[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.103]

[Page 9-10]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 310_NEW DRUGS--Table of Contents
 
         Subpart B_Specific Administrative Rulings and Decisions
 
Sec.  310.103  New drug substances intended for hypersensitivity testing.

    (a) The Food and Drug Administration is aware of the need in the 
practice of medicine for the ingredients of

[[Page 10]]

a new drug to be available for tests of hypersensitivity to such 
ingredients and therefore will not object to the shipment of a new drug 
substance, as defined in Sec.  310.3(g), for such purpose if all of the 
following conditions are met:
    (1) The shipment is made as a result of a specific request made to 
the manufacturer or distributor by a practitioner licensed by law to 
administer such drugs, and the use of such drugs for patch testing is 
not promoted by the manufacturer or distributor.
    (2) The new drug substance requested is an ingredient in a marketed 
new drug and is not one that is an ingredient solely in a new drug that 
is legally available only under the investigational drug provisions of 
this part.
    (3) The label bears the following prominently placed statements in 
lieu of adequate directions for use and in addition to complying with 
the other labeling provisions of the act:
    (i) ``Rx only''; and
    (ii) ``For use only in patch testing''.
    (4) The quantity shipped is limited to an amount reasonable for the 
purpose of patch testing in the normal course of the practice of 
medicine and is used solely for such patch testing.
    (5) The new drug substance is manufactured by the same procedures 
and meets the same specifications as the component used in the finished 
dosage form.
    (6) The manufacturer or distributor maintains records of all 
shipments for this purpose for a period of 2 years after shipment and 
will make them available to the Food and Drug Administration on request.
    (b) When the requested new drug substance is intended for 
investigational use in humans or the substance is legally available only 
under the investigational drug provisions of part 312 of this chapter, 
the submission of an ``Investigational New Drug Application'' (IND) is 
required. The Food and Drug Administration will offer assistance to any 
practitioner wishing to submit an Investigational New Drug Application.
    (c) This section does not apply to drugs or their components that 
are subject to the licensing requirements of the Public Health Service 
Act of 1944, as amended. (See subchapter F--Biologics, of this chapter.)

[39 FR 11680, Mar. 29, 1974, as amended at 55 FR 11578, Mar. 29, 1990; 
67 FR 4907, Feb. 1, 2002]