There are a number of firms engaged in the importation or domestic distribution of bulk drug and chemical substances for teaching, law enforcement or research uses. These are exempted from the requirement for adequate directions for use by 21 CFR 201.125. Problems have arisen and regulatory actions have been taken recently in cases where a firm was using this type bulk drug/chemical substance for the manufacture of unapproved new animal drugs or was advertising the products for unqualified uses in the animal drug and feed trade.
Questions also arise concerning the intended use of the product (see 21 CFR 201.128) and whether there is an approved or otherwise valid use in the animal drug and feed trade.
When chemical substances are promoted for animal drug or feed use they are brought under the jurisdiction of the Act.
When a bulk chemical has a bonafide use in human or animal medicine not requiring approval, it may be shipped domestically or imported for that use provided it is not offered or intended for an unapproved use.
Where the intended use of a bulk chemical substance makes it a new animal drug it must be covered by an approved NADA or INAD. The intended use may be determined by labeling, advertising, promotion, or previous mode of sale or by the definition found in 21 CFR 201.128. If there is no approved NADA or INAD it is adulterated within the meaning of Section 501(a)(5) in that it is unsafe within the meaning of Section 512.
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.