Monday, May 18, 2015

Question of the Day May 18, 2015 From a legal standpoint of trying to advise clients whether their actions will violate the law, guidance that says something is not permit and an agency "generally does not intend to take action" is very troublesome? Wouldn't clearly drawn lines in the sand be much better from a litigation standpoint i.e., that is x is legal; y is illegal? Why or why not in animal drug compounding?

 Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes that there are limited circumstances when an animal drug compounded from bulk drug substances may be an appropriate treatment option.   FDA’s GFI #230 outlines specific conditions under which the agency generally does not intend to take action against state-licensed pharmacies, veterinarians, and facilities registered as outsourcing facilities when drugs are compounded for animals from bulk drug substances. 
Quoted from here