Electronic Code of Federal Regulations
We invite you to try out our new beta eCFR site at
https://ecfr.federalregister.gov. We???ve made big
changes to make the eCFR easier to use. Be sure to leave feedback using the Help button on the bottom
right of each page!
|
e-CFR data is current as of August 6, 2020 |
Title 21 → Chapter I → Subchapter F → Part 640 → Subpart H → §640.83 |
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]