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GUIDANCE DOCUMENT

Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products May 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0322
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document is intended to provide guidance to firms that are manufacturing, marketing, or distributing orally ingested over-the-counter (OTC) liquid drug products (e.g., elixirs, suspensions, solutions, syrups) that are packaged with dosage delivery devices (e.g., calibrated cups, droppers, syringes, spoons).

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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-2009-D-0322 .

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