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.