The FDA recently issued three guidance documents for human drug compounding outsourcing facilities registered with the FDA under section 503B of the Federal Food, Drug, and Cosmetic Act. The first document describes the process of electronic registration for outsourcing facilities. Facilities choosing to register should submit registration information using the existing structured product labeling ("SPL") format, and after initial registration must register annually between October 1 and December 31 of each year. The second document explains the requirements for electronic drug product reporting. In June and December of each year, registered outsourcing facilities should electronically submit drug product reports in SPL format using FDA's electronic submissions system. These reports should identify all drugs compounded at the outsourcing facility during the previous six months and provide specific information about each drug, including active ingredients, dosage, and route of administration. The third document details two fees registered outsourcing facilities will be required to pay beginning in fiscal year 2015. First, at the time of registration, facilities must pay an annual establishment fee equal to $15,000 multiplied by an inflation adjustment factor tied to FDA personnel costs and the Consumer Price Index for urban consumers. Entities that qualify as small businesses under the Act will pay only one-third of the annual fee. Second, an outsourcing facility must pay a reinspection fee each time it is subject to a reinspection equal to $15,000 multiplied by the inflation adjustment factor.
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