Pharmaceutical Standards and Regulations

FDA Regulations

• 21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. This part covers general GMP requirements for drugs.
• 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals. This provides detailed regulations for the manufacture, processing, packing, or holding of finished pharmaceuticals.
• 21 CFR Part 312: Investigational New Drug Application (IND). This part outlines the requirements for IND submissions, allowing pharmaceuticals to be lawfully shipped across state lines for clinical trials.
• 21 CFR Part 314: Applications for FDA Approval to Market a New Drug or an Antibiotic Drug. This regulation covers the submission and review process for new drug applications (NDAs).
• 21 CFR Part 600: Biological Products: General. This part includes provisions specific to the manufacture and testing of biological products.

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

• Title 21 CFR Part 1301: Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances. Outlines the registration process for entities handling controlled substances.
• Title 21 CFR Part 1302: Labeling and Packaging Requirements for Controlled Substances. Specifies the requirements for labeling and packaging of controlled substances to prevent misuse and diversion.
• Title 21 CFR Part 1306: Prescriptions for Controlled Substances. Regulations that govern the issuance of prescriptions for controlled substances, including electronic prescriptions.

ICH Guidelines (International Council for Harmonisation)

• ICH Q1A-Q14: Harmonization achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Environmental Regulations

• Resource Conservation and Recovery Act (RCRA): Governs the disposal of solid and hazardous waste, including pharmaceutical waste.
• Clean Air Act (CAA): Regulates air emissions from area, stationary, and mobile sources to ensure that air quality standards are maintained.

OSHA Standards

• Hazard Communication Standard (29 CFR 1910.1200): Requires that the hazards of all chemicals produced or imported are classified, and that information concerning the classified hazards is communicated to employers and employees.
• Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR 1910.1450): Specific standard for laboratory activities involving hazardous chemicals, including pharmaceutical labs.

Export and Import Regulations

• Export Administration Regulations (EAR): Control the export and re-export of dual-use items.
• Import Regulations under the FDA: Guidelines and requirements for importing pharmaceuticals and related products into the United States.