AANP Speaks Up to FDA
3/10/2014
Mike Jawer, AANP Director of Government & Public Affairs
AANP provides a second set of comments to the FDA regarding drug ingredients
Monday, March 10, 2014
by: Mike Jawer, AANP Director of Government & Public Affairs

Section: State and Federal Advocacy




AANP has provided a second set of comments to the FDA regarding drug ingredients that ought to be approved by the agency for compounded medications.

A work group led by immediate past-president Michael Cronin, ND, identified dozens of ingredients that are essential for IV products and other compounded medications that demonstrably benefit patients. Last month, AANP weighed in on the safe and effective ‘office use’ of compounded products. Participating in the rulemaking process is essential since, in its proposed guidance, the FDA appears to be leaning towards elimination of office use – at least where drugs are obtained from smaller compounding pharmacies that opt to continue to be regulated by their state.

The agency will also review virtually all ingredients used in the compounding of sterile medications. All of this regulatory activity stems from the Drug Quality and Security Act, a law signed by President Obama last year, written by Congress to provide greater safeguards on compounded drugs following a deadly nationwide outbreak of meningitis more than a year ago.

In developing its comments, AANP worked with the International Academy of Compounding Pharmacists and other integrative medicine groups so that a wider range of physicians and their patients is now on record with FDA.

Click here to request a copy of AANP's comments.
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