FOR THOSE WHO HAVE ASKED “WHEN WILL THE SUBSTANCES BE TAKEN OFF THE COMPOUNDING MARKET THAT HAVE BEEN INVOLVED IN THE FDA HEARING PROCESS”:
From “regulations.gov”
Amendments to the List of Bulk Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act “FDA is also proposing that 26 other substances not be included on the list:”
Substances to be removed from the 503(a) bulk compounding list include the following:
NOTE THAT THIS REMOVAL RENDERS THESE SUBSTANCES ILLEGAL TO COMPOUND FOR ANY ROUTE OF ADMINISTRATION: (See link below the list for “what you can your patients can do”)
- 7-keto dehydroepiandrosterone (DHEA)
- acetyl-L-carnitine
- alanyl-L-glutamine
- Aloe vera
- artemisinin
- astragalus extract
- boswellia serrata
- cesium chloride
- 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
- (DCA) sodium dichloroacetate
- vanadyl sulfate
- vasoactive intestinal peptide (VIP)
WHAT YOU CAN DO:
– Donate generously to the Protect Patient Access to Compounded Medications fundraising campaign that supports this legal strategy. Consider sharing this information with your patients and colleagues who would consider supporting the effort.