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 2014_register executive 2014-01-10 article Notices D09002ee1c7fa936e D09002ee1c7fa93df 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 or the Agency) is announcing its intention to take enforcement action against unapproved and misbranded oral and injectable drug products labeled for prescription use and containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate, and against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Prescription drug products containing these ingredients pose serious risks, including the risk of addiction, and some unapproved drug products may lack warnings or other information required in the labeling of approved drug products that is important for safe use. These unapproved drug products compete with approved drug products and thus pose a direct challenge to the drug approval system. This document covers the following unapproved drug products labeled for prescription use: Single-ingredient codeine sulfate oral tablets and solutions, single-ingredient codeine phosphate injection products, fixed-dose combination products containing codeine phosphate, and fixed-dose combination products containing dihydrocodeine bitartrate. A new drug containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate requires an approved new drug application (NDA) or abbreviated new drug application (ANDA) to be legally marketed. 79 FR 1879 https://www.govinfo.gov/app/details/FR-2014-01-10/2014-00257 2014-00257 fr10ja14-70 4160-01-P Docket No. FDA-2013-N-1485 https://www.govinfo.gov/app/details/FR-2014-01-10/2014-00257 https://www.govinfo.gov/content/pkg/FR-2014-01-10/html/2014-00257.htm https://www.govinfo.gov/content/pkg/FR-2014-01-10/pdf/2014-00257.pdf 4 p. 1879 1882 79 FR 1879 Unapproved and Misbranded Oral and Injectable Drugs Labeled for Prescription Use Containing Codeine Sulfate, Codeine Phosphate, or Dihydrocodeine Bitartrate; Enforcement Action Dates; Federal Register Vol. 79, Issue NOTICE 2014-00257 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-01-10 Docket No. FDA-2013-N-1485 4160-01-P 2014-00257 Notice.

The Food and Drug Administration (FDA or the Agency) is announcing its intention to take enforcement action against unapproved and misbranded oral and injectable drug products labeled for prescription use and containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate, and against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Prescription drug products containing these ingredients pose serious risks, including the risk of addiction, and some unapproved drug products may lack warnings or other information required in the labeling of approved drug products that is important for safe use. These unapproved drug products compete with approved drug products and thus pose a direct challenge to the drug approval system. This document covers the following unapproved drug products labeled for prescription use: Single-ingredient codeine sulfate oral tablets and solutions, single-ingredient codeine phosphate injection products, fixed-dose combination products containing codeine phosphate, and fixed-dose combination products containing dihydrocodeine bitartrate. A new drug containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate requires an approved new drug application (NDA) or abbreviated new drug application (ANDA) to be legally marketed.

This document is effective January 10, 2014. For information about enforcement dates, see the SUPPLEMENTARY INFORMATION, section IV. Astrid Lopez-Goldberg, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5185, Silver Spring, MD 20993-0002, 301- 796-3485, Astrid.LopezGoldberg@fda.hhs.gov. Unapproved and Misbranded Oral and Injectable Drugs Labeled for Prescription Use Containing Codeine Sulfate, Codeine Phosphate, or Dihydrocodeine Bitartrate; Enforcement Action Dates , Astrid.LopezGoldberg@fda.hhs.gov eDRLS@fda.hhs.gov http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm239871.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm238675.htm#codeine_sulfate Vol. 79, no. 7 Office of the Federal Register, National Archives and Records Administration 2014-01-10 continuing daily deposited born digital 350 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-01-10 P0b002ee186c9765e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10ja14 https://www.govinfo.gov/app/details/FR-2014-01-10 https://www.govinfo.gov/content/pkg/FR-2014-01-10/pdf/FR-2014-01-10.pdf https://www.govinfo.gov/content/pkg/FR-2014-01-10/xml/FR-2014-01-10.xml fdlp 1733 2073 DGPO 2014-01-10 2024-06-03 FR-2014-01-10 machine generated eng FR FR-2014-01-10 79 7