Non-Hazardous Chemical List
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F1y3x CHAPTER 29 ORGANIC CHEMICALS VI 29-1 Notes 1
)&f1y3X CHAPTER 29 ORGANIC CHEMICALS VI 29-1 Notes 1. Except where the context otherwise requires, the headings of this chapter apply only to: (a) Separate chemically defined organic compounds, whether or not containing impurities; (b) Mixtures of two or more isomers of the same organic compound (whether or not containing impurities), except mixtures of acyclic hydrocarbon isomers (other than stereoisomers), whether or not saturated (chapter 27); (c) The products of headings 2936 to 2939 or the sugar ethers and sugar esters, and their salts, of heading 2940, or the products of heading 2941, whether or not chemically defined; (d) Products mentioned in (a), (b) or (c) above dissolved in water; (e) Products mentioned in (a), (b) or (c) above dissolved in other solvents provided that the solution constitutes a normal and necessary method of putting up these products adopted solely for reasons of safety or for transport and that the solvent does not render the product particularly suitable for specific use rather than for general use; (f) The products mentioned in (a), (b), (c), (d) or (e) above with an added stabilizer necessary for their preservation or transport; (g) The products mentioned in (a), (b), (c), (d), (e) or (f) above with an added antidusting agent or a coloring or odoriferous substance added to facilitate their identification or for safety reasons, provided that the additions do not render the product particularly suitable for specific use rather than for general use; (h) The following products, diluted to standard strengths, for the production of azo dyes: diazonium salts, couplers used for these salts and diazotizable amines and their salts. -
488 Part 184—Direct Food
§ 182.8217 21 CFR Ch. I (4–1–19 Edition) § 182.8217 Calcium phosphate. § 182.8988 Zinc gluconate. (a) Product. Calcium phosphate (a) Product. Zinc gluconate. (mono-, di-, and tribasic). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8991 Zinc oxide. § 182.8223 Calcium pyrophosphate. (a) Product. Zinc oxide. (a) Product. Calcium pyrophosphate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8994 Zinc stearate. § 182.8250 Choline bitartrate. (a) Product. Zinc stearate prepared (a) Product. Choline bitartrate. from stearic acid free from chickedema (b) Conditions of use. This substance factor. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8252 Choline chloride. § 182.8997 Zinc sulfate. (a) Product. Choline chloride. (b) Conditions of use. This substance (a) Product. Zinc sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate PART 184—DIRECT FOOD SUB- (mono-, di-, and tribasic). -
Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Updated June 07, 2021 Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Three categories of bulk drug substances: • Category 1: Bulk Drug Substances Under Evaluation • Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Category 3: Bulk Drug Substances Nominated Without Adequate Support Updates to Categories of Substances Nominated for the 503B Bulk Drug Substances List1 • Add the following entry to category 2 due to serious safety concerns of mutagenicity, cytotoxicity, and possible carcinogenicity when quinacrine hydrochloride is used for intrauterine administration for non- surgical female sterilization: 2,3 o Quinacrine Hydrochloride for intrauterine administration • Revision to category 1 for clarity: o Modify the entry for “Quinacrine Hydrochloride” to “Quinacrine Hydrochloride (except for intrauterine administration).” • Revision to category 1 to correct a substance name error: o Correct the error in the substance name “DHEA (dehydroepiandosterone)” to “DHEA (dehydroepiandrosterone).” 1 For the purposes of the substance names in the categories, hydrated forms of the substance are included in the scope of the substance name. 2 Quinacrine HCl was previously reviewed in 2016 as part of FDA’s consideration of this bulk drug substance for inclusion on the 503A Bulks List. As part of this review, the Division of Bone, Reproductive and Urologic Products (DBRUP), now the Division of Urology, Obstetrics and Gynecology (DUOG), evaluated the nomination of quinacrine for intrauterine administration for non-surgical female sterilization and recommended that quinacrine should not be included on the 503A Bulks List for this use. This recommendation was based on the lack of information on efficacy comparable to other available methods of female sterilization and serious safety concerns of mutagenicity, cytotoxicity and possible carcinogenicity in use of quinacrine for this indication and route of administration. -
Dimethylethanolamine (DMAE) [108-01-0] and Selected Salts
Dimethylethanolamine (DMAE) [108-01-0] and Selected Salts and Esters DMAE Aceglutamate [3342-61-8] DMAE p-Acetamidobenzoate [281131-6] and [3635-74-3] DMAE Bitartrate [5988-51-2] DMAE Dihydrogen Phosphate [6909-62-2] DMAE Hydrochloride [2698-25-1] DMAE Orotate [1446-06-6] DMAE Succinate [10549-59-4] Centrophenoxine [3685-84-5] Centrophenoxine Orotate [27166-15-0] Meclofenoxate [51-68-3] Review of Toxicological Literature (Update) November 2002 Dimethylethanolamine (DMAE) [108-01-0] and Selected Salts and Esters DMAE Aceglutamate [3342-61-8] DMAE p-Acetamidobenzoate [281131-6] and [3635-74-3] DMAE Bitartrate [5988-51-2] DMAE Dihydrogen Phosphate [6909-62-2] DMAE Hydrochloride [2698-25-1] DMAE Orotate [1446-06-6] DMAE Succinate [10549-59-4] Centrophenoxine [3685-84-5] Centrophenoxine Orotate [27166-15-0] Meclofenoxate [51-68-3] Review of Toxicological Literature (Update) Prepared for Scott Masten, Ph.D. National Institute of Environmental Health Sciences P.O. Box 12233 Research Triangle Park, North Carolina 27709 Contract No. N01-ES-65402 Submitted by Karen E. Haneke, M.S. Integrated Laboratory Systems, Inc. P.O. Box 13501 Research Triangle Park, North Carolina 27709 November 2002 Toxicological Summary for Dimethylethanolamine and Selected Salts and Esters 11/2002 Executive Summary Nomination Dimethylethanolamine (DMAE) was nominated by the NIEHS for toxicological characterization, including metabolism, reproductive and developmental toxicity, subchronic toxicity, carcinogenicity and mechanistic studies. The nomination is based on the potential for widespread human exposure to DMAE through its use in industrial and consumer products and an inadequate toxicological database. Studies to address potential hazards of consumer (e.g. dietary supplement) exposures, including use by pregnant women and children, and the potential for reproductive effects and carcinogenic effects are limited. -
DART-04: Prenatal Development Studies of Dimethylaminoethanol
NTP DEVELOPMEntAL And REprODUCTIVE TOXICITY TECHNICAL REPOrt ON THE PRENATAL DEVELOPMEnt STUDIES OF DIMETHYLAMINOETHANOL BITArtrATE (CASRN 5988-51-2) IN SprAGUE DAWLEY (Hsd:SprAGUE DAWLEY® SD®) RAts (GAVAGE STUDIES) NTP DART 04 JUNE 2020 NTP Developmental and Reproductive Toxicity Technical Report on the Prenatal Development Studies of Dimethylaminoethanol Bitartrate (CASRN 5988-51-2) in Sprague Dawley (Hsd:Sprague Dawley® SD®) Rats (Gavage Studies) DART Report 04 June 2020 National Toxicology Program Public Health Service U.S. Department of Health and Human Services ISSN: 2690-2052 Research Triangle Park, North Carolina, USA Dimethylaminoethanol Bitartrate, NTP DART 04 Foreword The National Toxicology Program (NTP), established in 1978, is an interagency program within the Public Health Service of the U.S. Department of Health and Human Services. Its activities are executed through a partnership of the National Institute for Occupational Safety and Health (part of the Centers for Disease Control and Prevention), the Food and Drug Administration (primarily at the National Center for Toxicological Research), and the National Institute of Environmental Health Sciences (part of the National Institutes of Health), where the program is administratively located. NTP offers a unique venue for the testing, research, and analysis of agents of concern to identify toxic and biological effects, provide information that strengthens the science base, and inform decisions by health regulatory and research agencies to safeguard public health. NTP also works to develop and apply new and improved methods and approaches that advance toxicology and better assess health effects from environmental exposures. The NTP Technical Report series for developmental and reproductive toxicity studies began in 2019. -
485 Part 184—Direct Food Sub- Stances Affirmed As
Food and Drug Administration, HHS Pt. 184 § 182.8217 Calcium phosphate. § 182.8988 Zinc gluconate. (a) Product. Calcium phosphate (a) Product. Zinc gluconate. (mono-, di-, and tribasic). (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8991 Zinc oxide. § 182.8223 Calcium pyrophosphate. (a) Product. Zinc oxide. (a) Product. Calcium pyrophosphate. (b) Conditions of use. This substance (b) Conditions of use. This substance is generally recognized as safe when is generally recognized as safe when used in accordance with good manufac- used in accordance with good manufac- turing practice. turing practice. § 182.8994 Zinc stearate. § 182.8250 Choline bitartrate. (a) Product. Zinc stearate prepared (a) Product. Choline bitartrate. from stearic acid free from chickedema (b) Conditions of use. This substance factor. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8252 Choline chloride. § 182.8997 Zinc sulfate. (a) Product. Choline chloride. (b) Conditions of use. This substance (a) Product. Zinc sulfate. is generally recognized as safe when (b) Conditions of use. This substance used in accordance with good manufac- is generally recognized as safe when turing practice. used in accordance with good manufac- turing practice. § 182.8778 Sodium phosphate. (a) Product. Sodium phosphate PART 184—DIRECT FOOD SUB- (mono-, di-, and tribasic). -
Pre- Review Report: Preparations of Codeine Listed in Schedule Lll of the 1961 Single Convention on Narcotic Drugs
Pre- Review Report: Preparations of codeine listed in Schedule lll of the 1961 Single Convention on Narcotic Drugs Acetyldihydrocodeine Codeine Dihydrocodeine Ethlymorphine Nicocodine Nicodicodine Norcodeine Pholcodine Expert Committee on Drug Dependence Forty-second Meeting Geneva, 21-25 October 2019 This report contains the views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the World Health Organization 42nd ECDD (2019): Preparations of codeine © World Health Organization 2019 All rights reserved. This is an advance copy distributed to the participants of the 42nd Expert Committee on Drug Dependence, before it has been formally published by the World Health Organization. The document may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means without the permission of the World Health Organization. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. -
English → French → English
Anglais → Français - A - Acetorphine Acétorphine Acetorphine hydrochloride Chlorhydrate d’acétorphine Acetyl-alpha-methylfentanyl Acétyl-alpha-méthylfentanyl Acetyldihydrocodeine Acétyldihydrocodéine Acetyldihydrocodeine hydrochloride Chlorhydrate d’acétyldihydrocodéine Acetylmethadol Acétylméthadol Alfentanil Alfentanil Alfentanil hydrochloride Chlorhydrate d’alfentanil Allobarbital Allobarbital Allobarbital-aminophenazone Allobarbital-aminophénazone Allylprodine Allylprodine Allylprodine hydrochloride Chlorhydrate d’allylprodine Alphacetylmethadol Alphacétylméthadol Alphacetylmethadol hydrochloride Chlorhydrate d’alphacétylméthadol Alphameprodine Alphaméprodine Alphamethadol Alphaméthadol Alpha-methylfentanyl Alpha-méthylfentanyl Alpha-methylfentanyl hydrochloride Chlorhydrate d’alpha-méthylfentanyl Alpha-methylthiofentanyl Alpha-méthylthiofentanyl Alpha-methylthiofentanyl hydrochloride Chlorhydrate d’alpha-méthylthiofentanyl Alphaprodine Alphaprodine Alphaprodine hydrochloride Chlorhydrate d’alphaprodine Alprazolam Alprazolam Amfepramone Amfépramone Amfepramone glutamate Glutamate d’amfépramone Amfepramone hydrochloride Chlorhydrate d’amfépramone Amfepramone resinate Amfépramone résinate Amfetamine Amfétamine Amfetamine acetylsalicylate Acétylsalicylate d’amfétamine Amfetamine adipate Adipate d’amfétamine Amfetamine p-aminophenylacetate Acétate p-aminophényle d’amfétamine Amfetamine aspartate Aspartate d’amfétamine Amfetamine (4-chlorophenoxy) acetate Acétate (chlorophénoxy-4) d’amfétamine Amfetamine hydrochloride Chlorhydrate d’amfétamine -
Controlled Substance Conversion Factors
SCHEDULES I - V CONTROLLED SUBSTANCE CONVERSION FACTORS Drug Conversion Controlled Substance Schedule Code Factor (+/-)cis -4-Methylaminorex I 1590 1.00 (+/-)cis -4-Methylaminorex Hydrochloride I 1590 0.83 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)propan-1-one (ethylone) I 7547 1.00 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)propan-1-one (ethylone) hydrochloride I 7547 0.86 (1-(4-fluorobenzyl)-1H -indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (FUB-144) I 7014 1.00 1-(4-cyanobutyl)-N -(2-phenylpropan-2-yl)-1H -indazole-3-carboxamide (4-CN-CUMYL-BUTINACA) I 7089 1.00 1-(5-fluoropentyl)-1H -indazol-3-yl](naphthalen-1-yl)methanone (THJ–2201) 1 7024 1.00 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201) I 7201 1.00 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) I 7694 1.00 1-(5-fluoropentyl)-N -(2-phenylpropan-2-yl)-1H -indazole-3-carboxamide (5F-CUMYL-PINACA; SGT-25) I 7083 1.00 1-(5-fluoropentyl)-N -(2-phenylpropan-2-yl)-1H -pyrrolo[2,3-b]pyridine-3-carboxamide (5F-CUMYL-P7AICA) I 7085 1.00 1-[1-(2-thienyl)cyclohexyl]pyrrolidine (TCPy) I 7473 1.00 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 200) I 7200 1.00 1-butyl-3-(1-naphthoyl)indole (JWH-073) I 7173 1.00 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine (MT-45) I 9560 1.00 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine hydrochloride (MT-45) I 9560 0.91 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 7008 (SR-18 and RCS-8) I 7008 1.00 1-hexyl-3-(1-naphthoyl)indole (JWH-019) I 7019 1.00 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678) I 7118 1.00 1-pentyl-3-(2-chlorophenylacetyl)indole -
List of Narcotic Drugs Under International Control
International Narcotics Control Board YYeellllooww LLiisstt Annex to Forms A, B and C 50th edition, December 2011 LIST OF NARCOTIC DRUGS UNDER INTERNATIONAL CONTROL Prepared by the INTERNATIONAL NARCOTICS CONTROL BOARD* Vienna International Centre P.O. Box 500 A-1400 Vienna, Austria Internet address: http://www.incb.org/ in accordance with the Single Convention on Narcotic Drugs, 1961** Protocol of 25 March 1972 amending the Single Convention on Narcotic Drugs, 1961 ___________ * On 2 March 1968, this organ took over the functions of the Permanent Central Narcotics Board and the Drug Supervisory Body, retaining the same secretariat and offices. ** Subsequently referred to as “1961 Convention”. Purpose The Yellow List contains the current list of narcotic drugs under international control and additional relevant information. It has been prepared by the International Narcotics Control Board to assist Governments in completing the annual statistical reports on narcotic drugs (Form C), the quarterly statistics of imports and exports of narcotic drugs (Form A) and the estimates of annual requirements for narcotic drugs (Form B) as well as related questionnaires. The Yellow List is divided into four parts: Part 1 provides a list of narcotic drugs under international control in form of tables and is subdivided into three sections: (1) the first section includes the narcotic drugs listed in Schedule I of the 1961 Convention and/or Group I of the 1931 Convention; (2) the second section includes the narcotic drugs listed in Schedule II of the 1961 Convention and/or Group II of the 1931 Convention; and (3) the third section includes the narcotic drugs listed in Schedule IV of the 1961 Convention and/or Group II of the 1931 Convention. -
California 3 Tier Drug List
California 3 Tier Drug List The 3 Tier Drug List (formulary) includes a list of drugs covered by Health Net. The drug list is updated at least monthly and is subject to change. All previous versions are no longer in effect. You can view the most current drug list by going to our website at www.healthnet.com. Refer to Evidence of Coverage or Certificate of Insurance for specific cost share information. California Large Group members Go to Drug List - Use the “3 Tier” Formulary NOTE: To search the drug list online, open the (pdf) document. Hold down the “Control” (Ctrl) and “F” keys. When the search box appears, type the name of your drug and press the “Enter” key. If you have questions or need more information call us toll free. If you have questions about your pharmacy coverage call Customer Service at 1-800-522-0088 Hours of Operation 8:00am – 6:00pm Monday through Friday Updated June 1, 2020 Health Net of California, Inc. and Health Net Life Insurance Company are subsidiaries of Health Net, LLC and Centene Corporation. Health Net is a registered service mark of Health Net, LLC. Table of Contents What If I Have Questions Regarding My Pharmacy Benefit?…………………… ii What is the Drug List?............................................................................................ ii How do I find a drug on the Drug List?.................................................................. ii How are the drugs listed in the categorical list? ………………………………… ii How much will I pay for my drugs?...................................................................... iii Tier description table Are there any limits on my drug coverage? ......................................................... .iv Abbreviations table How often does the Drug List change? ................................................................ -
SYNALGOS-DC (Aspirin, Caffeine, And
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use -----------------------DOSAGE AND ADMINISTRATION----------------------- SYNALGOS®-DC safely and effectively. See full prescribing information for • Use the lowest effective dose for the shortest duration consistent with SYNALGOS®-DC. individual patient treatment goals. (2.1) • Individualize dosing based on the severity of pain, patient response, prior SYNALGOS®-DC (aspirin, caffeine, and dihydrocodeine bitartrate) capsules, analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1) for oral use, CIII • Initiate treatment with two capsules orally every 4 hours as needed for pain. Initial U.S. Approval: 1958 (2.2) • Administer SYNALGOS-DC with food or a full glass of water to minimize WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE gastrointestinal (GI) distress. (2.1) THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL • Do not stop SYNALGOS-DC abruptly in a physically dependent patient. INGESTION; ULTRA-RAPID METABOLISM OF DIHYDROCODEINE (2.4) AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID ----------------------DOSAGE FORMS AND STRENGTHS-------------------- WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS Capsules: 16 mg dihydrocodeine bitartrate, 356.4 mg aspirin, and 30 mg caffeine AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM (3) CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ------------------------------CONTRAINDICATIONS------------------------------