Tuesday, February 21, 2017
Question of the Day February 21, 2017 What are the downsides to less regulations or guidance from federal agencies as far as businesses impacted by those regulations are concerned? Does less regulations mean what is left is only the statute passed by Congress which can then be enforced in the strictest manner by agencies and if that enforcement is upheld by the courts then business may end up on the losing side? Why or why not?
Is one example, the percentage rule relating to compounding and the MOU between states? Under section 503A, only 5 percent of the drugs produced by a traditional pharmacy can be sold outside of the state where the pharmacy is registered unless a state signs the MOU. Without regulations or guidance on this important issue, then the statutory language passed by Congress of 5 percent might apply across the board? Should President Trump have made an exception for regulations relating to public safety much like he did on the hiring freeze of federal workers? Why or why not? Will it be easier on federal agencies such as the FDA if there are less regulations? Why or why not?