Pharmaceuticals are not “food,” as defined in section 201(f) of the FD&C Act (21 U.S.C. 321(f)),
because they are not used for food or drink or for components of food or drink. Therefore,
facilities that manufacture, process, pack, or hold such products are not required to register as
food facilities under section 415 of the FD&C Act. However, such facilities may be subject to
registration under other statutory provisions. Pharmaceutical manufacturers may wish to consult
with FDA’s Center for Drug Evaluation and Research regarding facility registration. You may
email the eDRLS team at edrls@fda.hhs.gov. Animal drug manufacturers may wish to consult
with FDA’s Center for Veterinary Medicine regarding drug establishment registration by
emailing askCVM@fda.hhs.gov .
