[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.122]

[Page 53-54]
 
                        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. 201.122  Drugs for processing, repacking, or manufacturing.

    A drug in a bulk package, except tablets, capsules, or other dosage 
unit

[[Page 54]]

forms, intended for processing, repacking, or use in the manufacture of 
another drug shall be exempt from section 502(f)(1) of the act if its 
label bears the statement ``Rx only''; and if in substantially all 
dosage forms in which it may be dispensed it is subject to section 
503(b)(1) of the act, the statement ``Caution: Federal law prohibits 
dispensing without prescription'', or if in substantially all dosage 
forms in which it may be dispensed it is subject to section 503(f)(1) of 
the act, the statement ``Caution: Federal law restricts this drug to use 
by or on the order of a licensed veterinarian''. This exemption and the 
exemption under Sec. 201.120 may be claimed for the same article. 
However, the exemption shall not apply to a substance intended for a use 
in manufacture, processing, or repacking which causes the finished 
article to be a new drug or new animal drug, unless:
    (a) An approved new drug application or new animal drug application 
covers the production and delivery of the drug substance to the 
application holder by persons named in the application, and, for a new 
drug substance, the export of it by such persons under Sec. 314.410 of 
this chapter; or
    (b) If no application is approved with respect to such new drug or 
new animal drug, the label statement ``Caution: For manufacturing, 
processing, or repacking'' is immediately supplemented by the words ``in 
the preparation of a new drug or new animal drug limited by Federal law 
to investigational use'', and the delivery is made for use only in the 
manufacture of such new drug or new animal drug limited to 
investigational use as provided in part 312 or Sec. 511.1 of this 
chapter; or
    (c) A new drug application or new animal drug application covering 
the use of the drug substance in the production and marketing of a 
finished drug product has been submitted but not yet approved or 
disapproved, the bulk drug is not exported, and the finished drug 
product is not further distributed after it is manufactured until after 
the new drug application or new animal drug application is approved.

[41 FR 6911, Feb. 13, 1976, as amended at 41 FR 15844, Apr. 15, 1976; 50 
FR 7492, Feb. 22, 1985; 55 FR 11576, Mar. 29, 1990; 57 FR 54301, Nov. 
18, 1992; 67 FR 4906, Feb. 1, 2002]