[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.110]

[Page 21]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 801--LABELING--Table of Contents
 
         Subpart D--Exemptions From Adequate Directions for Use
 
Sec. 801.110  Retail exemption for prescription devices.

    A device subject to Sec. 801.109 shall be exempt at the time of 
delivery to the ultimate purchaser or user from section 502(f)(1) of the 
act if it is delivered by a licensed practitioner in the course of his 
professional practice or upon a prescription or other order lawfully 
issued in the course of his professional practice, with labeling bearing 
the name and address of such licensed practitioner and the directions 
for use and cautionary statements, if any, contained in such order.