114.11—Storage and handling.

Biological products at licensed establishments shall be protected at all times against improper storage and handling. Completed product shall be kept under refrigeration at 35 °to 45 °F. (2 °to 7 °C.) unless the inherent nature of the product makes storage at a different temperature advisable, in which case, the proper storage temperature shall be specified in the filed Outline of Production. All biological products to be shipped or delivered shall be securely packed.