Role of Compendia

The USP is recognized as the official compendium by the FDA (21 U.S.C 3 321(j)). Under General Notices in the USP 25, both foreign substances and 

TABLE 2 Common Organic Volatile Impurities (Class II) 

In many cases, drug articles may be covered by a monograph in a foreign compendium (European Pharmacopeia, British Pharmacopeia, Japanese Pharmacopeia, etc.). Until such time as pharmacopeial harmonization across the regions occurs, the FDA does not accept the items covered by foreign pharmacopeia as official. However, the specifications (test procedures and acceptance criteria) cited in these monographs can be used as a secondary source of information. 

ROLE OF DRUG MASTER FILES (DMF)—TYPE II AND IMPURITIES EVALUATION 

A Type II DMF may be filed for a drug substance (DS) or for a DS intermediate. For NDAs, drug substance information is usually filed in the NDA itself, instead of a DMF. The Agency reviews Drug Master Files only in connection with the evaluation of a filed IND, NDA, AND A, or supplemental application when a letter authorizing such review is provided. There is no regulatory requirement that a DMF be submitted to support any of the above applications. The agency does not approve or deny approval to a DMF. 

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