The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), is engaging in efforts to obtain particular information regarding certain bulk drug substances nominated for use in compounding by outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act).
In particular, we will, in collaboration with the FDA, review the nominations to identify information deficiencies and develop a prioritized list of specific information that M-CERSI will work with nominators to obtain. The research will assist FDA in its development of a list of bulk drug substances that outsourcing facilities can use in compounding under section 503B of the Act.
Scope of Work:
M-CERSI’s research will obtain particular information about bulk drug substances nominated for use in compounding under section 503B. Information priorities will relate to elements of information described in FDA’s Federal Register Notice requesting such nominations. M-CERSI will engage with entities that have submitted nominations to the 503B bulks list to obtain information needed to support the nominations. M-CERSI will conduct outreach to nominators to request specific information based on deficiencies in the information available to FDA.
Then, M-CERSI will compile the information that the nominator has provided for each nominated bulk drug substance. As needed, M-CERSI will engage in ad-hoc outreach to seek the submission of specific missing pieces of information needed to support review of nominated substances.
Dissemination of Findings:
M-CERSI will establish a structured database system to organize and manage completed packages of information for each nomination and provide FDA with electronic access to this system to review nomination packages as they are completed. This research is expected to inform FDA’s assessments as to the clinical need for the substances, and generally help inform agency decision-making, stakeholders, and the public. Ultimately, this project will help to improve patient and health care provider access to compounded drug products for which there is a clinical need.
Click here for completed nomination packets.
For More Information:
Additional information is also available on FDA’s website.