CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER F—BIOLOGICS (parts 600 to 680) > PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS > SUBPART H—Albumin (Human) (§640.80 to §640.84) > 640.83—General requirements.

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.

Code of Federal Regulations

[42 FR 27582, May 31, 1977]