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2014-10-08
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The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers; Draft Guidance for Industry; Availability
Notices
D09002ee1bdc39d83
D09002ee1bdc39deb
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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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers.'' FDA is issuing these questions and answers to assist industry and State governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on State product tracing requirements and on standards, requirements, and regulations with respect to wholesale distributor and third-party logistics provider (3PL) licensing. Title II is also referred to as the Drug Supply Chain Security Act (DSCSA).
79 FR 60853
https://www.govinfo.gov/app/details/FR-2014-10-08/2014-23972
2014-23972
fr08oc14-49
4164-01-P
Docket No. FDA-2014-D-1411
https://www.govinfo.gov/app/details/FR-2014-10-08/2014-23972
https://www.govinfo.gov/content/pkg/FR-2014-10-08/html/2014-23972.htm
https://www.govinfo.gov/content/pkg/FR-2014-10-08/pdf/2014-23972.pdf
2 p.
60853
60854
79 FR 60853
The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers; Draft Guidance for Industry; Availability; Federal Register Vol. 79, Issue
NOTICE
2014-23972
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-D-1411
4164-01-P
2014-23972
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers.'' FDA is issuing these questions and answers to assist industry and State governments in understanding the effects of section 585 (Uniform National Policy) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by Title II of the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013, on State product tracing requirements and on standards, requirements, and regulations with respect to wholesale distributor and third-party logistics provider (3PL) licensing. Title II is also referred to as the Drug Supply Chain Security Act (DSCSA).
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by December 8, 2014.
Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3100, drugtrackandtrace@fda.hhs.gov.
Guidance:
Effect of Uniform National Policy on Drug Product Tracing, Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Q A
,
drugtrackandtrace@fda.hhs.gov
http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 79, no. 195
Office of the Federal Register, National Archives and Records Administration
2014-10-08
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220 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2014-10-08
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https://www.govinfo.gov/app/details/FR-2014-10-08
https://www.govinfo.gov/content/pkg/FR-2014-10-08/pdf/FR-2014-10-08.pdf
https://www.govinfo.gov/content/pkg/FR-2014-10-08/xml/FR-2014-10-08.xml
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