[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.120]

[Page 53]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 201--LABELING--Table of Contents
 
         Subpart D--Exemptions From Adequate Directions for Use
 
Sec. 201.120  Prescription chemicals and other prescription components.

    A drug prepared, packaged, and primarily sold as a prescription 
chemical or other component for use by registered pharmacists in 
compounding prescriptions or for dispensing in dosage unit form upon 
prescriptions shall be exempt from section 502(f)(1) of the act if all 
the following conditions are met:
    (a) The drug is an official liquid acid or official liquid alkali, 
or is not a liquid solution, emulsion, suspension, tablet, capsule, or 
other dosage unit form; and
    (b) The label of the drug bears:
    (1) The statement ``For prescription compounding''; and
    (2) 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
    (3) If it is not subject to section 503(b)(1) of the act and is by 
custom among retail pharmacists sold in or from the interstate package 
for use by consumers, ``adequate directions for use'' in the conditions 
for which it is so sold.


Provided, however, That the information referred to in paragraph (b)(3) 
of this section may be contained in the labeling on or within the 
package from which it is to be dispensed.
    (c) This exemption shall not apply to any substance intended for use 
in compounding which results in a new drug, unless an approved new-drug 
application covers such use of the drug in compounding prescriptions.