Tuesday, March 26, 2013
Posted: Mar. 25, 2013
The International Academy of Compounding Pharmacists told the Senate health committee last week that expanding
FDA's authority to a new regulatory category would be “premature” and that an agency proposal to determine which
facilities would fall into this new area should be employed to draw a line between compounding and manufacturing.
FDA has privately floated to lawmakers a three-prong test involving whether the product is a sterile preparation, shipped
interstate and compounded prior to a prescription, according to a letter IACP sent to the committee and obtained by
Inside Health Policy.
IACP says it “strongly opposes” using undefined terms such as traditional and non-traditional compounding, reflecting
on a proposal FDA publicly outlined to lawmakers last year during congressional hearings. FDA has since developed a
test determining which facilities would fall into such a category, but IACP said such a test would be better employed to
draw a line between manufacturing and compounding, while also suggesting improvements to the test itself.
To continue reading subscription required at HeathPolicyNewstand