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 D09002ee1c7ed27de D09002ee1c7ed2939 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 a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act." One of the conditions to qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is that a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. This guidance sets forth FDA policies regarding this provision of section 503A, including the terms "commercially available," "essentially a copy of a commercially available drug product," and "regularly or in inordinate amounts." 83 FR 2790 https://www.govinfo.gov/app/details/FR-2018-01-19/2018-00915 2018-00915 fr19ja18-43 4164-01-P Docket No. FDA-2016-D-1309 https://www.govinfo.gov/app/details/FR-2018-01-19/2018-00915 https://www.govinfo.gov/content/pkg/FR-2018-01-19/html/2018-00915.htm https://www.govinfo.gov/content/pkg/FR-2018-01-19/pdf/2018-00915.pdf 3 p. 2790 2792 83 FR 2790 Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability; Federal Register Vol. 83, Issue NOTICE 2018-00915 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2016-D-1309 4164-01-P 2018-00915 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 a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act." One of the conditions to qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is that a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product. This guidance sets forth FDA policies regarding this provision of section 503A, including the terms "commercially available," "essentially a copy of a commercially available drug product," and "regularly or in inordinate amounts."

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 a Commercially Available Drug Products, etc. , 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