ABSTRACT
This chapter provides an overview of the building and zoning codes plus 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. In addition, there are agencies at the federal level developing regulations and standards that impact facility design and construction. Examples of these include the Americans with Disabilities Act (ADA), the Occupational Safety and Health Administration (OSHA), and many specialty concerns, such as the Nuclear Regulatory Commission (NRC) for control and use of radioactive materials and the Drug Enforcement Administration (DEA) for controlled substances.
