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When Is a Monograph Not a Monograph?
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In order to prepare a customized medication with a bulk ingredient, whether you are a 503A traditional compounder or a 503B outsourcing facility, the Active Pharmaceutical Ingredient(s) must meet certain requirements included in the Drug Quality & Security Act. Specifically, the API must have a USP or NF monograph, be a component of an FDA approved drug, and/or be formally included on a list established by the Secretary of Health and Human Services.

Pretty straightforward, right?  Well, maybe not.  

During the June 17, 2015 meeting of the FDA Pharmacy Compounding Advisory Committee (PCAC) a question was asked about the dietary supplement monographs included in USP. FDA representative Jane Axelrad stated that “we don't consider dietary supplement monographs to be the kind of monograph that they were referencing in the statute as being okay to compound.”  In other words, even if pharmacists and physicians and even USP believes that a published monograph is a monograph, the FDA now states that they have a completely different view.

Ms. Axelrad reaffirmed that position upon questioning from the USP appointed PCAC representative Gigi Davidson: “If there is not a USP monograph, not a dietary supplement monograph, then we do not consider it to meet the standard for a bulk drug substance that can be used in compounding unless it's on this list. It basically says compound with the standards of an applicable USP or National Formulary monograph, and we consider that to be the regular monographs that are used to support or address the standards for drugs, bulk active pharmaceutical ingredients, and finished drug products in that part of the USP, not the dietary supplement monographs and not the compounding monographs either. Those are not what we view as applicable monographs for this.”

IACP has filed a formal letter of inquiry with FDA asking for an explanation of this position. Please click here to view IACP's letter. In addition, if FDA does not accept all published USP monographs, the Academy has requested that the nomination process for bulk drugs be reopened so that the more than 260 dietary supplements with USP monographs can be formally submitted for review and inclusion on the bulk drug substances list. We are working closely with our FIX DQSA allies who have a particular interest in dietary supplements and their use in medical treatment including the Alliance for Natural Health and the American Association of Naturopathic Physicians to again point out to Congress that the agency is “interpreting” language in a manner that is contrary to what the statute actually says.

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