Tablet Splitting on FDA’s Agenda; It’s Not a Trivial Issue, and May Leave Drugmakers Vulnerable, says Expert Fred Rowley

Just found yet another interesting web log (with an imaginative name), "Regulatory Affairs of the Heart," which brought news of an upcoming FDA meeting to discuss the regulatory issues entailed by patients splitting their tablets to cut costs. Many of the lines or  "bisects" etched across many tablets no longer have any function.  If patients split the pill along the line,  in some cases, they won't receive the proper dose, which could potential liability and patient safety issues for makers of the drug.  Tableting expert Fred Rowley wrote recently for us with advice on how to determine whether or not your bisect is functional and some best practices.  Read Part 1 and Part 2 of this article here .