Food and Drug Regulations

C.01.433 No person shall sell chloramphenicol and its salts and derivatives, for oral or parenteral use, unless

• (a) the inner label carries a warning statement to the effect that

  • (i) bone marrow depression has been associated with the use of chloramphenicol, and

  • (ii) the enclosed warnings and precautions should be read carefully; and

• (b) the outer label or the package insert carries the following:

  • (i) a warning statement to the effect that chloramphenicol should not be used in the treatment or prophylaxis of minor infections or where it is not indicated, as in cold, influenza, or infections of the upper respiratory tract; that there are two types of bone marrow depression associated with the use of chloramphenicol; that some degree of depression of the bone marrow is commonly seen during therapy, is dose-related and is potentially reversible; that blood studies may detect early changes and; that the other type of bone marrow depression, a sudden, delayed and usually fatal bone marrow hypoplasia that may occur without warning, is very rare, and

  • (ii) a statement of precautions to be taken to the effect that it is essential that appropriate blood studies be made during treatment with chloramphenicol and that while blood studies may detect early peripheral blood changes, such studies cannot be relied on to detect the rare and generally irreversible bone marrow depression prior to development of aplastic anemia.