New Draft of House Compounding Bill Released; Coalition of Drug Companies and Patient Groups Seeks Stricter Office-Use Oversight in Senate Version

This week, Representatives Morgan Griffith (R-VA), Diana DeGette (D-CO), and Gene Green, (D-TX) released anew draft of the Compounding Clarity Act, a House bill aimed at improving the safety of compounded drugs. The bill includes a provision allowing for office use of compounded drugs and requires compounded drugs used in an office to be matched with patient prescriptions within seven days. The bill would also limit compounding pharmacies to producing no more than five percent of their overall volume of drugs for office use if they are being shipped interstate. Intrastate orders are not affected by volume limits in this legislation. A previous draft of the bill would have allowed for office use, but did not provide a specific volume limit.

A similar bill introduced in the Senate, S. 959, the Pharmaceutical Quality, Security, and Accountability Act, unanimously passed the Senate Health, Education, Labor and Pensions (HELP) Committee earlier this year. Rep. Griffith noted when the House version was released that he and other co-sponsors are working with Senate HELP Committee members to address differences in the two versions, such as differing volume limits. Senate sponsors also indicated that the talks were progressing and that they hoped to have the differences resolved soon. 

As we have reported, ASCRS and the ophthalmic community have been actively involved in the development of legislation to ensure the safety and sterility of compounded drugs and have pushed for an exemption in the Senate legislation to allow physicians to stock compounded drugs for office use without specific patient prescriptions for urgent and emergent cases. The latest version of the Senate bill would allow providers to stock biologics and sterile products for office use without a patient-specific prescription, but imposes a volume limit, which is included in many current state laws. Compounding for office use would be limited to 10 percent of the total drugs dispensed in a 30-day period, and pharmacies would have 14 days to match these drugs with a patient who receives them. Senate sponsors of the legislation have committed to address our concerns regarding the continued availability of drugs made from bulk substances as the bill moves through the process.

Earlier this week, The Working Group on Pharmaceutical Safety—a coalition comprised of drug companies and patient advocacy organizations formed to improve the safety of compounded drugs—announced that it is seeking to tighten limits on office use in the current version of Senate legislation, S. 959. The group recommends further limiting the volume to five percent of a pharmacy’s dispensed drugs annually.

ASCRS and our coalition partners will work to maintain provisions that allow for office use in both versions of the bills to ensure providers have access to the drugs they need to care for patients. We will continue to keep you updated as the bill moves through the process.