Guidance and Reference Materials

Global Regulatory Consulting

******!!!!***This site provides resources for an individual or company wanting to register a pesticide active ingredient or pesticide product in the United States. Features: a manual (blue book), other guidance, and coordinated lists of requirements by pesticide type.

******!!!!**** TITLE 40—Protection of Environment CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY SUBCHAPTER E—PESTICIDE PROGRAMS

Definitions: "Intent: ... The person who distributes or sells the substance claims, states, or implies (by labeling or otherwise): --that the substance (either by itself or in combination with any other substance) can or should be used as a pesticide; or that the substance consists of or contains an active ingredient and that it can be used to manufacture a pesticide; or the substance consists of or contains one or more active ingredients and has no significant commercially valuable use as distributed or sold other than (1) use for pesticidal purpose (by itself or in combination with any other substance), (2) use for manufacture of a pesticide; or the person who distributes or sells the substance has actual or constructive knowledge that the substance will be used, or is intended to be used, for pesticidal purpose." "Active ingredient (A.I.) – Any substance... that will prevent, destroy, repel or mitigate any pest" "Pests – This term means (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the [Agency] declares to be a pest" "Where a product label directs the user to add a particular adjuvant before use, the registering division will treat that adjuvant as if it were an "other ingredient""

- - YES, foreign establishments can submit their own establishment report to EPA

The information consists of the national list of all FIFRA Section 7 EPA-registered establishments in the Section Seven Tracking System (SSTS).

Jan 2021

This Viewpoint highlights loopholes in US orphan drug policy as exemplified by the use of remdesivir to treat coronavirus disease 2019.

1990

Although the FDA doesn't require pre-approval for launching an OTC drug product in the US, there are still strict requirements to launch it legally.

****!!!**** {This info is specific to traditional pesticides, but concepts may be extremely valuable when promoting new uses for chlorine dioxide} 1. A list of the use site(s)... 2. Expected use patterns for each site, including application timing or application method(s); 3. A summary of target pest(s) in the context of the use site, including the type and magnitude of damage caused by the main target pest(s); the frequency of occurrence; timing of occurrence; and any geographic or regional differences that may exist; 4. A summary of registered pesticides or other methods used to control the pest; 5. A comparison of the new pesticide to the current standard control methods and a discussion of how the new pesticide will benefit growers. Potential advantages that can lead to greater user (i.e. grower or producer [or other business or individual consumer) flexibility, better outcomes or lower costs include, but are not limited to: • a new mode/mechanism of action for that site to facilitate resistance management; • facilitating integrated pest management (IPM), including specificity against targeted pests; • providing equivalent or better efficacy or performance or improving pest [including pathogens] or crop [or other desired beneficial results] management compared to what is currently registered and available in the marketplace.

In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product.

1994

"ensure OTC manufacturers have the flexibility to innovate, improve and meet the challenges of developing and sustaining current monographs."

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This guidance for Office of Pesticide Program staff will assist in their evaluation of open literature studies of pesticides. It also describes how we identify, select, and ensure that data we use in risk assessments is of sufficient scientific quality.

Exploring small molecule API market trends.

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Exploring the untapped potential presented by current biowaiver regulations.

Official Publications from the U.S. Government Publishing Office.

"The Food and Drug Administration (FDA) is amending the food additive regulations to permit the manufacture of chlorine dioxide by electrolysis of an aqueous solution of sodium chlorite. This action is in response to a petition filed by Vulcan Chemicals."

"help to establish the foundation for quality pharmaceuticals through regulatory standards."

CDER Small Business and Industry Assistance: Import and Export of Human Drugs and Biologics

FDA regulates over-the-counter monograph drugs

The Over-the-Counter (OTC) Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972.

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"CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting."

"contains product listing data submitted for all unfinished drugs, including active pharmaceutical ingredients, drugs for further processing and bulk drug substances for compounding" {Also includes unfinished labelling}