FDA issues final guidances on interim policy for certain bulk drug substances used in compounding

FDA has issued two final guidance documents regarding the use of bulk drug substances in compounding under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

·         Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act

·         Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act

These guidance documents explain FDA’s policy regarding the conditions under which the agency does not intend to take action against state-licensed pharmacies, federal facilities, and licensed physicians (under section 503A) or outsourcing facilities (under section 503B) that compound drug products from bulk drug substances that cannot otherwise be used in compounding under these sections.

FDA is issuing these guidance documents to avoid unnecessary disruption to patient treatment while FDA evaluates the bulk drug substances nominated for use in compounding under sections 503A or 503B of the FD&C Act. Additionally, these guidance documents clarify the process FDA is using to evaluate these substances.

The guidance documents describe three categories of bulk drug substances nominated by the public for use in compounding. The substances listed in each category may be found at:

·         Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act

·         Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

The categories are:

Category 1 – These substances may be eligible for inclusion on the list of bulk drug substances that can be used in compounding under section 503A or 503B, were nominated with sufficient information for FDA to evaluate them and do not appear to present a significant safety risk in compounding at this time. FDA does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in Category 1 of either 503A or 503B, whichever is applicable, provided that the conditions described in the guidance documents and all other applicable requirements of the FD&C Act are met.

Category 2 – These are bulk drug substances that were nominated with sufficient supporting information for FDA to evaluate them, but raise significant safety concerns, and are not eligible for the policy that applies to substances in Category 1. These bulk drug substances cannot be used in compounding unless FDA publishes a final rule (section 503A (b)(1)(A)(i)(III)) or final Federal Register notice (section 503B(a)(2)(A)) authorizing the particular substance’s use in compounding. See Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding for a list of the substances and a summary of the identified safety risks.

Category 3 – These are bulk drug substances that were nominated for inclusion on the bulk drug substances lists without sufficient supporting information for FDA to evaluate them and are not eligible for the policy that applies to substances in Category 1. These bulk drug substances cannot be used in compounding, and FDA will not consider them for the bulk drug substances lists unless the substances are re-nominated with sufficient supporting information through the following dockets:

Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act 503A Category 1 – Bulk Drug Substances under Evaluation.

• 7 Keto Dehydroepiandrosterone

• Acetyl L Carnitine/Acetyl-Lcarnitine hydrochloride

• Acetyl-D-Glucosamine

• Alanyl-L-Glutamine

 • Aloe Vera/ Aloe Vera 200:1 Freeze Dried

 • Alpha Lipoic Acid

 • Ammonium Tetrathiomolybdate

 • Artemisia/Artemisinin

• Astragalus Extract 10:1

• Beta Glucan (1,3/1,4-D)

• Boswellia

• Brilliant Blue

• Bromelain

 • Cantharidin

• Capsaicin palmitate

 • Cesium Chloride

• Cetyl Myristoleate

 • Choline Chloride

 • Chondroitin Sulfate

• Chrysin

• Deoxy-D-Glucose

 • Dichloroacetate

 • Diindolylmethane

 • Dimercapto-1- propanesulfonic acid (DMPS)

 • Diphenylcyclopropenone (DPCP)

 • EGCg • Ferric Subsulfate

 • Germanium Sesquioxide

• Glutaraldehyde • Glutathione

 • Glycoaminoglycans

• Glycolic Acid

• Glycyrrhizin

 • Kojic Acid

• L-Citrulline

• Methylcobalamin

• Methylsulfonylmethane (MSM)

 • Nettle leaf (Urtica dioica subsp. dioica leaf)

• Nicotinamide Adenine Dinucleotide (NAD)

• Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)

• Ornithine Hydrochloride

• Oxitriptan

 • Phosphatidylserine

• Piracetam

• Pregnenolone

• Pyridoxal 5-Phosphate Monohydrate

• Pyruvic Acid

• Quercetin/Quercetin Dihydrate

• Quinacrine Hydrochloride (except for intrauterine administration)

 • Resveratrol

• Ribose (D)

• Rubidium Chloride

• Silver Protein Mild

• Squaric Acid Dibutyl Ester (aka dibutyl squarate)

 • Tea tree oil (Melaleuca alternifolia leaf oil)

 • Thymol Iodide

 • Tranilast

 • Trichloroacetic Acid

• Ubiquinol 30% Powder

• Vanadium

• Vasoactive Intestinal Peptide

For more details find below links..

·         Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

·         Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

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