Pharmaceuticals

BASICS OF PHARMACEUTICALS

INTRODUCTION

Aside from the requisites of drug manufacturing , a drug company must also have the knowledge on the legal aspect of the pharmaceutical business . A company must be able to know what agencies of the government he has to seek advice from before it undergoes the manufacturing process in to have a good start . Relative to this , the company needs to know which regulates the safety and efficacy of the drugs to be manufactured and which agency protects the rights of the manufacturer and the consumers against illicit

drugs . This will discuss the basic responsibilities of the Food and Drug Administration and the Drug Enforcement Agency including the approval process of manufacturing a generic drug copy

FOOD AND DRUG ADMINISTRATION AND ITS RESPONSIBILITIES

The Food and Drug Administration (FDA ) is generally responsible for ensuring the safety and efficacy of all drugs for human and veterinary use . FDA 's 1mission statement specifically states that the administration is responsible for protecting the public health by assuring the safety , efficacy , and security of human and veterinary drugs , biological products , medical devices , our nation 's food supply cosmetics , and products that emit radiation ' This will then give us the idea why FDA need to regulate drugs , and that is to ensure that they are safe and effective . The administration is also held responsible for ensuring that the drugs have information that is honest and accurate for the general public to use

The following drug and pharmaceutical products are under the regulation of the Food and Drug Administration including their specific scope of responsibilities

BIOLOGICS

licensing- manufacturing establishment and its products

safety of blood supply (nationwide research- for estabishment of product standards

- for development and improvement of testing methods

COSMETICS

safety and labeling

DRUGS

product approvals OTC and prescription drug labeling drug manufacturing standards

MEDICAL DEVICES

premarket approval of new devices manufacturing and performance standards tracking reports of device malfunctioning and serious adverse reactions

RADIATION-EMITTING ELECTRONIC PRODUCTS

radiation safety performance standards x-ray equipment and cabinet x-ray system laser products ultrasonic therapy equipment accreditation of inspecting mammography facilities

VETERINARY PRODUCTS

veterinary drugs and devices DRUG ENFORCEMENT AGENCY AND DRUG REGULATIONS

The Drug Enforcement Agency (DEA (Drug Enforcement Administration for the United States ) is primarily responsible for the enforcement of the Controlled Substances Laws and Regulations . In the United States , DEA is under the wing of the Department of Justice , where it serves as an arm of the justice against the 2those organizations and principal members of organizations , involved in the growing , manufacture , or distribution of controlled substances appearing in or destined for illicit traffic in the United States . The DEA 's drugs of concern include : Cocaine marijuana , heroin , inhalants , LSD , Ecstasy , Steroids , Oxycontin and Methamphetamine

The following list of specific responsibilities is adopted by this writer from the DEA 's official website Investigation and preparation for the prosecution of major violators of controlled substance laws operating at interstate and international levels Investigation and preparation for prosecution of criminals and drug...