[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.122]
[Page 71]
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
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]
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