In Recent Guidance, FDA aims for Patient Safety at 503B Facilities

The FDA has issued a guidance to 503B facilities regarding Current Good Manufacturing Practice (gCMB)

Healthcare Packaging explains:

"A Dec. 10 statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram focused on the importance of ensuring compounded product quality. FDA noted that it continues to implement its 2018 Compounding Priorities Plan as part of its “mission to preserve patient access to compounded drugs to meet patients’ individual medical needs while also protecting patients from the risks of contaminated or otherwise harmful products.

“Through enforcement actions, we’ve been addressing insanitary conditions and manufacturing quality issues at compounders’ facilities across the country. More activities are planned, and we’ve stepped up our collaborative work with the Department of Justice. But preventing problems before they put patient safety at risk is our key objective to protect consumers.”

In its announcement, the agency recognized that although compounded drugs “can serve an important role for certain patients whose medical needs cannot be met by an FDA-approved drug product, it’s important to understand that compounded drug products haven’t undergone FDA premarket review for safety and effectiveness. Compounders who are uniquely permitted under law to compound and distribute certain compounded drugs without receiving patient-specific prescriptions are referred to as outsourcing facilities.

“There has been a lot of discussion around the issue of “office stock” – the drugs that doctors may keep on hand for certain procedures. If certain conditions are met, the law allows outsourcing facilities to provide hospitals, physicians’ offices, and other health care facilities with supplies of compounded drugs to keep on hand as ‘office stock’ for their patients, who may need quick or emergency medication upon diagnosis.

“While this practice is permitted, outsourcing facilities must comply with certain requirements, including current good manufacturing practice (CGMP) requirements, and FDA routinely inspects outsourcing facilities to determine whether their products are manufactured appropriately. Today we’re updating some of our proposed policies related to these outsourcing facilities. Among our goals is to make it more feasible for compounding pharmacies to become outsourcing facilities.”

As part of its patient safety focus, the agency’s announcement addressed the importance of cGMP compliance in outsourcing facilities. “That is why today we’re releasing a revised draft guidance with recommendations for protecting patients from the risk of contaminated or otherwise substandard products produced by outsourcing facilities."


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