MC Endeavors Inc (MSMY)

[SYTI]

“in an effort to reduce the spread of COVID-19 our team is focusing attention and resources on the development of specialized products including Topical Sanitizer Solutions”

Mazurek...stop the STIPPICK BS !
Wasting time and money to TEST ! Doesn't happen overnight even with reduced criterias and those big hand sanitizing companies can make millions more bottles before MSMY even get their product to a lab !


Hand sanitizers are regulated in the USA by the Food and Drug Administration (FDA) as drugs. In 1994, the FDA published a document called the "Tentative Final Monograph for OTC Healthcare Antiseptic Drug Products." It is commonly known in the industry as the TFM. The document, though "tentative," serves as a road map to testing requirements and covers all sorts of antimicrobials meant to be applied to skin, including hand sanitizers

If efficacy testing of your product is required, FDA's suggestions per the TFM are detailed in the page below. If the active ingredient your company wishes to use to make a hand sanitizer is not listed, then it will likely be considered a "new drug" by FDA and subject to a New Drug Application (NDA)

Tentative Final Monograph suggests testing across a broad array of bacteria and fungi using both MIC and time-kill methods, which are the two in vitro; components of the efficacy testing process. It also indicates that a clinical "glove test" is performed, typically upon completion of the MIC and Suspension Time-Kill studies. The in vivo portion of efficacy testing is carried out using a bacterium called Serratia marcescens, which is inoculated onto the hands of volunteers and then recovered by massaging the hand in a broth filled, sterile glove.

http://microchemlab.com/information/introduction-hand-sanitizers