CODE OF FEDERAL REGULATIONS (CFR)

The Code of Federal Regulations (CFR) is comprised of the general and permanent rules of the federal government. The CFR contains the official text of regulations enforced by federal agencies such as:

Food and Drug Administration (FDA)

Environmental Protection Agency (EPA)

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Internal Revenue Service (IRS)

Department of Homeland Security (DHS)

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The CFR is organized as follows:

  • The CFR is divided into 50 titles that represent broad areas subject to Federal regulations.
  • Each title is divided into chapters that are assigned to various agencies issuing regulations pertaining to that broad subject area.
  • Each chapter is divided into parts covering specific regulatory areas.
  • Large parts may be subdivided into subparts.
  • Each part or subpart is then divided into sections — the basic unit of the CFR.
  • Sometimes sections are subdivided further into paragraphs or subsections. Citations pertaining to specific information in the CFR will usually be provided at the section level.

 

An example of a typical CFR citation for pharmaceuticals is 21 CFR 211.67(a). Here is what this citation actually means:

  • The number 21 is the CFR title [2]. The broad subject area is Food and Drugs.
  • The number 211 is the part. Part 211 is entitled “Current Good Manufacturing Practice for Finished Pharmaceuticals”.
  • The number .67 refers to a particular section. This section is about Equipment Cleaning and Maintenance.
  • The (a) is the first paragraph or subsection within the section.

 

The following image represents another example of a typical CFR citation.

 

There are several ways to access the portions of the CFR relating to the manufacture of pharmaceuticals using the web:

  1. The FDA website includes the CFR dealing with CGMP https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.
  2. The FDA website https://www.fda.gov/industry includes along with the federal regulations, notes, proposed changes in the regulations and other pertinent information concerning CGMP.
  3. You can find any part of the Code of Federal Regulations at http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR