NCL applauds USP for new and revised compounding standards

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Every day, thousands of consumers in the United States—including those with rare diseases or allergies to commercially available drugs—rely on specially and individually made medicines known as compounded drugs. Compounding is critically important for patients but, if done improperly, this process can pose significant risks to patients and healthcare workers alike. Patients could—and have—received contaminated drugs or preparations that are subpotent, contaminated, or super-potent. Healthcare workers, in turn, can face risks of exposure to hazardous drugs.

A stark example is the 2012 series of medical errors that resulted in the contamination of compounded medicines, which in turn caused a deadly fungal meningitis outbreak in the United States—killing more than 70 people and causing more than 750 cases of infection in 20 states.

To reduce these public health risks, Congress and other policymakers have swung into action. Today, compounding requires universal standards that advance public health and patient safety priorities. A key player in this is the United States Pharmacopeia (USP), a scientific non-governmental standards-setting organization, which recently published new and revised compounding standards to help produce consistent quality compounded medicines and ensure that patients receive medicines that are the right strength, quality, and free of contaminants.

These updated standards reflect the latest advancements in science and clinical practice, and incorporate input from thousands of stakeholders in the medical and public health community—patients, healthcare practitioners, policymakers, academicians, and industry. The standards complement robust implementation of existing laws intended to ensure quality compounded products with the goal of protecting the safety of patients.

Consumers have an important role to play as we roll out the new guidelines for quality compounding and implementation of the new USP standards:

  • If you receive compounded medicines through your pharmacist or healthcare provider, report any resulting adverse events to your healthcare provider.
  • Sign up for FDA email alerts on safe compounding.
  • Remember to always contact your healthcare provider if you have questions or concerns about your health.

NCL is encouraged to see that the revised USP standards are consistent with FDA guidances. We applaud the efforts of FDA and USP to collaborate with the public health community to help protect patient safety.

Meatpacking workers, consumers safeguarded by House measure to overhaul pork line speed rule

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June 5, 2019

Amendment blocks the USDA from issuing final rule on swine inspection, pending OIG study to support food safety rules

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242 or Taun Sterling, tauns@nclnet.org, (202) 207-2832

Washington, DC —The National Consumers League (NCL) is commending Reps. Rosa DeLauro (D-CT) and David Price (D-NC) for teaming up to offer an amendment to delay the U.S. Department of Agriculture’s misguided and hazardous proposed rule to strip all speed limits at pig slaughterhouses and to force transparency around its flawed process. The removal of limits could allow slaughterhouses to handle a mind-boggling 1,300 or more pigs per hour and risk improper stun-gunning of livestock in the rush to process them quickly, endangering workers’ safety, public health, and animal welfare.

“Even at current line speeds, pork slaughter and processing workers face many job risks that can lead to severe injury, illness, and death. Meatpacking workers in hog slaughter plants work in cold, wet, noisy, and slippery conditions, making tens of thousands of forceful repetitive motions on each shift. Meatpacking workers are injured at 2.4 times the rate of other industries and they face illness rates at 17 times the rate of other industries,” wrote members of Congress in a letter to USDA Secretary Sonny Perdue. The proposed rule would also turn over inspection responsibilities to company employees, allow slaughterhouses to define their own microbiological criteria for food safety performance, and usher in comprehensive reforms to longstanding inspection practices without a reliable means of evaluating their efficacy.

The “modernization” of the Swine Slaughter Inspection System will not lead to safer food. Eliminating line speed limits makes it harder for federal meat inspectors and workers in plants to do their jobs. Ultimately, this means it will be less safe for consumers to eat pork.

The amendment blocks funding for implementation of the rule until the USDA’s Office of Inspector General (OIG) conducts an investigation of all data used by the USDA to develop the proposal. Previously, this data, including worker-safety data was not publicly disclosed until after the closure of the public review and comment period for the proposed rule. The Amendment mandates that USDA’s Food Safety and Inspection Service fully address and resolve the issues raised by the OIG before the funding hold can be lifted.

NCL is deeply grateful for the leadership of Reps. DeLauro and Price and wishes for the Senate to sustain this vital amendment.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.