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 2018_register executive 2018-01-19 article Notices D09002ee1c7ed27db D09002ee1c7ed290c 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 Agency) is announcing the availability of a guidance for industry entitled "Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act." For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it must not be essentially a copy of one or more approved drug products and must meet other conditions in section 503B. This guidance sets forth FDA's policies concerning the "essentially a copy" provision of section 503B of the FD&C Act. 83 FR 2786 https://www.govinfo.gov/app/details/FR-2018-01-19/2018-00914 2018-00914 fr19ja18-40 4164-01-P Docket No. FDA-2016-D-1267 https://www.govinfo.gov/app/details/FR-2018-01-19/2018-00914 https://www.govinfo.gov/content/pkg/FR-2018-01-19/html/2018-00914.htm https://www.govinfo.gov/content/pkg/FR-2018-01-19/pdf/2018-00914.pdf 2 p. 2786 2787 83 FR 2786 Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability; Federal Register Vol. 83, Issue NOTICE 2018-00914 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2016-D-1267 4164-01-P 2018-00914 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act." For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it must not be essentially a copy of one or more approved drug products and must meet other conditions in section 503B. This guidance sets forth FDA's policies concerning the "essentially a copy" provision of section 503B of the FD&C Act.

The announcement of the guidance is published in the Federal Register on January 19, 2018. 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: Compounded Drug Products That Are Essentially Copies of Approved Drug Products , 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 Vol. 83, no. 13 Office of the Federal Register, National Archives and Records Administration 2018-01-19 continuing daily deposited born digital 161 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-01-19 P0b002ee198092a60 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19ja18 https://www.govinfo.gov/app/details/FR-2018-01-19 https://www.govinfo.gov/content/pkg/FR-2018-01-19/pdf/FR-2018-01-19.pdf https://www.govinfo.gov/content/pkg/FR-2018-01-19/xml/FR-2018-01-19.xml fdlp 2733 2884 DGPO 2018-01-19 2024-06-01 FR-2018-01-19 machine generated eng FR FR-2018-01-19 83 13