Nonprescription Drug Safe Use Regulatory Expansion

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A NEW FDA-Driven Rx-to-OTC Switch Initiative: The Expansion of “Conditions of Safe Use” Additional Building Blocks for Rx-to-OTC Switch Success. Monmouth Beach, NJ: Francesco International; 2012.

FDA approves OXYTROL FOR WOMEN, the first over-the-counter treatment for overactive bladder in women [press release]. Merck. January 25, 2013. http://www.mercknewsroom.com/press-release/consumer-care-news/fda-approves-oxytrol-women-first-over-counter-treatment-overactive-. April 18, 2013.

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Using innovative technologies and other conditions of safe use to expand which drug products can be considered nonprescription. Public Hearing. US Food and Drug Administration. [Docket No. FDA–2012–N–0171]. Federal Register. 2012;77(39):12059–12062. http://www.gpo.gov/fdsys/pkg/FR-2012-02-28/pdf/2012-4597.pdf. Accessed April 18, 2013.