Access to safely compounded medications for NDs and their patients is of increasing concern. The FDA is indicating that:
It may prohibit traditional (i.e., small) compounders from distributing drugs for office use.
Even if traditional compounders are allowed to distribute drugs for office use, out-of-state sales may be limited to 5% of total sales.
For larger compounders (known as “outsourcing facilities”), even though sales for office use will continue to be permitted, the range of approved drug ingredients may be significantly curtailed.
AANP is collaborating with the International Association of Compounding Pharmacists (whose interests here parallel our own) as well as with the Integrative Medicine Consortium in developing a joint strategy. In previous comments to the FDA, we’ve emphasized that NDs should be able to continue treating patients with safely compounded medications in the office. We’ve noted that these nutritional, herbal and homeopathic remedies are compounded to meet unique patient needs and are not typically available from the large drug manufacturers that don’t make small batches of such specialized products.
Of immediate concern is the FDA’s call for extensive information about compounded drugs – and the ingredients they’re made from. An AANP Work Group, led by Dr. Michael Cronin, has identified the priority ingredients (especially where injectables are concerned), and is seeking knowledgeable NDs who can help document “clinical need,” e.g., the types of conditions a given compounded drug is meant to remedy, and why that drug is needed by certain patients versus the mass produced, FDA-approved drug.
If you can assist in this effort, please contact Mike Jawer
, Director of Government and Public Affairs, as soon as possible.