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Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate

Federal Register Notice:
Product-Specific Guidances; Guidance for Industry; Availability

Docket Number:

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States (U.S.) from threats including emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to this pandemic.

In anticipation of increased demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available by publishing product-specific guidances (PSGs) to support generic drug development for these drugs. The PSG for chloroquine phosphate clarifies that the product is AA rated in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), meaning that there are no known or suspected bioequivalence problems, and no in vivo studies are necessary. The PSG for hydroxychloroquine sulfate adds advice about a Biopharmaceutics Classification System-based biowaiver option.

Given this public health emergency, and as discussed in the Notice in the Federal Register of April 13, 2020, titled “Product-Specific Guidances; Guidance for Industry,” available at Federal Register - Guidance: Product-Specific Guidances the PSG for chloroquine phosphate is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the FDA’s good guidance practices.


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