The goal of this compliance program’s activities is to ensure that establishments consistently produce drug products of acceptable quality and minimize consumers’ exposure to adulterated drug products.
Under this compliance program, inspections, investigations, sample collections, sample analyses, and
regulatory or administrative follow-up are conducted to identify quality problems and adverse trends at establishments, so that FDA can develop strategies to mitigate them. The objectives of this
• Determine whether inspected establishments7 are operating in compliance with applicable CGMP requirements to produce sterile and non-sterile compounded drugs. If they are not compliant, provide evidence to act against responsible persons and take appropriate actions to prevent adulterated products from entering the market or to remove adulterated products from the market.
• Provide input to establishments during inspections to improve their compliance with federal regulations.
• Understand current practices in Outsourcing Facilities for the purpose of updating the CGMP requirements, regulatory policy, and guidance documents.