U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Innovative Approaches for Nonprescription Drug Products
  1. Search for FDA Guidance Documents


Innovative Approaches for Nonprescription Drug Products July 2018


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes two innovative approaches that may be useful to consider for 16 demonstrating safety and effectiveness for a nonprescription drug product in cases where the 17 drug facts labeling (DFL) alone is not sufficient to ensure that the drug product can be used 18 safely and effectively in a nonprescription setting: (1) the development of labeling in addition to 19 the DFL, and (2) the implementation of additional conditions so that consumers appropriately self-select and use the product.

Submit Comments

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-2018-D-2281.

Back to Top