Regulatory Focus™ > News Articles > GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders

GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders

Posted 18 November 2016 | By Michael Mezher 

GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders

A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain.


Unlike traditional drugmakers, drug compounders are exempt from certain requirements of the Federal Food, Drug and Cosmetic (FD&C) Act. These exemptions allow compounders operating under section 503A of the act to produce drugs without complying with current good manufacturing practice (cGMP) and certain labeling requirements, and sell those drugs without marketing approval from FDA.

The safety of compounded drugs has been a high profile issue for FDA since an outbreak of fungal meningitis linked to a Massachusetts-based compounder killed 64 people in 2012.

In response to the outbreak, Congress passed the Drug Quality and Security Act (DQSA), which amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to clarify requirements for compounders and created a pathway for compounders to register with FDA as outsourcing facilities.

Under the DQSA, registered outsourcing facilities operating under section 503B of the FD&C Act must follow cGMP requirements and are required to report adverse events to FDA for the drugs they produce in order to maintain exemptions for labeling and approval requirements.

GAO Report

Since the passage of the DQSA, GAO says FDA has made progress toward its new and clarified responsibilities with regard to drug compounding.

According to GAO, the agency has conducted more than 300 inspections of compounding facilities between May 2012 and April 2016, 75 of which were of registered outsourcing facilities. Many of these inspections led to action by FDA, including issuing numerous Form 483s and warning letters to compounders.

"These 75 inspections were at 59 of the 91 facilities that had registered with FDA," GAO writes. However, according to GAO, "many of the entities that were registered as outsourcing facilities withdrew their outsourcing facility registration submission before the agency scheduled an inspection, and others were not yet operating when the agency attempted to inspect them."

GAO says it also found that FDA generally met its obligations to publish guidance and other documents related to compounding, some of which were required under the DQSA.

In total, FDA has finalized seven guidance documents and 10 draft guidances related to compounding since 2014.

However, despite FDA's actions, GAO found that some stakeholders felt the agency was slow to publish guidance.

"Some stakeholder organizations said the amount of time it takes FDA to finalize the guidance and other documents … is challenging," GAO writes, noting that FDA cited the number of comments it received contributed to the delay.

However, overall, states appear to be content with the level of communication, with roughly three quarters of states saying they are either very or somewhat satisfied, or at least neither satisfied nor dissatisfied with the agency.

Another issue, GAO says, is that the data being collected by FDA and states paints an incomplete picture of the extent of drug compounding.

"According to FDA officials, there is no good source for data on the extent of drug compounding and who is doing it except for data on outsourcing facilities," GAO writes. Despite requirements for outsourcing facilities to provide FDA with data on the number of units of drugs they produce every six months, FDA told GAO that "not all outsourcing facilities provided these reports and the data provided were not yet collected and maintained in a standard format."

Furthermore, FDA told GAO that most registered outsourcing facilities have failed to submit all the required data to the agency. "As of April 22, 2016, 40 of the 59 outsourcing facilities had not provided some or all required reports," GAO writes.

As such, GAO says it was unable to look at aggregate data for drugs produced by registered outsourcing facilities for the report.

Going forward, FDA told GAO it plans to update its electronic reporting system so that future reports can be submitted electronically in a standardized format.



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