{"database": "press", "table": "releases", "rows": [["https://www.burr.senate.gov/public/index.cfm?FuseAction=PressOffice.PressReleases&Type=Press Release&ContentRecord_id=6cbec278-a65f-bee7-0b68-cb62b47c37bc", "Senate Health Policy Leaders Hail Passage of Bipartisan Legislation to Improve Safety of Compounded Drugs, Track All Prescription Drugs; Bill Now Heads to the President's Desk", "2013-11-18", "2013", "2013-11", "Republican", "House", "NC", "Richard Burr", "B001135", "www.burr.senate.gov", null, null, "legacy", "11.18.13\n\t\t\t Senate Health Policy Leaders Hail Passage of Bipartisan Legislation to Improve Safety of Compounded Drugs, Track All Prescription Drugs; Bill Now Heads to the President\u2019s Desk \n\t\t\t\n\t\t\t\t\n\t\n\t\n\t\n\t\n\t \n\t\t\n\t\n\t\t\t\n\t\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n        \n\t\t\t\t Bipartisan, Bicameral Drug Quality and Security Act Endorsed by Community Pharmacists, State Health Officials, and Dozens of Other Stakeholder Groups\n\t\t\t\n\t\t\t \r\nSenate\r\nHealth, Education, Labor, and Pensions (HELP) Committee Chairman Tom Harkin\r\n(D-IA), Ranking Member Lamar Alexander (R-TN), and HELP Committee members\r\nSenator Al Franken (D-MN), Senator Pat Roberts (R-KS), Senator Michael Bennet\r\n(D-CO), and Senator Richard Burr (R-NC) today hailed Senate passage of\r\nlegislation to help ensure the safety of compounded drugs and to track all\r\nprescription drugs from the time they are manufactured to the moment they are\r\npicked up at the drugstore. The Drug Quality and Security Act\r\nreflects a bipartisan, bicameral effort to address these drug safety and\r\nsecurity issues. It is aimed at helping prevent a future public health\r\ncrisis like the 2012 meningitis outbreak tied to the New England Compounding\r\nCenter and securing the pharmaceutical supply chain. The bill has now cleared\r\nboth houses of Congress and will go on to the President to be signed into law.\r\n\r\n\r\n\"Just\r\nover one year ago, a widespread fungal meningitis outbreak brought attention to\r\nthe legal and regulatory gaps that allowed owners and managers at the New\r\nEngland Compounding Center to disregard basic procedures to ensure that the\r\nproducts they were manufacturing were sterile. This gross negligence had\r\nheartbreaking consequences for families nationwide,\" Harkin said. \"And\r\nthe contamination at the NECC was not an isolated incident: over the last\r\ndecade, patients have suffered a range of grievous\u2014even fatal\u2014infections as a\r\nresult of compounded drugs that were contaminated or improperly formulated.\"\r\n\r\n\r\n\"This bipartisan bill represents a monumental step forward\r\nfor drug safety and is a testament to what Congress can achieve when Democrats\r\nand Republicans work together,\" Harkin continued. \"This legislation will\r\nimprove the safety of compounded drugs as well as establish an unprecedented\r\ntracing system that will, for the first time ever, track prescription drugs\r\nfrom manufacturing to distribution, thereby thwarting drug counterfeiters.\r\nAmericans must have the confidence that their drugs\u2014 whether obtained at a\r\nhospital, at a doctor's office, or at the pharmacy counter\u2014are safe, and that\r\nis exactly what this bill does.\" Alexander said: \"We have worked for a year to find a solution that would\r\nhelp prevent a repeat of the tragic meningitis outbreak that has killed 16\r\nTennesseans and made so many others so sick. Those Tennesseans deserve this\r\nbill, which will make it clear exactly who is in charge of overseeing each\r\ncompounding facility, so there will be no questions about who's on the\r\nflagpole.\r\n\r\n\r\n\"Patients\r\nin Minnesota and around the country should be able to trust that the\r\nmedications they are taking are safe, but we've seen that hasn't always\r\nhappened. But I'm pleased that with the passage of this bipartisan legislation,\r\nwe've taken an important step forward in helping give patients a little more\r\npeace of mind about their prescriptions,\" Franken said. \"While we still\r\nhave more work to do, the passage of this legislation marks real progress in\r\npreventing another outbreak like the one that happened last year.\" \r\n\r\n\r\nRoberts\r\nadded, \"I became involved in this issue after a Kansas City pharmacist\r\nrisked thousands of patient lives with illegal practices. After the deadly\r\nmeningitis outbreak caused by contaminated medication, a bipartisan, bicameral\r\ngroup of lawmakers came together with industry stakeholders and made a\r\nconcerted effort to prevent tragedies like these from ever occurring again.\r\nThis legislation protects traditional pharmacies, while giving patients more\r\nconfidence in the quality and safety of their compounded drugs.\"\r\n\r\n\r\n\"After\r\nyears of bipartisan work in Congress and feedback from business and\r\nstakeholders, we're glad that this bill has passed and is on its way to the\r\nPresident's desk for his signature,\" Bennet said. \"We know more from a\r\nbarcode on a gallon of milk than on a bottle of prescription drugs, which could\r\nmean the difference between life and death. Whether it is through a stronger\r\ndrug supply chain that strengthens our national security or better oversight\r\nfor compounded drugs, this commonsense bill will help restore confidence in our\r\nprescription drugs and protect our families from any potential health risks.\" \r\n\r\n\r\nBurr\r\nsaid: \"After years of hard work, I am very proud to see this bill sent to\r\nthe President to be signed into law. This bipartisan bill reflects a\r\ncollaborative effort to produce balanced legislation that appropriately\r\nresponds to the tragic meningitis outbreak over the past year and proactively\r\nputs in place uniform, workable standards that will provide stakeholders with\r\ncritical regulatory certainty and give patients renewed confidence in the\r\nsafety and security of our nation's pharmaceutical drug supply chain. I\r\nwant to thank my colleagues on both sides of the aisle for their hard work and\r\nsteadfast commitment to seeing this process through to the end.\"\r\n\r\n\r\nA\r\nbroad range of stakeholders, including the American Society of Health-System\r\nPharmacists, the Pew Charitable Trusts, the U.S. Chamber of Commerce, the\r\nNational Community Pharmacists Association, the Federation of American\r\nHospitals, Premier Healthcare Alliance, the American Medical Student\r\nAssociation, the American Public Health Association, the Annie Appleseed\r\nFoundation, the Association of State and Territorial Health Officials, the\r\nCenter for Science and Democracy, the Union of Concerned Scientists, the Center\r\nfor Medical Consumers, Community Catalyst, the Connecticut Center for Patient\r\nSafety, the National Association of County and City Health Officials, the\r\nOvarian Cancer National Alliance, Trust for America's Health, the Healthcare\r\nDistribution Management Association, the Pharmaceutical Distribution Security\r\nAlliance, the Generic Pharmaceutical Association, the Pharmaceutical Research\r\nand Manufacturers of America, PharMEDium, the Biotechnology Industry\r\nOrganization, the National Association of Chain Drug Stores, Pfizer, UPS, and\r\nRichie's Specialty Pharmacy endorsed the Drug Quality and Security Act.\r\nExcerpts from their endorsements can be seen\r\nhere. \r\n\r\n\r\nA\r\nsummary of the bill follows. Title I\r\n\r\n\r\nOne\r\nyear ago, the meningitis outbreak tied to contaminated compounded drugs from\r\nthe New England Compounding Center alerted the nation that providers and\r\npatients need sources of safe compounded drugs. Following the outbreak, a\r\nbipartisan group of HELP Committee Senators\u2014 led by Chairman Harkin, Ranking\r\nMember Alexander, Sen. Franken, and Sen. Roberts\u2014developed legislation to help\r\nensure that quality compounded drugs are available to patients and providers\r\nwho need them.\r\n\r\n\r\nAmong\r\nother highlights, the legislation:\r\n\r\n \r\n\tDistinguishes compounders engaged in traditional\r\n\tpharmacy practice from those making large volumes of compounded drugs\r\n\twithout individual prescriptions. Compounders who wish to practice outside\r\n\tthe scope of traditional pharmacy practice can register as outsourcing\r\n\tfacilities, but those who choose to remain traditional pharmacies will\r\n\tcontinue to be primarily regulated by State Boards of Pharmacy as they are\r\n\tin current law.\r\n\tDefines the Food and Drug Administration's (FDA's) role\r\n\tin oversight of outsourcing facilities. Outsourcing facilities would\r\n\tbe subject to FDA oversight in much the same way as traditional\r\n\tmanufacturers. FDA will know who these outsourcers are and what they\r\n\tare making, receive adverse event reports about compounded drugs, and have\r\n\tthe authority and resources to conduct risk-based inspections. The\r\n\tlegislation will give providers and patients the option of purchasing\r\n\tproducts from outsourcing facilities that comply with FDA quality standards.\r\n\tOffers providers and patients better information about\r\n\tcompounded drugs. The legislation directs FDA to make a list of\r\n\tFDA-regulated outsourcing facilities available on FDA's website, requires\r\n\tdetailed labeling on compounded drugs, and prohibits false and misleading\r\n\tadvertising.\r\n\tClarifies current federal law regarding pharmacy\r\n\tcompounding. The legislation strikes unconstitutional provisions in\r\n\tcurrent law, resolving the patchwork of current federal regulation and\r\n\tapplying a uniform standard nationwide.\r\n \r\n\r\nTitle\r\nII\r\n\r\n\r\nChairman\r\nHarkin, Ranking Member Alexander, Sen. Bennet, and Sen. Burr have developed\r\ntrack and trace legislation that improves patient safety by replacing today's\r\npatchwork of state product tracing laws with a strong, uniform standard that\r\nwould ultimately result in electronic, interoperable unit level product tracing\r\nfor the entire country. The last comprehensive effort to establish\r\nsafeguards for the drug distribution supply chain was twenty-five years\r\nago. This bipartisan, bicameral draft is the result of several years of\r\nwork to address the growing problem of pharmaceutical theft, counterfeiting,\r\nand diversion. \r\n\r\n\r\nAmong\r\nother highlights, the legislation:\r\n\r\n \r\n\tDevelops a workable pathway to unit-level tracing in a\r\n\tdecade. Over the course of seven years, the major sectors of the\r\n\tpharmaceutical supply chain, such as manufacturers, repackagers, wholesale\r\n\tdistributors, and dispensers will all be passing and holding onto key\r\n\tinformation about each drug's distribution history. Within ten\r\n\tyears, supply chain stakeholders will participate in electronic,\r\n\tinteroperable product tracing.\r\n\tStrengthens licensure requirements for wholesale\r\n\tdistributors and third-party logistics providers. Wholesale\r\n\tdistributors will have higher standards for their licenses nationwide, and\r\n\tthird-party logistics providers will be recognized for the first time as a\r\n\tpart of the drug supply chain. FDA will also keep a database of\r\n\twholesalers that will be available to the public through the FDA's\r\n\twebsite, allowing consumers and members of the drug supply chain to\r\n\tidentify appropriately licensed wholesalers.\r\n \r\nEstablishes nationwide drug serial numbers. Four\r\nyears after the date of enactment, manufacturers will serialize drugs in a\r\nconsistent way across the industry. This will allow for efficient tracing\r\nto respond to recalls and notices of theft and counterfeiting.", 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": ["https://www.burr.senate.gov/public/index.cfm?FuseAction=PressOffice.PressReleases&Type=Press Release&ContentRecord_id=6cbec278-a65f-bee7-0b68-cb62b47c37bc"], "units": {}, "query_ms": 1.352888997644186, "source": "dwillis/congress-press", "source_url": "https://github.com/dwillis/congress-press", "license": "MIT", "license_url": "https://github.com/dwillis/congress-press/blob/main/LICENSE"}