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2017-01-13
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Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry; Availability
Notices
D09002ee1bdbfb204
D09002ee1bdbfb2d5
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The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This revised draft guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy. This revised draft guidance for industry replaces the draft guidance for industry of the same title issued in February 2015.
82 FR 4358
https://www.govinfo.gov/app/details/FR-2017-01-13/2017-00722
2017-00722
fr13ja17-87
4164-01-P
Docket No. FDA-2014-D-1525
https://www.govinfo.gov/app/details/FR-2017-01-13/2017-00722
https://www.govinfo.gov/content/pkg/FR-2017-01-13/html/2017-00722.htm
https://www.govinfo.gov/content/pkg/FR-2017-01-13/pdf/2017-00722.pdf
4 p.
4358
4361
82 FR 4358
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance For Industry; Availability; Federal Register Vol. 82, Issue
NOTICE
2017-00722
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-D-1525
4164-01-P
2017-00722
Notice.
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance for industry entitled ``Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.'' This revised draft guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application (BLA). It also describes the conditions under which FDA does not intend to take action when a State-licensed pharmacy, a Federal facility, an outsourcing facility, or a physician prepares prescription sets of allergenic extracts for subcutaneous immunotherapy. This revised draft guidance for industry replaces the draft guidance for industry of the same title issued in February 2015.
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 either electronic or written comments on the draft guidance by March 14, 2017.
Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20903, 301-796- 3110; 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:
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/medwatch
http://www.fda.gov/regulatoryinformation/dockets/default.htm
https://www.regulations.gov
Federal Register
Vol. 82, no. 9
Office of the Federal Register, National Archives and Records Administration
2017-01-13
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Table of Contents:
AE 2.7:
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KF70.A2
https://www.govinfo.gov/app/details/FR-2017-01-13
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0042-1219
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https://www.govinfo.gov/app/details/FR-2017-01-13
https://www.govinfo.gov/content/pkg/FR-2017-01-13/pdf/FR-2017-01-13.pdf
https://www.govinfo.gov/content/pkg/FR-2017-01-13/xml/FR-2017-01-13.xml
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