FDA Wants to Further Regulate Hand Cleaners used in Hospitals
FDA issued a proposed rule of 1 May 2015 to revise a previous law from 20 years ago regulating over-the-counter (OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital. Hand cleaners are generally recognized as safe and effective, however recent scientific data has cast doubts about the overall protection from infections offered by certain hand cleaners indicating that these cleaners may not be as effective as previously thought. Under the new rule, when final, manufacturers of antiseptic hand cleaners will be required to provide additional cell culture (in vitro) and animal (in vivo) data to support the safety and effectiveness of antiseptic active ingredients. These include in vitro data characterizing the ingredient's antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient. The proposed rule is open for public comments for 180 days which is till 28 Oct 2015. [Learn about how to meet FDA to ask for advice]
Article Source:
FDA’s antiseptic products
The Washington Post
Our regulatory expert shares his thought below.
FDA issued a proposed rule of 1 May 2015 to revise a previous law from 20 years ago regulating over-the-counter (OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital. Hand cleaners are generally recognized as safe and effective, however recent scientific data has cast doubts about the overall protection from infections offered by certain hand cleaners indicating that these cleaners may not be as effective as previously thought. Under the new rule, when final, manufacturers of antiseptic hand cleaners will be required to provide additional cell culture (in vitro) and animal (in vivo) data to support the safety and effectiveness of antiseptic active ingredients. These include in vitro data characterizing the ingredient's antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient. The proposed rule is open for public comments for 180 days which is till 28 Oct 2015. [Learn about how to meet FDA to ask for advice]
Article Source:
FDA’s antiseptic products
The Washington Post
Our regulatory expert shares his thought below.
