A milk bank must maintain detailed standard operating procedures that are available to all staff. Standard operating procedures must be updated every two years. Standard operating procedures must include, at a minimum, procedures addressing the following:

(1) Donor screening and serological testing;

(2) Pasteurization or thermal processing;

(3) Microbiological testing;

(4) Receiving, storage, and transport of donor milk;

(5) Sanitation and cGMPs;

(6) Emergency preparedness;

(7) Recall.