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About Us
The Office of Compliance advances CDER’s mission of assuring
that safe and effective drugs are available to the American people
by protecting Americans from unsafe or ineffective drugs. We
do this by:
- Addressing public health risks associated with legal violations.
- Developing and overseeing drug compliance programs designed to
reduce consumer exposure to risks of unsafe and ineffective drugs.
- Monitoring the quality of human drugs through inspectional coverage, product testing, and other pre- and post-market surveillance activities.
- Advising the Center Director and other Agency officials on
regulatory and enforcement issues involving human drugs.
- Coordinating Center-Field relations and providing support and
guidance to field offices on case development and regulatory
actions.
- Ensuring uniform interpretation of standards.
- Developing policies and compliance strategies to ensure that
over-the-counter
and prescription drugs are of high quality, properly labeled, safe, pure,
and meet applicable drug approval requirements.
- Developing policy and standards to achieve high product quality
through application of current good manufacturing practice
requirements. We accomplish this by coordinating surveillance and pre-approval
inspections.
- Coordinating evaluation and classification of drug recalls and
working with field offices for implementation of recalls.
- Monitoring resolution of drug shortage situations involving
compliance issues.
- Implementing programs and projects to identify, assess, and
prioritize the public health significance of legal violations.
- Developing and using innovative enforcement strategies to
reduce public health risks associated with legal violations.
Office Organization
The Office of Compliance is composed of the Immediate Office of the Director and four divisions. The divisions are:
Contact Us
CDER
Comment Form
Office of Compliance
10903 New Hampshire Ave.
Bldg. 51, Rm 5271
Silver Spring, MD 20993-0002
Phone: (301) 796-3100
Fax: (301) 847-8747
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