Policyholder Services

We are considering importing a drug from a wholesaler in another country. Is this acceptable?

At this time, OMIC recommends that insureds refrain from purchasing drugs from outside of the United States, even if they are FDA approved. This recommendation is based on the increasing difficulty in ensuring that the same standards for manufacturing, quality assurance, and distribution that apply to drugs made within the US also apply to drugs manufactured elsewhere. This is one reason that the FDA does not extend FDA approval to foreign-manufactured drugs, even when the manufacturer is based in the US and the same drug is FDA approved.

Given the risk that a drug purchased outside of the US may not be of the same quality, OMIC believes an additional professional liability risk is created. Defensibility on this point may be difficult if a patient suffers an unanticipated outcome traced back to the drug. This risk is increased due to the uncertain legal interpretation of FDA regulations prohibiting importing drugs from outside the US that are not FDA approved (United States Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. Section 331). The exception to this regulation is drugs used by physicians for treatment rather than for distribution or sale. However, according to an attorney that has advised OMIC on this matter, the interpretation of this exception is not clear. In some cases that have gone before the courts, the use of unapproved drugs by physicians was deemed to be part of the distribution process prohibited by the Act. Given this additional uncertainty in the courts, we recommend against such proposed purchases.

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