Compounding Hotline

Mr. Erickson is director of professional affairs at Gallipot Inc.

What source are we to use for active ingredients for compounding? One of my third-party payers insists that we are supposed to submit only national drug codes (NDCs) from manufactured dose forms.

The US Pharmacopeia (USP) 32 <795>, "Pharmaceutical Compounding-Nonsterile Preparations" provides, "A USP or NF [National Formulary] substance is the preferred source of ingredients for compounding.... If that is not available, ...the use of another high-quality source, such as Analytical Reagent, certified American Chemical Society, or Food Chemicals Codex grade, is an option for professional judgment." The monograph goes on to specify the conditions under which materials purchased from a "nonregistered" manufacturer might be used. Manufacturers (suppliers) of bulk chemicals registered with the FDA should be able to provide NDCs for their products. Because the USP monograph specifies bulk powders as the preferred source and also indicates that the compounder must consider all ingredients (potential incompatibilities, unacceptability of final preparation, etc) in a manufactured dose form used as a source of active ingredients, it seems that some misunderstanding may exist. A further conversation with the third-party payer at a supervisory level may be useful.

What is "Argyrol"?

It is a brand name for Mild Silver Protein. Strong Silver Protein and this mild form have been used as antibacterials, especially in eyedrops and in topical preparations applied to mucous membranes. The ?mild? form is less irritating but also less active. Colloidal silver is elemental silver in combination with protein and has also been used as a topical anti-infective.

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