Offshore Specialty Pharmacies: What We Know and What to Be Aware Of

Oct 1, 2025

Offshore Specialty Pharmacies What We Know and What to Be Aware Of

By Alisa Redmon

Over the years, I have used a handful of Canadian pharmacies for expensive topical medications. I never expected that we would start seeing this in the specialty medication world, but it is happening. Recently, I was working on a renewal for a patient’s biologic. She had changed insurance plans and had a new, but familiar, PBM. After getting the approval, I sent the prescription to the specialty pharmacy that was generally the one in-network. A few days later, I received a voicemail from a pharmacy I have never heard of (ok, nothing new). When I called them back and spoke to an agent is when I realized that the patient’s medication would be coming from Canada. Fortunately, she was kind enough to answer all of my questions I had about how this all worked… The patient’s new insurance was a “self-funded” plan.

The patient’s prescriber sends the prescription to this pharmacy, as usual. Then, one of the pharmacy’s prescribers writes the prescription so it can be processed and filled by the pharmacy. The medication can take anywhere from 2 to 7 days to be delivered to the patient in the U.S. There is a temperature monitoring device to ensure that the medication is still at the required temperature when it is delivered. The agent explained that utilizing the offshore specialty pharmacy not only saves the employer monthly but also the patient. Sounds great, right? Sure, if everything goes as planned…

Here are our concerns: The Unknown Prescriber: We have to trust that the pharmacy’s prescriber is going to write it the exact same way it is written, since there is no way (that I know of) for us to verify how the prescription is written on the dispensed medication. Medication/Temperature Integrity: What if the medication is not at temperature when received by the patient? Does the device log daily temperatures or just what the current temperature is? Will the pharmacy replace the medication if it is not received at temperature?

Enforcement: How do we/the patient know if and when the medication (for whatever reason) has been confiscated by Customs and Border Protection? Is that going to be a recurring issue? What happens to the patient’s treatment if that happens?

Legality/Regulations: Since the FDA cannot regulate these offshore specialty pharmacies, their use is generally “illegal” and not FDA approved. The FDA allows importation on a case-by-case basis. Are these cases approved by the FDA? How do we know? What is that process?

Many plans are changing their formulary to save employers’ money, and many are not honoring those treatments that patients have been well controlled on for however long. While I am glad this plan approved the medication that the patient has been stable on, I can only hope that this cost-saving change is beneficial to the patient. As Biologic Coordinators, we take it personally when we can’t get our patients the medication that they should be on, especially in these certain situations when we have exhausted every option and resource and it is out of our hands. These kinds of changes are why it is so important to have a community to reach out to so we can all provide the best support and outcome to our patients.

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At BC Educators, we are dedicated to empowering biologic coordinators, healthcare professionals, and patient advocates with the education, tools, and resources needed to optimize patient care. From expert-led webinars to hands-on training, we provide comprehensive support to help you navigate the ever-evolving landscape of specialty medications and prior authorizations.