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]