21 C.F.R. 21 CFR--PART 310


Title 21 - Food and Drugs


Amendment from October 11, 2005

21 CFR--PART 310
View Printed Federal Register page 70 FR 58977 in PDF format.

Amendment(s) published October 11, 2005, in 70 FR 58977


Effective Date(s): April 11, 2007

2. Section 310.545 is amended by adding paragraph (a)(6)(ii)(C) to read as follows:

§ 310.545   Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

(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.

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