Office of Compounding Quality and Compliance
Who we are
The Office of Compounding Quality and Compliance (OCQC) aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.
What We Do
- Work to protect consumers from unsafe compounded drugs.
- Develop and implement the Compounding Quality Center of Excellence focused on improving the quality of compounded drugs.
- Develop and implement policies and compliance strategies to protect the public health by helping assure the quality of compounded drugs.
- Evaluate incidents, compliance, regulatory and enforcement actions related to compounded drugs.
- Review bulk drug substances nominated for use in compounding.
- Collaborate with state regulators in the development and implementation of compliance and enforcement strategies related to compounded drugs.
- Issue compounding risk alerts to inform stakeholders about risks associated with compounded drugs, including information on adverse events, outbreaks or drug quality.
Organization
- Division of Compounding I
- Division of Compounding II
- Division of Compounding Policy and Outreach
Contact Us
Email: [email protected]
Phone: 301-796-3100
Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Room 5271
Silver Spring, MD 20993-0002