21 CFR 201.115 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 200.5 To § 299.5) — Food And Drug Administration, Department Of Health And Human Services (Continued) (§ 200.5 To § 299.5) — Drugs: General (§ 200.5 To § 299.5) — Labeling (§ 201.1 To Appendix A To Part 201) — Exemptions From Adequate Directions For Use (§ 201.100 To § 201.129) — New drugs or new animal 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 an index listing with respect to such drug under section 572 of the act; or

(b) If no application under section 505 or 512 of the act is approved and no request for addition to the index is granted under section 572 with respect to such drug but it complies with section 505(i), 512(j), or 572(g) 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.