Bill seeks to clarify compounding provisions

Thursday, June 15, 2017

ALEXANDRIA, Va. – Reps. Morgan Griffith, R-Va., and Henry Cuellar, D-Texas, have introduced a bill in the House of Representatives that would clarify congressional intent on several compounding provisions included in the Drug Quality and Security Act of 2013. Since the passage of DQSA, there has been a lack of understanding as to where federal regulatory oversight of traditional compounding pharmacies begins and ends, according to the National Home Infusion Association. Specifically, there are questions regarding the dispensing of compounded products across state lines, inspection standards, and several other DQSA provisions, the association says. In explaining the need for the bill, the NHIA stated in a press release: “It is important for home and specialty infusion providers to have clarification on application of a provision in the DQSA that calls for a Memorandum of Understanding (MOU) between the U.S. Food and Drug Administration (FDA) and states, specifically regarding the distribution of compounded products across state lines. NHIA has long maintained that dispensing a compounded product to an individual patient pursuant to a prescription is not commonly considered distribution of the product under state or federal law. The FDA, in its draft MOU released in 2015, included dispensing as an act of distribution and imposed strict limits that could negatively affect access to medications for a patient whose provider is based in another state. This would have serious implications, since the common business practice of dispensing medications for administration in a patient’s home can occur across a state line from the physical site where the drug is compounded.”