StacksVerified U.S. regulatory reference

21 CFR §640.83

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Preservative. The final product shall not contain a preservative.
  2. (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.