OIG: FDA Must Increase Education Outreach to Pharmacies on Drug Tracing Requirements

March 30, 2018

Most independent, chain and hospital pharmacies are implementing requirements for drug tracing but many are not properly reviewing the data, according to a new report from the HHS Office of Inspector General.

While 26 of the 40 dispensers analyzed in the review received all required elements, including transaction information, history and statements, 14 did not, and two of those were not aware of Drug Supply Chain Security Act requirements. Twenty-five dispensers said their drug receipt procedures do not include reviewing the product tracing information.

The OIG found that the most commonly missing transaction information was the dosage form. The DSCSA requires that the transaction information include both the National Drug Code and the dosage form.

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