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Sec. 420.300 Changes in Compendial Specifications and NDA Supplements (CPG 7132c.04)

BACKGROUND:

Periodically due to advances in technology, methodology, etc., the compendial specifications for a NDA drug will be changed. The question then arises as to whether the NDA and ANDA holder(s) are required to supplement their application(s).

POLICY:

Any change in the compendial specifications for an NDA drug will normally require the submission of an NDA supplement as set forth in 21 CFR 314.8 and the supplement must normally be approved before the changes can be effected by the NDA holder. However certain changes, as set forth in 21 CFR 314.8(a)(5), may be placed into effect without the approval of a supplement under the conditions described in that section. Such changes included:

1. A change to more stringent specifications without altering the method described in the approved application.

2. Inclusion of additional specifications and methods without deletion of those described in the approved application.

3. The alteration of specifications or methods for inactive ingredients to bring them into compliance with new or revised specification or methods in an official compendium.

Issued: 10/1/80