KV Pharmaceutical Company, a developer and marketer of branded and generic or non-branded prescription pharmaceutical products, has entered into a consent decree with the FDA regarding the company’s drug manufacturing and distribution.
The decree provides a series of measures that, when satisfied, will permit KV to resume the manufacture and distribution of products marketed by its subsidiaries, Ethex and Ther-Rx.
As part of the consent decree, KV has agreed not to market products it manufactures until it has satisfied certain requirements designed to demonstrate compliance with the FDA’s current good manufacturing practices (CGMP) regulations. KV has also agreed that it will not distribute certain products, including its prenatal vitamins and hematinic products, until the products are approved by the FDA’s abbreviated new drug application or new drug application processes.
The consent decree provides that, before resuming manufacturing, KV will have an independent third party CGMP expert consultant undertake a review of KV’s facilities and certify compliance with the FDA’s CGMP regulations. Following that certification, the FDA will make a determination as to whether the KV facilities are in compliance.
The decree further provides that KV may request the FDA that it be permitted to resume manufacturing and distribution of certain products before the company is cleared by the FDA to resume full operations. KV said that it has already retained the third party CGMP expert consultant, which has been on-site for several weeks.
David Vliet, KV’s interim CEO, said: We look forward to co-operating with the FDA during this process that will facilitate our return to the market. Predicting the timing for the return and the ultimate product assortment that we will market are presently very difficult due to the range of variables that must be managed. As we gain certainty, we will notify customers and all other stakeholders.