United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2017_register executive 2017-01-13 article Notices D09002ee1c7f2f421 D09002ee1c7f2f4c5 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities." This guidance describes the conditions under which FDA does not intend to take action for violations of certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a State-licensed pharmacy, a Federal facility, or an outsourcing facility repackages certain human drug products. 82 FR 4343 https://www.govinfo.gov/app/details/FR-2017-01-13/2017-00723 2017-00723 fr13ja17-79 4164-01-P Docket No. FDA-2014-D-1524 https://www.govinfo.gov/app/details/FR-2017-01-13/2017-00723 https://www.govinfo.gov/content/pkg/FR-2017-01-13/html/2017-00723.htm https://www.govinfo.gov/content/pkg/FR-2017-01-13/pdf/2017-00723.pdf 3 p. 4343 4345 82 FR 4343 Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Final Guidance for Industry; Availability; Federal Register Vol. 82, Issue NOTICE 2017-00723 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-D-1524 4164-01-P 2017-00723 Notice of availability.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities." This guidance describes the conditions under which FDA does not intend to take action for violations of certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a State-licensed pharmacy, a Federal facility, or an outsourcing facility repackages certain human drug products.

Submit either electronic or written comments on Agency guidances at any time. Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796- 3110. Guidance: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities , http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 82, no. 9 Office of the Federal Register, National Archives and Records Administration 2017-01-13 continuing daily deposited born digital 627 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-01-13 P0b002ee193544b78 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13ja17 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 fdlp 4149 4768 DGPO 2017-01-13 2024-06-01 FR-2017-01-13 machine generated eng FR FR-2017-01-13 82 9