Laws and Regulations

                                       

Finished Pharmaceuticals: Current Good Manufacturing Practice (CGMP) Regulations

• Title 21, U.S. Code, Part 210 - Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs; General
• Title 21, U.S. Code, Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals
• History of Revisions to CGMP Regulations(Federal Register Publication Dates)

Preamble to the Finished Pharmaceutical Regulations

• Preamble to Title 21, Subchapter C, Human and Veterinary Drug, Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding

Positron Emission Tomography Regulations

• Positron Emission Tomography (PET) Webpage
• Positron Emission Tomography (PET Drugs): Federal Register Notice 12/9/09

Part 11 Regulations

• Part 11, Electronic Records; Electronic Signatures — Scope and Application
• FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs

Federal Food, Drug, and Cosmetic Act

Public Health Service Act (PHS Act)

• Public Health Service Act

Food and Drug Administration Safety and Innovation Act (FDASIA)

• Food and Drug Administration Safety and Innovation Act (FDASIA)

ResourcesForYou

• Office of Manufacturing and Product Quality
• Office of Pharmaceutical Quality