| FDA | Center for Drug Evaluation and Research | Office of Compliance | | | The FDA Compounding Quality Center of Excellence is announcing the availability of a self-guided online course: Insanitary conditions and sterility assurance. The purpose of the course is to provide information on how to improve sterility assurance and prevent insanitary conditions to protect patient health. This course covers how insanitary conditions relate to sterility assurance, the most encountered insanitary conditions in non-sterile and sterile drug production facilities and the consequences of each, the "systems approach" to sterility assurance and preventing insanitary conditions, as well as how to identify, mitigate, and correct insanitary conditions. These courses are free of charge and offer continuing education units. This course is approved for four continuing education units for pharmacists, physicians, and nurses. The Compounding Quality Center of Excellence offers training to support outsourcing facilities and other stakeholders in their efforts to enhance the quality of compounded drugs. - Pharmacists
- Pharmacy technicians
- Laboratory staff
- Quality staff, including quality control, quality assurance
- Operations, production or manufacturing
- Microbiologists
- Compounding facility management
| | | FDA's human drug compounding program 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. More Information | | This is an automated message delivery system, replying to this message will not reach the FDA. Contact us at Compounding@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707. | | | |
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