FDA Works to Strengthen Oversight of Compounding Pharmacies

The FDA’s oversight of compounded drug manufacturing is evolving five years after a tragedy that tarnished the industry.

The agency Jan. 19 released a 2018 compounding policy priorities plan, which, among other things, lays out how the agency will address quality standards for outsourcing facilities that make large amounts of compounded drugs.

The agency’s goal is to make it more efficient and less costly for more compounding pharmacies to voluntarily meet the higher production standards for outsourcing facilities as a way to promote patient access to higher quality compounded drugs, FDA Commissioner Scott Gottlieb said Jan. 19 when announcing the plan. Outsourcing facilities voluntarily register with the FDA in order to be able to make large amounts of compounded drugs and are subject to higher standards than traditional compounding pharmacies.

The Drug Quality and Security Act (DQSA) of 2013 gave the FDA more power to oversee drug compounders and created the outsourcing facility category for compounders. The DQSA was enacted in response to a 2012 fungal meningitis outbreak associated with contaminated injectable drugs produced by a compounding pharmacy. The outbreak sickened 753 patients and caused 64 deaths.

In 2018, the FDA said, it will issue proposed regulations on current good manufacturing practice (cGMP) requirements for outsourcing facilities. In the interim, the FDA said, it will issue a revised version of a 2014 draft guidance to describe a new flexible, risk-based approach to cGMP requirements for outsourcing facilities.

But a consumer group has concerns that the FDA’s plan will create different manufacturing standards for different outsourcing facilities.

Michael Carome, director of Public Citizen’s Health Research Group, told me FDA’s plan “suggests that different outsourcing facilities will be held to different standards in terms of what good manufacturing practices they need to follow” and “that means for some of them the standards are going to be less rigorous.”

Before the DQSA was enacted, Public Citizen opposed the creation of the outsourcing facility category because “it created a second lower tier of drug manufacturers,” Carome said. “Outsourcing facilities are essentially engaged in manufacturing, not pharmacy” and “ultimately, these drugs made by outsourcing facilities are riskier than FDA-approved drugs made by traditional drug manufacturers.”

“We think the standards should be consistent across the industry,” Carome said.

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