[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.115]
[Page 70]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart D Exemptions From Adequate Directions for Use
Sec. 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
(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.
Back to Top
© 2007 Betterchem Corp.
|
