New guidance from the U.S. Food and Drug Administration (FDA) explains how regulators will enforce the agency’s 2012 Safety and Innovation Act by including outsourcing facilities that register with the FDA in accordance with the Drug Quality & Security Act.
“They’re now on notice that they’re going to be held to the exact same standard as any other establishment,” said Cathy Burgess, partner in Alston & Bird’s Health Care Group.
The guidance also noted numerous examples of what the FDA would consider “reasonable explanations” for inhibiting inspections.
“They don’t want to limit themselves because they don’t know what they’re going to find when they go into an establishment,” Burgess said. “They’re trying to give themselves as much leeway as possible.”