More US FDA draft guidance for compounders
The outbreak – which was traced to contaminated methylprednisolone made by the New England Compounding Center (NECC) of Framingham, Massachusetts – resulted in 64 deaths and the arrest of supervising pharmacist, Glenn Chin, in September last year.
The scandal prompted the Government to revisit the rules that govern compounders in the Drug Quality and Safety Act (DQSA), which was passed in September 2013.
In the year or so since the DQSA became law, several US compounding organisations have been hit with warning letters.
In August, Zion Rx Formulation Services was cautioned about contaminated drug products made at its facility in Arizona.
The following month Florida’s Compounding Shop was warned about its use of the unapproved ingredient domperidone.
And later that month the FDA advised patients not to use sterile injectable drugs made by Texas compounder NuVision Pharmacy – which is owned by Downing Labs - after the firm failed to comply with a recall order
The latest US Food and Drug Administration (FDA) draft guidance documents cover when a compounder is required to register as an outsourcing facility, how they should repackage small molecule drugs and biologics and how adverse events should be reported.
There is also a memorandum of understanding (MoU) for compounders that do not register as outsourcers – so called 503A manufacturers that are monitored by State rather than Federal regulators – designed to provide a framework for supply deals.
The documents – for which the FDA is seeking comment – add to final guidelines issued by the agency last year on fees for outsourcers, registrations, electronic reporting and compounding as well as proposed rules on withdrawn products and GMP for such facilities.