AmerisourceBergen to 'set the bar' for compounding quality as it closes PharMEDium deal

By Dan Stanton contact

- Last updated on GMT

The 2013 DQSA helped drive the recent acquisition of a compounding pharmacy, says AmerisourceBergen
The 2013 DQSA helped drive the recent acquisition of a compounding pharmacy, says AmerisourceBergen

Related tags: Food and drug administration

Legislation allowing compounders to register as outsourcing facilities was a key driver in the acquisition of PharMEDium, AmerisourceBergen says as it completes the $2.6bn deal.

Last month, the drug wholesale and healthcare supply chain services firm announced it was paying $2.6bn (€2.3bn) to private equity group Clayton, Dubilier & Rice, for Illinois-based compounder PharMEDium Healthcare Holdings.

The deal closed Friday, adding four compounding pharmacies which supplies around 3,000 US hospitals with sterile drug preparations to AmerisourceBergen’s services.

Compounding pharmacies have been subjected to increased regulatory scrutiny over the past few years following a number of quality and contamination-related issues with compounded drug products, culminating in the 2013 Drug Quality and Security Act (DQSA) and guidance from the US Food and Drug Administration (FDA)​ on how compounders can register as outsourcing facilities.

This “turned out to be what we think is probably one of the key drivers for our investment decision,”​ said AmerisourceBergen’s CEO Steven Collis during a conference call two weeks ago (transcript here​), adding further regulations will only improve quality and subsequently volumes from PharMEDium’s four registered outsourcing sites.

“Did you guys take your bold pills?”

Collis also spoke on the firm’s reaction to buying a compounder. “The acquisition idea has been very well received by our health systems customers… [but] one of our big customers said: ‘Did you guys take your bold pills?’”

He continued, adding the firm had been “just so impressed with their competitive differentiation and their commitment to quality” ​during the diligence period where it inspected all four sites.

“We think that there will be a very iterative dialogue always with the FDA and other regulators, but we expect that we will continue to set the bar for quality in this area.”

Furthermore, the firm stressed the acquisition is not a commodity service but a high-quality service.

“If my family was getting a sterile IV, I'd like it to come from PharMEDium,”​ Collis said. “I can't believe that a hospital on its own can create the centre of excellence that a company like PharMEDium can for these sterile preparations.”

PharMEDium was struck with an FDA warning​ at its Cleveland site last year, and days after AmerisourceBergen announced its intentions the Agency released details of a re-inspection of the facility during July which resulted in a Form 483 with nine observations​, five of which were repeats.

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