21 C.F.R. 21 CFR--PART 310
Title 21 - Food and Drugs
Effective Date(s): April 11, 2007 2. Section 310.545 is amended by adding paragraph (a)(6)(ii)(C) to read as follows: (a) * * * (6) * * * (ii) * * * (C) Approved as of April 11, 2007; October 11, 2007, for products with annual sales less than $25,000. Any ingredient(s) labeled with claims or directions for use for sinusitis or for relief of nasal congestion associated with sinusitis. * * * * *
Amendment from October 11, 2005
21 CFR--PART 310
Amendment(s) published October 11, 2005, in 70 FR 58977
§ 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

