PharMEDium is hiring - don't work there

PharMEDium is hiring for sales - you don't want to work here. It is kind of sweet because reps don't have a quota and are being paid at 100%. But that can't last too much longer because this sinking ship continues to take on water.

With only 2 out of 4 facilities actually compounding drugs, PharMEDium's customers live in a state of constant disappointment. Backorders continually occur without warning. There is not an adequate system to forecast demand, produce the right amount of drug, and deliver it in a timely manner. PharMEDium's competitors (especially Quva) are taking share left and right from them. PharMEDium basically created 503b outsourcing and was once the industry leader. Now they are a shell of what they used to be and will be saddled with burdensome FDA regulations that their competition does not have for many years to come.

Info about FDA actions taken against the company...
A federal judge in Illinois has slapped a permanent injunction against PharMEDium Services LLC in the wake of the Lake Forest-based drug maker's repeated safety lapses at compounding pharmacies in four states.

"PharMEDium exposed patients across the United States to risk of receiving a harmful drug, which we find unacceptable," Acting Food and Drug Administration Commissioner Ned Sharpless, MD, said in a media release.

"We will continue to take appropriate enforcement actions when compounding pharmacies and outsourcing facilities produce drugs under substandard conditions or use inappropriate practices that could lead to serious harm to patients," Sharpless said.

Under a consent decree that came with Wednesday's injunction, PharMEDium cannot make or distribute its drugs from its Memphis, Tennessee plant until the FDA approves a corrective action.

PharMEDium President Scott Aladeen and Warren Horton, the company's vice president for Quality and Research and Development, were named in the permanent injunction as the people responsible for compliance with the consent decree.

PharMEDium had already shuttered its Cleveland, Mississippi plant in the wake of publicity surrounding the safety lapses.

Under the injunction, the company's Sugar Land, Texas, and Dayton, New Jersey plants must also hire independent compliance inspectors, FDA said.

PharMEDium is a major national supplier of ready-to-use IV bags and prefilled syringes. The safety concerns raised by the FDA and the ensuing plant closures greatly disrupted the supply of critically needed drugs to the nation's hospitals.

In a complaint filed this week by the Department of Justice at the request of the FDA, federal officials accused PharMEDium of violating the Federal Food, Drug, and Cosmetic Act "by distributing adulterated, misbranded, and unapproved new drugs in interstate commerce."

The FDA said in its complaint that "PharMEDium's drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health and because PharMEDium failed to comply with current good manufacturing practices."

The allegedly adulterated drugs included oxytocin and morphine sulfate.

The FDA said that PharMEDium also "distributed unapproved new drugs and misbranded drugs because PharMEDium failed to comply with all of the requirements for drugs compounded in a registered outsourcing facility."

Since 2013, the FDA said it has inspected PharMEDium's compounding pharmacies and found numerous infraction that resulting in a 2018 warning letter. The company had been previously warned of similar concerns about unsanitary conditions in 2007, FDA said.