According to a story from outsourcing-pharma.com, the US Food and Drug Administration (FDA) has recently started a new initiative with the opening of its Compounding Quality Center of Excellence. Janet Woodcock, who is the director for the FDA’s Center for Drug Evaluation and Research, has said that the primary goal of the new Center is to provide educational tools that will help facilitate the more reliable manufacture of compounded drugs that will be able to consistently meet regulatory standards. Another goal of the new establishment will be to improve the FDA’s engagement with outsourcing facilities.

What Are Compounded Drugs?

Compounded drugs are bit different from the typical, mass produced prescription drugs that are most commonly used. A compounded drug is a custom medication that is produced for a specific patient on a doctor’s orders. These drugs can be tailored to fit the patient’s needs more effectively, allowing for more personalized care. In many cases, a compounded drug may be modified in such a way that it is easier for a patient to administer. Compounded drugs are more likely to be ordered by specialists, such as pain specialists, dermatologists, gastroenterologists, podiatrists, and endocrinologists. These medications are of particular concern to the FDA because they don’t have to undergo evaluations that confirm their effectiveness and safety.

Operations

The Compounding Quality Center of Excellence was established in response to recent recalls of compounded drugs; inspections of some outsourced production facilities raised serious concerns that highlighted the need for more clearly spelled out standards.

The operations of the center will prioritize three main areas of focus. These areas will include:

1. Training for compounded drug manufacture that will be available as in-person courses and online. Training classes are expected to begin in March of this year and will address a variety of relevant subjects, such as quality assurance, preventative measures, environmental monitoring, and sterilization.
2. A conference that will allow the agency, manufacturers, and other stakeholders to converge and collaborate on best practices and other ideas.
3. Market research that will help keep the FDA informed on issues that outsourcing facilities are facing.

Hopefully, the Compounding Quality Center of Excellence will succeed in its goals and allow compounded drugs to be both safer and more effective.

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