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 2016_register executive 2018-02-02 article Part III Rules and Regulations D09002ee1c7f43f54 D09002ee1c7f44086 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 governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine. 81 FR 60170 https://www.govinfo.gov/app/details/FR-2016-08-31/2016-20471 2016-20471 fr31au16-15 RIN 0910-AA49 4164-01-P Docket No. FDA-2005-N-0464 (formerly Docket No. 2005N-0403) https://www.govinfo.gov/app/details/FR-2016-08-31/2016-20471 https://www.govinfo.gov/content/pkg/FR-2016-08-31/html/2016-20471.htm https://www.govinfo.gov/content/pkg/FR-2016-08-31/pdf/2016-20471.pdf Human Cells and Tissue-Based Products Medical Devices Confidential Business Information Courts Freedom of Information Government Employees Drugs Labeling Reporting and Recordkeeping Requirements Administrative Practice and Procedure Animal Drugs Biologics Blood 55 p. 60170 60224 81 FR 60170 Title 21 Part 1271 21 CFR Part 1271 Title 21 Part 201 21 CFR Part 201 Title 21 Part 207 21 CFR Part 207 Title 21 Part 20 21 CFR Part 20 Title 21 Part 314 21 CFR Part 314 Title 21 Part 514 21 CFR Part 514 Title 21 Part 515 21 CFR Part 515 Title 21 Part 601 21 CFR Part 601 Title 21 Part 607 21 CFR Part 607 RIN 0910-AA49 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Federal Register Vol. 81, Issue RULE 2016-20471 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-11-29 Docket No. FDA-2005-N-0464 (formerly Docket No. 2005N-0403) 4164-01-P 2016-20471 Final rule.

The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.

This rule is effective on November 29, 2016. See section IV for compliance dates. For information pertaining to human drug products: Paul Loebach, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2262, Silver Spring, MD 20993, 301-796-2173. Human Cells and Tissue-Based Products Medical Devices Confidential Business Information Courts Freedom of Information Government Employees Drugs Labeling Reporting and Recordkeeping Requirements Administrative Practice and Procedure Animal Drugs Biologics Blood Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs , http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/cber/tissue/tisreg.htm http://www.fda.gov/Drugs http://www.regulations.gov Vol. 81, no. 169 Office of the Federal Register, National Archives and Records Administration 2016-08-31 continuing daily deposited born digital 419 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-08-31 P0b002ee1982b72d8 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr31au16 https://www.govinfo.gov/app/details/FR-2016-08-31 https://www.govinfo.gov/content/pkg/FR-2016-08-31/pdf/FR-2016-08-31.pdf https://www.govinfo.gov/content/pkg/FR-2016-08-31/xml/FR-2016-08-31.xml fdlp 59827 60234 DGPO 2018-02-02 2024-06-01 FR-2016-08-31 machine generated eng FR FR-2016-08-31 81 169