FDA Focuses on Compounded Drug Quality; cGMPs for Outsourcing

Agency updates its compounding priorities plan to address patient safety while revising cGMP draft guidance to make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality.

Agency updates its compounding priorities plan to address patient safety while revising cGMP draft guidance to make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality.
Agency updates its compounding priorities plan to address patient safety while revising cGMP draft guidance to make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality.

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.

“We’ve heard the feedback from stakeholders to our proposed 2014 draft guidance that certain cGMP policies would have made it difficult for outsourcing facilities to fill smaller orders and that some compounded drug products that practitioners requested for office stock were not available from outsourcing facilities due to those policies. We want to advance policies that make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality. This revised draft guidance includes changes intended to help achieve this goal, particularly through revisions related to release testing, stability testingand beyond-use dating, as well as policies that differentiate between productionof sterile and non-sterile drug products.”

In May, FDA plans to hold a public meeting to solicit comments on the potential impact of the policies, if finalized as described in the updated draft guidance, on outsourcing facilities supplying compounded drugs for office stock.

“We’ll also continue to conductrisk-basedinspection and enforcement efforts with respect to compounders not registered as outsourcing facilities, especially if they appear to be distributing compounded sterile drugs nationwide without valid patient-specific prescriptions,” says the statement. “Our goal is to ensure industry compliance. And the FDA will take action against facilities with deficient practices to try and stop issues before they lead to patient harm.”

The agency noted, “Soon we’ll also be taking action to further define what substances can be used in compounded products by traditional compounders. We’ll be issuing a final rule that identifies the criteria we are using to evaluate bulk drug substances for the list of bulk drug substances that may be used in compounding under section 503A (503A bulks list). This final rule will also identify bulk substances the agency has evaluated and will or will not place on the 503A bulks list. It’s key to balancing access to appropriately compounded drugs and protecting patients from compounded products that could cause harm. We’ll continue our rulemaking effort and plan to seek public comment on additional bulk drug substances for the 503A bulks list.

“Compounded drug products play an important role for many patients, and we have made meaningful progress throughout 2018 on our compounding policy priorities and the implementation of the Drug Quality Security Act. We remain committed to this critical public health effort and look forward to continuing this important work next year, including laying out new compounding priorities in 2019.”

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