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 2004_register executive 2010-09-23 article Part IV Rules and Regulations D09002ee1c8163a89 D09002ee1c8163bfa 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) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report. 69 FR 18728 https://www.govinfo.gov/app/details/FR-2004-04-08/04-7532 04-7532 fr08ap04-14 RIN 0910-AB61 4160-01-S Docket No. 1999N-0193 https://www.govinfo.gov/app/details/FR-2004-04-08/04-7532 https://www.govinfo.gov/content/pkg/FR-2004-04-08/html/04-7532.htm https://www.govinfo.gov/content/pkg/FR-2004-04-08/pdf/04-7532.pdf 40 p. 18728 18767 69 FR 18728 Title 21 Part 206 21 CFR Part 206 Title 21 Part 250 21 CFR Part 250 Title 21 Part 314 21 CFR Part 314 Title 21 Part 600 21 CFR Part 600 Title 21 Part 601 21 CFR Part 601 RIN 0910-AB61 Supplements and Other Changes to an Approved Application; Federal Register Vol. 69, Issue RULE 04-7532 IV DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2004-06-22 Docket No. 1999N-0193 4160-01-S 04-7532 Final rule.

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.

This rule is effective June 22, 2004. David J. Cummings, Center for Drug Evaluation and Research (HFD-357), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5187, or Robert A. Yetter, Center for Biologics Evaluation and Research (HFM-10), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0373. Human drugs and biological products: Supplements and other changes to approved application, http://www.fda.gov/cber/guidelines.htm http://www.fda.gov/cder/guidance/index.htm www.fda.gov/cder/gmp/index.htm Vol. 69, no. 68 Office of the Federal Register, National Archives and Records Administration 2004-04-08 continuing daily deposited born digital 340 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2004-04-08 P0b002ee180970424 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr08ap04 https://www.govinfo.gov/app/details/FR-2004-04-08 https://www.govinfo.gov/content/pkg/FR-2004-04-08/pdf/FR-2004-04-08.pdf https://www.govinfo.gov/content/pkg/FR-2004-04-08/xml/FR-2004-04-08.xml fdlp 18471 18800 DGPO 2010-09-23 2024-06-07 FR-2004-04-08 machine generated eng FR FR-2004-04-08 69 68