[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: 21CFR201.127]
[Page 71-72]
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. 201.127 Drugs; expiration of exemptions.
(a) If a shipment or delivery, or any part thereof, of a drug which
is exempt under the regulations in this section is made to a person in
whose possession the article is not exempt, or is made for any purpose
other than those specified, such exemption shall expire, with respect to
such shipment or delivery or part thereof, at the beginning of that
shipment or delivery. The causing of an exemption to expire shall be
considered an act which results in such drug being misbranded unless it
is disposed of under circumstances in which it ceases to be a drug or
device.
(b) The exemptions conferred by Sec. Sec. 201.117, 201.119,
201.120, 201.122, and 201.125 shall continue until the drugs are used
for the purposes for which they are exempted, or until they are
relabeled to comply with section 502(f)(1) of the act. If, however, the
drug is converted, compounded, or manufactured into a dosage form
limited to prescription dispensing, no exemption shall thereafter apply
to the
[[Page 72]]
article unless the dosage form is labeled as required by section 503(b)
and Sec. Sec. 201.100 or 201.105.
[41 FR 6911, Feb. 13, 1976]
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