There has been a lot of activity relative to inspection of outsourcing facilities (facilities that compound drug products under Section 503B of the Federal Food, Drug and Cosmetic Act). These facilities are held to cGMP standards and are subject to FDA inspection. Outsourcing facilities must be registered with the FDA and must pay a fee each year. In a Notice in today’s Federal Register (here), the fees for outsourcing facilities for 2017 are announced.
There are two fees associated with outsourcing facilities: an establishment fee and a re-inspection fee. The establishment fee comes in two types – one for qualified small businesses and one for non-small businesses. Fees assessed for small businesses are one-third those of non-small businesses. The fees for last year were $5000 and $15,000, respectively. Every outsourcing facility pays the same re-inspection fee if a re-inspection of the facility is necessary, based on a previously bad inspection. Those fees are adjusted for inflation and other factors and the new fees are provided in the table below.
Outsourcing Compounder Fees for 2017
According to FDA records, there are 58 outsourcing facilities registered with FDA so far in FY 2016. In the FR Notice, FDA estimates that 79 outsourcing facilities will be registered in 2017. If you have any question about outsourcing facilities, their inspection, and or the user fees associated with them Lachman Consultants can assist you. Contact us at: lcs@LachmanConsultants.com
