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  <FDSYS>
    <CFRTITLE>21</CFRTITLE>
    <CFRTITLETEXT>Food and Drugs</CFRTITLETEXT>
    <VOL>1</VOL>
    <DATE>2001-04-01</DATE>
    <ORIGINALDATE>2001-04-01</ORIGINALDATE>
    <COVERONLY>false</COVERONLY>
    <TITLE>Test and control article handling.</TITLE>
    <GRANULENUM>58.107</GRANULENUM>
    <HEADING>Section 58.107</HEADING>
    <ANCESTORS>
      <PARENT HEADING="Title 21" SEQ="4">Food and Drugs</PARENT>
      <PARENT HEADING="CHAPTER I" SEQ="3">FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES</PARENT>
      <PARENT HEADING="SUBCHAPTER A" SEQ="2">GENERAL</PARENT>
      <PARENT HEADING="PART 58" SEQ="1">GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES</PARENT>
      <PARENT HEADING="Subpart F" SEQ="0">Test and Control Articles</PARENT>
    </ANCESTORS>
  </FDSYS>
  <SECTION>
    <SECTNO>§ 58.107</SECTNO>
    <SUBJECT>Test and control article handling.</SUBJECT>
    <P>Procedures shall be established for a system for the handling of the test and control articles to ensure that:</P>
    <P>(a) There is proper storage.</P>

    <P>(b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.<PRTPAGE P="311"/>
    </P>
    <P>(c) Proper identification is maintained throughout the distribution process.</P>
    <P>(d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.</P>
  </SECTION>
</CFRGRANULE>
