Understanding the FDA Compounding Pharmacy Guidance Document

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The Compounding Pharmacy industry has recently been criticized by the FDA for mixing products that have caused considerable patient harm due to sterility. The guidance document put out describes conditions under which the agency considers insanitary. The agencies guidance is vague, it is up to Compounding Pharmacies to prevent any insanitary conditions and put the proper controls into place to prevent insanitary conditions from occurring. The webinar will help Compounding Pharmacies to understand what actions are needed in order to prevent insanitary conditions.

Why should you attend? 

The FDA has recently been cracking down on Compounding Pharmacy facilities due to the fungal meningitis outbreak in 2012 that caused 60 deaths and 750 cases of infection. As a result of this, the Agency is not confident in the ability of Compounding Facilities to maintain a state of control on their facilities and the conditions under which the product is compounded. Many of the insanitary conditions described by the agency are outlined in this guidance document. By understanding and implementing the concepts described in the Aseptic Guidance document – Sep 2004, many of the conditions described can be eliminated and controlled

Description of the topic:

The process of aseptic filling of final drug products provide an excellent reference when it comes putting the proper procedures and controls into place for preventing many of the insanitary conditions outlined in the guidance document. By understanding how final drug product is aseptically filled, Compounding Pharmacies can implement many of the controls used. The guidance reference the industry uses to process products aseptically is the Aseptic Processing Guidance Document –Sept 2004. By reviewing and implementing the concepts in this document, many of the examples of insanitary conditions outline the proposed guidance document can be eliminated.

Areas Covered in the Session:

  • A brief history of reason why the Compounding Pharmacy Guidance document is being implemented. 
  • A brief overview of the Aseptic Processing Guidance Document – Sep 2004.
  • Reviewing the Aseptic Guidance document and how it implies to the insanitary conditions described in the proposed guidance document.
  • Examples on how the concepts outlined in the Aseptic Processing

Who will benefit:

 Employees, Supervisors, and Managers involved in compounding drug products. Quality personnel involved with reviewing procedures, batch records, and results associated with aseptically compounding drug products.

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