{"operation":"document","citation":"99-0080","title":"GensiaSicor Pharmaceuticals, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1999-08-27","effective_on":null,"summary":"99-0080 response to GensiaSicor Pharmaceuticals, Inc. concerning 171.8.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0080.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0080.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0080","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1999/990080.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\nWashington, D.C.\n400 Seventh Street, S.W.\n20590\nResearch and\nAdministration\nSpecial Programs\nAUG 2 7 1999\nMr. Jim\nD. Smith\nRef. No. 99-0080\n• Manager,\nEnvironmental Engineering\nGensiaSicor Pharmaceuticals, Inc.\n17 Hughes\nIrvine,\nCA\n92618-1902\nDear Mr.\nSmith:\nThis is in response to your letter postmarked March 26, 1999,\nregarding the relevance of the distribution method in determining\nwhether a drug or medicine is eligible for a consumer commodity\nexception under the Hazardous Materials Regulations (HMR; 49 CFR\nParts 171-180). I apologize for the delay in responding\nand hope\nit has not caused any\ninconvenience.\nDrugs and medicines are eligible for consumer commodity\nexceptions regardless of whether they are suitable or intended\nfor retail sale.\nFederal, state or local regulations (or\nindustry guidelines) that address controls on the administration\nof a drug or medicine by a licensed physician, nurse or any other\nindividual are not relevant to a decision to reclassify and\nrename these materials under applicable provisions of the HMR.\nI hope this satisfies your request.\nSincerely,\nThe\namar\nI. Allan\nThomas G. Allan\nOffice of Hazardous Materials Standards\nActing Director\n990080\n171.8\n...\n22300\n\n<<<PAGE 2>>>\n\n:\ntarim\nGensiaSicor™\n3171.8\nPHARMACEUTICALS\nConsumer\nA GensiaSicor Company\ncommodity\n99-0080\nRet: 99-077\nMr. Ed Mazzullo\nUSDOT/RSPA\nDirector Office of Hazardous Materials Standards\n100 7' Street S.W.\nWashington D.C. 20590-0001\nDear Mr. Mazzullo:\ndefined in 49 CFR 171.8. In this section Consumer commodity is defined as follows:\nI am writing this letter to request your assistance in interpreting the definition of Consumer commodity as\n\"Consumer commodity means a material that is packaged and distributed in a form\nconsumption by individuals for purposes of personal care or household use. This\nintended or suitable for sale through retail sales agencies or instrumentalities for\nterm also includes drugs and medicines.\"\nGensiaSicor Pharmaceuticals is a manufacture of injectable drugs. These \"drugs or medicines\" are not sold\ndirectly to the general public but must be administered by a health care professional in a hospital or clinic\nsetting.\nUnder this definition, \"drugs or medicines\" that meet one or more of the hazard class definitions and are\nclassified and shipped as a consumer commodity. However, injectable drugs that must be administered to a\nsold directly to the general public through a retail outlet such as Sav-On Drug or Rite-Aid could be\npatient by a health care protessional in a hospital or clinic setting does not meet this definition and cannot\nbe shipped as a consumer commodity.\nIs my interpretation of this definition correct?\nYour prompt response and guidance will be appreciated. If you have any questions, please call me at 949-\n455-4712.\nSincerely,\nmD. Smit\nManager, Environmental Engineering\nGensia Sicor Pharmaceuticals, Inc. • 17 Hughes • Irvine CA • 92618-1902 • USA\nPhone (714) 455-4700, (800) 729-9991 • Fax (714) 855-8210 • http://www.gensiasicor.com","truncated":false,"body_characters":3061}