Regulatory Focus™ > News Articles > FDA to OTC Antiseptic Manufacturers: Label Changes, Packaging Changes Needed

FDA to OTC Antiseptic Manufacturers: Label Changes, Packaging Changes Needed

Posted 14 November 2013 | By Alexander Gaffney, RAC

US regulators said Wednesday that they are requesting that all manufacturers of certain over-the-counter (OTC) topical antiseptic products reformulate the packaging for their products in light of the potential for users to introduce contaminants into them.


OTC topical antiseptics are generally used to prepare a site prior to injection to reduce the chance of site infection. While some of the products are currently distributed in single-use form, many are packaged in multiple-use packages like tubes that permit the end user to apply the desired amount and then administer more of the product at a later time.

The problem, regulators said, is that the re-use of the products introduces a higher chance of contamination.

To illustrate the point, consider a standard container of isopropyl or ethyl alcohol-generally a plastic container with a top that can be removed and replaced by the user. When the top is open, contaminants can fall into the container, such as droplets of unsterile water from a nearby faucet.

Other antiseptic products include solutions, swabs, pads saturated with a solution and applicators containing a solution.

Known Harms and Recommended Action

FDA says in its 13 November 2013 announcement that it is aware of at least four deaths, five wound infections, 10 cases of septic arthritis, 14 cases of indwelling catheters requiring replacement, 16 cases of injection site infection and 32 cases of bacteremia associated with contaminated antiseptic products.

As a result, FDA said it will be requesting that manufacturers make changes to the labeling of the products and to-where possible-institute single-use packaging to decrease the risk of a product becoming contaminated during normal use.

"We are requesting that manufacturers package antiseptics indicated for preoperative or pre-injection skin preparation in single-use containers," FDA explained.

In addition, because topical antiseptics are not required to be manufactured sterile, FDA will request that products be labeled with a statement indicating whether or not they are sterile.

Regulators did not offer a timetable for action, and neither did they say whether they would consider the changes under a Changes Being Effected (CBE) -0 or -30 (day) supplement, or even under a prior approval supplement (PAS) in certain cases. FDA's guidance on change notifications is available on its website.

FDA Announcement

Tags: drug

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