By Amy Shank, PCCA Director of Government Relations

In June 2021, more than 70 registrants attended the annual PCCA ACT (action, commitment and time) Legislative Conference. The goal of the event is to empower compounding pharmacists to build relationships with their lawmakers in Washington, D.C., so that policymakers are more informed about pharmacy compounding. Those who are more informed are more likely to make patient-centered decisions. The conference was virtual since Congressional offices were not yet open to the public for large group meetings.

Lawmakers who are informed about compounding by their constituents — including PCCA members — tend to be the most supportive of patient access to compounded medications. Our hope is that these champions will engage the Food and Drug Administration (FDA) and others about barriers that could restrict or eliminate a pharmacist’s ability to lawfully compound a medication, despite a patient-specific prescription from a health care provider. What follows is a brief summary of the conference highlights.

PCCA’s 2021 ACT Legislative Conference by the Numbers

• 2 pharmacists serving in Congress addressed the conference:
  • Representatives Diana Harshbarger, R-TN, and Buddy Carter, R-GA, spoke about the need to educate lawmakers on issues impacting pharmacy compounding and patients
• 5 additional lawmakers delivered remarks:
  • Representatives Henry Cuellar, D-TX; Diana DeGette, D-CO; Morgan Griffith, R-VA; Dr. John Joyce, R-PA; and Markwayne Mullin, R-OK, also addressed ACT participants
• 110 congressional appointments were held between pharmacists and lawmakers
  • These meetings were supported by PCCA team members, along with support from our trade associations the Alliance for Pharmacy Compounding and the National Community Pharmacists Association

What Pharmacists Asked of Their Legislators

• Preserve patients’ access to compounded hormones
• Sign a Congressional letter to the FDA — led by Reps. Henry Cuellar, D-TX, and Neal Dunn, MD, R-FL — asking the FDA to delay enforcement of the memorandum of understanding (MOU) to allow more time for states to review the policy
• Cosponsor legislation that would allow access to compounds needed for urgent medical situations and during drug shortages (H.R. 3662)
• Ask the FDA to withdraw their animal compounding guidance and work with compounding pharmacy stakeholders on a revised proposal
• Call for the FDA to allow all ingredients with United States Pharmacopeia and National Formulary monographs — including dietary supplement monographs — to be lawfully compounded
• Send a letter to the Centers for Medicare and Medicaid Services asking for Medicare patients to have access to compounded medications by reimbursing them for compounds made from active pharmaceutical ingredients

We encourage compounding pharmacists, prescribers and patients to stay informed on the issues that could affect the ability to prescribe, compound medication or take a compounded medication. If PCCA members have questions or requests for additional information, they can contact our Public Affairs team at publicaffairs@pccarx.com.

Also on The PCCA Blog: What the FDA’s Final MOU Means for Your Practice

Amy Shank, PCCA’s Director of Government Relations, previously served as Vice President of Capitol Hill Consulting Group, where she advised pharmacy, pharmaceutical and university clients on federal legislative priorities. Amy also has over 10 years of experience in the United States Senate. She was the Director of Oversight and Investigations for the Senate Health, Education, Labor and Pensions Committee. She was also a senior policy advisor to the Senate HELP Committee. Amy was a senior analyst for the Chairman of the Senate Budget Committee, former Senator Don Nickles, R-OK, and began her legislative career in his Republican Whip office as a policy advisor.