§ 640.83 General requirements.
Current through Sep 8, 2026 · Read all of Part 640
(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]