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The work of the association relies on the many contributions of members such as you. Volunteer leaders are the mainstay of any professional organization.

Nutrition Care Manual
Nutrition Care ManualSubscribe

The Academy's Nutrition Care Manual is a comprehensive online resource that covers all aspects of nutrition management. NCM’s user-friendly resources include:

  • Disease-specific nutrition assessment, diagnosis, intervention, monitoring and evaluation recommendations.
  • Printable client handouts in English and Spanish.
  • Formulary database.
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...from the publication: Eat Right Weekly - June 28

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FDA Rule Will Require Early Notification of Drug Discontinuances or Interruptions

The Food and Drug Administration plans to release a proposed rule requiring drug manufacturers to give notification of discontinuances or interruptions in the manufacturing of life-supporting and other critical drugs. This rule would break down barriers that prevent many Academy members from providing optimal care to their patients.

For more than a year, drug shortages have affected registered dietitian nutritionists working in hospitals and clinics. According to the FDA, the most recent drug shortage was due to the closing of a large drug manufacturer that produces total peripheral nutrition, or TPN, products. The manufacturer temporarily ceased operations to address a quality issue. Upon learning of the shutdown, the FDA looked for ways to increase supply, such as seeking the assistance of foreign companies. However, this new partner did not meet demand; therefore, FDA worked with other American manufacturers to increase supply.

The Academy has been vigilantly working on this issue to ensure life-supporting and life-sustaining vitamins, minerals and electrolytes are accessible to clinicians and patients. Last year, Academy staff and members visited Congress to voice support for legislation to amend the Federal Food, Drug and Cosmetic Act to provide FDA with improved capacity to prevent drug shortages. Eventually the Food and Drug Administration Safety and Innovation Act of 2012 was passed and now the FDA is preparing to release its proposed rule. The rule has been sent to the Office of Management and Budget for final review before publication.

According to FDA, early notification of issues that could lead to shortages helped the agency prevent more than 100 shortages during 2012. Now, early notification will be mandated. Under the new law and forthcoming rule, manufacturers of drugs deemed as life-supporting, life-sustaining or used in the prevention or treatment of a debilitating disease or condition must report expected production issues six months prior to discontinuation or interruption, or as soon as possible if six months notification is not practical.

The Academy anticipates commenting on the FDA’s proposed rule when it is released to the public for feedback. In addition, the Academy will continue to work with its partners at the American Society for Parenteral and Enteral Nutrition to develop a strategy to prevent future drug shortages.

« Back To Eat Right Weekly - June 28