Pharmaceutical Affairs Act Enforcement Rules Article 36

When, during the inspection and batch-sealing procedures required under Article 74 of the Act, review or test results indicate non-conformance with standards, then in the case of a foreign imported drug, personnel shall be dispatched by the competent health authority of the special municipality or county (or county-level city) to oversee return shipment of the drugs within a specified period by the original importer; in the case of domestically manufactured drugs that can be used after re-modification, personnel shall be dispatched by the competent health authority of the special municipality or county (or county-level city) to oversee their re-modification within a specified period by the original manufacturer. If the return shipment or re-modification cannot be accomplished within that time period, or if re-modification is not possible, the drugs shall be destroyed.