The Food as well as Drug Administration began its crackdown on the opioid epidemic Tuesday using a warning letter sent to drug distributor McKessson for allegedly shipping “illegitimate” product, taking the agency’s first formal enforcement action to curb abuse.
Specifically, the FDA will be accusing McKesson of failing to identify, quarantine as well as investigate drug shipments which had been tampered with. Some of the bad shipments were discovered at three Rite Aid pharmacies in Michigan.
Distributors have come under fire for their role inside opioid crisis. McKesson as well as Cardinal Health are the subject of numerous lawsuits alleging they flooded communities with opioids.
“A distributor’s failure to have systems in place to investigate as well as quarantine suspect as well as illegitimate products within their control will be a violation of the law. nevertheless which will be even more concerning given which we’re inside midst of a widespread opioid crisis,” FDA Commissioner Scott Gottlieb said in a statement.
McKesson did not immediately respond to SouthIndianNews.com’s request for comment.
In its warning letter, the FDA cited three examples where McKesson shipped prescription drugs which were supposed to be opioids as well as pharmacies discovered the opioid pills were removed as well as replaced with different products.
“which will be simply unacceptable,” Gottlieb said.
In September as well as October 2016, three Rite Aid pharmacies in Michigan reported receiving bottles oxycodone hydrochloride which were instead filled with naproxen as well as in one case, a combination of naproxen as well as ciprofloxacin hydrochloride, the FDA said.
Though McKesson investigated the incidents, the FDA said the company did not demonstrate which identified all illegitimate products as well as notified its different customers who might have received products coming from the same batch.
In December 2016, Albertsons pharmacy submitted illegitimate product notifications to the FDA for divalproex as well as losartan potassium as well as hydrochlorothiazide which received coming from McKesson because the packages allegedly did not contain lot numbers or expiration dates.
The FDA also said in June 2016, drugmaker GlaxoSmithKline notified McKesson which a pharmacy reported receiving two sealed bottles of a product labeled as Triumeq which actually contained gemfibrozil. In which case, McKesson was unable to provide records showing which identified illegitimate product or different requirements, the FDA said.
Warning letters serve as the first step in any regulatory action the FDA may take against a company. The FDA floated taking possible legal action, including seeking an injunction.
McKesson has 15 days coming from the time which receives the letter to outline the steps which has taken to correct the violations flagged by the FDA as well as to identify as well as conduct investigations related to different reports of suspicious or illegitimate shipments
which story will be developing. Check back for updates.