As appropriators question FDA's inspection of traditional compounders . . .

IACP: FDA's Interpretation Of Compounding Statute Does Not Make Sense

April 25, 2016 at 3:23 PM
The International Academy of Compounding Pharmacists says FDA's draft guidance that bans office-use compounding by traditional pharmacies while carving out a small exception for some hospital-owned pharmacies makes no sense and might clash with congressional intent, coming as Republican Rep. Buddy Carter (GA) tells Inside Health Policy the agency's stance that only outsourcing facilities may compound for office stock is a “direct attack” on small community pharmacies. Likewise, House appropriators are urging FDA to issue final guidance allowing office-use compounding...


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