Bulk Drug Compounders Confounded by FDA Plan

The FDA, citing safety, says large-scale drug compounders should use agency-approved drug substances instead of bulk substances whenever possible, but critics say that’s neither necessary nor wise.

The FDA’s recently issued draft guidance explaining how it’ll accept nominations for the “503B Bulks List"—approved bulk drug substances that can be used by large-scale drug compounders known as “outsourcing facilities”—prioritizes FDA-approved drugs.

But 503B outsourcing facilities need to comply with FDA current good manufacturing practice regulations just like traditional pharmacy compounders, and industry representatives say that makes the safety rationale unconvincing.

“[T]his guidance document appears to be a direct giveaway to drug manufacturers, as 503Bs would now be required to start with higher-priced products while meeting cGMP standards,” Outsourcing Facilities Association chairman and Baker & Hostetler LLP partner Lee Rosebush told me in an email. “This is simply a way for pharma to continue to protect their products and FDA to continue to collect user fees.”

As we noted when the FDA issued its draft guidance, that’s one of several gripes outsourcing facilities have with the FDA’s insistence that 503Bs look to agency-approved drug products first.

The agency has said it wants to encourage companies to register as 503Bs to help develop a bulk compounding sector and keep drug costs down, but the new guidance document gives traditional pharmacies “a more lenient standard on when they can compound from bulk,” Rosebush said.

“Therefore, the incentive is stay a 503A, not register with FDA as a 503B,” said Rosebush, whose organization represents FDA-registered 503B outsourcing facilities. Currently there are 73, according to the FDA’s registration list.

Rosebush, who testified at a House subcommittee hearing in January on the FDA’s compounding priorities plan, also chides the FDA for what he says is an intrusion on patient treatment decisions.

“While the authority to determine what is right for a patient has been vested with physicians and state boards for years,” Rosebush said, “it appears that FDA is trying take this authority away and step into the shoes of the physician and pharmacist by becoming the clinical decision-maker on what’s right for the patient.”

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