Regulation and Standard Library

We've compiled links to regulations, major standards, and guidelines that impact FDA-regulated manufacturers marketing products in the United States.

Pharmaceutical Standards and Regulations

FDA Regulations

USP Standards (United States Pharmacopeia)

  • USP General Chapters: Various chapters that set standards for chemical and biological drug substances, dosage forms, and compounded preparations. Examples include:
    • USP <795>: Pharmaceutical Compounding – Nonsterile Preparations.
    • USP <797>: Pharmaceutical Compounding – Sterile Preparations.
    • USP <800>: Handling of Hazardous Drugs in Healthcare Settings.
  • USP Monographs: Specific monographs for individual drug substances and ingredients, describing tests, procedures, and acceptance criteria.

DEA Regulations

ICH Guidelines (International Council for Harmonisation)

Environmental Regulations

OSHA Standards

Export and Import Regulations

Medical Device Standards and Regulations

FDA Regulations

ISO Standards

IEC Standards

ASTM Standards

UL Standards

AAMI Standards

NEMA Standards