[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR701.9]

[Page 149-150]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 701_COSMETIC LABELING--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 701.9  Exemptions from labeling requirements.

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

[[Page 150]]

such establishment, from compliance with the labeling requirements of 
sections 601(a) and 602(b) of the act if:
    (1) The person who introduced such shipment or delivery into 
interstate commerce is the operator of the establishment where such 
cosmetic 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 cosmetic in such 
establishment as will insure, if such specifications are followed, that 
such cosmetic 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 cosmetic 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 cosmetic 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 cosmetic 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 cosmetic 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 clause.
    (d) An exemption of a shipment or other delivery of a cosmetic 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 cosmetic 
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 
cosmetic is to be processed, labeled, or repacked, to make available for 
inspection a copy of the agreement, as required by such clause.