In June 21 comments on Rep. Morgan Griffith’s (R-VA) compounding discussion draft, APhA recommended modifications in the draft pertaining to radiopharmaceuticals, an advisory committee on compounding, more clarity on state oversight, and more resources for inspections.
Griffith has taken the lead on drafting compounding legislation for the House Energy & Commerce Subcommittee on Health. He requested an updated comment letter from the Association. APhA is working with Griffith’s office as the legislative process moves forward.
“There needs to be clear delineation with respect to state and FDA authorities and requirements regarding compounding and inspection authorities,” APhA wrote in the letter on the topic of state oversight. “While we agree FDA should have inspection authority if a pharmacy crosses the line into manufacturing, this line should be drawn in advance to avoid surprises.”
APhA supported provisions in the draft proposal related to increased communication and coordination by FDA with state boards of pharmacy but recommended increased communication from, and between, states as well.