Reps. Green, Griffith, and DeGette Introduce Bipartisan Compounding Clarity Act
Washington, DC – Congressman Gene Green (D-TX), Congressman Morgan Griffith (R-VA), and Congresswoman Diana DeGette (D-CO) today introduced the Compounding Clarity Act (H.R. 3089), bipartisan legislation that would clarify Food and Drug Administration (FDA) authority over compounding, particularly large-scale entities like the New England Compounding Center (NECC) that act as drug manufacturers. Nationwide, there were 64 deaths and 750 confirmed cases of fungal meningitis resulting from tainted steroid injections.
Congressman Green said, “For the last several weeks, a bipartisan and bicameral group of lawmakers have been meeting to make sure we never relive the tragedy of the 2012 fungal meningitis outbreak that originated in a compounding pharmacy in Massachusetts. Congressman Griffith and Congresswoman DeGette have been exceptional leaders on addressing this public health threat and I believe this bill is a good step in that direction. These discussions have been productive and are ongoing, and by dropping this bill we are keeping the pressure on House leadership and maintaining the momentum we have built.”
Congressman Griffith said, “As we approach the anniversary of the fungal meningitis outbreak that devastated so many families across the nation including Southwest Virginia, it is vital for Congress to take action to prevent another public health crisis. Since the outbreak, I have been working hand-in-hand with my friends across the aisle on a legislative solution that we are proud to be introducing today. This bipartisan proposal would prevent another NECC-type outbreak from occurring and ensuring the quality and safety of all compounded drugs in the country. The Compounding Clarity Act also requires the FDA to better communicate with state boards of pharmacy, and safeguards our local community pharmacies who were not at fault in last year’s outbreak from burdensome federal regulations. I am grateful to Congressman Green and Congresswoman DeGette for their partnership and dedication, and look forward to our continued work on this issue.”
Congresswoman DeGette said, “Almost a year has passed since a deadly fungal meningitis outbreak sickened hundreds across the United States. This rare incident was traced to contaminated steroid injections produced by a so-called compounding pharmacy. The outbreak, and subsequent troubling incidents, highlight the need for a stronger and more effective regulatory framework to oversee the compounding pharmacy system. That is why today I am pleased to join with my friends and colleagues Congressmen Griffith and Green to introduce the Compounding Clarity Act, a critical step in working to prevent these types of deadly outbreaks in the future. This bill represents a bi-partisan effort to develop a more robust regulatory framework that can save people’s lives and I look forward to working together to see it become law.”
According to FDA Commissioner Margaret Hamburg, the FDA’s ability to take action against large-scale entities that exceed the bounds of traditional pharmacy compounding and pose risks to patients has been hampered by ambiguities in the Food, Drug and Cosmetic Act (FDCA). While claiming they were exempt from FDA oversight, NECC had long ago ceased operating as a traditional compounding pharmacy and were clearly engaged in illegal drug manufacturing.
To clarify FDA’s authority, the Compounding Clarity Act replaces section 503A of the FDCA with a new regulatory framework for traditional compounding pharmacies. The legislation removes the constitutional concerns about advertising that were raised in court cases that created ambiguities that the agency had cited.
The Compounding Clarity Act protects traditional pharmacies by clarifying FDA's role in regulating compounding. Under the legislation, traditional pharmacies will continue to remain under the jurisdiction of state boards of pharmacy and remain exempt from FDA’s manufacturing authority. The bill protects access to the customized, compounded medications that patients need. Chiefly, all compounding must be done pursuant to a patient-specific prescription, while allowing for anticipatory compounding based on a preexisting relationship with a patient or doctor. Recognizing a need for uniform quality, the legislation also establishes an enforceable safety standard for all compounded drugs.
The legislation also maintains the important practice of office use where drugs can be dispensed to hospitals, doctors’ offices, and other healthcare settings to administer before an identified patient is known. However, once these compounded drugs are administered to a patient, a prescription or patient name must be reconciled back to the pharmacy within 7 days. The legislation also draws a volume limitation on the practice that both protects public health, while maintaining patient access to these drugs, especially in border regions.
Given the concerns that FDA received numerous complaints from state boards about NECC and failed to act on them or alert other concerned state boards, the Compounding Clarity Act requires the timely implementation of a notification system to allow for meaningful communication with the state boards of pharmacy; submissions of concerns relating to the products and practices of compounding pharmacies; and facilitation of appropriate inspections and/or enforcement actions from the FDA.
Finally, the legislation clarifies FDA’s authority over the large-scale compounding entities, or outsourcing facilities, by outlining new federal requirements. Outsourcing facilities are compounding entities that exceed the legislation’s volume limitations and would now be subject to annual registration; reporting and listing of the drugs they compound; labeling; adverse event reporting; inspections and user fees.
Text of the Compounding Clarity Act is below.