SMG 1262.62

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 DRUG SECURITY, INTEGRITY AND RECALLS

DIVISION OF SUPPLY CHAIN INTEGRITY

Effective Date: 07/08/2011

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1. DIVISION OF SUPPLY CHAIN INTEGRITY (DKKNDFB)

A. Serves as FDA focal point for drug integrity and security issues and policies related to drugs

B. Devises and implements importation, drug component and finished drug security policy, including securing supply chains to prevent counterfeit, diversion, economically motivated adulteration, theft, and other supply chain threats; fostering good distribution practices; and developing and implementing standards for identification, track and trace, and authentication in the U.S

C. Develops compliance strategies, programs and policies to ensure that the nation’s drug supply is safe and secure and that all drugs in distribution and offered for import meet applicable statutory and regulatory requirements

D. Engages in and supports strategic, risk-based, enforcement activities to minimize consumer exposure to unsafe, ineffective, and poor quality drug products

E. Develops educational programs to promote compliance with applicable laws and regulations that pertain to drug integrity and security

F. Leverages data and information on drug integrity and security to identify trends in order to develop targeted policies and compliance strategies to enhance assurance that drugs are of high quality, safe, and effective and meet applicable requirements

G. Develops and implements standards, programs, and policies for identification, track and trace, and authentication in the U.S. and other means to secure our nation’s drug supply

H. Prevents the diversion of counterfeit, sub potent, adulterated, and misbranded prescription drug products by administering the Prescription Drug Marketing Act

I. Coordinates FDA drug import policies with ORA, including the development and institution of joint initiatives with other Federal agencies and foreign governments

2. 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