About FDA
SMG 1262.42
FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF COMPLIANCE
OFFICE OF MANUFACTURING AND PRODUCT QUALITY
DIVISION OF DOMESTIC DRUG QUALITY
Effective Date: 07/08/2011
1. DIVISION OF DOMESTIC DRUG QUALITY (DKKNDAB)
A. Manages the human drug CGMP enforcement program through case review and support
B. Reviews all domestic recommendations (including small molecules and specialized biotech) for judicial and administrative actions based on adulteration charges under the Act, to ensure consistency and adherence to agency policy
C. Provides technical support for contested judicial actions (injunctions, seizures, and prosecutions), including identification of outside expert witnesses, assistance on witness declarations, preparation of witnesses, review of other legal documents, and performance of other activities in support of government counsel
D. Determines the need for requesting and coordinating additional investigations to develop support for regulatory action enforcement recommendations and to respond to emerging adverse drug quality patterns
E. Performs front-loading of cases and technical guidance on ongoing investigations, domestic quality problems, and input into regulatory procedures
2. DOMESTIC COMPLIANCE BRANCH 1 (DKKNDAB1)
A. Reviews domestic recommendations for judicial and administrative actions based on adulteration charges under the Act to ensure consistency and adherence to agency policy
B. Provide enforcement decision based on review of evidence of violations, compliance policy, public health risks, and resource availability
C. Participates with other Agency offices, divisions, and districts on domestic compliance issues and in regulatory meetings to ensure consistency of interpretation of GMPs
D. Provides CGMP support on “for-cause” or “directed” assignments, and other related domestic inquiries and assignments
3. DOMESTIC COMPLIANCE BRANCH 2 (DKKNDAB2)
A. Reviews domestic recommendations for judicial and administrative actions based on adulteration charges under the Act to ensure consistency and adherence to agency policy
B. Provide enforcement decision based on review of evidence of violations, compliance policy, public health risks, and resource availability
C. Participates with other Agency offices, divisions, and districts on domestic compliance issues and in regulatory meetings to ensure consistency of interpretation of GMPs
D. Provides CGMP support on “for-cause” or “directed” assignments, and other related domestic inquiries and assignments
4. AUTHORITY AND EFFECTIVE DATE
The functional statements for this Division were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.
| STATUS (I, R, C) | DATE APPROVED | LOCATION OF CHANGE HISTORY | CONTACT | APPROVING OFFICIAL |
|---|---|---|---|---|
| Initial | 05/20/2011 | N/a | CDER/OM | Commissioner of Food and Drugs |
| Revision | 07/08/2011 | N/a | CDER/OM | Secretary of the Department of Health and Human Services |
