Essentials of Healthcare Product Labeling
51
27. 21 CFR Part 205.50(c), Minimum requirements for
the storage and handling of prescription drugs and
for the establishment and maintenance of prescription
drug distribution records – Storage. Up to date as of 19
October 2023. Accessed 16 October 2023. https://www.
ecfr.gov/cgi-bin/text-idx?SID=4e400bbbc84ddc2df6ad-
c37db123ccc0&mc=true&node=se21.4.205_150&rgn
=div8.
28. 21 CFR Part 610.60, Container label. Up to date as of
19 October 2023. Accessed 16 October 2023. https://
www.ecfr.gov/cgi-bin/text-idx?SID=eb6f56d8a8b-
90540bca92e1471252802&mc=true&node=se21.7.610
_160&rgn=div8
29. 19 CFR Part 134, Country of origin marking. Up to
date as of 19 October 2023. Accessed 16 October 2023.
https://www.ecfr.gov/current/title-19/chapter-I/part-
134
30. 21 CFR Part 201.100, Prescription drugs for human
use. Up to date as of 19 October 2023. Accessed 16
October 2023. https://www.ecfr.gov/cgi-bin/text-idx-
?SID=6aa1c8c6ff3a8239ff7043adfb0c69ad&mc=true&
node=se21.4.201_1100&rgn=div8
31. Food and Drug Administration. Labeling for Human
Prescription and Biological Products – Implementing
the PLR Content and Format Requirements [guid-
ance]. Current as of 24 August 2018. Accessed
31 August 2023. https://www.fda.gov/regulato-
ry-information/search-fda-guidance-documents/
labeling-human-prescription-drug-and-biologi-
cal-products-implementing-plr-content-and-format
32. 21 CFR Part 201.57, Specific requirements on content
and format of labeling for human prescription drug
and biological products described in §201.56(b)(1). Up
to date as of 19 October 2023. Accessed 16 October
2023. https://www.ecfr.gov/cgi-bin/retrieveEC-
FR?gp=&SID=eeb61ecc25745f1cd57f6871c96fd-
0d2&mc=true&n=pt21.4.201&r=PART&ty=HTM-
L#se21.4.201_157
33. Food and Drug Administration. Drug Guidances.
Accessed 31 August 2023. https://www.fda.gov/drugs/
guidance-compliance-regulatory-information/guidanc-
es-drugs
34. Food and Drug Administration. Biologics Guidances.
Accessed 31 August 2023. https://www.fda.gov/
vaccines-blood-biologics/guidance-compliance-regula-
tory-information-biologics/biologics-guidances
35. Food and Drug Administration. Indications and Usage
Section of Labeling for Human Prescription Drug and
Biological Products – Content and Format Guidance
for Industry. Current as of 18 October 2019. Accessed
31 August 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM612697.pdf
36. Food and Drug Administration. Dosage and
Administration Section of Labeling for Human
Prescription Drug and Biological Products –
Content and Format [guidance]. Current
as of 12 January 2023. Accessed 31 August
2023. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM075066.pdf
37. Food and Drug Administration. Warnings and
Precautions, Contraindications, and Boxed Warning
Sections of Labeling for Human Prescription Drug
and Biological Products – Content and Format
[guidance]. Current as of 5 May 2020. Accessed
31 August 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM075096.pdf
38. Food and Drug Administration. Adverse Reactions
Section of Labeling for Human Prescription Drug
and Biological Products – Content and Format
[guidance]. Current as of 24 August 2018. Accessed
31 August 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM075057.pdf
39. Food and Drug Administration. Clinical Pharmacology
Labeling for Human Prescription Drug and
Biological Products – Content and Format [guid-
ance]. Current as of 7 May 2020. Accessed 31
August 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM109739.pdf
40. Food and Drug Administration. Clinical Studies
Section of Labeling for Human Prescription Drug
and Biological Products – Content and Format.
Current as of 7 May 2020. Accessed 31 August
2023. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM075059.pdf
41. Food and Drug Administration. Patient
Counseling Information Section of Labeling
for Human Prescription Drug and Biological
Products – Content and Format [guidance].
Current as of 24 August 2018. Accessed 31 August
2023. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM368602.pdf
42. Food and Drug Administration. Pregnancy,
Lactation, and Reproductive Potential: Labeling
for Human Prescription Drug and Biological
Products – Content and Format [draft guidance].
Current as of 29 July 2020. Accessed 31 August
2023. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM425398.pdf
43. Food and Drug Administration. Pregnancy, Lactation,
and Reproductive Potential: Labeling for Human
Prescription Drug and Biological Products – Content
and Format [guidance]. Small Entity Compliance
Guide. Dated June 2015. Accessed 31 August 2023.
https://www.fda.gov/media/92565/download
51
27. 21 CFR Part 205.50(c), Minimum requirements for
the storage and handling of prescription drugs and
for the establishment and maintenance of prescription
drug distribution records – Storage. Up to date as of 19
October 2023. Accessed 16 October 2023. https://www.
ecfr.gov/cgi-bin/text-idx?SID=4e400bbbc84ddc2df6ad-
c37db123ccc0&mc=true&node=se21.4.205_150&rgn
=div8.
28. 21 CFR Part 610.60, Container label. Up to date as of
19 October 2023. Accessed 16 October 2023. https://
www.ecfr.gov/cgi-bin/text-idx?SID=eb6f56d8a8b-
90540bca92e1471252802&mc=true&node=se21.7.610
_160&rgn=div8
29. 19 CFR Part 134, Country of origin marking. Up to
date as of 19 October 2023. Accessed 16 October 2023.
https://www.ecfr.gov/current/title-19/chapter-I/part-
134
30. 21 CFR Part 201.100, Prescription drugs for human
use. Up to date as of 19 October 2023. Accessed 16
October 2023. https://www.ecfr.gov/cgi-bin/text-idx-
?SID=6aa1c8c6ff3a8239ff7043adfb0c69ad&mc=true&
node=se21.4.201_1100&rgn=div8
31. Food and Drug Administration. Labeling for Human
Prescription and Biological Products – Implementing
the PLR Content and Format Requirements [guid-
ance]. Current as of 24 August 2018. Accessed
31 August 2023. https://www.fda.gov/regulato-
ry-information/search-fda-guidance-documents/
labeling-human-prescription-drug-and-biologi-
cal-products-implementing-plr-content-and-format
32. 21 CFR Part 201.57, Specific requirements on content
and format of labeling for human prescription drug
and biological products described in §201.56(b)(1). Up
to date as of 19 October 2023. Accessed 16 October
2023. https://www.ecfr.gov/cgi-bin/retrieveEC-
FR?gp=&SID=eeb61ecc25745f1cd57f6871c96fd-
0d2&mc=true&n=pt21.4.201&r=PART&ty=HTM-
L#se21.4.201_157
33. Food and Drug Administration. Drug Guidances.
Accessed 31 August 2023. https://www.fda.gov/drugs/
guidance-compliance-regulatory-information/guidanc-
es-drugs
34. Food and Drug Administration. Biologics Guidances.
Accessed 31 August 2023. https://www.fda.gov/
vaccines-blood-biologics/guidance-compliance-regula-
tory-information-biologics/biologics-guidances
35. Food and Drug Administration. Indications and Usage
Section of Labeling for Human Prescription Drug and
Biological Products – Content and Format Guidance
for Industry. Current as of 18 October 2019. Accessed
31 August 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM612697.pdf
36. Food and Drug Administration. Dosage and
Administration Section of Labeling for Human
Prescription Drug and Biological Products –
Content and Format [guidance]. Current
as of 12 January 2023. Accessed 31 August
2023. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM075066.pdf
37. Food and Drug Administration. Warnings and
Precautions, Contraindications, and Boxed Warning
Sections of Labeling for Human Prescription Drug
and Biological Products – Content and Format
[guidance]. Current as of 5 May 2020. Accessed
31 August 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM075096.pdf
38. Food and Drug Administration. Adverse Reactions
Section of Labeling for Human Prescription Drug
and Biological Products – Content and Format
[guidance]. Current as of 24 August 2018. Accessed
31 August 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM075057.pdf
39. Food and Drug Administration. Clinical Pharmacology
Labeling for Human Prescription Drug and
Biological Products – Content and Format [guid-
ance]. Current as of 7 May 2020. Accessed 31
August 2023. https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM109739.pdf
40. Food and Drug Administration. Clinical Studies
Section of Labeling for Human Prescription Drug
and Biological Products – Content and Format.
Current as of 7 May 2020. Accessed 31 August
2023. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM075059.pdf
41. Food and Drug Administration. Patient
Counseling Information Section of Labeling
for Human Prescription Drug and Biological
Products – Content and Format [guidance].
Current as of 24 August 2018. Accessed 31 August
2023. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM368602.pdf
42. Food and Drug Administration. Pregnancy,
Lactation, and Reproductive Potential: Labeling
for Human Prescription Drug and Biological
Products – Content and Format [draft guidance].
Current as of 29 July 2020. Accessed 31 August
2023. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM425398.pdf
43. Food and Drug Administration. Pregnancy, Lactation,
and Reproductive Potential: Labeling for Human
Prescription Drug and Biological Products – Content
and Format [guidance]. Small Entity Compliance
Guide. Dated June 2015. Accessed 31 August 2023.
https://www.fda.gov/media/92565/download