[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: 21CFR201.120]
[Page 70-71]
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. 201.120 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
``Rx only''; 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
[[Page 71]]
drug, unless an approved new-drug application covers such use of the
drug in compounding prescriptions.
[40 FR 13998, Mar. 27, 1975, as amended at 67 FR 4906, Feb. 1, 2002]
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