AANP Comments to FDA
Mike Jawer, AANP Director of Government & Public Affairs
AANP responds to FDA on office use. The FDA is charged with regulating compounding pharmacies under the Drug Quality and Security Act.
Friday, January 31, 2014
by: Mike Jawer, AANP Director of Government & Public Affairs

Section: State and Federal Advocacy

AANP has provided comment to the Food and Drug Administration on its proposed guidance that would greatly restrict the ability of physicians to administer compounded medications – including injectables and IV solutions – to patients in the office.
The FDA is charged with regulating compounding pharmacies under the Drug Quality and Security Act (HR 3204), which was signed by the President last November.  The new law is intended to fundamentally change the regulation of drug compounding and drug distribution in the US.  One of the ways it does this is by creating a new category of drug facilities, known as “outsourcing facilities,” that can choose to register with and be regulated by the FDA, in turn being allowed to compound sterile drugs and ship them out-of-state without first obtaining individual prescriptions.  But compounding pharmacies that choose not to register (typically smaller operations that compound in limited quantities) will have very limited out-of-state distribution and the FDA is proposing that any medications compounded by these pharmacies be tied to the receipt of an individual patient prescription.
An AANP Work Group, chaired by immediate past president Michael Cronin, ND, developed our association’s comments.  AANP cited congressional intent in crafting the new law, arguing that Congress meant for the states – and not FDA – to continue having the authority to regulate compounded medications obtained by physicians for in-office use.  Furthermore, AANP argued that patients seen by NDs derive tremendous benefit from having access to safely compounded medications made available or administered to them in the physician’s office.  Nutritional, herbal, and homeopathic remedies are compounded to meet unique patient needs, and are unavailable from large pharmaceutical manufacturers that do not have the skill to make small batches of these specialized products.  These compounded medications have also been used safely for decades. 
In addition to Dr. Cronin, members of the Work Group include Drs. Ken Rifkin, Brenna Murphy, Paul Anderson, Virginia Osborne, Shanon Sidell, Bill Caradonna, and Duffy MacKay.  Non-voting advisory members include Ron Beaman, Dr. Alan Gaby, and Alan Dumoff, Esq., representing the Integrative Medicine Consortium. 
If you would like a copy of AANP’s comments to the FDA, submit your request here.  Our work group is continuing to meet and will be developing another set of comments regarding drug ingredients that are essential in the compounded medications that NDs use.  The FDA is proposing to restrict such ingredients to an ‘approved’ list but organizations have until March 4 to nominate ingredients for that list (especially those that do not already have a US Pharmacopeia or National Formulary monograph or are not considered an Active Pharmaceutical Ingredient or API).
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