Regulation Text
(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 .
Authority
21 U.S.C. 321,351,352,353,355,360,371;42 U.S.C. 216,262,263,263a,264.