Code of Federal Regulations (CFR) : Pharmaguideline -->

Editable Pharmaceutical Documents in MS-Word Format


Code of Federal Regulations (CFR)

Code of Federal Regulations (CFR) is a part of Federal Register that has codification of the rules and regulations for different departments.
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) distributed in the Federal Register by the executive departments, leader offices, and agencies of the Federal Government of the United States. The Office of the Federal Register, also known as the agency of the National Archives and Records Administration (NARA) publishes the CFR.

The CFR is split into 50 titles that address extensive areas subject to federal regulations.
Every year each volume is updated and issued every quarter are as follow:

Title 1-16 1st January
Title 17-27 1st April
Title 29-41 1st July
Title 42-50 1st October
  • The change of color of each set of volumes takes place every year.
  • Each title is separated into chapters, which as a rule bear the name of the issuing agency.
  • Each chapter is sub-divided into parts that enclose specified regulatory areas.
  • Large parts may be subdivided into subparts. All parts are organized in sections.
  • CFR titles are separated by Chapter, Subchapter, and Part.
Before foregoing, let us know each part is a Table of Contents for the individual guidelines contained inside that part.

List of Regulation Titles
Title 1:General Provisions
Title 2:Grants and Agreements
Title 3: The President
Title 4: Accounts
Title 5: Administrative Personnel
Title 6: Homeland Security
Title 7: Agriculture
Title 8: Aliens and Nationality
Title 9: Animals and Animal Products
Title 10: Energy
Title 11: Federal Elections
Title 12: Banks and Banking
Title 13: Business Credit and Assistance
Title 14: Aeronautics and space
Title 15: Commerce and Foreign Trade
Title 16: Commercial Practices
Title 17: Commodity and Securities Exchanges
Title 18: Conservation of Power and Water Resources
Title 19: Customs Duties
Title 20: Employees Benefits
Title 21: Food and Drugs (administered by the US Food and Drug Enforcement Administration)
Title 22: Foreign Relations
Title 23: Highways
Title 24: Housing and Urban Development
Title 25: Indians
Title 26: Internal Revenue
Title 27: Alcohol, Tobacco Products and Firearms
Title 28: Judicial Administration
Title 29: Labor
Title 30: Mineral Resources
Title 31: Money and Finance: Treasury
Title 32: National Defense
Title 33: Navigation and Navigable Waters
Title 34: Education
Title 35: Reserved (formerly Panama Canal)
Title 36: Parks, Forests, and Public Property
Title 37: Patents and Trademarks and Copyrights
Title 38: Pensions, Bonuses and Veterans Relief
Title 39: Postal Service
Title 40: Protection of environment
Title 41: Public contracts and Property Management
Title 42: Public health
Title 43: Public lands interior
Title 44: Emergency management and assistance
Title 45: Public welfare
Title 46: Shipping
Title 47: Telecommunication
Title 48: Federal acquisition regulations system
Title 49: Transportation
Title 50: Wildlife and Fisheries

Title 21- Food and drugs inside the United States is governed by this portion (Title 21) of the CFR for the Food and Drug Administration (FDA). This index is composed of PARTS 200-299. 210 and 211, deal with cGMP.
210- Current Good Manufacturing Practice in manufacturing, processing, packing, or holding of drugs
211- Current Good Manufacturing Practice for finished pharmaceuticals.

Part 210 is composed of the following sections:
210.1- This section contains the Status of current good manufacturing practice regulation
210.2- This section holds on the Applicability of current good manufacturing practice regulations
210.3- This section deals with Definitions

Part 211 consists of sub-parts A to K. They are as follow:
Subpart A-General provisions
Subpart B- Organization and personnel
Subpart C- Buildings and Facilities
Subpart D-Equipment
Subpart E- Control of components and drug product containers and closures
Subpart F- Production and process controls
Subpart G- Packaging and labeling control
Subpart H- Holding and distribution
Subpart I- Laboratory controls
Subpart J- Records and reports
Subpart K- Returned and salvaged drug products

Part 211 contains subparts, which contains sections like:
Subpart A-General Provisions
211.1 - Scope
211.3- Definitions
Subpart B- Organization and Personnel
211.22-Responsibilities of a quality control unit
211.25- personnel qualifications
211.28- personnel responsibilities
211.34- consultants

Why is CFR of Prior Importance?
All federal departments and agencies produce CFRs so that the public and government officials are aware of the changes in regulations and also they get updates on literally every subject that the federal government has jurisdiction to manage. These constantly updated federal regulations can unfold fantastic opportunities for the general public. CFRs are updated on a routine basis based upon new federal legislation, changes in economic or social objectives.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

No comments: Read Comment Policy ▼

Post a Comment

Please don't spam. Comments having links would not be published.

Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Resume Pro


Show All ❭❭Jobs by PharmaJobs

Follow Pharmaguideline



Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...




Pharmaceutical Updates

✔ Worldwide Regulatory Updates
✔ Pharmaceutical News Updates
✔ Interview Questions and Answers
✔ All Guidelines in One Place


Recent Posts