[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.109]

[Page 20-21]
 
                        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. 801.109  Prescription devices.


    A device which, because of any potentiality for harmful effect, or 
the method of its use, or the collateral measures necessary to its use 
is not safe except under the supervision of a practitioner licensed by 
law to direct the use of such device, and hence for which ``adequate 
directions for use'' cannot be prepared, shall be exempt from section 
502(f)(1) of the act if all the following conditions are met:
    (a) The device is:
    (1)(i) In the possession of a person, or his agents or employees, 
regularly and lawfully engaged in the manufacture, transportation, 
storage, or wholesale or retail distribution of such device; or
    (ii) In the possession of a practitioner, such as physicians, 
dentists, and veterinarians, licensed by law to use or order the use of 
such device; and
    (2) Is to be sold only to or on the prescription or other order of 
such practitioner for use in the course of his professional practice.
    (b) The label of the device, other than surgical instruments, bears:
    (1) The statement ``Caution: Federal law restricts this device to 
sale by or on the order of a --------'', the blank to be filled with the 
word ``physician'', ``dentist'', ``veterinarian'', or with the 
descriptive designation of any other practitioner licensed by the law of 
the State in which he practices to use or order the use of the device; 
and
    (2) The method of its application or use.
    (c) Labeling on or within the package from which the device is to be 
dispensed bears information for use, including indications, effects, 
routes, methods, and frequency and duration of administration, and any 
relevant hazards, contraindications, side effects, and precautions under 
which practitioners licensed by law to administer the device can use the 
device safely and for the purpose for which it is intended, including 
all purposes for which it is advertised or represented:

[[Page 21]]

Provided, however, That such information may be omitted from the 
dispensing package if, but only if, the article is a device for which 
directions, hazards, warnings, and other information are commonly known 
to practitioners licensed by law to use the device. Upon written 
request, stating reasonable grounds therefor, the Commissioner will 
offer an opinion on a proposal to omit such information from the 
dispensing package under this proviso.
    (d) Any labeling, as defined in section 201(m) of the act, whether 
or not it is on or within a package from which the device is to be 
dispensed, distributed by or on behalf of the manufacturer, packer, or 
distributor of the device, that furnishes or purports to furnish 
information for use of the device contains adequate information for such 
use, including indications, effects, routes, methods, and frequency and 
duration of administration and any relevant hazards, contraindications, 
side effects, and precautions, under which practitioners licensed by law 
to employ the device can use the device safely and for the purposes for 
which it is intended, including all purposes for which it is advertised 
or represented. This information will not be required on so-called 
reminder--piece labeling which calls attention to the name of the device 
but does not include indications or other use information.
    (e) All labeling, except labels and cartons, bearing information for 
use of the device also bears the date of the issuance or the date of the 
latest revision of such labeling.