Clinical Use of Drugs Including Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the Food and Drug Administration (FDA), is conducting research and outreach to solicit input from the public, including medical specialists, to better understand the use of 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 are interested in how drugs compounded with these bulk drug substances have been used historically, and how they are currently used in clinical practice. 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 include review of clinical practice guidelines, published literature, and other sources. The research also will involve conducting outreach to medical specialty groups, medical experts in the relevant field(s), and outsourcing facilities. When evaluating current and historical uses of substances, M-CERSI will be considering the conditions the substances are used to treat, the length of time the substances have been used, the patient population they have been used to treat, the extent of their use, and whether the substances are typically used to compound drugs that health care providers maintain in their offices in advance of identifying the individual patients that will receive the drugs.

Dissemination of Findings:

M-CERSI will prepare reports summarizing its findings with respect to the historical and current clinical use of the substances nominated for the bulks list. These findings are intended to help inform the FDA’s decisions about whether to include the substances on the list of bulk drug substances that outsourcing facilities can use in compounding. Completed reports are available in the University of Maryland Digital Archive: https://archive.hshsl.umaryland.edu/handle/10713/11647.

For More Information:

More information about this project can be found on this website. Additional information is also available on FDA’s website.