21 C.F.R. § 201.115 New drugs or new animal drugs.
Title 21 - Food and Drugs
A new drug shall be exempt from section 502(f)(1) of the act: (a) To the extent to which such exemption is claimed in an approved application with respect to such drug under section 505 or 512 of the act; or (b) If no application under section 505 of the act is approved with respect to such drug but it complies with section 505(i) or 512 of the act and regulations thereunder. No exemption shall apply to any other drug which would be a new drug if its labeling bore representations for its intended uses.
Title 21: Food and Drugs
PART 201—LABELING
Subpart D—Exemptions From Adequate Directions for Use
§ 201.115 New drugs or new animal drugs.
