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SMG 1264.52

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH

OFFICE OF PHARMACEUTICAL SCIENCE

OFFICE OF TESTING AND RESEARCH

DIVISION OF PHARMACEUTICAL ANALYSIS

Effective Date: 12/15/1999

Transmittal Number 00-69 -- Date: 05/08/2000

[PDF Version]

1. DIVISION OF PHARMACEUTICAL ANALYSIS (DBNSDB).

A. Collaborates in the chemical, microbiological, and/or biological evaluation of new and abbreviated new drug applications, U.S. Pharmacopeia and AOAC International Monographs (AOAC formerly known as Association of Official Analytical Chemists), and proposed U.S. Pharmacopeia Reference Standards.

B. Develops and disseminates new chemical, microbiological and biological drug assessment techniques, and conducts research on drug and their impurities.

C. Conducts surveillance and laboratory testing of marketed Active Pharmaceutical Ingredients (APIs) of human drug products and hormones to evaluate their quality in support of scientific and regulatory components of the Agency.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this Division were approved by the Director, Center for Drug Evaluation and Research on December 15, 1999.