Despite a long history of safe use and patient need, the FDA is in the process of reviewing and potentially blocking patient access to ingredients used in compounded medications
“Thousands of patients are at risk of losing access to life-saving compounded medications, and we need your help.” -The American Association of Naturopahtic Physicians (AANP)
The FDA’s current position is that if there is an approved pharmaceutical equivalent that will address the condition, the compounded ingredient is not needed. By dismissing why patients need personalized medicine, the FDA is discounting functional medicine uses and only taking into consideration whether an ingredient addresses a specific disease.
“In September, the FDA published a draft rule that – if finalized as currently written – would make 26 ingredients illegal to compound. “
Pleasesubmit comments to the FDA byDECEMBER 4th, 2019 using the link below. To assist the AANP, please comment ONLY on the 26 ingredients listed – we’ve been informed comments mentioning other ingredients will be ignored by the FDA.
Ingredients Impacted
7-keto dehydroepiandrosterone (DHEA)
Acetyl-L-Carnitine
Alanyl-L-Glutamine
Aloe Vera 200:1 Freeze Dried
Artemisinin
Astragalus extract 10:1
Boswellia
CesiumChloride
Chondroitin Sulfate
Chrysin
Curcumin
D-Ribose
Deoxy-D-Glucose
Diindolylmethane
Domperidone
Epigallocatechin gallate (EGCG)
Germanium Sesquioxide
Glycyrrhizin
Kojic acid
Nettle
Nicotinamide adenine dinucleotide (NAD)
Nicotinamide adenine dinucleotide disodium reduced (NADH)
Rubidium Chloride
Sodium Dichloroacetate
Vanadyl Sulfate
Vasoactive intestinal peptide
The American Association of Naturopathic Physicians (AANP) is asking for ALL of us to help protect patient access by submitting comments directly to the FDA by clicking here: https://naturopathic.org/page/LegislativeActionCenter#/90
