[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.122]

[Page 73]
 
                        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 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 ``Caution: For manufacturing, 
processing, or repacking''; 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 ``Rx only'', 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 
or a new animal drug index listing covers the production and delivery of 
the drug substance to the application or index listing holder by persons 
named in the application or in the request for determination of 
eligibility for indexing, 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, and it is not listed in the index, 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 or Sec.  516.125 of this chapter; or
    (c) A new drug application or new animal drug application or a 
request for addition to the index covering the use of the drug substance 
in the production and marketing of a finished drug product has been 
submitted but not yet approved, disapproved, granted, or denied, 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 or the request 
for addition to the index is granted.

[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; 72 FR 69119, Dec. 6, 2007]