Chapter 5: Pharmaceutical Labeling in the US
50 Regulatory Affairs Professionals Society (RAPS)
5. Federal Anti-Tampering Act, HR 1544. 98th cong.
Accessed 16 October 2023. https://www.govinfo.
gov/content/pkg/STATUTE-97/pdf/STATUTE-
97-Pg831.pdf
6. Food and Drug Administration Modernization Act
of 1997, HR 1411. 105th cong. Accessed 16 October
2023. https://www.govinfo.gov/content/pkg/PLAW-
105publ115/pdf/PLAW-105publ115.pdf
7. Food and Drug Administration. Guidance for Industry:
Implementation of Section 126 of the Food and
Drug Administration Modernization Act of 1997 –
Elimination of Certain Labeling Requirements, Notice,
63 Fed. Reg. 12473. Dated 13 March 1998. Accessed 6
November 2023. https://www.govinfo.gov/content/pkg/
FR-1998-03-13/pdf/98-6572.pdf
8. Best Pharmaceuticals for Children Act, HR 2887.
107th cong. Accessed 16 October 2023. https://www.
govinfo.gov/content/pkg/PLAW-107publ109/pdf/
PLAW-107publ109.pdf
9. Food and Drug Administration Safety and Innovation
Act of 2012, HR 5334. 112th cong. Accessed 16
October 2023. https://www.govinfo.gov/content/pkg/
PLAW-112publ144/pdf/PLAW-112publ144.pdf
10. Food and Drug Administration Amendments Act, HR
3580. 110th cong. Accessed 16 October 2023. https://
www.govinfo.gov/content/pkg/PLAW-110publ85/pdf/
PLAW-110publ85.pdf
11. US Customs and Border Protection. Marking of
Country of Origin on U.S. Imports. Last modified 12
August 2020. Accessed 31 August 2023. https://www.
cbp.gov/trade/rulings/informed-compliance-publica-
tions/marking-country-origin-us-imports
12. 19 CFR Part 134.11, Country of origin marking
required. Up to date as of 4 October 2023. Accessed 31
August 2023. https://www.ecfr.gov/cgi-bin/text-idx-
?SID=aca322d1927aa6da96a04be0412a53a5&mc=true
&node=se19.1.134_111&rgn=div8
13. USP-NF. 7 Labeling. Dated 1 September 2023.
Accessed 6 November 2023. https://www.uspnf.com/
sites/default/files/usp_pdf/EN/USPNF/revisions/gc-7-
ira-20200731.pdf
14. US Supreme Court. Kordel v. United States, 335 U.S.
345 (1948). Accessed 6 November 2023. https://www.
loc.gov/item/usrep335345/
15. National Library of Medicine. https://dailymed.nlm.
nih.gov/dailymed/. Accessed 31 August 2023.
16. Food and Drug Administration. Requirements
on Content and Format of Labeling for Human
Prescription Drug and Biological Products, Final Rule,
71 Fed. Reg. 3922. Federal Register website. Effective
30 June 2006. Accessed 6 November 2023. https://www.
federalregister.gov/documents/2006/01/24/06-545/
requirements-on-content-and-format-of-label-
ing-for-human-prescription-drug-and-biological-prod-
ucts
17. 21 CFR Part 201.56(a)(1), Requirements on content
and format of labeling for human prescription drug
and biological products. Up to date as of 4 October
2023. Accessed 31 August 2023. https://www.ecfr.
gov/cgi-bin/text-idx?SID=309933c00482af85ea5a-
604641d0adac&mc=true&node=se21.4.201_156&rgn
=div8
18. 21 CFR Part 201.56(a)(2), Requirements on content
and format of labeling for human prescription drug
and biological products. Up to date as of 4 October
2023. Accessed 31 August 2023. https://www.ecfr.
gov/cgi-bin/text-idx?SID=309933c00482af85ea5a-
604641d0adac&mc=true&node=se21.4.201_156&rg
n=div
19. Thornton RG. Package inserts and the standard of care.
Proc (Bayl Univ Med Cent). 2003 16(4):502–504.
20. Council for International Organizations of Medical
Sciences. Management of Safety Information from
Clinical Trials – Report of CIOMS Working Group VI.
Dated 2005. Accessed 31 August 2023. https://cioms.
ch/wp-content/uploads/2017/01/Mgment_Safety_Info.
pdf
21. Food and Drug Administration. FDA’s Labeling
Resources for Human Prescription Drugs. Current as of
13 July 2023. Accessed 31 August 2023. https://www.
fda.gov/drugs/laws-acts-and-rules/fdas-labeling-re-
sources-human-prescription-drugs
22. 21 CFR. Food and Drugs. Up to date as of 4 October
2023. Accessed 6 November 2023. https://www.ecfr.
gov/current/title-21
23. 21 CFR Part 201, Labeling. Up to date as of 19
October 2023. Accessed 6 November 2023. https://
www.ecfr.gov/cgi-bin/text-idx?SID=3ed3da9f06d3f-
c54e9f2668ba2c4eecf&mc=true&node=pt21.4.201&r
gn=div5
24. 21 CFR Part 610, General Biological Products
Standards. Up to date as of 19 October 2023. Accessed
6 November 2023. https://www.ecfr.gov/cgi-bin/
text-idx?SID=3ed3da9f06d3fc54e9f2668ba2c4eecf&mc
=true&node=pt21.7.610&rgn=div5
25. International Council for Harmonisation. Stability
Testing of New Drug Substances and Products
QIA(R2), Section 2.2.10 (Current Step 4 version).
Dated 6 February 2003. Accessed 16 October
2023. https://database.ich.org/sites/default/files/
Q1A%28R2%29%20Guideline.pdf
26. 21 CFR Part 211, Current Good Manufacturing
Practice for Finished Pharmaceuticals. Up to date as of
19 October 2023. Accessed 16 October 2023. https://
www.ecfr.gov/cgi-bin/text-idx?SID=3ed3da9f06d3f-
c54e9f2668ba2c4eecf&mc=true&node=pt21.4.211&r
gn=div5
50 Regulatory Affairs Professionals Society (RAPS)
5. Federal Anti-Tampering Act, HR 1544. 98th cong.
Accessed 16 October 2023. https://www.govinfo.
gov/content/pkg/STATUTE-97/pdf/STATUTE-
97-Pg831.pdf
6. Food and Drug Administration Modernization Act
of 1997, HR 1411. 105th cong. Accessed 16 October
2023. https://www.govinfo.gov/content/pkg/PLAW-
105publ115/pdf/PLAW-105publ115.pdf
7. Food and Drug Administration. Guidance for Industry:
Implementation of Section 126 of the Food and
Drug Administration Modernization Act of 1997 –
Elimination of Certain Labeling Requirements, Notice,
63 Fed. Reg. 12473. Dated 13 March 1998. Accessed 6
November 2023. https://www.govinfo.gov/content/pkg/
FR-1998-03-13/pdf/98-6572.pdf
8. Best Pharmaceuticals for Children Act, HR 2887.
107th cong. Accessed 16 October 2023. https://www.
govinfo.gov/content/pkg/PLAW-107publ109/pdf/
PLAW-107publ109.pdf
9. Food and Drug Administration Safety and Innovation
Act of 2012, HR 5334. 112th cong. Accessed 16
October 2023. https://www.govinfo.gov/content/pkg/
PLAW-112publ144/pdf/PLAW-112publ144.pdf
10. Food and Drug Administration Amendments Act, HR
3580. 110th cong. Accessed 16 October 2023. https://
www.govinfo.gov/content/pkg/PLAW-110publ85/pdf/
PLAW-110publ85.pdf
11. US Customs and Border Protection. Marking of
Country of Origin on U.S. Imports. Last modified 12
August 2020. Accessed 31 August 2023. https://www.
cbp.gov/trade/rulings/informed-compliance-publica-
tions/marking-country-origin-us-imports
12. 19 CFR Part 134.11, Country of origin marking
required. Up to date as of 4 October 2023. Accessed 31
August 2023. https://www.ecfr.gov/cgi-bin/text-idx-
?SID=aca322d1927aa6da96a04be0412a53a5&mc=true
&node=se19.1.134_111&rgn=div8
13. USP-NF. 7 Labeling. Dated 1 September 2023.
Accessed 6 November 2023. https://www.uspnf.com/
sites/default/files/usp_pdf/EN/USPNF/revisions/gc-7-
ira-20200731.pdf
14. US Supreme Court. Kordel v. United States, 335 U.S.
345 (1948). Accessed 6 November 2023. https://www.
loc.gov/item/usrep335345/
15. National Library of Medicine. https://dailymed.nlm.
nih.gov/dailymed/. Accessed 31 August 2023.
16. Food and Drug Administration. Requirements
on Content and Format of Labeling for Human
Prescription Drug and Biological Products, Final Rule,
71 Fed. Reg. 3922. Federal Register website. Effective
30 June 2006. Accessed 6 November 2023. https://www.
federalregister.gov/documents/2006/01/24/06-545/
requirements-on-content-and-format-of-label-
ing-for-human-prescription-drug-and-biological-prod-
ucts
17. 21 CFR Part 201.56(a)(1), Requirements on content
and format of labeling for human prescription drug
and biological products. Up to date as of 4 October
2023. Accessed 31 August 2023. https://www.ecfr.
gov/cgi-bin/text-idx?SID=309933c00482af85ea5a-
604641d0adac&mc=true&node=se21.4.201_156&rgn
=div8
18. 21 CFR Part 201.56(a)(2), Requirements on content
and format of labeling for human prescription drug
and biological products. Up to date as of 4 October
2023. Accessed 31 August 2023. https://www.ecfr.
gov/cgi-bin/text-idx?SID=309933c00482af85ea5a-
604641d0adac&mc=true&node=se21.4.201_156&rg
n=div
19. Thornton RG. Package inserts and the standard of care.
Proc (Bayl Univ Med Cent). 2003 16(4):502–504.
20. Council for International Organizations of Medical
Sciences. Management of Safety Information from
Clinical Trials – Report of CIOMS Working Group VI.
Dated 2005. Accessed 31 August 2023. https://cioms.
ch/wp-content/uploads/2017/01/Mgment_Safety_Info.
21. Food and Drug Administration. FDA’s Labeling
Resources for Human Prescription Drugs. Current as of
13 July 2023. Accessed 31 August 2023. https://www.
fda.gov/drugs/laws-acts-and-rules/fdas-labeling-re-
sources-human-prescription-drugs
22. 21 CFR. Food and Drugs. Up to date as of 4 October
2023. Accessed 6 November 2023. https://www.ecfr.
gov/current/title-21
23. 21 CFR Part 201, Labeling. Up to date as of 19
October 2023. Accessed 6 November 2023. https://
www.ecfr.gov/cgi-bin/text-idx?SID=3ed3da9f06d3f-
c54e9f2668ba2c4eecf&mc=true&node=pt21.4.201&r
gn=div5
24. 21 CFR Part 610, General Biological Products
Standards. Up to date as of 19 October 2023. Accessed
6 November 2023. https://www.ecfr.gov/cgi-bin/
text-idx?SID=3ed3da9f06d3fc54e9f2668ba2c4eecf&mc
=true&node=pt21.7.610&rgn=div5
25. International Council for Harmonisation. Stability
Testing of New Drug Substances and Products
QIA(R2), Section 2.2.10 (Current Step 4 version).
Dated 6 February 2003. Accessed 16 October
2023. https://database.ich.org/sites/default/files/
Q1A%28R2%29%20Guideline.pdf
26. 21 CFR Part 211, Current Good Manufacturing
Practice for Finished Pharmaceuticals. Up to date as of
19 October 2023. Accessed 16 October 2023. https://
www.ecfr.gov/cgi-bin/text-idx?SID=3ed3da9f06d3f-
c54e9f2668ba2c4eecf&mc=true&node=pt21.4.211&r
gn=div5