What is the Pure Food and Drug Act of 1906?
This act required that most OTC and prescription drugs be packaged in child-resistant containers.
What is the Poison and Prevention Packaging Act of 1970?
A medication that targets a specific need in the body.
The Drug Listing Act of 1972 gave the FDA the authority to compile a list of currently marketed drugs and assign them each a numbered code called this
What is an NDC number or National Drug Code number?
A set of written rules and procedures that exist to carry out a law
What are regulations?
This act required drug manufacturers to submit an application showing that new drugs were safe before they could be marketed, and gave FDA the authority to regulate cosmetics and medical devices.
What is the Food, Drug, and Cosmetic Act of 1938?
This act gave the FDA the authority to compile a list of currently marketed drugs and assign them each a numbered code (NDC number)
What is the Drug Listing Act of 1972?
This prevents illness or disease from occurring
What is a prophylactic agent?
The NDC number is comprised of this many characters
What is 10-11 characters?
A guideline, benchmark, or desired level of quality to serve as the expected norm for a product of professional performance.
What is a standard?
This amendment to the FD&C Act of 1938 established the distinction between legend drugs and OTC drugs and also allowed pharmacists to take refill prescriptions for some substances over the telephone verbally
What is the Durham-Humphrey Amendment of 1951?
This act was established to give drug companies certain financial benefits for developing orphan drugs that are safe and effective.
What is the Orphan Drug Act of 1983?
This works to kill specific living elements, such as bacteria, fungi, viruses, or abnormal cancer cells
What is a destructive agent?
The first four or five number indicate the
Standards of behaviors that all professionals are encouraged to follow
What are ethics?
This Amendment required that manufacturers prove the effectiveness of drug products before they go on the market, and afterwards report any serious side effects.
What is the Kefauver-Harris Amendment of 1962?
This legislation, also known as the Hatch-Waxman Act, streamlined the process to approve equally effective drugs with nonproprietary names, or generic names
What is the Drug Price Competition and Patent Term Restoration Act of 1984?
A medication that alters body functioning in a desired way
What is a pharmacodynamic agent?
The second three or four digit code indicate the
What is the active ingredient and its dosage form - or the drug?
This law always applies if there is a conflict between a state and a federal law
What is the more stringent law?
This Act was created to combat and control drug abuse and to supersede previous federal laws regarding drug abuse.
What is the Controlled Substances Act or the Comprehensive Drug Abuse Prevention and Control Act of 1970?
This act required each state to establish a Drug Utilization Review (DUR) board in order to receive Medicaid funding.
What is the Omnibus Budget Reconciliation Act of 1990?
This is a substance that helps healthcare providers diagnose a medical condition
What is a diagnostic agent?
The last one or two digits in an NDC number indicate
What is the package code that identifies the packaging size and type?