Regulation Text
For a particular listed drug, upon our request, the registrant must briefly state the basis for its belief that the drug is not subject to section 505 or 512 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.
Authority
21 U.S.C. 321,331,351,352,355,360,360b,371,374,381,393;42 U.S.C. 262,264,271.