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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 275.100- Immune Milk March 1995

Final

BACKGROUND:

Immune Milk was developed by W. E. Peterson, Ph.D., Professor of Dairy Science, at the University of Minnesota. The product is prepared by giving cows a series of intramammary infusions of polyvalent antigens comprising phenol-killed bacterial pathogens. The antigen is infused at weekly intervals, by the teat canal into the udder tissues, four times before the cow freshens. The milk is collected, processed by pasteurization and kept in a frozen state until used.

Immune Milk has been recommended for such human disease conditions as rheumatoid arthritis, gastroenteritis, urinary tract and sinus infections, certain types of allergies, and chronic neurologic conditions (i.e. multiple sclerosis).

POLICY:

Immune Milk is regarded as a biologic drug and subject to the licensing provisions of the Public Health Service Act, administered by the *Center for Biologics Evaluation and Research.* To date, no establishment or product licenses have been issued for this product. Any shipments of such products should be brought to the attention of the *Center for Biologics Evaluation and Research.* for the purpose of initiating appropriate regulatory action. The following are currently active INDs for immune milk products:

IND NUMBER
SPONSOR
546
Impro Products, Inc., Waukon, Iowa
857 & *1920*
Stole Research and Development Corporation, Cincinnati, Ohio
*1774
Richard McClead, M.D.
Columbus, Ohio*
 

*Material between asterisks is new or revised*

Issued: 6/23/76
Revised: 10/1/80, 4/2/82, 3/95


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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