FDA to Add Five New Substances to Pharmacy Compounding List

06 September 2019

GMP News

The US Food and Drug Administration (FDA) proposed adding five new substances to the list of bulk drug substances that can be compounded by licensed pharmacists and physicians.

The agency also determined that another 26 bulk drug substances are not appropriate for compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA notes that it is still considering additional substances nominated for inclusion on the list that will be included in future rulemaking.

The proposal marks the first time FDA has sought to expand the list of bulk drug substances for pharmacy compounding since the agency finalized a rule establishing the criteria it will use to determine which bulk drug substances can be compounded under Section 503A last February.

At the time, FDA identified six bulk drug substances that can be used to compound drugs, and four that do not meet the agency’s criteria for pharmacy compounding.

The five bulk drug substances FDA is now proposing to allow for pharmacy compounding are glutaraldehyde, glycolic acid, L-citrulline, pyruvic acid and trichloroacetic acid (TCA).

The 26 that will be excluded from the list are 7-keto dehydroepiandrosterone (DHEA), acetyl-L-carnitine (ALC), alanyl-L-glutamine, Aloe vera 200:1 freeze dried, artemisinin, astragalus extract 10:1, boswellia serrata extract (BWSE), 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, sodium dichloroacetate, vanadyl sulfate and vasoactive intestinal peptide (VIP).

In recent years, FDA has made a number of moves to increase its oversight of drug compounding after a fungal meningitis outbreak linked to the New England Compounding Center led to at least 60 deaths.

Since then the agency has issued dozens of guidance documents related to compounding, stepped up its inspection and enforcement efforts and taken legal action against compounders found in violation of the FD&C Act. In June, FDA announced it would move its oversight of compounding to the Office of Compliance within the Center for Drug Evaluation and Research.

Last week, FDA also identified nine bulk drug substances that it says should not be compounded by outsourcing facilities under Section 503B of the FD&C Act after determining there is no clinical need for those substances to be compounded.

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