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Is ExCel_AP^® FDA approved?

Excerpts from FDA’s website at http://www.fda.gov/cder/handbook/otcintro.htm explain the regulatory path by which ExCel_AP is marketed in the US (key language underlined for emphasis)...

Over-the-Counter (OTC) drug products are those drugs that are available to consumers without a prescription. As with prescription drugs, CDER oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks. FDA has been evaluating the ingredients and labeling of these products as part of "The OTC Drug Review Program." The goal of this program is to establish OTC drug monographs for each class of products. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System." The NDA system--and not the monograph system--is also used for new ingredients entering the OTC marketplace for the first time.

The particular monograph under which topical antiseptics are regulated is entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products” (Federal Register, Vol. 59, No. 116, Friday, June 17, 1994, p. 31402-52 (Proposed Rule). 21 CFR Parts 333 and 369.) which is available at http://www.fda.gov/cder/otcmonographs/Antimicrobial/antimicrobial_antiseptic_TF_PR_19940617.pdf.  Among the active ingredients which this monograph considers “generally recognized as safe and effective” (GRASE) “For preparation of the skin prior to surgery or injection” are: Povidone-Iodine  (PVP-I) 5% to 10% and Isopropyl alcohol (IPA) 70% to 91%.

According to the above mentioned monograph, an antiseptic product is considered to be effective for preparation of “dry” skin sites (e.g. abdomen, arm, subclavian) prior to surgery if it achieves a two (2) log₁₀/cm² reduction in microorganism populations within ten (10) minutes post product application and maintains those populations below pre-treatment “baseline” levels for at least six (6) hours.  Examples of procedures considered by the FDA to be consistent with the “For preparation of the skin prior to surgery” indication include…

• Placement of an arterial catheter
• Venous catheterization for an extended delivery of medication, such as a slow infusion of an antibiotic
• Venous catheterization for blood donation

An antiseptic product is considered to be effective for preparation of the skin prior to injection if it achieves a one (1) log₁₀/cm² decrease in microorganism populations within thirty (30) seconds post product application.  Examples of procedures considered by the FDA to be consistent with the “For preparation of the skin prior to injection” indication include…

• Intramuscular injection for delivery of medication
• Venipuncture for blood drawing for laboratory testing

Containing concentrations of PVP-I and IPA within the limits described in the monograph, and having passed the tests described in it, ExCel_AP has clearance from FDA to be marketed in the US “For preparation of the skin prior to surgery or injection” – the identical indications as was approved by the FDA for ChloraPrep^® via the New Drug Application (vs. monograph) process alluded to above.

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