[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: 21CFR201.127]

[Page 54]
 
                        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. 201.127  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 Secs. 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 
article unless the dosage form is labeled as required by section 503(b) 
and Secs. 201.100 or 201.105.

[41 FR 6911, Feb. 13, 1976]