FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Taking Nominations for List of Difficult-to-Compound Drugs

Aug. 2, 2017
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The FDA established a public docket so companies can nominate drug products or categories for the agency’s Difficult to Compound List — which blocks pharmacies from compounding certain products unless they are listed as a manufacturer.

The agency previously took nominations for the list in 2013 and gathered more than 70 products or categories. Criteria for inclusion on the list were subsequently updated by the FDA’s Pharmacy Compounding Advisory Committee.

In the new docket, the agency is allowing companies to submit new products, resubmit previous products with additional supporting information or submit comments. Nominations should include the reasons for inclusion and account for any risks and benefits to patients, the agency said.

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