Guidance and Reference Materials

"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}

This web page is an attempt to present drugs similar to 76769-0003-2. Please feel free to use this infromation at your convenience. Thank you.

****!!!!**** {Databases, approved drugs, info}

Search EPA’s list of registered disinfectants for use against SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19).

{Includes recommendations for disinfection of transportation vehicles} "surface of environment objects can be wiped, sprayed or soaked with chlorine-containing disinfectants, chlorine dioxide and other disinfectants... Indoor air can be disinfected by peroxyacetic acid, chlorine dioxide, hydrogen peroxide and other disinfectants by spraying." "Floor and Wall--Visible pollutants should be completely removed before disinfection while invisible pollutants can be wiped or sprayed with 1,000 mg/L chlorine-containing disinfectant or 500 mg/L chlorine dioxide disinfectant. " "For invisible pollutants, spraying, wiping or soaking with 1,000 mg/L chlorine-containing disinfectant or 500 mg/L chlorine dioxide disinfectant for 30 minutes are recommended."

{Definitions and standards}

{OSHA definition of "working life" number of years for chronic exposure limits} "The OSH Act requires OSHA to set the standard that most adequately protects employees against harmful workplace exposures for the period of their ‘‘working life’’ (29 U.S.C. 655(b)(5)). OSHA’s longstanding policy is to define ‘‘working life’’ as constituting 45 years; thus, it assumes 45 years of exposure when evaluating the risk of material impairment to health caused by a toxic or hazardous substance."

{Includes list of types of industry standards for exposure limits}

The NIOSH Pocket Guide to Chemical Hazards is intended as a source of general industrial hygiene information for workers, employers, and occupational health professionals.

10049-04-4 - OSVXSBDYLRYLIG-UHFFFAOYSA-N - Chlorine dioxide - Similar structures search, synonyms, formulas, resource links, and other chemical information.

"EPA applications/systems, statutes/regulations, or other sources that track or regulate this substance. "

{Definitions of TWA and Ceiling values for airborne exposures in workplaces}

"The Division of Public Education and Outreach (DPEO) provides timely and accurate information to the public about approval and regulation of drugs, safety issues and the benefits and risks of drugs. The efforts of DPEO help increase the understanding of CDER and its activities, foster informed decision-making and improve health."

"Chlorine Dioxide: ...WSs and NTNCWSs must collect daily samples at the entry point to the distribution system and monthly samples in the distribution system. Utilities using chlorine dioxide may have to use granular activated carbon or a chemical reducing agent, such as sulfur dioxide, to remove or reduce the chlorite residual"

{OSHA definition of "working life" number of years for chronic exposure limits} "The OSH Act requires OSHA to set the standard that most adequately protects employees against harmful workplace exposures for the period of their ‘‘working life’’ (29 U.S.C. 655(b)(5)). OSHA’s longstanding policy is to define ‘‘working life’’ as constituting 45 years; thus, it assumes 45 years of exposure when evaluating the risk of material impairment to health caused by a toxic or hazardous substance."

Explanation of requirements under FIFRA for importing and exporting pesticides.

This Pesticide Registration notice expands the changes to registration that may be made by notification and non-notification, maintains the expedited review of minor formulation changes, and modifies procedures for notifications of antimicrobial products.

{Note: Other guidance on related topic says label should not encourage user to wrap a container.} Acceptable alternative statement for household/domestic use products: "Do not reuse empty container (bottle, can, bucket). Wrap (container) and put in trash."

This Notice is to inform all registrants that the label of all pesticide products must include updated storage and disposal statements. No application for amended registration is required if you use the exact wording contained in this Notice.

{Includes extensive recommendations for use of chlorine dioxide disinfectant.} {Note: 1,000 ppm is for "a chlorine releasing agent's" recommended concentration--NOT chlorine dioxide's (which varies per manufacturer instructions}

"Prohibition of manufacture and sale of certain drugs and cosmetics .From such [date] as may be fixed by the State Government... no person shall himself or by any other person on his behalf (a) [manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute... any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims [to prevent, cure or mitigate] any such disease or ailment, or to have any such other effect as may be prescribed;" "Inspector may, within the local limits of the area for which he is appointed, [ (a) inspect... require any person to produce any record, register, or other document relating to the manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale or distribution of any drug"