Sunday, December 7, 2014

Second Question of the Day December 7, 2014 Should DOJ/FDA start prosecuting those compounders who don't register as outsourcing facilities but that are not traditional compounders either because of amount produced, lack of patient-specific (individual not mass produced) drugs, replicas of commercially availables, etc. are manufacturing unapproved drugs in violation of the law? Would prosecution stop these mass producers? Why or why not? If prosecution is not the answer, then what is? What do compounders say to manufactuers of FDA approved drugs who contend they follow the rules to bring new drugs to market but that compounders do not, and thus if compounders can produce new unapproved drugs manufacturers should be allowed to do so also? Why does one group have to follow the rules and laws but the other does not?


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