[Ed Groleau]

Reply To: Update of labels and Health Authority grace period

For edits to information on existing labels that do not impact patient safety I have informed the agency that the change will be made on future supplies but the existing material will be used as it is labeled with no change being made. This was not done as a question to the agency but as a notification of the plan to correct the issue and I have never had it rejected. If you think it is important for the information change to be know you can provide a supplemental means of communication such as a document given to the patient by the site rather than actually modifying the labeled material. Risking a disruption to the patient’s drug supply has a much worse than having an incorrect sponsor address listed.