Title 21

SECTION 516.157

516.157 Publication of the index and content of an index listing.

§ 516.157 Publication of the index and content of an index listing.

(a) FDA will make the list of indexed drugs available through the FDA Web site at http://www.fda.gov. A printed copy can be obtained by writing to the Freedom of Information Staff or by visiting FDA's Freedom of Information Staff's Public Reading Room at the address listed on the Agency's Web site at http://www.fda.gov.

(b) The list will contain the following information for each indexed drug:

(1) The name and address of the person who holds the index listing;

(2) The name of the drug and the intended use and conditions of use for which it is indexed;

(3) Product labeling; and

(4) Conditions and any limitations that FDA deems necessary regarding use of the drug.

[72 FR 69121, Dec. 6, 2007; 76 FR 31470, June 1, 2011, as amended at 79 FR 68115, Nov. 14, 2014]

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