Drug development regulations governing

The federal government develops regulations and recommendations to protect public health. Regulations can be enforced by law. Federal agencies that develop regulations for toxic substances include the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), and the Food and Drug Administration (FDA). 

This is the infrastructure that makes it possible for the clinical pharmacologist is to advise government and to provide leadership in drug policy, clinical trials, ethics of clinical studies, pharmacoeconomics, pharmacoepidemiology, drug regulation, the scientific basis of drug development, traditional medicines, and complementary medicines. 

Nations Consolidated List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or not Approved by Governments. WHO publishes updates to this list Pharmaceuticals Restrictions in use and availability. WHO publishes also quarterly WHO Drug Information (http //www.who.int/druginformation/) journal which provides an overview of topics of current relevance relating to drug development, safety and regulation. Latest lists of proposed and recommended International Nonproprietary Names (INN) for Pharmaceutical Substances are also published in this journal. 

Governments are also key players in the development of new drugs. They regulate and provide guidance for the development and approval of new drugs for marketing. In some countries they also play a role in pricing and reimbursement. After the launch of a new product they closely follow its safety, quality and various other aspects such as inappropriate use, promotion, etc. 

This chapter begins with a discussion of standards for pharmacists professional performance and their importance to a manager. It continues with a brief overview of some key historical mileposts in the development of laws and regulations governing both the quality of drug products (at the federal level) and the conduct of pharmacy professionals (at the state level). Next, it concludes with an examination of how the existence of standards can affect what an organization should and/or needs to do. These concepts are then... 

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