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 2000_register executive 2010-09-24 article Proposed Rules D09002ee1c81ef8dd D09002ee1c81ef958 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 proposing to require that all systemic antibacterial drug products (i.e., antibiotics and their synthetic counterparts) intended for human use contain additional labeling information about the emergence of drug-resistant bacterial strains. The proposal reflects a growing concern in FDA and the medical community that overprescription and inappropriate use of systemic antibacterials has contributed to a dramatic increase in recent years in the prevalence of drug-resistant bacterial infections. The proposal is intended to encourage physicians to prescribe systemic antibacterials more judiciously and only when clinically necessary. The proposal is also intended to encourage physicians to counsel their patients about the proper use of such drugs and the importance of taking them exactly as directed. 65 FR 56511 https://www.govinfo.gov/app/details/FR-2000-09-19/00-24007 00-24007 fr19se00-21 RIN 0910-AB78 4160-01-F Docket No. 00N-1463 https://www.govinfo.gov/app/details/FR-2000-09-19/00-24007 https://www.govinfo.gov/content/pkg/FR-2000-09-19/html/00-24007.htm https://www.govinfo.gov/content/pkg/FR-2000-09-19/pdf/00-24007.pdf Drugs Labeling Reporting and Recordkeeping Requirements 8 p. 56511 56518 65 FR 56511 Title 21 Part 201 21 CFR Part 201 RIN 0910-AB78 Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use; Federal Register Vol. 65, Issue PRORULE 00-24007 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2000-12-04 Docket No. 00N-1463 4160-01-F 00-24007 Proposed rule.

The Food and Drug Administration (FDA) is proposing to require that all systemic antibacterial drug products (i.e., antibiotics and their synthetic counterparts) intended for human use contain additional labeling information about the emergence of drug-resistant bacterial strains. The proposal reflects a growing concern in FDA and the medical community that overprescription and inappropriate use of systemic antibacterials has contributed to a dramatic increase in recent years in the prevalence of drug-resistant bacterial infections. The proposal is intended to encourage physicians to prescribe systemic antibacterials more judiciously and only when clinically necessary. The proposal is also intended to encourage physicians to counsel their patients about the proper use of such drugs and the importance of taking them exactly as directed.

Submit written comments by December 4, 2000. See section III of this document for the proposed effective date of a final rule based on this document. Gary K. Chikami, Center for Drug Evaluation and Research (HFD-520), Food and Drug Administration, 9201 Corporate Blvd., Rockville, MD 20852, 301-827-2120. Drugs Labeling Reporting and Recordkeeping Requirements Human drugs: Systemic antibacterial products; labeling requirements, http://www.ahrq.gov/data/hcup/hcupnet.htm Vol. 65, no. 182 Office of the Federal Register, National Archives and Records Administration 2000-09-19 continuing daily deposited born digital 323 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2000-09-19 P0b002ee1809fcbd9 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19se00 https://www.govinfo.gov/app/details/FR-2000-09-19 https://www.govinfo.gov/content/pkg/FR-2000-09-19/pdf/FR-2000-09-19.pdf https://www.govinfo.gov/content/pkg/FR-2000-09-19/xml/FR-2000-09-19.xml fdlp 56457 56772 DGPO 2010-09-24 2024-06-08 FR-2000-09-19 machine generated eng FR FR-2000-09-19 65 182