Last week, AANP filed comments with the Food and Drug Administration (FDA) defending the availability of safely compounded medications. Through collaboration with McGuff, a well-respected compounding firm that has long been active on this issue, ND volunteers documented the clinical need for 43 ingredients that are essential in the compounded drugs that naturopathic medicine patients are treated with. AANP also worked with other like-minded organizations to assist them in submitting their own comments attesting to the value compounded medications.
AANP’s comments relate to two parallel tracks referencing sections of the Food, Drug and Cosmetic Act:
Section 503A, which covers traditional (mostly small) compounders that elect not to be regulated by the FDA, but to be regulated by their state; and
Section 503B, which covers larger compounding firms known as outsourcing facilities, which elect to come under FDA regulation.
AANP objected to the extensive and burdensome information that FDA has required in order to nominate compounded drug ingredients for the Agency’s review and approval. AANP also took issue with FDA’s putting itself in the position to determine whether sufficient clinical need exists for a given compounded drug – versus physicians making this determination for their own patients.
Appreciation goes to AANP’s Work Group on this issue, led by Drs. Michael Cronin and Virginia Osborne. They and other NDs put considerable time into developing the ‘clinical need’ case for various ingredients.
AANP will be refining its strategy since indications are that the FDA will not be looking favorably on compounded medications. The stakes are no less than the continued availability of safely compounded drugs – especially their continued availability for office use, i.e., without a patient specific prescription.
If you can assist the Work Group in our continuing efforts, please email AANP staff