Essentials of Healthcare Product Labeling
53
65. 21 CFR Part 601.12(c), Changes requiring supplement
submission at least 30 days prior to distribution of the
product made using the change. Up to date as of 19
October 2023. Accessed 31 August 2023. https://www.
ecfr.gov/cgi-bin/text-idx?SID=68c65905a80147a-
99ca0689c0112b1ab&mc=true&node=se21.7.601_112
&rgn=div8
66. 21 CFR Part 601.12(f)(2), Labeling changes requir-
ing supplement submission – product with a labeling
change that may be distributed before FDA approval.
Up to date as of 19 October 2023. Accessed 31 August
2023. https://www.ecfr.gov/cgi-bin/text-idx?SID=-
68c65905a80147a99ca0689c0112b1ab&mc=true&node
=se21.7.601_112&rgn=div8
67. Food and Drug Administration. Guidance for Industry:
Safety Labeling Changes – Implementation of Section
505(o)(4) of the Federal Food, Drug, and Cosmetic
Act, Notice, 78 Fed. Reg. 45930. Dated 30 July 2013.
Accessed 31 August 2023. https://www.govinfo.gov/
content/pkg/FR-2013-07-30/pdf/2013-18236.pdf
68. Food and Drug Administration. Safety Labeling
Changes – Implementation of Section 505(o)(4) of
the FD&C Act [guidance]. Dated July 2013. Accessed
31 August 2023. https://www.fda.gov/media/116594/
download
69. 21 CFR Part 601.12(d), Changes to be described in
an annual report (minor changes). Up to date as of 19
October 2023. Accessed 31 August 2023. https://www.
ecfr.gov/cgi-bin/text-idx?SID=68c65905a80147a-
99ca0689c0112b1ab&mc=true&node=se21.7.601_112
&rgn=div8
70. 21 CFR Part 601.12(f)(3), Labeling changes requiring
submission in an annual report. Up to date as of 19
October 2023. Accessed 31 August 2023. https://www.
ecfr.gov/cgi-bin/text-idx?SID=68c65905a80147a-
99ca0689c0112b1ab&mc=true&node=se21.7.601_112
&rgn=div8
71. 21 CFR Part 314.92(a)(1), Drug products for which
abbreviated applications may be submitted Drug
products that are the same as a listed drug. Up to
date as of 19 October 2023. Accessed 31 August
2023. https://www.ecfr.gov/cgi-bin/retrieveEC-
FR?gp=&SID=15c4f56e757b113463adae576d-
9509be&mc=true&n=pt21.5.314&r=PART&ty=HT-
ML#se21.5.314_192
72. 21 CFR Part 314.94(a)(7), Bioequivalence. Up to
date as of 19 October 2023. Accessed 31 August
2023. https://www.ecfr.gov/cgi-bin/text-idx?SID=fc-
be18196eaad34219bfcaeaa7010ea4&mc=true&node=se
21.5.314_194&rgn=div8
73. 21 CFR Part 314.94(a)(9), Chemistry, man-
ufacturing, and controls. Up to date as of
2 November 2023. Accessed 6 November
2023. https://www.ecfr.gov/cgi-bin/
retrieveECFR?gp=&SID=356002501c339cf2ff2d12fd-
c1d6202f&mc=true&n=pt21.5.314&r=PART&ty=HT-
ML#se21.5.314_194
74. 21 CFR Part 314.94(a)(8), Labeling. Up to
date as of 19 October 2023. Accessed 31
August 2023. https://www.ecfr.gov/cgi-bin/
retrieveECFR?gp=&SID=356002501c339cf2ff2d12fd-
c1d6202f&mc=true&n=pt21.5.314&r=PART&ty=HT-
ML#se21.5.314_194
75. Food and Drug Administration. Revising ANDA
Labeling Following Revision of the RLD Labeling
[guidance]. Dated May 2000. Accessed 31 August 2023.
https://www.fda.gov/media/71488/download
76. Food and Drug Administration. ANDA Submissions
– Content and Format [guidance]. Dated September
2018. Accessed 31 August 2023. https://www.fda.gov/
media/123269/download
77. Food and Drug Administration. Labeling for Biosimilar
Products [guidance]. Current as of 18 November 2019.
Accessed 31 August 2023. https://www.fda.gov/regu-
latory-information/search-fda-guidance-documents/
labeling-biosimilar-products-guidance-industry
78. Food and Drug Administration. Drugs@FDA: FDA
Approved Drug Products. Accessed 31 August 2023.
https://www.accessdata.fda.gov/scripts/cder/daf/index.
cfm
79. Food and Drug Administration. Updating ANDA
Labeling After the Marketing Application for the
Reference Listed Drug Has Been Withdrawn [draft
guidance]. Dated July 2016. Accessed 31 August 2023.
https://www.fda.gov/media/99041/download
80. Food and Drug Administration. Supplemental
Applications Proposing Labeling Changes
for Approved Drugs and Biological Products,
Proposed Rule, 78 Fed. Reg. 67985. Federal
Register website. Dated 13 November 2013.
Accessed 31 August 2023. https://www.federal-
register.gov/documents/2013/11/13/2013-26799/
supplemental-applications-proposing-labeling-chang-
es-for-approved-drugs-and-biological-products
81. Statement from FDA Commissioner Scott Gottlieb,
MD, and Director of FDA’s Center for Drug
Evaluation and Research Janet Woodcock, MD, on
efforts to modernize generic drug labels while main-
taining the efficiency of generic development. Released
13 December 2018. Accessed 31 August 2023. https://
www.fda.gov/news-events/press-announcements/
statement-fda-commissioner-scott-gottlieb-md-and-di-
rector-fdas-center-drug-evaluation-and-research
82. 21 CFR Part 201, Subpart D – Exemptions
from adequate directions for use, 201.100 (c)
(1), Prescription drugs for human use. Up
to date as of 19 October 2023. Accessed 31
August 2023. https://www.ecfr.gov/cgi-bin/
retrieveECFR?gp=&SID=3a8954151b406f36b946e-
90be11a2adb&mc=true&n=sp21.4.201.d&r=SUB-
PART&ty=HTML#se21.4.201_1100
83. 21 CFR Part 201.100(c)(1), Adequate information
for use. Up to date as of 19 October 2023. Accessed 6
November 2023. https://www.ecfr.gov/cgi-bin/text-idx-
?SID=677d5b9bff9bfb37e6f417059c06f097&mc=true&
node=se21.4.201_1100&rgn=div8
53
65. 21 CFR Part 601.12(c), Changes requiring supplement
submission at least 30 days prior to distribution of the
product made using the change. Up to date as of 19
October 2023. Accessed 31 August 2023. https://www.
ecfr.gov/cgi-bin/text-idx?SID=68c65905a80147a-
99ca0689c0112b1ab&mc=true&node=se21.7.601_112
&rgn=div8
66. 21 CFR Part 601.12(f)(2), Labeling changes requir-
ing supplement submission – product with a labeling
change that may be distributed before FDA approval.
Up to date as of 19 October 2023. Accessed 31 August
2023. https://www.ecfr.gov/cgi-bin/text-idx?SID=-
68c65905a80147a99ca0689c0112b1ab&mc=true&node
=se21.7.601_112&rgn=div8
67. Food and Drug Administration. Guidance for Industry:
Safety Labeling Changes – Implementation of Section
505(o)(4) of the Federal Food, Drug, and Cosmetic
Act, Notice, 78 Fed. Reg. 45930. Dated 30 July 2013.
Accessed 31 August 2023. https://www.govinfo.gov/
content/pkg/FR-2013-07-30/pdf/2013-18236.pdf
68. Food and Drug Administration. Safety Labeling
Changes – Implementation of Section 505(o)(4) of
the FD&C Act [guidance]. Dated July 2013. Accessed
31 August 2023. https://www.fda.gov/media/116594/
download
69. 21 CFR Part 601.12(d), Changes to be described in
an annual report (minor changes). Up to date as of 19
October 2023. Accessed 31 August 2023. https://www.
ecfr.gov/cgi-bin/text-idx?SID=68c65905a80147a-
99ca0689c0112b1ab&mc=true&node=se21.7.601_112
&rgn=div8
70. 21 CFR Part 601.12(f)(3), Labeling changes requiring
submission in an annual report. Up to date as of 19
October 2023. Accessed 31 August 2023. https://www.
ecfr.gov/cgi-bin/text-idx?SID=68c65905a80147a-
99ca0689c0112b1ab&mc=true&node=se21.7.601_112
&rgn=div8
71. 21 CFR Part 314.92(a)(1), Drug products for which
abbreviated applications may be submitted Drug
products that are the same as a listed drug. Up to
date as of 19 October 2023. Accessed 31 August
2023. https://www.ecfr.gov/cgi-bin/retrieveEC-
FR?gp=&SID=15c4f56e757b113463adae576d-
9509be&mc=true&n=pt21.5.314&r=PART&ty=HT-
ML#se21.5.314_192
72. 21 CFR Part 314.94(a)(7), Bioequivalence. Up to
date as of 19 October 2023. Accessed 31 August
2023. https://www.ecfr.gov/cgi-bin/text-idx?SID=fc-
be18196eaad34219bfcaeaa7010ea4&mc=true&node=se
21.5.314_194&rgn=div8
73. 21 CFR Part 314.94(a)(9), Chemistry, man-
ufacturing, and controls. Up to date as of
2 November 2023. Accessed 6 November
2023. https://www.ecfr.gov/cgi-bin/
retrieveECFR?gp=&SID=356002501c339cf2ff2d12fd-
c1d6202f&mc=true&n=pt21.5.314&r=PART&ty=HT-
ML#se21.5.314_194
74. 21 CFR Part 314.94(a)(8), Labeling. Up to
date as of 19 October 2023. Accessed 31
August 2023. https://www.ecfr.gov/cgi-bin/
retrieveECFR?gp=&SID=356002501c339cf2ff2d12fd-
c1d6202f&mc=true&n=pt21.5.314&r=PART&ty=HT-
ML#se21.5.314_194
75. Food and Drug Administration. Revising ANDA
Labeling Following Revision of the RLD Labeling
[guidance]. Dated May 2000. Accessed 31 August 2023.
https://www.fda.gov/media/71488/download
76. Food and Drug Administration. ANDA Submissions
– Content and Format [guidance]. Dated September
2018. Accessed 31 August 2023. https://www.fda.gov/
media/123269/download
77. Food and Drug Administration. Labeling for Biosimilar
Products [guidance]. Current as of 18 November 2019.
Accessed 31 August 2023. https://www.fda.gov/regu-
latory-information/search-fda-guidance-documents/
labeling-biosimilar-products-guidance-industry
78. Food and Drug Administration. Drugs@FDA: FDA
Approved Drug Products. Accessed 31 August 2023.
https://www.accessdata.fda.gov/scripts/cder/daf/index.
cfm
79. Food and Drug Administration. Updating ANDA
Labeling After the Marketing Application for the
Reference Listed Drug Has Been Withdrawn [draft
guidance]. Dated July 2016. Accessed 31 August 2023.
https://www.fda.gov/media/99041/download
80. Food and Drug Administration. Supplemental
Applications Proposing Labeling Changes
for Approved Drugs and Biological Products,
Proposed Rule, 78 Fed. Reg. 67985. Federal
Register website. Dated 13 November 2013.
Accessed 31 August 2023. https://www.federal-
register.gov/documents/2013/11/13/2013-26799/
supplemental-applications-proposing-labeling-chang-
es-for-approved-drugs-and-biological-products
81. Statement from FDA Commissioner Scott Gottlieb,
MD, and Director of FDA’s Center for Drug
Evaluation and Research Janet Woodcock, MD, on
efforts to modernize generic drug labels while main-
taining the efficiency of generic development. Released
13 December 2018. Accessed 31 August 2023. https://
www.fda.gov/news-events/press-announcements/
statement-fda-commissioner-scott-gottlieb-md-and-di-
rector-fdas-center-drug-evaluation-and-research
82. 21 CFR Part 201, Subpart D – Exemptions
from adequate directions for use, 201.100 (c)
(1), Prescription drugs for human use. Up
to date as of 19 October 2023. Accessed 31
August 2023. https://www.ecfr.gov/cgi-bin/
retrieveECFR?gp=&SID=3a8954151b406f36b946e-
90be11a2adb&mc=true&n=sp21.4.201.d&r=SUB-
PART&ty=HTML#se21.4.201_1100
83. 21 CFR Part 201.100(c)(1), Adequate information
for use. Up to date as of 19 October 2023. Accessed 6
November 2023. https://www.ecfr.gov/cgi-bin/text-idx-
?SID=677d5b9bff9bfb37e6f417059c06f097&mc=true&
node=se21.4.201_1100&rgn=div8