Source: https://www.law.cornell.edu/cfr/text/21/640.76
Timestamp: 2016-10-27 07:20:46
Document Index: 425536301

Matched Legal Cases: ['art 640', '§ 640', '§ 553', '§ 702', '§ 703', '§ 704']

21 CFR 640.76 - Products stored or shipped at unacceptable temperatures. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter F › Part 640 › Subpart G › Section 640.76 21 CFR 640.76 - Products stored or shipped at unacceptable temperatures.
§ 640.76 Products stored or shipped at unacceptable temperatures.
(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 °C and colder than 10 °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.
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 °C and colder than 10 °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.
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] This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES§ 553 - Rule making§ 702 - Right of review§ 703 - Form and venue of proceeding§ 704 - Actions reviewable