21 CFR 201.115 - New drugs or new animal drugs.

§ 201.115 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.
[ 40 FR 13998, Mar. 27, 1975, as amended at 72 FR 69119, Dec. 6, 2007]

Title 21 published on 09-Jun-2018 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 201 after this date.

  • 2018-05-14; vol. 83 # 93 - Monday, May 14, 2018
    1. 83 FR 22224 - Partial Withdrawal of Proposed Amendment to the Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of partial withdrawal.
      As of May 14, 2018, FDA withdraws the proposed additions to §§ 343.3 and 343.10, and proposed revisions to §§ 343.20 and 343.50 published on August 21, 2002 (67 FR 54139).
      21 CFR Parts 201 and 343
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