Compounders, Lawmakers To Press FDA To Leave Office Use To States

An international group of compounders is working with lawmakers to draft a new letter asking FDA to rescind guidance requiring a patient-specific prescription for each drug compounded under 503A, and to return to states control over office-use compounding, saying the agency's prohibition on such compounding runs against congressional intent. The call to rescind the guidance comes as President Donald Trump orders agency heads to improve efficiency by shifting functions to state or local governments. John Voliva, executive vice president of...