Caution. Contains a new animal drug for investigational use only in laboratory research animals or for tests in vitro. Not for use in humans.
Caution. Contains a new animal drug for use only in investigational animals in clinical trials. Not for use in humans. Edible products of investigational animals are not to be used for food unless authorization has been granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture.
In the case of containers too small or otherwise unable to accommodate a label with sufficient space to bear the caution statements required by paragraph (a) or (b) of this section, the statements may be included on the carton label and other labeling on or within the package from which the new animal drug is to be dispensed.
Authorizations granted under this paragraph do not exempt investigational animals and their products from compliance with other applicable inspection requirements. Any person who contests a refusal to grant such authorization shall have an opportunity for a regulatory hearing before FDA pursuant to part 16 of this chapter.
21 C.F.R. §511.1