Key Standards, Laws, Regulations, and Guidelines
United States
Federal Food,
Drug, and Cosmetic Act
The Federal Food, Drug and Cosmetic Act was originally passed in 1938 as a
response to a tragedy whereby Elixir Sulfanilamide was
manufactured using antifreeze as a dissolving medium and killed over 100
people. It has been revised many times since then. This law grants FDA power
to regulate food, drugs, medical devices, cosmetics and biological products.
Other Laws Enforced By FDA
In addition to the Federal Food, Drug, and Cosmetic Act, FDA
is responsible for enforcing a variety of other laws. This link to FDA's
website provides a list of laws that FDA enforces, along with links to full
text copies of each.
GMP Regulations and Current Preambles
GMP Regulations help FDA to enforce the Federal Food, Drug, and Cosmetic
Act by specifically listing requirements needed to ensure that products are
manufactured in a state of control. These regulations ensure that
manufacturers build quality into their products in order to maximize consumer
protection. They do carry the force of law, and it is therefore required that
manufacturers comply. Preambles contain FDA's responses to comments
submitted regarding the regulation when it was proposed. They provide
insight into the spirit and meaning of the regulation.
Products Regulated By Specific GMP Regulations
Positron Emission Tomography Drug Products
This page provides links to information on the GMP
regulation of PET drug products. Information includes citations from the
FDA Modernization Act, a history of rulemaking, and various
presentations, meeting transcripts, and guidelines relating to PET drug
products.
Dietary Supplements
This page provides links to information on
dietary supplements, and FDA's regulation of them. Information provided
includes links to information on dietary supplements on FDA's site, the
history of rulemaking with regard to dietary supplements, and guidelines.
Key GMP-Related Compliance Guidelines
As an aid to industry, FDA periodically publishes guidelines which are
intended to help industry interpret regulations. Guidelines do not have
the force of law, however, they do offer insight into the intent of the
regulations.
HACCP (Hazard
Analysis Critical Control Points)
HACCP is a scientifically designed program that identifies the critical
steps in food preparation where contamination is most likely to occur and then
puts in place preventive measures. It is a regulation binding the seafood
industry. However, in August of 1994 FDA announced in an advanced notice of
proposed rule-making, that it is considering developing HACCP regulations form
many other segments of the U.S. food supply.
United States Pharmacopeia
USP establishes standards for the manufacture and distribution of drugs and
related products in the US, and develops drug information that is recognized
by Federal and State legislation.
ISO 9000
International
Organization for Standardization
ISO Easy
International Healthcare Organizations
Producing Standards
Listed below are links to international agencies regulating health
care. Please note that links are provided only to those agencies which
provide English language web sites.
United Nations
