Reducing Risks of Compounded Drugs: Online Training Support Learning Management System

This is a REQUEST FOR INFORMATION ONLY, not a Request for Quote (RFQ) and does not commit the Government to award a contract now or in the future. The purpose of this sources sought is to identify Small Businesses with the capabilities to provide the services stated herein. Submission of any information in response to this market survey is purely voluntary and FDA welcomes responses from all interested parties; the Government assumes no financial responsibility for any costs incurred.

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make biologics, medicines and foods more effective, safer and more affordable; and helping the public access accurate science-based information for drug products and foods. The FDA’s mission is to ensure the safety purity, potency, and effectiveness of all regulated products. The agency is committed to providing the public with accurate, timely and easy to understand information on agency policies, programs and actions.

The Center for Drug Evaluation and Research’s (CDER) mission is to protect and promote public health by helping to ensure that human drugs are safe and effective for their intended use, they meet established quality standards and that they are available to patients.

CDER’s Office of Compliance (OC) plays a critical role in protecting and promoting public health in shielding patients from poor quality, unsafe and ineffective drugs.  The complexity of the human drug supply and development pipeline and the global nature of regulated industry present unprecedented challenges to effective regulatory oversight.  CDER’s Office of Compliance encompasses six offices who collectively support FDA’s overall mission:  

• Office of Manufacturing Quality (OMQ)
• Office of Unapproved Drug Labeling and Compliance (OUDLC)
• Office of Drug Security, Integrity and Response (ODSIR)
• Office of Scientific Investigations (OSI)
• Office of Program and Regulatory Operations (OPRO)
• Program Management and Analysis Staff (PMAS)

CDER’s Office of Compliance, as well as other offices in CDER (such as the Office of Pharmaceutical Quality) and other offices at the FDA (such as the Office of Regulatory Affairs) work together to advance FDA’s work related to drug compounding.

Drug compounding is generally the practice of combining, mixing, or altering ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also present a risk to patients. Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. Since compounded drugs are subject to a lower regulatory standard than approved drugs, Federal law places conditions on compounding that are designed to protect the public health.

The Drug Quality and Security Act of 2013 created “outsourcing facilities” – a new industry sector of drug compounders held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers.  Five years since its creation, this domestic industry is still relatively small (approximately 70 entities) and is experiencing growth and market challenges. FDA continues to find concerning quality and safety problems during inspections.

To help this industry meet its intended function, FDA intends to engage in several initiatives to address challenges and support advancement. These include the development and provision of practical and virtual training, as well as in-depth research to better understand barriers that impede growth and potential solutions.