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 2006_register executive 2010-09-22 article Part II Rules and Regulations D09002ee1c810209b D09002ee1c81021c2 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 the content and format of labeling for human prescription drug products (including biological products that are regulated as drugs). The final rule revises current regulations to require that the labeling of new and recently approved products include highlights of prescribing information and a table of contents. The final rule also reorders certain sections, requires minor content changes, and sets minimum graphical requirements. These revisions will make it easier for health care practitioners to access, read, and use information in prescription drug labeling. The revisions will enhance the safe and effective use of prescription drug products and reduce the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information. For both new and recently approved products and older products, the final rule requires that all FDA-approved patient labeling be reprinted with or accompany the labeling. The final rule also revises current regulations for prescription drug labeling of older products by clarifying certain requirements. These changes will make the labeling for older products more informative for health care practitioners. 71 FR 3922 https://www.govinfo.gov/app/details/FR-2006-01-24/06-545 06-545 fr24ja06-17 RIN 0910-AA94 4160-01-S Docket No. 2000N-1269 https://www.govinfo.gov/app/details/FR-2006-01-24/06-545 https://www.govinfo.gov/content/pkg/FR-2006-01-24/html/06-545.htm https://www.govinfo.gov/content/pkg/FR-2006-01-24/pdf/06-545.pdf 76 p. 3922 3997 71 FR 3922 Title 21 Part 201 21 CFR Part 201 Title 21 Part 314 21 CFR Part 314 Title 21 Part 601 21 CFR Part 601 RIN 0910-AA94 Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products; Federal Register Vol. 71, Issue RULE 06-545 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2006-06-30 Docket No. 2000N-1269 4160-01-S 06-545 Final rule.

The Food and Drug Administration (FDA) is amending its regulations governing the content and format of labeling for human prescription drug products (including biological products that are regulated as drugs). The final rule revises current regulations to require that the labeling of new and recently approved products include highlights of prescribing information and a table of contents. The final rule also reorders certain sections, requires minor content changes, and sets minimum graphical requirements. These revisions will make it easier for health care practitioners to access, read, and use information in prescription drug labeling. The revisions will enhance the safe and effective use of prescription drug products and reduce the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information. For both new and recently approved products and older products, the final rule requires that all FDA-approved patient labeling be reprinted with or accompany the labeling. The final rule also revises current regulations for prescription drug labeling of older products by clarifying certain requirements. These changes will make the labeling for older products more informative for health care practitioners.

This rule is effective June 30, 2006. See section III of this document for the implementation dates of this final rule. For information on drug product labeling: Janet Norden, Center for Drug Evaluation and Research (HFD-40), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4202, Silver Spring, MD 20993- 0002, 301-796-2270, nordenj@CDER.FDA.GOV, or Elizabeth Sadove, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041, sadovee@CDER.FDA.GOV. Human drugs and biological products: Prescription drug products; labeling requirements, nordenj@CDER.FDA.GOV sadovee@CDER.FDA.GOV stifano@CBER.FDA.GOV http://oc.nci.nih.gov/services/Clear_and_Simple/HOME.htm http://www.ahcpr.gov/about/cpcr/ptsafety/ambpts2.htm http://www.ahrq.gov/HCUPnet.htm http://www.ama-assn.org/ama/pub/category/3627.html http://www.bls.gov/oco/ocos079.htm http://www.bls.gov/oes/2000/oes291051.htm http://www.census.gov/epcd/susb/1999/us/US325412.htm http://www.census.gov/epcd/susb/1999/us/US325414.htm http://www.fda.gov/cber/guidelines.htm http://www.fda.gov/cder/ddmac/y2ktable.htm http://www.fda.gov/cder/ddmac/y2kTITLE.htm http://www.fda.gov/cder/guidance/index.htm http://www.fda.gov/medwatch http://www.fda.gov/vaers http://www.ims-health.com http://www.imshealth.com/public/structure/dispcontent/1,2779,1362-1362-143626,00.html http://www.nacds.org/wmspage.cfm?parm1=507#rx Vol. 71, no. 15 Office of the Federal Register, National Archives and Records Administration 2006-01-24 continuing daily deposited born digital 290 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2006-01-24 P0b002ee18095dbdf 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr24ja06 https://www.govinfo.gov/app/details/FR-2006-01-24 https://www.govinfo.gov/content/pkg/FR-2006-01-24/pdf/FR-2006-01-24.pdf https://www.govinfo.gov/content/pkg/FR-2006-01-24/xml/FR-2006-01-24.xml fdlp 3753 4032 DGPO 2010-09-22 2024-06-06 FR-2006-01-24 machine generated eng FR FR-2006-01-24 71 15