21 C.F.R. § 640.83 General requirements.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart H—Albumin (Human)
§ 640.83 General requirements.