FDA Announces Compounding Research Projects

04 October 2018

BioPrarm International

The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.

FDA announced on Sept. 26, 2018 that it has entered into an agreement with the National Academies of Science, Engineering & Medicine (NASEM) and has expanded agreements with the University of Maryland (UMD) and Johns Hopkins University Centers for Regulatory Science and Innovation (JHU CERSIs) to conduct research on the compounding of drugs.

NASEM will examine the use of compounded bioidentical hormone replacement therapy (BHRT) products, such as progesterone and testosterone, that sometimes are used instead of FDA-approved drug products for hormone replacement therapy. NASEM will evaluate the safety and effectiveness of these products.

NASEM will also examine the safety and effectiveness of multi-ingredient compounded topical pain creams, which typically contain multiple APIs. According to FDA, some of these APIs may not be approved for topical use or for pain relief. The agency has seen adverse events, including skin reactions and death, in patients who have used these types of products.

The agency’s previous collaborations with UMD and JHU CERSIs to research the development of a list of bulk drug substances, or APIs, used in compounding have been expanded. UMD CERSI’s research will expand to 225 bulk drug substances over the next three years. JHU CERSI, which completed its exploratory research, will initiate a one-year research project to evaluate the safety and effectiveness of six bulk drug substances—inositol, methylcobalamin, glutathione, 2,3-dimercapto-1-propanesulfonic acid sodium, oxytocin, and melatonin—used to treat autism spectrum disorder.

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