Categorical Exclusion Memo - Bivigam



To:            Administrative File, BL STN 125389/0, Immune Globulin Intravenous (Human) Biotest Pharmaceuticals Corporation (US License No. 1792)

From:        Destry Sillivan, Acting Branch Chief, OCBQ/DMPQ/MRB II, HFM-676

Subject:    Categorical Exclusion under 21 CFR  25.31(c)

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Biotest Pharmaceutical Corporation requested categorical exclusion from an environmental assessment pursuant to 21 CFR 25.31 (c), which applies to a biologic product containing substances that occur naturally in the environment when the introduction of the product does not alter significantly the concentration or distribution of the substances, their metabolites, or degradation products in the environment.

 

I evaluated the request for categorical exclusion and concluded that this request is justified as the product meets the applicable exclusion criteria in 21 CFR Part 25, and that there is no information indicating that extraordinary circumstances exist.

 

 

________________________________________

Destry Sillivan, Acting Branch Chief            Date

Division of Manufacturing and Product Quality, MRBII

 

 

 

 

Concurrence:

 

 

 

 

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John A. Eltermann, Jr., R.Ph., M.S.               Date

Director

Division of Manufacturing and Product Quality