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Food and Drug Administration and Compliance Issues
Tuesday, March 26, 2013
PharMEDium Supports a New FDA Category for Sterile Compounding
March 26, 2013
The purpose of this communication is to offer our perspective on recent articles in the mainstream press, and the recent blog post "FDA Must Have New Authorities to Regulate Compounding Pharmacies" by Dr. Margaret A. Hamburg, Commissioner of the U.S. Food and Drug Administration (FDA) (https://blogs.fda.gov/)
First and foremost, PharMEDium has long advocated for FDA oversight of the compounding industry, for Congress to clarify the FDA’s authority, and for the adoption of rigorous national quality and safety standards. We support the passage of federal legislation to establish a new FDA category for sterile compounders governed by applicable current Good Manufacturing Practices (cGMPs). We believe FDA oversight of interstate shipments of sterile compounders is necessary.
PharMEDium has shared proposed guidelines for defining the new category of sterile compounders with the FDA, American Society of Health-System Pharmacists (ASHP), National Association of Boards of Pharmacy (NABP) and other organizations. We will continue to work with the FDA and other regulatory agencies to encourage passage of new legislation which addresses the specific needs of sterile drug compounding operations.
While our advocacy for increased federal oversight continues, we remain committed to complying with all applicable federal and state regulations. Since PharMEDium’s inception, we have been registered with the FDA and State Board of Pharmacy in our resident states and are licensed in all states to which we currently ship. The FDA routinely inspects our centers, and we have been fully responsive to the Agency.
The March 20, 2013 Washington Post article "States Cracking Down on Specialty Pharmacies" and the March 15, 2013 Wall Street Journal article "Pharmacies Feel More Heat " mention that PharMEDium is involved in regulatory discussions with New York State and Iowa. Neither New York State nor Iowa have identified any quality or patient safety concerns related to our compounding services. These specific state discussions relate to PharMEDium shipping medications to hospitals in anticipation of specific patient orders based on routine, regularly observed prescribing and dispensing patterns within the hospital.
PharMEDium is an outsourcer of sterile compounding services and operates as an extension of the hospital pharmacy, strictly using FDA approved sterile drugs and components. The hospital pharmacy is responsible for dispensing PharMEDium’s compounded preparations to its patients.
The recent articles suggest that "PharMEDium was one of several companies highlighted in a previous investigation about problems at manufacturing-style compounding pharmacies years before last fall’s outbreak." PharMEDium promptly addressed all concerns raised by inspectors and leads the industry with state of the art sterile compounding processes that meet or exceed the current USP Chapter <797> standards. We continue to provide total transparency to our customers and regulatory agencies. And, as previously stated, PharMEDium is in support of additional FDA oversight and new federal controls.
Patient safety is PharMEDium’s single highest priority and we are committed to maintaining the highest levels of quality in our sterile preparations. We believe this commitment, along with advocacy and support of a new federal compounding category, will help us to continue to support the many hospital pharmacies and patients that rely on us each and every day.