C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 201—LABELING › Subpart D—Exemptions From Adequate Directions for Use

21 C.F.R. § 201.115

New drugs or new animal drugs

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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]
Notes of Decisions
Cited in 5 cases, 1978–2012 · leading case: United States v. Articles of Drug, Etc. Appeal of the Lannett Company, Inc
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United States v. Articles of Drug, Etc. Appeal of the Lannett Company, Inc (1978) ca3 “-100(c)(2) (1977); see 21 C.F.R. § 201.115 (1977). The Government contended that all of Lannett’s drugs were “new drugs” which had not received approval by the FDA.”
United States v. Articles of Drug (1980) ca5 “21 C.F.R. § 201.115 (a) (1980). Rucker contended in the district court that section 201.”
United States v. Regenerative Sciences, LLC (2012) dcd “” 21 C.F.R. § 201.115 . It is undisputed that Defendants have neither sought nor has the FDA approved a new drug application for RegenexxTM Procedure.”
Public Pension Fund Group v. Kv Pharmaceutical Co. (2010) moed “§ 352 (f)(1), and they are not exempt from this requirement *1097 pursuant to 21 C.F.R. §§ 201.115 or 201.100. .”
United States v. Syntrax Innovations, Inc. (2001) moed “§ 352 (f)(1), in that their labeling fails to bear adequate directions for use and they are not exempt from such requirement under 21 C.F.R. § 201.115 because the articles are unapproved new drugs.”
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