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GUIDANCE DOCUMENT

Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry Draft Revised Draft October 2019

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Revised Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2017-D-6580
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This draft guidance describes how we intend to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval. As discussed below, FDA has developed a risk-based approach under which the Agency intends to prioritize enforcement and regulatory actions involving certain categories of such products that potentially pose a higher risk to public health.

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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:

Dockets Management
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-2017-D-6580.

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