Bare ActsThe drugs and cosmetics act, 1940

Section 108

Container

Amendment status not verified — confirm the current text below against the official source.

Container.—5[(1) No substance specified in Schedule C shall be sold or offered for sale unless it has been sealed in a previously sterilized container made of glass or any other suitable material approved for the purpose by the Licensing Authority appointed under rule 21, in such manner as may, in the opinion of the Licensing Authority, suffice to preclude the access of bacteria: Provided that it shall not be necessary to use a previously sterilized container if the filled and sealed container is to be sterilized after the sealing and such sterilizing procedure would render the product sterile. However, the Licensing Authority may, for any special reasons, direct the licensee to pre-sterile such containers.] (2) When any such substance is issued in liquid form in containers which are sealed in such a manner that portions of the contents can be withdrawn for use on different occasions, the liquid shall contain a sufficient proportion of some antiseptic to prevent the growth of any organism which may be accidentally introduced in the process of removing a portion of the contents of the container: 6[Provided that nothing in this sub-rule shall apply to a penicillin suspension in oil and wax.]

Section 108 – The drugs and cosmetics act, 1940 | DailyLaw.ai