Laws, Regulations, Policies and Procedures for Drug

Applications

• The mission of FDA(Food and Drug administration) is to enforce laws enacted

by the U.S. Congress and regulations established by the Agency to protect the
consumer's health, safety, and pocketbook.

• The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S.
With numerous amendments, it is the most extensive law of its kind in the world.

• The law is intended to assure the consumer that foods are pure and wholesome,
safe to eat, and produced under sanitary conditions; that drugs and
devices are safe and effective for their intended uses; that cosmetics are safe
and made from appropriate ingredients; and that all labeling and packaging is
 NAME OF THE DRUGS
• Drugs may be known as several names.

1. Chemical name:

 Which is known to chemist, it indicates the ingredient of the drug.

 E.g. N-(4 –hydroxyphenyl) acetamide for Paracetamol.

2. Generic name:

 It is given by the manufacturer who first develops the drug; it is given before the drug
becomes official. It is the name by which the drug will be known throughout the world,
no matter how many companies manufacture it. This name is usually agreed upon by
WHO. Often the generic name is derived from chemical name.

 E.g. Acetaminophen
 NAME OF THE DRUGS
3. Official name:

 It is assigned by the Food and Drug administration after

approval.

 It is often same as Generic name.

4. Trade name:

 It is assigned by manufacturer and is copyrighted.

 One drug may be manufactured by several companies.

 E.g. Paracetamol such as Crocin, Calpol, Ifimol, Metacin etc.