21 CFR 640.93 - 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.
Title 21 published on 2015-12-03.
No entries appear in the Federal Register after this date, for 21 CFR Part 640.