As I read the FDA explanatory memo & regs, unless the method of proposed administration would necessarily require a device or procedure which was prohibited, or itself subject to a prior approval process, it's a matter for the attending physician (& his/ her personal indemnity insurance policy & practise constraints).
So, no I don't think either IV or direct injection would be an unavailable method of administration for a physician that wanted to go 'off-label', with all that implies.
Not advice, of course.
Ann: Ulcerative Colitis & Crohns Results Presented at ECCO, page-120
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