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FDA suggests replacement of label, packaging process for topical antiseptics

US Food and Drug Administration (FDA) has urged manufacturers to replace the label and packaging of certain over-the-counter (OTC) topical antiseptic products to improve safety.

The move is part of the ongoing evaluation of infrequent reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation.

The new label would contain directions for health care professionals and patients to reduce chances of infection.

FDA also requests manufacturers to package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers, to further reduce the risk of infection with improper topical antiseptic use and the possibility of the products becoming contaminated with bacteria during use.

The antiseptics in these containers should be applied to one patient one time only, FDA added.

The authorities have also asked the manufacturers to provide information regarding the manufacturing process for topical antiseptics to indicate if the drug is produced as a sterile or nonsterile product.

According to the agency, the topical antiseptics should be manufactured under its Current Good Manufacturing Practice (cGMP) standards for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.