[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.76]

[Page 109]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
--Table of Contents
 
                         Subpart G_Source Plasma
 
Sec. 640.76  Products stored or shipped at unacceptable temperatures.

    (a) Storage temperature. (1) Except as provided in paragraph (a)(2) 
of this section, Source Plasma intended for manufacture into injectable 
products that is inadvertently exposed (i.e., an unforeseen occurrence 
in spite of compliance with good manufacturing practice) to a storage 
temperature warmer than -20 [deg]C and colder than +10 [deg]C may be 
issued only if labeled as ``Source Plasma Salvaged.'' The label shall be 
revised before issuance, and appropriate records shall be maintained 
identifying the units involved, describing their disposition, and 
explaining fully the conditions that caused the inadvertent temperature 
exposure.
    (2) Source Plasma intended for manufacture into injectable products 
that is exposed inadvertently (i.e., an unforeseen occurrence in spite 
of compliance with good manufacturing practice) to one episode of 
storage temperature fluctuation that is warmer than -20 [deg]C and 
colder than -5 [deg]C for not more than 72 hours is exempt from the 
labeling requirements of paragraph (a)(1) of this section, provided that 
the plasma has been and remains frozen solid. Appropriate records shall 
be maintained identifying the units involved, describing their 
disposition, explaining fully the conditions that caused the inadvertent 
temperature exposure, and documenting that the episode of temperature 
elevation did not exceed 72 hours, that the temperature did not rise to 
warmer than -5 [deg]C in storage, and that the plasma remained frozen 
solid throughout the period of elevated temperature. When requested, 
copies of the records shall be provided to the plasma derivative 
manufacturer.
    (b) Shipping temperature. If Source Plasma for manufacture into 
injectable products is exposed inadvertently (i.e., an unforeseen 
occurrence in spite of compliance with good manufacturing practice) to a 
shipping temperature warmer than -5 [deg]C and colder than +10 [deg]C, 
the plasma derivative manufacturer shall label it ``Source Plasma 
Salvaged.'' Appropriate records shall be maintained identifying the 
units involved, describing their disposition, and explaining fully the 
conditions that caused the inadvertent temperature exposure.
    (c) Relabeling. If Source Plasma is required to be relabeled as 
``Source Plasma Salvaged'' under paragraph (a)(1) or (b) of this 
section, the person responsible for the relabeling shall cover the 
original label with either (1) a complete new label containing the 
appropriate information or (2) a partial label affixed to the original 
label and containing the appropriate new information, which covers the 
incorrect information regarding storage temperature.

[45 FR 80501, Dec. 5, 1980, as amended at 50 FR 4140, Jan. 29, 1985]