FDA Issues Adverse Event Reporting Guidelines for Outsourced Facilities

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FDA finally bears down on outsourced compounding facilities in 2015, as a result of having found dozens of potentially dangerous safety problems at 30 specialized pharmacies, in 2013, months after tainted steroid shots made by a Massachusetts pharmacy triggered the worst drug disaster in decades.

In 2012, FDA had found filthy conditions at the New England Compounding Center (NECC), the Massachusetts pharmacy at the heart of the fungal meningitis outbreak that killed 53 people and sickened 680 others. These “priority inspections” were focused on firms that produce high-risk sterile products, a key segment of the multi-billion-dollar industry that has fallen between the regulatory cracks. Read more about the corporate criminal acts committed by NECC.

Outsourcing Facility Registration and Reporting

The new law allows an entity that compounds sterile drugs to register as an outsourcing facility. Once registered, an outsourcing facility must meet certain conditions in order to be exempt from the FDCA’s approval requirements and the requirement to label products with adequate directions for use. Under the new law, the drugs must be compounded in compliance with CGMP by or under the direct supervision of a licensed pharmacist in a registered facility (section 503B(a)). The outsourcing facility must also report specific information about the products that it compounds, including a list of all of the products it compounded during the previous six months, and information about the compounded products, such as the source of the ingredients used to compound (section 503B(3)). In addition, the outsourcing facility must meet other conditions described in the new law, including reporting adverse events and labeling its compounded products with certain information (section 503B(b)(5) and section 503B(a)(10)).

Under the new law, an outsourcing facility will not be considered registered until it has paid the applicable annual registration fee (see section 744K(g)(3)(A)). An outsourcing facility may register without paying a fee until September 30, 2014, however, because fees are not required until October 1, 2014. In addition, the new law requires that outsourcing facilities register and report their products to FDA electronically unless the Secretary grants a request for a waiver of such requirement because use of electronic means is not reasonable for the person requesting the waiver (section 503B(b)). FDA has issued draft guidances on registering and reporting for those entities that intend to register as outsourcing facilities.

Download the guidance for adverse event reporting here.