Compounders Want Intervention to Put Brakes on Proposed MOU

The International Academy of Compounding Pharmacists is urging Congress to require the FDA to revise a memorandum of understanding outlining how states should regulate small compounders, saying the 30 percent a month limit on units sent to other states is unfair and unworkable.

The MOU, released in February, is meant to address interstate distribution of “inordinate quantities” of compounded medicine.

The 30 percent figure appears to be completely arbitrary, with the FDA not showing any studies or scientific basis to support it, IACP Executive Vice President and CEO David Miller said during a roundtable in Washington D.C. “We want to know where they got that number.”

The restriction is a particular concern for compounders that frequently do business with nearby states — for example, Virginia and Maryland or the New England states. No accommodations have been made for these pharmacies, despite long-standing state laws that provide for the licensure of out-of-state pharmacies, Miller said.

Miller also wants the FDA to clarify whether the term “unit” refers to an individual prescription, a case of a product or a single vial.

IACP is lobbying lawmakers to support a bill, S. 1406, that would resolve the interstate distribution concerns and a do away with a ban on office-use compounding — drugs compounded and transferred to a physician to administer to patients without a patient-specific prescription.

The FDA has told state boards of pharmacy that office-use is no longer authorized under the FD&C Act, even though many states permit the practice. This creates a catch-22 where compounders are okay under state law, but violate federal law, IACP says.

To read Senate Bill 1406, go to www.fdanews.com/06-09-15-S1406.pdf. The MOU is available at www.fdanews.com/02-17-15-MOU.pdf. — Kellen Owings