Food and Drug Regulations

C.04.654 The packager/labeller of an insulin preparation may, in lieu of printing adequate directions for its use on both the inner and outer labels thereof as required by subparagraph C.04.019(a)(vii), print the descriptions for use in a descriptive circular prepared in accordance with section C.04.655, but in such case he shall

• (a) enclose a copy of the circular in the package containing the preparation; and

• (b) state on the outer label of the package that such a circular is enclosed therein.