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SMG 1262.32

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 UNAPPROVED DRUGS AND LABELING COMPLIANCE

DIVISION OF NON-PRESCRIPTION DRUGS AND HEALTH FRAUD

Effective Date: 07/08/2011

[PDF Version]

1. DIVISION OF NON-PRESCRIPTION DRUGS AND HEALTH FRAUD (DKKNDDB)

A. Develops compliance strategies, programs and policies to ensure that all non-prescription drugs marketed in the United States meet applicable requirements of the Federal Food, Drug and Cosmetic Act

B. Engages in strategic, risk-based, enforcement activities to minimize consumer exposure to unsafe non-prescription and fraudulent drug products

2. OVER-THE-COUNTER DRUGS BRANCH (DKKNDDB1)

A. Directs field inspections and investigations and recommends, directs and/or coordinates case development and compliance actions relating to OTC drug products

B. Provides enforcement and litigation support and guidance for OTC drug products

C. Uses risk based assessments to identify and prioritize OTC drugs for regulatory action and develops compliance strategies to address violations

D. Reviews and develops legislative proposals and implementing regulations, policy and guidance documents, enforcement strategies, and outreach activities related to OTC drugs

3. HEALTH FRAUD AND CONSUMER OUTREACH BRANCH (DKKNDDB2)

A. Directs field inspections and investigations and recommends, directs and/or coordinates case development and compliance actions related to fraudulent drug products

B. Provides enforcement and litigation support and guidance relating to fraudulent drug products

C. Monitors the Internet in support of Division's enforcement initiatives, actions and outreach programs

D. Uses risk based assessments to identify and prioritize fraudulent drug products for regulatory action and develops compliance strategies to address violations

E. Reviews and develops legislative proposals and implementing regulations, policy documents, enforcement strategies, and outreach activities related to fraudulent drug products

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 APPROVEDLOCATION
OF CHANGE HISTORY		CONTACTAPPROVING OFFICIAL
Initial05/20/2011N/aCDER/OMCommissioner of Food and Drugs
Revision07/08/2011N/aCDER/OMSecretary of the Department
of Health and Human Services

 

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