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U.S. Department of Health and Human Services

Drugs

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CGMP Regulations in the Federal Register

The table below presents the drug current good manufacturing practice (CGMP) regulation codifications, or changes, finalized since the original publication of these regulations in 1963. The changes are presented by CGMP regulation subparts and include a brief reason for each change to the regulations.

The CGMP regulations are published in the Code of Federal Regulations, which is a codification of the general and permanent rules published in the Federal Register (FR) by the Executive departments and agencies of the Federal Government. Each volume of the Code contains amendments published in the Federal Register since the last revision of that volume of the Code.

The CGMP changes published on September 29, 1978, at 43 FR 45077, represent the most extensive revisions to these regulations since their original promulgation in 1963. The 1978 Preamble contains most of the background information for the current version of these regulations.

21 CFR 211 Subject FR No. FR Date Brief Reason for Change
Subpart A - General Provisions
211.1 Scope 43 FR 45077 9/29/78  
211.1 Scope 62 FR 66522 12/19/97 Revokes 211.1(d) concerning Positron Emission Tomography drugs
Subpart B – Organization and Personnel
under revision        
211.42 Design and Construction Features 43 FR 45077 9/29/78  
211.42 Design and Construction Features 60 FR 4087-4091 1/20/95  
211.48 Plumbing 43 FR 45077 9/29/78  
211.48 Plumbing 48 FR 11426 3/18/83  
211.68 Automatic, mechanical, and electronic equipment 43 FR 45077 9/29/78  
211.68 Automatic, mechanical, and electronic equipment 60 FR 4087-4091 1/20/95  
211.84 Testing and approval or rejection of components, drug product containers, and closures. 43 FR 45077 9/29/78  
211.84 Testing and approval or rejection of components, drug product containers, and closures. 63 FR 14355/14356 3/25/98 Correct typo: "data" corrected to read "date"
Subpart C – Buildings and Facilities
under revision        
211.122 Materials examination and usage criteria 43 FR 45077 9/29/78  
211.122 Materials examination and usage criteria 58 FR 41348-41354 8/3/93  
211.125 Labeling issuance 43 FR 45077 9/29/78  
211.125 Labeling issuance 58 FR 41348-41354 8/3/93  
211.130 Packaging and labeling operations 43 FR 45077 9/29/78  
211.130 Packaging and labeling operations 58 FR 41348-41354 8/3/93  
211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 54 FR 5228   2/2/89  
211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 63 FR 59463-59470 11/4/98 Require hard-gel cap banding; change term "tamper-resistant" to "tamper-evident"
211.137 Expiration dating 43 FR 45077 9/29/78  
211.137 Expiration dating 46 FR 56412 11/17/81  
211.137 Expiration dating 60 FR 4087-4091 1/20/95  
Subpart D – Equipment
under revision        
211.68 Stability testing 43 FR 45077 9/29/78  
211.68 Stability testing 46 FR 56412 11/17/81  
211.170 Reserve samples 48 FR 13025 3/29/83  
211.170 Reserve samples 60 FR 4087-4091 1/20/95  
211.176 Penicillin contamination 43 FR 45077 9/29/78  
211.176 Penicillin contamination 47 FR 9396 3/5/82  
211.176 Penicillin contamination 50 FR 8993-8996 3/6/85  
211.176 Penicillin contamination 55 FR 11575-11577 3/29/90  
211.176 Penicillin contamination 66 FR 56035 11/6/01 Update address of CFSAN
211.180 General Requirements 43 FR 45077 9/29/78  
211.180 General Requirements 60 FR 4087-4091 1/20/95  
211.194 Laboratory records 43 FR 45077 9/29/78  
211.194 Laboratory records 55 FR 11575-11577 3/29/90  
211.194 Laboratory records 65 FR 18888/18889 4/10/00 Correct footnote numbering
211.196 Distribution records 49 FR 9865 3/16/84  
211.198 Complaint files 43 FR 45077 9/29/78  
211.198 Complaint files 51 FR 24476-24479 7/3/86  
211.198 Complaint files 68 FR 15364 3/31/03 (Note: effective date of amendment is 6/30/03) Add reference to 21 CFR 514.80
Subpart E – Control of Components and Drug Product Containers and Closures
under revision        
21 CFR Part… Original Date Original Reference Revision Date(s) Revision Reference(s)
600.10 11/20/1973 38 FR 32048 6/08/1984; 3/26/1990; 10/15/1997; 12/30/2003 49 FR 23833; 55 FR 11014; 62 FR 53538; 68 FR 75119
600.11 11/20/1973 38 FR 32048 03/11/1976; 6/08/1984; 3/26/1990; 12/30/2003; 3/24/2005; 10/18/2007 41 FR 10428; 49 FR 23833; 55 FR 11013; 68 FR 75119; 70 FR 14982; 72 FR 59003
600.12 11/20/1973 38 FR 32048 6/8/1984; 3/26/1990; 3/24/2005 49 FR 23833; 55 FR 11013; 70 FR 14982
600.13 3/11/1976 41 FR 10428 6/8/1984; 1/29/1985; 3/26/1990; 3/24/2005 49 FR 23833; 50 FR 4133; 55 FR 11013; 70 FR 14982
600.14 11/7/2000 65 FR 66634 3/24/2005 70 FR 14982
600.15 11/12/1974 39 FR 39872 6/8/1984; 1/29/1985; 3/6/1985; 3/26/1990; 9/28/1994; 10/20/1999 49 FR 23833; 50 FR 4133; 50 FR 9000; 55 FR 11013; 59 FR 49351; 64 FR 56449
600.20 11/20/1973 38 FR 32048 N/A N/A
600.21 11/20/1973 38 FR 32048 6/7/1983; 10/20/1999 48 FR 26314; 64 FR 56449
600.22 11/20/1973 38 FR 32048 6/8/1984; 3/26/1990; 3/24/2005 49 FR 23833; 55 FR 11013; 70 FR 14982
600.3 11/20/1973 38 FR 32048 7/25/1975; 3/26/1990; 5/14/1996; 8/24/1997; 10/20/1999; 11/7/2000; 4/8/2004; 3/24/2005; 7/10/2008 40 FR 31313; 55 FR 11014; 61 FR 24232; 62 FR 39901; 64 FR 56449; 65 FR 66634; 69 FR 18766; 70 FR 14982; 73 FR 39610
600.80 10/27/1994 59 FR 54042 6/25/1997; 10/7/1997; 3/26/1998; 10/20/1990; 3/24/2005 62 FR 34168; 62 FR 52252; 63 FR 14612; 64 FR 56449; 70 FR 14982
600.81 10/27/1994 59 FR 54042 10/20/1999; 3/24/2005 64 FR 56449; 70 FR 14983
601.12 7/24/1997 62 FR 39901 12/1/1998; 10/6/2000; 4/8/2004; 3/24/2005; 1/24/2006; 12/28/2007 63 FR 66399; 65 FR 59718; 69 FR 18766; 70 FR 14983; 71 FR 3997; 72 FR 73600
601.14 12/11/2003 68 FR 69020 N/A N/A
601.15 3/24/2005 70 FR 14983 N/A N/A
601.2 10/20/1999 64 FR 56450 3/24/2005 70 FR 14983
601.20 10/20/1999 64 FR 56451 3/24/2005 70 FR 14983
601.21 10/20/1999 64 FR 56451 N/A N/A
601.22 1/25/1977 42 FR 4718 5/14/1996; 10/20/1999 61 FR 24233; 64 FR 56452
601.25 11/20/1973 38 FR 32052 3/29/1974; 3/27/1975; 9/29/1978; 10/5/1982; 11/5/1982; 4/25/1986; 3/26/1990; 10/15/1997; 10/20/1999 39 FR 11535; 40 FR 13498; 43 FR 44838; 47 FR 44071; 47 FR 50211; 51 FR 15607; 55 FR 11014; 62 FR 53538; 64 FR 56452
601.26 10/5/1982 47 FR 44071 10/20/1999 64 FR 56452
601.27 12/2/1998 63 FR 66671 N/A N/A
601.28 10/6/2000 65 FR 59718 10/30/2000; 3/24/2005 65 FR 64618; 70 FR 14984
601.29 9/19/2000 65 FR 56480 3/24/2005 70 FR 14984
601.3 7/10/2008 73 FR 39611 N/A N/A
601.4 1/25/1977 42 FR 4718 3/22/1977; 4/12/1977; 10/20/1999; 3/24/2005 42 FR 15676; 42 FR 19142; 64 FR 56450; 70 FR 14983
601.43 12/11/1992 57 FR 58959 6/11/2003; 3/24/2005 68 FR 34797; 70 FR 14984
601.5 10/20/1999 64 FR 56451 N/A N/A
601.50 12/24/1974 39 FR 44656 N/A N/A
601.51 12/24/1974 39 FR 44656 3/22/1977; 6/8/1984; 3/26/1990; 10/2/1996; 10/20/1999; 5/9/2003; 3/24/2004; 3/24/2005 42 FR 15676; 49 FR 23833; 55 FR 11013; 61 FR 51530; 64 FR 56452; 68 FR 24879; 69 FR 13717; 70 FR 14984
601.6 10/20/1999 64 FR 56451 3/24/2005 70 FR 14983
601.7 1/25/1977 42 FR 4718 3/22/1977; 4/12/1977 42 FR 15676; 42 FR 19143
601.70 10/30/2000 65 FR 64618 3/24/2005 70 FR 14984
601.8 1/25/1977 42 FR 4718 N/A N/A
601.9 10/20/1999 64 FR 56451 3/24/2005 70 FR 14983
601.92 5/31/2002 67 FR 37996 3/24/2005 70 FR 14984
606.100 11/18/1975 40 FR 53532 6/8/1984; 3/26/1990; 9/9/1996; 8/18/1999; 6/11/2001; 8/24/2007 49 FR 23833; 55 FR 11013; 61 FR 47422; 64 FR 45370; 66 FR 31176; 72 FR 48798
606.110 11/18/1975 40 FR 53532 6/8/1984; 3/26/1990 49 FR 23833; 55 FR 11013
606.120 8/30/1985 50 FR 35469 N/A N/A
606.121 8/30/1985 50 FR 35469 1/5/1988; 3/26/1990; 3/31/1992; 5/6/1994; 4/6/1998; 8/19/1999; 6/11/2001; 2/1/2002; 2/26/2004; 3/24/2005 53 FR 116; 55 FR 11014; 57 FR 10814; 59 FR 23636; 63 FR 16685; 64 FR 45371; 66 FR 31162; 67 FR 4907; 69 FR 9171; 70 FR 14984
606.122 8/30/1985 50 FR 35470 1/5/1988; 8/19/1999 53 FR 116; 64 FR 45371
606.151 11/18/1975 40 FR 53532 8/19/1999; 1/10/2001; 8/6/2001 64 FR 45371; 66 FR 1835; 66 FR 40889
606.160 11/18/1975 40 FR 53532 9/9/1996; 8/19/1999; 11/7/2000; 6/11/2001; 8/24/2007 61 FR 47422; 64 FR 45371; 65 FR 66635; 66 FR 31176; 72 FR 48798
606.170 11/18/1975 40 FR 53532 6/8/1984; 8/30/1985; 3/36/1990; 8/19/1999; 3/4/2002 49 FR 23833; 50 FR 35471; 55 FR 11014; 64 FR 45371; 67 FR 9586
606.171 11/7/2000 65 FR 66635 3/24/2005 70 FR 14984
606.20 11/18/1975 40 FR 53532 6/8/1984; 3/26/1990; 10/15/1997 49 FR 23833; 55 FR 11014; 62 FR 53538
606.3 11/18/1975 40 FR 53532 8/19/1999; 11/7/2000; 1/10/2001; 8/6/2001; 8/16/2007 64 FR 45370; 65 FR 66635; 66 FR 1835; 66 FR 40889; 72 FR 45886
606.60 11/18/1975; 12/2/1975 40 FR 53532; 40 FR 55849 2/12/1980; 4/2/1992; 4/13/1992 45 FR 9261; 57 FR 11263; 57 FR 12862
606.65 11/18/1975 40 FR 53532 5/6/1994 59 FR 23636
607.20 11/12/1975 40 FR 52788 10/20/1999; 11/27/2001 64 FR 56452; 66 FR 59158
607.21 11/12/1975 40 FR 52788 10/20/1999 64 FR 56453
607.22 11/27/2001 66 FR 59158 3/24/2005 70 FR 14984
607.25 11/12/1975 40 FR 52788 6/8/1984; 3/26/1990; 11/27/2001 49 FR 23833; 55 FR 11013; 66 FR 59158
607.26 11/12/1975 40 FR 52788 11/27/2001 66 FR 59158
607.3 11/12/1975 40 FR 52788 3/26/1990; 11/17/2001 55 FR 11014; 66 FR 59158
607.31 11/27/2001 66 FR 59158 N/A N/A
607.35 11/12/1975 40 FR 52788 6/8/1984; 11/27/2001 49 FR 23833; 66 FR 59159
607.37 11/12/1975 40 FR 52788 6/8/1984; 3/26/1990; 11/27/2001; 3/24/2005 49 FR 23833; 55 FR 11014; 66 FR 59159; 70 FR 14984
607.40 11/27/2001 66 FR 59159 N/A N/A
607.65 11/12/1975 40 FR 52788 8/25/1978; 12/30/1980; 8/31/1984; 6/11/2001; 11/27/2001; 8/16/2007 43 FR 37997; 45 FR 85729; 49 FR 34449; 66 FR 31162; 66 FR 59159; 72 FR 45886
607.7 11/12/1975 40 FR 52788 6/8/1984; 3/26.1990; 11/27/2001; 3/24/2005 49 FR 23833; 55 FR 11014; 66 FR 59158; 70 FR 14984
610.11 3/15/1976 41 FR 10891 4/18/1984; 6/8/1984; 1/29/1985; 4/25/1986; 3/26/1990; 9/28/1994; 4/20/1998; 8/5/1998; 3/4/2003; 3/24/2005 49 FR 15187; 49 FR 23834; 50 FR 4133; 51 FR 15607.pdf; 55 FR 11013; 59 FR 49351; 63 FR 19401; 63 FR 41718; 68 FR 10160; 70 FR 14984
610.11a 11/13/1974 39 FR 40016 N/A N/A
610.12 11/20/1973 38 FR 32056 1/28/1976; 3/11/1976; 3/2/1979; 4/18/1984; 6/8/1984; 1/29/1985; 12/15/1986; 4/19/1988; 3/26/1990; 9/15/1997; 3/4/2002; 4/9/2004; 3/25/2005 41 FR 4015; 41 FR 10428; 44 FR 11754; 49 FR 15187; 49 FR 23834; 50 FR 4133; 51 FR 44906; 53 FR 12764; 55 FR 11013; 62 FR 48175; 67 FR 9587; 69 FR 18803; 70 FR 14985
610.13 11/20/1973 38 FR 32056 7/15/1975; 3/11/1976; 9/22/1976; 7/10/1979; 12/29/1981; 4/18/1984; 1/28/1985; 7/11/1990; 10/20/1999; 3/4/2002; 3/24/2005 40 FR 29710; 41 FR 10429; 41 FR 41424; 44 FR 40289; 46 FR 62845; 49 FR 15187; 50 FR 4134; 55 FR 28381; 64 FR 56453; 67 FR 9587; 70 FR 14985
610.15 11/20/1973 38 FR 32056 10/23/1981; 3/29/1983; 8/16/1983; 6/8/1984; 1/29/1985; 4/25/1986; 3/26/1990; 3/24/2005 46 FR 51903; 48 FR 13025; 48 FR 37023; 49 FR 23834; 50 FR 4134; 51 FR 15607; 55 FR 11013; 70 FR 14985
610.18 11/20/1973 38 FR 32056 12/10/1986; 3/26/1990; 3/4/2002; 3/24/2005 51 FR 44453; 55 FR 11013; 67 FR 9587; 70 FR 14985
610.2 8/25/1975 40 FR 31313 6/8/1984; 3/19/1985; 3/26/1990; 3/4/2002; 3/24/2005 49 FR 23834; 50 FR 10941; 55 FR 11013; 67 FR 9587; 70 FR 14984
610.20 11/20/1973 38 FR 32056 3/11/1976; 5/3/1976; 6/8/1984; 3/26/1990 41 FR 10429; 41 FR 18295; 49 FR 23834; 55 FR 11013
610.21 3/11/1976 41 FR 10429 5/3/1976; 12/19/2005 41 FR 18295; 70 FR 75028
610.30 11/20/1973 38 FR 32056 4/6/1998 63 FR 16685
610.40 6/11/2001 66 FR 31162 N/A N/A
610.41 6/11/2001 66 FR 31164 8/24/2007 72 FR 48798
610.42 6/11/2001 66 FR 31164 N/A N/A
610.44 6/11/2001 66 FR 31164 N/A N/A
610.46 8/24/2007 72 FR 48799 N/A N/A
610.47 8/24/2007 72 FR 48799 N/A N/A
610.48 8/24/2007 72 FR 48800 N/A N/A
610.50 11/20/1973 38 FR 32056 5/31/1977 42 FR 27582
610.53 1/29/1985 50 FR 4134 4/25/1986; 6/2/1986; 10/7/1987; 4/19/1988; 3/31/1997; 10/20/1999; 3/24/2005; 8/16/2007; 9/24/2007 51 FR 15607; 51 FR 19750; 52 FR 37450; 53 FR 12764; 62 FR 15110; 64 FR 56453; 70 FR 14985; 72 FR 45887; 72 FR 54208
610.60 11/20/1973 38 FR 32056 5/25/1982; 12/1/1998; 2/1/2002 47 FR 22518; 63 FR 66400; 67 FR 4097
610.61 11/20/1973 38 FR 32056 5/25/1982; 3/21/1990; 2/1/2002 47 FR 22518; 55 FR 10423; 67 FR 4907
610.63 10/20/1999 64 FR 56453 N/A N/A
610.64 11/6/1996 61 FR 57330 N/A N/A
610.67 2/26/2004 69 FR 9171 N/A N/A
610.68 12/28/2007 72 FR 73600 N/A N/A
610.90 7/24/1997 62 FR 39903 3/24/2005 70 FR 14984
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