§ Mr. Viantasked the Minister of Health why the Therapeutic Substances Regulations, 1931 (b), have been amended and the tests for determining conformity with the standards of strength, quality and purity of therapeutic substances will no longer apply to vaccine lymph; and why Regulation 15, which relates to the tests of sterility, is no longer to apply to vaccine lymph.
§ Mr. WillinkExperience has shown that the tests for the purity of vaccine lymph which were prescribed in the Regulations of 1931 resulted in the rejection of considerable quantities of safe material. The new Regulations accordingly prescribe a revised schedule of conditions for vaccine lymph, including a less stringent test for the presence of bacteria. A secondary effect of the revision is to remove the requirement that354W the prescribed tests shall be applied at the final stage of manufacture. Regulation 15, which required the application of tests for the presence of living bacteria, is in effect replaced by a provision in the Schedule specifying the maximum number of living bacteria which may be present.