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 2011_register executive 2011-07-26 article Rules and Regulations D09002ee1c7ff8c96 D09002ee1c7ff8d29 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 the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an "Asthma alert") and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products. 76 FR 44475 https://www.govinfo.gov/app/details/FR-2011-07-26/2011-18347 2011-18347 fr26jy11-11 RIN 0910-AF32 4160-01-P Docket No. FDA-1995-N-0031 (Formerly Docket No. 1995N-0205) https://www.govinfo.gov/app/details/FR-2011-07-26/2011-18347 https://www.govinfo.gov/content/pkg/FR-2011-07-26/html/2011-18347.htm https://www.govinfo.gov/content/pkg/FR-2011-07-26/pdf/2011-18347.pdf Drugs Labeling Reporting and Recordkeeping Requirements Over-The-Counter Drugs 15 p. 44475 44489 76 FR 44475 Title 21 Part 201 21 CFR Part 201 Title 21 Part 341 21 CFR Part 341 RIN 0910-AF32 Labeling for Bronchodilators To Treat Asthma; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Federal Register Vol. 76, Issue RULE 2011-18347 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2012-01-23 Docket No. FDA-1995-N-0031 (Formerly Docket No. 1995N-0205) 4160-01-P 2011-18347 Final rule.

The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an "Asthma alert") and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products.

Effective Date: This regulation is effective January 23, 2012. Elaine Abraham, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5410, Silver Spring, MD 20993, 301-796- 2090. Drugs Labeling Reporting and Recordkeeping Requirements Over-The-Counter Drugs Labeling for Bronchodilators to Treat Asthma; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products, etc. , http://chestjournal.chestpubs.org/content/110/3/604 http://chestjournal.chestpubs.org/content/112/4/987.full.pdf http://chestjournal.chestpubs.org/content/118/2/522.long http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0731SG3&-_lang=en http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD001115/frame.html http://www.aapcc.org/dnn/Portals/0/2008annualreport.pdf http://www.bepress.com/fhep/6/2 http://www.bls.gov/oes/current/oes_nat.htm http://www.cdc.gov/nchs/data/nhsr/nhsr026.pdf http://www.cdc.gov/nchs/data/nhsr/nhsr027.pdf http://www.cdc.gov/nchs/data/nhsr/nhsr029.pdf http://www.cdc.gov/nchs/data/nhsr/nhsr032.pdf http://www.cdc.gov/nchs/data/nvsr/nvsr58/nvsr58_19.pdf http://www.cdc.gov/nchs/data/series/sr_10/sr10_247.pdf http://www.cdc.gov/nchs/data/series/sr_10/sr10_249.pdf http://www.hcup-us.ahrq.gov/reports/statbriefs/sb54.pdf http://www.heartandlung.org http://www.meps.ahrq.gov/mepsweb/data_files/publications/st166/stat166.pdf http://www.meps.ahrq.gov/mepsweb/data_files/publications/st241/stat241.pdf http://www.meps.ahrq.gov/mepsweb/data_files/publications/st248/stat248.pdf http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf http://www.sba.gov/sites/default/files/Size_Standards_Table.pdf http://www.uspharmacist.com http://yosemite.epa.gov/ee/epa/eed.nsf/pages/Guidelines.html/$file/Guidelines.pdf Vol. 76, no. 143 Office of the Federal Register, National Archives and Records Administration 2011-07-26 continuing daily deposited born digital 311 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2011-07-26 P0b002ee180db04d2 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr26jy11 https://www.govinfo.gov/app/details/FR-2011-07-26 https://www.govinfo.gov/content/pkg/FR-2011-07-26/pdf/FR-2011-07-26.pdf https://www.govinfo.gov/content/pkg/FR-2011-07-26/xml/FR-2011-07-26.xml fdlp 44451 44750 DGPO 2011-07-26 2024-06-04 FR-2011-07-26 machine generated eng FR FR-2011-07-26 76 143