As well, this initiative was posted on the Therapeutic Products Directorate Electronic Bulletin Board. A notice of this regulatory proposal was published in Canada Gazette, Part I on October 11, 1997. In addition, direct notification of this proposal, with a copy of the draft labelling standard, was provided to pharmaceutical industry associations and all manufacturers of sodium cromoglicate. Affected manufacturers were advised to amend their product labelling in order to comply with the new requirements. This amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and Food and Drug Regulations, enforced by Therapeutic Products Programme inspectors.
Indirect enforcement is provided through complaints from the medical profession and competitors.
Inspection mechanisms at the federal level will be maintained.