Posted July 16, 2014
There are two FDA documents open for comments that greatly need your input.
- The terms of the request for nominations for bulk substances that may be used to compound drug products for outsourcing facilities are entirely too broad, and will greatly diminish patients’ access to important medications.
- As for the list of compounded drugs that are deemed unsafe or ineffective, the FDA should not have sole authority to add ingredients to a “do not compound” list, and all additions to the list should go through an advisory committee that is open to public comment.