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Executive Summary

NDA/ANDA CHANGES "SPECIFICALLY DESCRIBED" IN OFFICIAL COMPENDIUM may be made without the sponsor submitting a supplemental application, FDA said in a clarification of requirements for supplemental filings published in the June 4 Federal Register. The agency said it was proposing to change the regulations "to allow the holder of an approved application to adopt, without the filing of a supplemental application, 'any test, method, labeling statement, or specification . . . to comply with the adoption of that same test, method, labeling statement, or specification in an official compendium.'" The agency explained that it was proposing to revise the wording of the current regulation because existing language is being misinterpreted, and to make clear that the intent of the provision is "confined to changes specifically described in the compendium." According to the current language, FDA explained, a supplemental application need not be filed for an NDA/ANDA change which is "made to comply with an official compendium." The agency noted that "the phrase has been read by some drug companies to include not only those changes specifically described in an official compendium, but also other changes that, although not described in the compendium, are, arguably, 'made necessary' by the change that was described." For example, FDA pointed to the case of one drug company that interpreted the language "as allowing it to reformulate a product on the basis that the official compendium had adopted a dissolution testing requirement for the product. Because the approved formulation of the product could not meet the newly adopted dissolution testing requirement, the company claimed that a change in formulation was 'made necessary' by the compendial change even though the formulation itself was not described in the compendium." Because FDA and the United States Pharmacopeial Convention work closely in the development of compendial standards, the agency explained that it is aware of compendial changes before they are finalized. Therefore, FDA "emphasized that agency review of proposed compendial changes under this process is limited to review of the particular revision being considered by the USPC." Although the changes are allowed to be made without submission of a supplemental application, FDA noted that the changes must be described in the next annual report with FDA.

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