ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ~CFR law
Code of Federal Regulations Title 21 Animal Drugs, Feeds & Related Products
Guidance and Reference Materials
Safety Testing of Drug Metabolites ~FDA
Designing and Conducting Toxicity Studies (FDA Redbook 2000: IV.B.1.) ~FDA
Toxicological Principles for the Safety Assessment of Food Ingredients - Chapter IV.B.1 - General Guidelines for Designing and Conducting Toxicity Studies
Nonclinical Safety Studies for Human Clinical Trials & Marketing Authorization for Pharmaceuticals M3(R2) **FAQs** ~FDA
* Specific Questions & Answers
Toxicological principles for the safety assessment of food ingredients ~FDA
revised 2007
Recommended Toxicological Testing for Food Additives ~FDA
The purpose of this document is to provide a brief summary of recommendations for the minimum toxicity tests to be performed for safety evaluation of direct food additives and color additives used in food based on their levels of concern.
Nonclinical Safety Studies for Human Clinical Trials & Marketing Authorization for Pharmaceuticals M3(R2) **Guidance Doc** ~FDA
Main guidance document
Summary of standards regulations and guidelines related to hospital or air quality
{No universal standards are apparent as mandatory?}
Pesticide Registration Manual ~EPA
Pesticide registration process for companies and individuals
Pesticide Registration Manual: Chapter 4 - Additional Considerations for Antimicrobial Products ~EPA
***"A product makes a public health claim if one or more of the following apply: A claim is made for control of specific microorganisms directly or indirectly infectious or pathogenic to man ... sterilant, disinfectant, virucide, sanitizer, or tuberculocide... product does not clearly state that it is intended for use only against non-public health fungi... microbiological water purifier or microbial purification system... ***A non-specific claim is made that the pesticide product will beneficially impact or affect public health at the site of use or in the environment in which applied, and the pesticide ingredients that are an active ingredient with respect to a public health microorganism and there is no other functional purpose for the ingredient in the product; or the pesticide product is similar in composition to a registered pesticide product that makes explicit antimicrobial public health claims."
Types of Registrations under FIFRA ~EPA
Federal pesticide law (the Federal Insecticide, Fungicide, and Rodenticide Act) provides for several types of registrations.
Recommendations for cleaning in Healthcare facilities in resource-limited settings ~CDC
***Recommends not using foggers, spray bottles or fumigators***
Disinfection guidance for COVID ~WHO
FDA ?generic drugs? -Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations ~FDA
Risk Evaluation and Mitigation Strategies (REMS) for high-risk medications ~FDA
REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.
Guidance for developing COVID drugs & biological products ~FDA
Hand Sanitizer Registration process ~FDA
** Excellent collection of FDA registration links
Drug listing form for application ~FDA
Guidance for Microbiology section of application ~FDA
(This doc is quite old. Not sure if there is a more recent version?)
Hand sanitizer ineligible ingredients ~FDA
EPA List L: Disinfectants for Use Against the Ebola Virus ~EPA
This list of registered disinfectants meets the Center for Disease Control’s (CDC) criteria for use against the Ebola virus on hard, non-porous surfaces.
Classification & Recommendation Outline for Disinfection Methods ~CDC
Highly systematic charts of extremely broad range of methods. Includes analyses and recommendations on fogging, endoscopes & more
Antimicrobial Pesticide Registration ~EPA
Resources for an individual or company wanting to register an antimicrobial pesticide.
Requirements for federal facilities under FIFRA ~EPA
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is the Federal statute that governs the registration, distribution, sale, and use of pesticides in the United States.
EPA general search
Simple Search page for EPA publications, etc. | NSCEP | US EPA
****!!!!**** {Excellent sources to search}
Disinfection Guidelines for COVID-19 ~Chinese CDCP
Guidelines from Chinese Center for Disease Control and Prevention
Regulations: Good Clinical Practice and Clinical Trials ~FDA
regulations, preambles, human subject protection, good clinical practice, research, investigation, trial, investigator, IRB, institutional review board
Process Safety Management ~OSHA
Process Safety Management (PSM)
Calcs to keep CD level under Process Safety Management limits ~OSHA
HHC's as it applies to pulp and paper industry processes that contain chlorine dioxide. | Occupational Safety and Health Administration