[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: 21CFR201.150]

[Page 54-55]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 201--LABELING--Table of Contents
 
                       Subpart E--Other Exemptions
 
Sec. 201.150  Drugs; processing, labeling, or repacking.


    (a) Except as provided by paragraphs (b) and (c) of this section, a 
shipment or other delivery of a drug which is, in accordance with the 
practice of the trade, to be processed, labeled, or repacked in 
substantial quantity at an

[[Page 55]]

establishment other than that where originally processed or packed, 
shall be exempt, during the time of introduction into and movement in 
interstate commerce and the time of holding in such establishment, from 
compliance with the labeling and packaging requirements of sections 
501(b) and 502 (b), (d), (e), (f), and (g) of the act if:
    (1) The person who introduced such shipment or delivery into 
interstate commerce is the operator of the establishment where such drug 
is to be processed, labeled, or repacked; or
    (2) In case such person is not such operator, such shipment or 
delivery is made to such establishment under a written agreement, signed 
by and containing the post-office addresses of such person and such 
operator, and containing such specifications for the processing, 
labeling, or repacking, as the case may be, of such drug in such 
establishment as will insure, if such specifications are followed, that 
such drug will not be adulterated or misbranded within the meaning of 
the act upon completion of such processing, labeling, or repacking. Such 
person and such operator shall each keep a copy of such agreement until 
2 years after the final shipment or delivery of such drug from such 
establishment, and shall make such copies available for inspection at 
any reasonable hour to any officer or employee of the Department who 
requests them.
    (b) An exemption of a shipment or other delivery of a drug under 
paragraph (a)(1) of this section shall, at the beginning of the act of 
removing such shipment or delivery, or any part thereof, from such 
establishment, become void ab initio if the drug comprising such 
shipment, delivery, or part is adulterated or misbranded within the 
meaning of the act when so removed.
    (c) An exemption of a shipment or other delivery of a drug under 
paragraph (a)(2) of this section shall become void ab initio with 
respect to the person who introduced such shipment or delivery into 
interstate commerce upon refusal by such person to make available for 
inspection a copy of the agreement, as required by such paragraph (a)(2) 
of this section.
    (d) An exemption of a shipment or other delivery of a drug under 
paragraph (a)(2) of this section shall expire:
    (1) At the beginning of the act of removing such shipment or 
delivery, or any part thereof, from such establishment if the drug 
comprising such shipment, delivery, or part is adulterated or misbranded 
within the meaning of the act when so removed; or
    (2) Upon refusal by the operator of the establishment where such 
drug is to be processed, labeled, or repacked, to make available for 
inspection a copy of the agreement, as required by such clause.

[41 FR 6911, Feb. 13, 1976, as amended at 64 FR 400, Jan. 5, 1999]