- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to address questions FDA has received asking for clarification regarding FDA’s enforcement of certain requirements relating to the distribution of drug samples under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 public health emergency (PHE). PDMA is part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the relevant implementing regulations regarding drug samples are in 21 CFR part 203 (part 203), subpart D.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1136.