21 CFR part 211 updates

1 Reply

21 CFR part 211 updates

Posted by Jenna Gay on Mar 24, 2020 3:16 pm

Can someone please assist in how I determine what sections of 21 CFR part 211 sections have been updated during revisions?  It looks like they are updated annually in April every year.  Is that correct?  Thanks.

Re: 21 CFR part 211 updates

Posted by Jeremiah Genest on Mar 24, 2020 8:13 pm

Most of 211 has not been revised since 1978 in any significant way.

Go to the eCFR - https://www.ecfr.gov/cgi-bin/text-idx?SID=c95f59020a7c0f43313637e3a89639a7&mc=true&node=pt21.4.211&rgn=div5

I strongly recommend the ecfr version. The April date you are seeing on the fda.gov site (or somewhere else) just means the last date that copy was pulled.

You'll see it say Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted. This is after the contents.

Throughout the document, at end of certain sections, you'll see this sort of language:

[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]

That tells you when it was last amended and in what federal register.  

You can search on the federal register, most likely your local library has access and can show you how.

So basically, 211 is from 1978, except where noted. Mostly those changes are pretty darn negligible.