The use of propranolol (Schedule 3) for performance and test…
The use of propranolol (Schedule 3) for performance and test anxiety is a common but off-label practice that addresses the physical symptoms of stress, such as a racing heart and shaking.Your marketing product manager has identified a need for short-term, situational events and has requested that you apply for the down scheduling of propranolol from Schedule 3 to Schedule 2 to formalise the off-label use.A new proprietary name and a new limited pack size for the typical dose of 10 to 40 mg to be taken 30 to 60 minutes before the event, would make the short term use possible. Provide an outline of ‘table of contents’ i.e. the relevant headings of the body of the application that would be required, and the requirements for the summary of the application.Justify your answer by providing the relevant reference(s) that address the form, headings and requirements for such an application.