[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: 21CFR201.150]
[Page 72-73]
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 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 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.
[[Page 73]]
(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]
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