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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 682.200 The Use of Antibiotic Drug Residue By-Products in Animal Feed Feed October 1982

Final
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Affairs

BACKGROUND:

Mycelium presscake and other by-products of the production of antibiotic drugs by fermentation of penicillium and streptomyces, as well as other mold fermentation products, are widely sold in this country for use as ingredients in animal feed. They are defined in the official publication of the Association of American Feed Control Officials. We are also aware that small amounts of mycelia and perhaps culture media do exist in so-called feed grade antibiotic premixes.

POLICY:

We do not object to the use of mycelia and other by-products of mold fermentation/antibiotic propagation in animal feeds provided the antibiotic activity does not exceed two grams per ton of cake and no more than three pounds of cake is used per ton of animal feed. This would provide approximately 0.002 ppm antibiotic activity to the final feed which we consider to be insignificant and not to constitute a concern. The labeling of the animal feed must not make any claim for the antibiotic furnished by the fermentation product.

*This policy applies only to those antibiotics approved for use in food-producing animals before August 24, 1982 (47 FR 36968).*

*Material between asterisks is new or revised*

Issued: 10/1/82


Submit Comments

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)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
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Rockville, MD 20852

All comments should be identified with the title of the guidance.

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Food and Drug Administration
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