ABSTRACT
INTRODUCTION This chapter provides an overview of the building and zoning codes and associated standards and regulations that impact the design and construction of pharmaceutical manufacturing facilities. Local municipal and state governments are the primary authorities promulgating these codes. However, there are also additional agencies at the federal level promulgating regulations and standards that impact facility design and construction. Examples of these include the Americans with Disabilities Act (ADA), Occupational Safety and Health Agency (OSHA), and many specialty concerns such as the Nuclear Regulatory Commission (NRC) for control and use of radioactive materials, and the Drug Enforcement Agency (DEA) for controlled substances.
