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[A2]
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Electronic Code of Federal Regulations
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e-CFR data is current as of December 10, 2019
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Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart H—Albumin (Human)
§640.83 General requirements.(a) Preservative. The final product shall not contain a preservative. (b) Storage of bulk solution. After all processing steps have been completed, the sterile bulk solution shall be stored in a manner that will ensure the continued sterility of the product, and at a temperature that shall not exceed the recommended storage temperature of the final product prescribed in §610.53 of this chapter.
[42 FR 27582, May 31, 1977]
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