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Interpretation Response #99-0080 ([GensiaSicor Pharmaceuticals, Inc.] [Mr. Jim D. Smith])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: GensiaSicor Pharmaceuticals, Inc.

Individual Name: Mr. Jim D. Smith

Location State: CA Country: US

View the Interpretation Document

Response text:

August 27, 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,

 

Thomas G. Allan
Acting Director
Office of Hazardous Materials Standards

171.8

Regulation Sections

Section Subject
171.8 Definitions and abbreviations