Many view innovation and regulation as diametrically opposed, ., the more regulation we have, the less innovation. While I understand why this is the predominant view, it does not have to be so. I believe it is possible to have great innovation and at the same time decent regulation. The solution in my opinion, however, is not more regulation—that stifles innovation even further. The solution is to get people to think and ironically that’s much more difficult to do. Like in many aspects of life, it’s all about balance… something often easier said than done.
Under section 503B(b) of the FD&C Act, after the initial registration, a facility that elects to continue to be registered with FDA as an outsourcing facility must re-register annually. Beginning in fiscal year (FY) 2015 (October 1, 2014 to September 30, 2015), a facility that elects to register (or re-register) with FDA as an outsourcing facility must pay an annual establishment fee. The “date of most recent registration as an outsourcing facility” reflects the date FDA determined the most recently submitted registration information was complete and the annual establishment fee for that fiscal year paid in full.
Compounding pharmacies are subject to far less government oversight than pharmaceutical companies. They exist in a regulatory gray area between the federal . Food and Drug Administration (FDA) and 50 different state pharmacy boards. The FDA doesn’t provide much oversight for compounding pharmacies. The FDA is not required to inspect facilities, and the pharmacies do not need to prove their products are safe or effective before they can sell them across state lines. Compounding pharmacies must be licensed by state pharmacy boards, however, many experts say these boards do not have the resources or expertise to inspect or regulate thousands of compounding pharmacies.