21 CFR 201.115 - New drugs or new animal drugs.

Status message

There is 1 rule appearing in the Federal Register for 21 CFR 201. View below or at eCFR (GPOAccess)
§ 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 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-12-04; vol. 79 # 233 - Thursday, December 4, 2014
    1. 79 FR 72064 - Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective June 30, 2015. See section IV of this document for the implementation dates of this final rule.
      21 CFR Part 201

Title 21 published on 2014-04-01

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

  • 2014-12-18; vol. 79 # 243 - Thursday, December 18, 2014
    1. 79 FR 75506 - Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by March 18, 2015. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 20, 2015 (see the “Paperwork Reduction Act of 1995” section of this document). See section XI for the proposed effective date of a final rule based on this proposed rule.
      21 CFR Parts 201, 606, and 610