The report, which was issued to Congressional Committees as part of the Drug Quality and Security Act (DQSA), concluded that while the FDA has taken steps to implement compounding law, some stakeholders reported challenges, including communication issues with the FDA.
As Outsourcing-Pharma.com previously reported, the FDA published the DQSA after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a compounding pharmacy in Massachusetts.
In addition to outlining new rules for drug compounders the DQSA also created the 503B outsourcing facilities category of compounders, which allows facilities to compound drugs with or without a patient-specific prescription.
503B outsourcing facilities
The DQSA was enacted three years ago in November 2013, and as such, Marcia Crosse, Ph.D., Director, Health Care, US Government Accountability Office (GAO), told us the FDA is in the early stages of its efforts to oversee these facilities.
“The agency is working to obtain better and more complete information, to issue guidance, and to inspect registered facilities,” she added.
The FDA specifically has had challenges with the 503B facilities submitting the required reports of the drugs they compound. “Because the agency has not established a standard format for reporting, FDA cannot readily produce aggregate data about the drugs compounded by 503B facilities,” said Crosse.
However, she explained that the FDA is working to address this issue and plans to issue final guidance on the format for reporting to the agency.
According to GAO’s report, as of April 22, 2016, 40 of the 59 outsourcing facilities had not provided some or all required reports.
However, the FDA has not taken regulatory action against these facilities “unless FDA was already taking steps to address some other violation of statute by the outsourcing facility, including through the issuance of a warning letter,” the report added.
Per the report, “this is because addressing all of the firm’s violations that FDA has identified in a single action is a more effective mechanism to bring the firm into compliance and a more efficient use of agency resources than pursuing separate actions for discrete violations of the FDCA.”
As of April 22, 2016 the FDA had completed 75 inspections of outsourcing facilities, according to GAO’s review of FDA data.
“FDA has issued warning letters and form 483 inspection observation reports on many of the facilities they have inspected,” added Crosse – notably, the FDA issued an FDA form 483 inspection observation report to 85% of the outsourcing facilities inspected.
Crosse added that the “FDA has not yet inspected all registered 503B facilities, but plans to do so.”
According to the report, these 75 inspections were carried out at 59 of the 91 facilities registered with FDA as an outsourcing facility. However, the FDA explained that many of the registered facilities withdrew their outsourcing registration submission before the agency scheduled an inspection.
Quick takeaways from the report
- The FDA and some states collect data on the number of drug compounders, but not the volume of compounded drugs.
- Most states (about 80%) have drug compounding laws or policies for pharmacists, but not for physicians.
- 60% of respondents reported that they were very or somewhat satisfied with FDA communication regarding drug compounding issues.
- 23% reported they were very or somewhat dissatisfied.
- About ¾ of the states reported participating in FDA-sponsored activities, such as intergovernmental meetings, and obtaining information from FDA’s website.