Food and Drug Regulations

C.04.238 A fabricator, packager/labeller or distributor referred to in paragraph C.01A.003(b) may issue human serum or human plasma, or fractions of either of them, for prophylactic or therapeutic use in any of the following forms:

• (a) immune human serum, which shall be serum separated from the blood of persons recovered from the disease or from persons specifically immunized against the disease for which the serum is intended as a prophylactic or therapeutic agent;

• (b) immune human globulins, or other immune human serum fractions, which shall be prepared from immune human serum or plasma;

• (c) normal human serum, or normal human plasma, or fractions of either of these prepared from the blood of normal individuals; and

• (d) dried products prepared from any of these.