21 CFR – Understanding the FDA Regulations
Every year the 21 CFR for the Food and Drug Regulations gets updated. Yet many of you who use the Code of Federal Regulations don’t understand exactly what they are, how they work and how they are modified. We know many of our customers must meet one or more of the requirements of the various parts. So having a clear understanding of the process and content is essential.
The CFR system was developed as part of the reduction of paperwork act. It is a resource that compiles all regulations from each of the executive department in one place. It’s a lot of information, so it’s updated on a yearly basis, with a publication cycle that releases approximately one-fourth of the titles each quarter.
For the 21 CFR, the resource for the regulations issued by the FDA, the annual date is April 1. This means that each April 1st all the FDA regulations that are in force are handed over for publication as part of title 21. However, it takes a bit of time to actually push the material through the publication cycle. The pdf format copy is usually available relatively quickly. The paper format copy is usually released 3 to 4 months after the cut-off date.
The 21 CFR contains FDA regulations separated by Parts. Each part is a regulation on a specific topic. So for example, 21CFR Part 11 is on electronic records and electronic signatures. Part 820 is on quality systems. Since the 21 CFR comes as a 9 volume set, you’ll need to know which part you’re looking for in order to get the volume that includes that material you need.
One common question is “How do I know if the part I use has been updated?” Since the 21 CFR volumes are released on an annual basis, you don’t know the answer by looking at the publication date. You need to have the new volume in order to check this out. For your part, you’ll look section by section through the regulation. At the end of each portion, there are a series of dates.
The first date at the end of each section tells you when the regulation was originally enacted. Then additional dates monitor the issuing of any modifications to the original text of the reg. Specifically, these dates all refer to the publishing of the material in the Federal Register. If the last date on this list is less than a year old, there has been a change to your requirements.
Since regulations are updated constantly throughout the year, only publishing them in the CFR’s is not appropriate. Indeed, there are other protocols that need to be met in order to provide for the kind of regulatory activity that is allowed by law. The true vehicle for this is the Federal Register.
The Federal Register is used for a number of purposes. First, it announces regulations that are being considered for implementation by any given department. This allows for the necessary public comment period required by law. Secondly, it is the official publication vehicle for the announcement of the adoption of any given regulation. This can happen any time throughout the year. And thirdly, agencies like the FDA use the Federal Register to announce workshops and other activities of interest to the general public.
Since all agencies use the Federal Register, it can be overwhelming to try to follow any specific piece of rule-making or the regulations released to enforce a particular piece of legislation. This means that the CFR’s have a real role to play. They give U.S. citizens a place to review this material by topic and source, not by date.
Of course, keeping up with an agency like the FDA is more complex that just following the 21 CFR’s each year. You may have specific issues that can be helped by using the FDA Guidance Documents or other tools. That’s why Document Center Inc. carries a wide variety of publications from many of the Federal Level agencies.
If you have questions about this, please get in touch with us. Document Center has been working with government publications and a wide spectrum of standards since 1982. You can reach us by phone (650-591-7600) or email (info@document-center.com). Our webstore is located at www.document-center.com. We provide you with a resource for compliance documentation requirements and questions. Make Document Center Inc. your Standards Experts!