00-55519. Drugs for Human Use

CFR Correction

In Title 21 of the Code of Federal Regulations, parts 300 to 499, revised as of April 1, 2000, make the following corrections:

1. On page 56, §310.545 is corrected by adding paragraph (d)(2) to read as follows:

§ 310.545

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

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(d) * * *

(2) February 10, 1992, for products subject to paragraph (a)(20) of this section.

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2. On page 61, §312.3(b) is corrected by revising the definition for “Marketing application” to read as follows:

§ 312.3

Definitions and interpretations.

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(b) * * *

Marketing application means an application for a new drug submitted under section 505(b) of the act or a biologics license application for a biological product submitted under the Public Health Service Act.

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3. In part 314, in both the table of contents on page 97, and in the text on page 165, add “Subpart F [Reserved]”.