Prescription Drug Importation – Protecting the US Drug Supply Chain
Caroline D. Juran, BSPharm, DPh (Hon)
Following the final rule approved by Trump Administration and published by Food and Drug Administration in 2020, states can now submit proposals to establish their own wholesale prescription drug importation program from Canada. While NABP understands the desire to decrease the costs of prescription drugs, states may face challenges while ensuring patient safety and securing the global supply chain. Increasing efforts to support the boards of pharmacy and to educate and protect the public about state drug importation plans is a key focus and the presidential initiative of NABP President Juran.
There are three areas of focus for the initiative:
- providing guidance to state and federal governments and other policy makers on the risks associated with prescription drug importation and the necessary regulatory oversight process to help mitigate those risks;
- working with state and federal regulators to implement the Drug Supply Chain Security Act (DSCSA), including providing education and other tools to regulators and supply chain participants to assist in implementation; and
- educating the public about the risks associated with purchasing prescription drugs from unknown sources online and through social media.
Increasing awareness about state importation programs is necessary to maintain patient safety. More information about prescription drug importation can be found in the below resources.
Background Information and Guidance
- Department of Health and Human Services and Food and Drug Administration released the Safe Importation Action Plan describing the two pathways for lower cost medications for patients.
- FDA published a guidance for industry that outlines requirements to import biological products.
- FDA released a financial impact analysis report about the final rule.
- United States Pharmacopeia (USP) provides resources including a supply chain map to help strengthen the pharmaceutical supply chain and reduce risk.
- Read President Juran’s blog post about how NABP can help states to safely develop drug importation plans.
- NABP released a statement on the prescription drug importation proposals in February 2019.
- In February 2017, NABP sent a letter to Congress regarding Canadian online pharmacies.
- Review talking points from the Task Force on State Oversight and Drug Importation about regulatory challenges states will face.
- NABP’s 2020 and 2019 Rogue Rx Reports detail how illegal online pharmacies prey on consumers.
- Learn more about HHS and FDA’s Safe Importation Action Plan and the future of drug importation during this on-demand home study webinar.
Looking for more information?
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Looking for NABP Chairperson Tim Fensky’s 2020-2021 initiative? Visit the Medication-Assisted Treatment page.