After Intense Scrutiny, FDA Set to Take Another Look at OTC Antiseptics

Regulatory NewsRegulatory News | 28 July 2014 |  By 

The US Food and Drug Administration (FDA) will soon hold a meeting regarding the safety and efficacy of non-prescription antiseptic products, just months after raising concerns about the products to manufacturers.


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.

In November 2013, FDA issued a warning to manufacturers, saying that it was aware of at least four deaths, five wound infections and dozens of other infections caused by OTC antiseptics. The problem, the regulator said, was that the products were becoming contaminated after being opened.

FDA's proposal to manufacturers was that they reformulate their products to be single-use products. "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 requested that products be labeled with a statement indicating whether or not they are sterile. FDA has previously warned some companies for manufacturing supposedly sterile products under unsanitary conditions, however.

One month later, in December 2013, FDA also issued a rule affecting antiseptic products used with water (i.e. hand soaps). Under FDA's rule, manufacturers would need to submit additional safety data to indicate that antiseptic products are safe and effective compared to non-antibacterial soaps.

New Regulatory Examination

But FDA apparently isn't done examining OTC antiseptics.

In a 28 July 2014 notice posted by FDA in the Federal Register, the regulator said it was calling a meeting of its Nonprescription Drugs Advisory Committee (NDAC) in September 2014, which will discuss the safety and efficacy of various antiseptic products.

Those products, FDA said, will include healthcare personnel hand washes and rubs, surgical hand scrubs and rubs and patient preoperative and pre-injection skin preparations.

"The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective," FDA explained.

Unusually, FDA offered no other details about the scope or intent of the meeting. The regulator often includes questions it wants meeting attendees to ponder in advance of the meeting

The one-day meeting will take place on 3 September 2014 at FDA's White Oak campus in Silver Spring, MD.


Federal Register Notice


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