The U.S. drug supply chain is one of the safest in the world. However, it has become increasingly complex as it extends beyond U.S. borders. The FDA works diligently to protect consumers from threats such as counterfeiting, diversion, theft, and the import of falsified, unapproved, or otherwise unsafe drugs. These threats can result in the distribution of ineffective and unsafe drugs. The FDA has established numerous safeguards to maintain the integrity of the drug supply chain and ensure that safe, effective, and high-quality drugs reach U.S. consumers.
The FDA employs multiple strategies to prevent unsafe drugs from reaching U.S. consumers. Through the BeSafeRx campaign, the FDA educates consumers about the risks of purchasing prescription medicines from unsafe online pharmacies and how to buy medicines safely online. The FDA ensures that all imported drugs comply with U.S. legal and regulatory requirements, meeting FDA’s standards for quality, safety, and effectiveness. To protect the U.S. drug supply from counterfeit medicines, the FDA takes action against websites that illegally sell potentially dangerous, unapproved prescription medicines. The FDA also coordinates with drug manufacturers to recall drugs that may be unsafe, ineffective, or of poor quality and ensures that drugs exported from the U.S. meet quality and safety standards.
Information for Health Care Professionals and Industry
The FDA’s Know Your Source program educates health care professionals about buying medicines from licensed sources and safe purchasing practices. This program helps prevent unsafe or ineffective drugs from harming patients by promoting awareness among healthcare providers. The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve interoperable, electronic product tracing at the package level to identify and trace certain prescription drugs as they are distributed in the U.S. This enhances the FDA’s ability to protect consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs.
The FDA also issued guidance for drug manufacturers on using physical-chemical identifiers in solid oral dosage forms to help authenticate drugs and ensure their safety. The Prescription Drug Marketing Act of 1987 mandates that significant losses, theft, and falsified prescription drug samples be reported to the FDA. Securing the U.S. drug supply chain requires collaboration beyond U.S. borders. The FDA works with both domestic and international stakeholders to maintain the integrity of the supply chain.
The FDA collaborates with the Asia Pacific Economic Cooperation to maintain the Supply Chain Security Toolkit for Medical Products, a resource designed to protect consumers in the global marketplace. The FDA also participates in the World Health Organization’s Member State Mechanism on Substandard and Falsified Medical Products, strengthening international partnerships to combat these threats. Additionally, the FDA hosts Online Controlled Substances Summits to work with stakeholders in reducing the illegal availability of opioids and other controlled substances online.
Ensuring High Standards Through Vigilance and Collaboration
Consumers and healthcare professionals are encouraged to report product problems to the FDA when there are concerns about the quality, authenticity, performance, or safety of any medication or device. The FDA remains vigilant in protecting the integrity of the U.S. drug supply chain. Through comprehensive strategies and collaborations, the FDA ensures that safe, effective, and high-quality drugs are available to U.S. consumers.
By maintaining a “closed” drug distribution system and leveraging international partnerships, the FDA is committed to safeguarding the U.S. drug supply from various threats. Continuous efforts in consumer education, healthcare professional training, and industry guidance play a vital role in this mission, ultimately aiming to maintain the highest standards of drug safety and efficacy.
Resource: U.S. Food and Drug Administration, July 18, 2024
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