21 CFR 640.93 - General requirements.
(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 2014-04-01
no entries appear in the Federal Register after this date.