GensiaSicor Pharmaceuticals, Inc. — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department Washington, D.C. 400 Seventh Street, S.W. 20590 Research and Administration Special Programs AUG 2 7 1999 Mr. Jim D. Smith Ref. No. 99-0080 • Manager, Environmental Engineering GensiaSicor Pharmaceuticals, Inc. 17 Hughes Irvine, CA 92618-1902 Dear Mr. Smith: This is in response to your letter postmarked March 26, 1999, regarding the relevance of the distribution method in determining whether a drug or medicine is eligible for a consumer commodity exception under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). I apologize for the delay in responding and hope it has not caused any inconvenience. Drugs and medicines are eligible for consumer commodity exceptions regardless of whether they are suitable or intended for retail sale. Federal, state or local regulations (or industry guidelines) that address controls on the administration of a drug or medicine by a licensed physician, nurse or any other individual are not relevant to a decision to reclassify and rename these materials under applicable provisions of the HMR. I hope this satisfies your request. Sincerely, The amar I. Allan Thomas G. Allan Office of Hazardous Materials Standards Acting Director 990080 171.8 ... 22300#

Page 2: tarim GensiaSicor™ 3171.8 PHARMACEUTICALS Consumer A GensiaSicor Company commodity 99-0080 Ret: 99-077 Mr. Ed Mazzullo USDOT/RSPA Director Office of Hazardous Materials Standards 100 7' Street S.W. Washington D.C. 20590-0001 Dear Mr. Mazzullo: defined in 49 CFR 171.8. In this section Consumer commodity is defined as follows: I am writing this letter to request your assistance in interpreting the definition of Consumer commodity as "Consumer commodity means a material that is packaged and distributed in a form consumption by individuals for purposes of personal care or household use. This intended or suitable for sale through retail sales agencies or instrumentalities for term also includes drugs and medicines." GensiaSicor Pharmaceuticals is a manufacture of injectable drugs. These "drugs or medicines" are not sold directly to the general public but must be administered by a health care professional in a hospital or clinic setting. Under this definition, "drugs or medicines" that meet one or more of the hazard class definitions and are classified and shipped as a consumer commodity. However, injectable drugs that must be administered to a sold directly to the general public through a retail outlet such as Sav-On Drug or Rite-Aid could be patient by a health care protessional in a hospital or clinic setting does not meet this definition and cannot be shipped as a consumer commodity. Is my interpretation of this definition correct? Your prompt response and guidance will be appreciated. If you have any questions, please call me at 949- 455-4712. Sincerely, mD. Smit Manager, Environmental Engineering Gensia Sicor Pharmaceuticals, Inc. • 17 Hughes • Irvine CA • 92618-1902 • USA Phone (714) 455-4700, (800) 729-9991 • Fax (714) 855-8210 • http://www.gensiasicor.com#