Interpretation Response #98-0303 ([Glaxo Wellcome, Inc.] [Ms. Sally Hamam])

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

Interpretation Response Details

Response Publish Date: 11/19/1998

Company Name: Glaxo Wellcome, Inc.

Individual Name: Ms. Sally Hamam

Location State: NC Country: US

View the Interpretation Document

Response text:

NOV 19, 1998

Mr. James R. Hendricks                Ref No. 98-0303
Manager, Dangerous Goods Compliance
Glaxo Wellcome, Inc.
P.O. Box 13398
Research Triangle Park, NC 27709-3390

Dear Mr. Hendricks:

This is in response to your letter in which you request clarification concerning the definition of "biological product," as used in the Hazardous Materials Regulations (HMR; 49 CFR parts 171­180) and in the regulations of the Food and Drug Administration (FDA) of the Department of Health and Human Services (21 CFR part 312 and parts 600 to 680). I apologize for the delay in responding to your inquiry.

Your letter is quoted, in part, as follows:

An infectious material which meets the FDA definition of "biological product," as defined in 21 CFR Part 312 or 21 CFR Parts 600-680 may be shipped in any additional packaging; essentially non-regulated. Our question is whether an infectious material which does not meet the FDA definition of "biological product" while outside a "medical device," automatically becomes a "biological product" when placed into a "medical device?"

Our confusion results from the fact a packaging manufacturer currently offers a package that has been registered with the FDA as a "medical device;" with the implication that any biological material inside a registered medical device (including infectious materials) may be treated as a biological product.

Our understanding of the FDA definition of "biological product" does not include mention of "medical devices." Furthermore, we do not believe the two terms are inter­related. Although our question may be more appropriately directed to the FDA, we would appreciate RSPA's response/comments to the following question: Does an infectious material that is not a "biological product" outside a FDA-approved medical device become a "biological product" when placed inside the medical device?

We agree that it does not appear that a medical device meets the FDA definition of "biological product" in 21 CPR 600.3(h). However, you are correct that it would be more appropriate to address your question concerning this definition to the FDA.

Under the HMR, a material which meets the definition of "biological product" in 49 CPR
173 . 134(a)(3) is excepted from regulation. With regard to FDA regulations, the HMR definition applies only to materials prepared and manufactured in accordance with 21 CPR part 312 (Investigational new drug application) and 21 CFR 600 to 680 (Biologics). If a material is not prepared and manufactured in accordance with these regulations, it is not a biological product under the HMR. An infectious material that is not a biological product does not become a biological product by the act of placing it in an FDA-registered medical device and, unless otherwise excepted, is fully subject to the HMR.

For your information, we have been in contact with the packaging manufacturer and they have agreed to discontinue making claims that might imply that an infectious substance becomes a biological product when shipped in their packaging.

I trust this satisfies your inquiry. Ifwe can be of further assistance, please contact us.

Sincerely,

Edward T. Muzzullo
Director, Office of Hazardous Materials Standards

Regulation Sections