In 2012, the Food and Drug Administration issued a notice to health care providers
about the risks of purchasing unapproved medications from unlicensed sources,
and included information on how to identify whether distributor or the products
received are legitimate.
In question
were certain injectable cancer drugs that have not been approved by the FDA. Similar notices have been issued regarding the use of unapproved versions of Botox. The FDA noted that “these medications may be counterfeit, contaminated, improperly
stored and transported, ineffective, and or unsafe.” In the Botox matter, the FDA asked that
“medical practices stop administering unapproved version of Botox.”
The FDA urges the health care community to examine its
purchasing practices to make sure that the products are purchased directly from
the manufacturer or state-licensed whole drug distributors in the US. The FDA stated, “The receipt of
suspicious or unsolicited offers from unknown suppliers should be questioned
and extra caution should be taken when considering them.”
Note, in certain circumstances the FDA may
authorize limited importation of medications that are in short supply. Such medications are imported from approved
international sources and distributed in the US through a controlled network,
and would not be sold in direct-to-clinic solicitations.
If the FDA has arranged for limited
importation of the foreign version of a medication, information obtained on that
medication would be available on the FDA drug shortages website often in the form of a “Dear
healthcare Professional” letter.
Medical practices should be aware that
importing medications from foreign sources other than those authorized by the
FDA is in violation of the Federal Food Drug and Cosmetic Act.
If
you believe you have been sold, or solicited to purchase, illegally imported
drugs, you can report this suspected criminal activity to the FDA’s Office of
Criminal Investigations (OCI) by calling (800) 551-3989 or visiting the OCI website.
