Composition information is essential to establish whether medicated feeds are being manufactured in compliance with medicated feed application approvals, the requirements of applicable regulations, or if they are otherwise adulterated or misbranded.
Feed mills have occasionally refused to allow review or copying of formulae or batch assay records for feeds containing new animal drugs subject to medicated feed application approval, contending that the quantities of non-drug ingredients are trade secrets or that Section 704 of the Act does not provide authority to inspect formulae of medicated feeds. Manufacturers are required to submit a quantitative statement of the active ingredient(s) but only a qualitative listing of the non-drug ingredients as part of their medicated feed application.
FDA's authority to inspect both quantitative and qualitative formulae of medicated feeds is based on Section 512(m)(5) of the Act. The medicated feed CGMP's (21 CFR 255.102) require the Master Record File to contain qualitative and quantitative information for each drug and non-drug ingredient.
It is essential that qualitative information be obtained to determine whether the ingredients are generally recognized as safe and suitable for animal feed use. In this regard the regulations may prohibit the use of certain non-drug ingredients. For example, bentonite may not be used in medicated feeds containing amprolium. Also, the regulations require the labeling of feeds containing certain food additives to bear warnings, cautions, or other information should certain ingredients be used (e.g., ammoniated rice hulls).
On the other hand, quantitative information on some non-drug ingredients may be essential to determine compliance with limitations specified in the regulations for certain ingredients (e.g., menadione dimethylpyrimidinol bisulfite). Quantitative information is always necessary for active drug ingredients to determine whether the finished product is formulated to conform with the permitted levels specified in the regulations and with the approved medicated feed application.
Refusals of the following information by medicated feed manufacturers warrant consideration of administrative/regulatory follow-up:
- Quantitative composition of active drug ingredients.
- Quantitative composition of non-drug ingredients when such information is essential for a determination as to compliance with a limitation established by regulation.
- Qualitative composition of all other non-drug ingredients.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.