{"database": "press", "table": "releases", "rows": [["http://morgangriffith.house.gov/news/documentsingle.aspx?DocumentID=349397", "Griffith, Green, DeGette Introduce Bipartisan Compounding Clarity Act", "2013-09-12", "2013", "2013-09", "Republican", "House", "VA", "Morgan Griffith", "G000568", "morgangriffith.house.gov", null, null, "legacy", "Congressman Morgan Griffith (R-VA), Congressman Gene Green (D-TX), 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.\u00a0 Nationwide, there were 64 deaths and 750 confirmed cases of fungal meningitis resulting from tainted steroid injections.\r\nGriffith said, \u201cAs 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.\u00a0 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.\u00a0 This bipartisan proposal would prevent another NECC-type outbreak from occurring and ensuring the quality and safety of all compounded drugs in the country.\u00a0 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\u2019s outbreak from burdensome federal regulations.\u00a0 I am grateful to Congressman Green and Congresswoman DeGette for their partnership and dedication, and look forward to our continued work on this issue.\u201d\r\nGreen said, \u201cFor 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.\u00a0 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.\u00a0 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.\u201d\r\nDeGette said, \u201cAlmost a year has passed since a deadly fungal meningitis outbreak sickened hundreds across the United States. \u00a0This rare incident was traced to contaminated steroid injections produced by\u00a0a so-called compounding pharmacy. \u00a0The outbreak, and subsequent troubling incidents, highlight the need for a stronger and more effective regulatory framework to oversee the compounding pharmacy system. \u00a0That 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.\u00a0 This bill represents a bi-partisan effort to develop a more robust regulatory framework that can save people\u2019s lives and I look forward to working together to see it become law.\u201d\r\nBACKGROUND:\r\nAccording to FDA Commissioner Margaret Hamburg, the FDA\u2019s 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).\u00a0 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. \r\nTo clarify FDA\u2019s authority, the Compounding Clarity Act replaces section 503A of the FDCA with a new regulatory framework for traditional compounding pharmacies.\u00a0 The legislation removes the constitutional concerns about advertising that were raised in court cases that created ambiguities that the agency had cited.\r\nThe Compounding Clarity Act protects traditional pharmacies by clarifying FDA's role in regulating compounding. \u00a0Under the legislation, traditional pharmacies will continue to remain under the jurisdiction of state boards of pharmacy and remain exempt from FDA\u2019s manufacturing authority. \u00a0The bill protects access to the customized, compounded medications that patients need.\u00a0 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. \u00a0Recognizing a need for uniform quality, the legislation also establishes an enforceable safety standard for all compounded drugs.\r\nThe legislation also maintains the important practice of office use where drugs can be dispensed to hospitals, doctors\u2019 offices, and other healthcare settings to administer before an identified patient is known. \u00a0However, once these compounded drugs are administered to a patient, a prescription or patient name must be reconciled back to the pharmacy within 7 days. \u00a0The 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.\r\nGiven 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.\r\nFinally, the legislation clarifies FDA\u2019s authority over the large-scale compounding entities, or outsourcing facilities, by outlining new federal requirements. \u00a0Outsourcing facilities are compounding entities that exceed the legislation\u2019s 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.\r\nText of the Compounding Clarity Act is attached.\r\n###", 1, "2026-03-30T12:14:52Z", "2026-03-30T12:14:52Z"]], "columns": ["url", "title", "date", "year", "month", "party", "chamber", "state", "member_name", "bioguide_id", "domain", "scraper", "source", "date_source", "text", "has_text", "collected_at", "updated_at"], "primary_keys": ["url"], "primary_key_values": ["http://morgangriffith.house.gov/news/documentsingle.aspx?DocumentID=349397"], "units": {}, "query_ms": 1.9662869162857533, "source": "dwillis/congress-press", "source_url": "https://github.com/dwillis/congress-press", "license": "MIT", "license_url": 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