FDA and DEA send joint warning letters to illegal opioid sites
Posted: 3 October 2019 | Victoria Rees (European Pharmaceutical Review) | No comments yet
The FDA and DEA have, for the first time, sent joint warning letters to four networks which were illegally selling opioid products.
The US Food and Drug Administration (FDA) has issued warning letters to four online networks which were illegally marketing unapproved and misbranded versions of opioid medicines. The cautions were sent as joint with the Drug Enforcement Administration (DEA).
A total of 10 websites were found to be within the networks, which also violated the Controlled Substances Act (CSA) by failing to register their online pharmacies. The sites have been told they must cease selling the opioids, including unapproved tramadol, immediately.
The FDA has warned that any products bought from illegal online pharmacies may be counterfeit, contaminated, expired or otherwise unsafe.
“As the FDA works to forcefully tackle the opioid crisis on all fronts, we cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and circumventing the important safeguards that have been put in place for opioids to help protect the public health,” said Acting FDA Commissioner Ned Sharpless, MD.
The sites have been told they must cease selling the opioids, including unapproved tramadol”
The companies must now inform each of the agencies of their specific steps taken to correct the violations. If these are not corrected, legal actions may be taken against them.
The letters mark the first time that the FDA and the DEA have issued joint warnings.
Related topics
Drug Safety, Drug Supply Chain, QA/QC, Regulation & Legislation
Related organisations
US Drug Enforcement Administration (DEA), US Food and Drug Administration
