FDA is moving quickly to give regulatory flesh to the compounding provisions of the new Drug Quality and Security Act of 2013 (DQSA), signed into law by President Obama on November 27.
On December 4, a week after the signing, FDA issued three draft guidances and three companion Federal Register (FR) notices related to the implementation of the compounding provisions of the act.
The three draft guidances cover: ● overarching rules for what constitutes pharmacy compounding and how enforcement for violations may be applied ● a definition of a new category of compounder created by the DQSA – “an outsourcing facility” – and the registration requirements, and ● interim requirements for ongoing reporting of information to FDA by the outsourced facilities on their products and services.
The FR notices explain that FDA will be producing listings of bulk drug substances used in pharmacy compounding and products made from those substances as well as a list of “difficult-to-compound” products. The agency is requesting that industry nominate candidates for the lists. Included in the FR notices are the information required for nominations to be considered as well as a template for the submission of candidates for the difficult to compound list.
The 60-day comment period on the three guidances extends until February 3. Comments on the FR notices are due by March 4.
The speed at which the agency is moving in the act’s implementation reflects the central place that compounding operations have occupied on FDA’s inspection and health protection radar screen since the fall 2012 meningitis outbreak caused by fungal-contaminated sterile methylpredisone produced by NECC (IPQ Special Report November, 2012).
Pharmaceutical manufacturers are impacted by what is happening in the compounding arena and should be paying close attention to how the new act is being implemented.
A longstanding issue is the line between compounding and unapproved drugs, which may compete with products that have to meet stringent approval and inspection demands. The drug shortage issue is also at play in that pharmacy compounders step in to fill perceived market gaps – again, often with unclear authority to do so.
The association of pharma products with the quality and public health problems created by compounding pharmacies and other handlers of their products downstream in the distribution chain is also of very real concern to the industry – both in terms of brand-name tarnishing, but also in their potential involvement in recalls and other follow up legal and enforcement actions.
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