E-Mail: lseidman@madisoncollege.edu
Address: Madison College
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Revised November 8, 2012
This page explains how to use the internet to obtain the current Good Manufacturing Practices (cGMP) regulations. It describes how the regulations are organized and how they can be searched and retrieved.
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules of the federal government [1]. The CFR contains the complete and official text of the regulations that are enforced by federal agencies.
The CFR is organized as follows:
An example of a typical CFR citation is 21 CFR 211.67(a). Here is what this citation actually means:
There are several ways to access the portions of the CFR relating to the manufacture of pharmaceuticals using the web [4]:
Footnotes:
1 This explanation is based largely on information from the National Archives web site, https://www.archives.gov/federal-register/cfr. This government web site explains what the Federal Register is and provides access to government documents.
2 Each of the titles of the CFR is assigned to a specific agency. The Government agencies that have regulatory control can be determined by the relevant CFR Titles, Subchapters or Chapters.
3 Title 21 contains three Chapters that relate to Food and Drugs. Often the Chapter and Subchapter are not cited, but the citation in the example here is found under Chapter 1. The agency that is responsible for compliance with Chapter 1 is The Food and Drug Administration (FDA). The other Chapters are controlled by other federal agencies. Chapter 1 has seven subchapters and 1299 Parts. Subchapter C covers regulations for General Drugs. Other Subchapters within this Chapter cover regulations for Food, Food additives, and other products regulated by FDA.
4 Federal regulations are first published in the Federal Register (FR) by the executive departments and agencies of the Federal Government. The Federal Register is a legal newspaper published every business day by the National Archives and Records Administration (NARA). It contains Federal agency regulations; proposed rules and notices; and Executive orders, proclamations and other Presidential documents. The Federal Register informs citizens of their rights and obligations and provides access to a wide range of Federal benefits and opportunities for funding. The CFR is kept up-to-date by the daily Federal Register. For the most up-to-date information, these two publications must be used together to determine the latest version of any given rule. When a Federal agency publishes a regulation in the Federal Register, that regulation usually is an amendment to the existing CFR in the form of a change, an addition, or a removal.