United States Government Publishing Office
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2019-08-14
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Child-Resistant Packaging Statements in Drug Product Labeling; Guidance for Industry; Availability
Notices
D09002ee1c12c83f4
D09002ee1c12c849d
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Child- Resistant Packaging Statements in Drug Product Labeling.'' This guidance is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child- resistant packaging (CRP) statements in prescription and over-the- counter human drug product labeling. The guidance discusses what information should be included to support CRP statements and to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.
84 FR 40424
https://www.govinfo.gov/app/details/FR-2019-08-14/2019-17433
2019-17433
fr14au19-67
4164-01-P
Docket No. FDA-2017-D-2163
https://www.govinfo.gov/app/details/FR-2019-08-14/2019-17433
https://www.govinfo.gov/content/pkg/FR-2019-08-14/html/2019-17433.htm
https://www.govinfo.gov/content/pkg/FR-2019-08-14/pdf/2019-17433.pdf
3 p.
40424
40426
84 FR 40424
Child-Resistant Packaging Statements in Drug Product Labeling; Guidance for Industry; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-17433
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2017-D-2163
4164-01-P
2019-17433
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Child- Resistant Packaging Statements in Drug Product Labeling.'' This guidance is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child- resistant packaging (CRP) statements in prescription and over-the- counter human drug product labeling. The guidance discusses what information should be included to support CRP statements and to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.
The announcement of the guidance is published in the Federal Register on August 14, 2019.
Richard Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993, 301-796- 1697; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Guidance:
Child-Resistant Packaging Statements in Drug Product Labeling
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 157
Office of the Federal Register, National Archives and Records Administration
2019-08-14
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1377 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-08-14
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0042-1219
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000582072
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https://www.govinfo.gov/app/details/FR-2019-08-14
https://www.govinfo.gov/content/pkg/FR-2019-08-14/pdf/FR-2019-08-14.pdf
https://www.govinfo.gov/content/pkg/FR-2019-08-14/xml/FR-2019-08-14.xml
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FR-2019-08-14
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