Guidance and Reference Materials

2020. EPA is announcing the availability of and seeking public comment on a draft guidance document

OPPTS 870.2500 Acute Dermal Irritation

Issued 2016. [Effective date noted is 9/6/2017] The FDA is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water are not...

Page 50, 2-301.16 Hand Antiseptics

Primary Dermal Testing procedures on pg 55

How to obtain waiver

** Excellent collection of FDA registration links

As companies re-open post COVID-19 hand hygiene is key. Hand sanitizer is now a necessity for all businesses but what type & where can I find it. This blog covers all angles.

Resources for small-scale soap makers

An overview of the legal differences between cosmetics and drugs, and whether a cosmetic can be both or just a soap.

2013? 2018? Preliminary Regulatory *Impact Analysis* of *Proposed Amendment* of the Tentative Final Monograph for Topical Antimicrobial Drug Products for Over-the-Counter Human Use

FDA letters on topical antiseptic products.

Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. Food and Drug Administration issued this action establishing that certain active ingredients used in nonprescription (OTC)) consumer antiseptic products intended for use without water/consumer...

2016, 21337 page 15 & 16

Product listed Amosilq (benzalkonium chloride/silica complex) ingredient rather than just BAK, plus made extravagant claims, etc

Information about handwashing and hand hygiene

Concentration levels for effective hand sanitizers

If used for 30 seconds or more, a variety of hand sanitizers kill the virus.

Pathogens & log reductions, no-wash or sequential hand sanitization, wipes, industry contact people, impacts of temperature. ETC