DOCSLIB.ORG

Food and Drug Administration, HHS § 310.545

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Food and Drug Administration, HHS § 310.545 Food and Drug Administration, HHS § 310.545 201(p) of the Federal Food, Drug, and Benzocaine Cosmetic Act (the act), for which an Benzoic acid approved application or abbreviated Boric acid application under section 505 of the act Calcium polysulfide Calcium thiosulfate and part 314 of this chapter is required Camphor for marketing. In the absence of an ap- Chloroxylenol proved new drug application or abbre- Cloxyquin viated new drug application, such prod- Coal tar uct is also misbranded under section Dibenzothiophene 502 of the act. Estrone (c) Clinical investigations designed Magnesium aluminum silicate to obtain evidence that any drug prod- Magnesium sulfate uct labeled, represented, or promoted Phenol Phenolate sodium for OTC use as a smoking deterrent is Phenyl salicylate safe and effective for the purpose in- Povidone-iodine tended must comply with the require- Pyrilamine maleate ments and procedures governing the Resorcinol (as single ingredient) use of investigational new drugs set Resorcinol monoacetate (as single ingre- forth in part 312 of this chapter. dient) (d) After May 7, 1991, any such OTC Salicylic acid (over 2 up to 5 percent) drug product containing cloves, cori- Sodium borate Sodium thiosulfate ander, eucalyptus oil, ginger (Ja- Tetracaine hydrochloride maica), lemon oil (terpeneless), licorice Thymol root extract, menthol, methyl salicy- Vitamin E late, quinine ascorbate, silver nitrate, Zinc oxide and/or thymol initially introduced or Zinc stearate initially delivered for introduction into Zinc sulfide interstate commerce that is not in (2) Anticaries drug products—(i) Ap- compliance with this section is subject proved as of May 7, 1991. to regulatory action. After December 1, 1993, any such OTC drug product con- Hydrogen fluoride taining lobeline (in the form of lobeline Sodium carbonate Sodium monofluorophosphate (6 percent sulfate or natural lobelia alkaloids or rinse) Lobelia inflata herb), povidone-silver ni- Sodium phosphate trate, silver acetate, or any other in- gredients initially introduced or ini- (ii) Approved as of October 7, 1996. tially delivered for introduction into Calcium sucrose phosphate interstate commerce that is not in Dicalcium phosphate dihydrate compliance with this section is subject Disodium hydrogen phosphate 1 to regulatory action. Phosphoric acid 1 Sodium dihydrogen phosphate [58 FR 31241, June 1, 1993] Sodium dihydrogen phosphate monohydrate Sodium phosphate, dibasic anhydrous rea- § 310.545 Drug products containing gent 1 certain active ingredients offered over-the-counter (OTC) for certain (3) Antidiarrheal drug products—(i) Ap- uses. proved as of May 7, 1991. (a) A number of active ingredients Aluminum hydroxide have been present in OTC drug prod- Atropine sulfate ucts for various uses, as described Calcium carbonate below. However, based on evidence cur- Carboxymethylcellulose sodium rently available, there are inadequate Glycine data to establish general recognition of Homatropine methylbromide Hyoscyamine sulfate the safety and effectiveness of these in- Lactobacillus acidophilus gredients for the specified uses: Lactobacillus bulgaricus (1) Topical acne drug products. Alcloxa 1 These ingredients are nonmonograph ex- Alkyl isoquinolinium bromide cept when used to prepare acidulated phos- Aluminum chlorohydrex phate fluoride treatment rinses identified in Aluminum hydroxide § 355.10(a)(3) of this chapter. 37 VerDate Mar<15>2010 13:22 May 12, 2011 Jkt 223069 PO 00000 Frm 00047 Fmt 8010 Sfmt 8010 Y:\SGML\223069.XXX 223069 WReier-Aviles on DSKGBLS3C1PROD with CFR § 310.545 21 CFR Ch. I (4–1–11 Edition) Opium, powdered Thymol Opium tincture Thymol (lozenge) Paregoric Thymol (mouthwash) Phenyl salicylate Turpentine oil Scopolamine hydrobromide Zinc phenolsulfonate (B) Approved as of August 23, 1995. (ii) Approved as of April 19, 2004; April Bornyl acetate (topical) Cedar leaf oil (topical) 18, 2005, for products with annual sales Creosote, beechwood (topical) less than $25,000. Ephedrine (oral) Attapulgite, activated Ephedrine hydrochloride (oral) Bismuth subnitrate Ephedrine sulfate (oral) Calcium hydroxide Racephedrine hydrochloride (oral/topical) Calcium polycarbophil (C) Approved as of April 11, 2007; Oc- Charcoal (activated) tober 11, 2007, for products with annual Pectin sales less than $25,000. Any ingre- Polycarbophil Potassium carbonate dient(s) labeled with claims or direc- Rhubarb fluidextract tions for use for sinusitis or for relief of nasal congestion associated with si- (4) Antiperspirant drug products—(i) nusitis. Ingredients—Approved as of May 7, 1991. (iii) Expectorant drug products. Alum, potassium Ammonium chloride Aluminum bromohydrate Antimony potassium tartrate Aluminum chloride (alcoholic solutions) Beechwood creosote Aluminum chloride (aqueous solution) (aer- Benzoin preparations (compound tincture of osol only) benzoin, tincture of benzoin) Aluminum sulfate Camphor Aluminum sulfate, buffered (aerosol only) Chloroform Sodium aluminum chlorohydroxy lactate Eucalyptol/eucalyptus oil (ii) Approved as of December 9, 2004; Horehound Iodides (calcium iodide anyhydrous, hydroid- June 9, 2005, for products with annual ic acid syrup, iodized lime, potassium io- sales less than $25,000. dide) Aluminum sulfate buffered with sodium alu- Ipecac minum lactate Ipecac fluidextract Ipecac syrup (5) [Reserved] Menthol/peppermint oil (6) Cold, cough, allergy, bronchodilator, Pine tar preparations (extract white pine and antiasthmatic drug products—(i) compound, pine tar, syrup of pine tar, com- Antihistamine drug products—(A) Ingre- pound white pine syrup, white pine) Potassium guaiacolsulfonate dients. Sodium citrate Methapyrilene hydrochloride Squill preparations (squill, squill extract) Methapyrilene fumarate Terpin hydrate preparations (terpin hydrate, Thenyldiamine hydrochloride terpin hydrate elixir) Tolu preparations (tolu, tolu balsam, tolu (B) Ingredients. balsam tincture) Turpentine oil (spirits of turpentine) Phenyltoloxamine dihydrogen citrate Methapyrilene hydrochloride (iv) Bronchodilator drug products—(A) Methapyrilene fumarate Approved as of October 2, 1987. Thenyldiamine hydrochloride Aminophylline (ii) Nasal decongestant drug products— Belladonna alkaloids (A) Approved as of May 7, 1991. Euphorbia pilulifera Metaproterenol sulfate Allyl isothiocyanate Methoxyphenamine hydrochloride Camphor (lozenge) Pseudoephedrine hydrochloride Creosote, beechwood (oral) Pseudoephedrine sulfate Eucalyptol (lozenge) Theophylline, anhydrous Eucalyptol (mouthwash) Theophylline calcium salicylate Eucalyptus oil (lozenge) Theophylline sodium glycinate Eucalyptus oil (mouthwash) Menthol (mouthwash) (B) Approved as of January 29, 1996. Peppermint oil (mouthwash) Any combination drug product con- Thenyldiamine hydrochloride taining theophylline (e.g., theophylline 38 VerDate Mar<15>2010 13:22 May 12, 2011 Jkt 223069 PO 00000 Frm 00048 Fmt 8010 Sfmt 8010 Y:\SGML\223069.XXX 223069 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 310.545 and ephedrine, or theophylline and Pepsin ephedrine and phenobarbital). Sodium bicarbonate (C) Approved as of June 19, 1996. Any Sodium citrate Sorbitol ingredient(s) in a pressurized metered- dose inhaler container. (ii) Approved as of November 10, 1993. (D) Approved as of October 29, 2001. Alcohol Any oral bronchodilator active ingre- Aluminum hydroxide dient (e.g., ephedrine, ephedrine hydro- Amylase chloride, ephedrine sulfate, Anise seed racephedrine hydrochloride, or any Aromatic powder other ephedrine salt) in combination Asafetida with any analgesic(s) or analgesic-anti- Aspergillus oryza enzymes (except lactase enzyme derived from Aspergillus oryzae) pyretic(s), anticholinergic, antihis- Bacillus acidophilus tamine, oral antitussive, or stimulant Bean active ingredient. Belladonna alkaloids (7) Dandruff/seborrheic dermatitis/psori- Belladonna leaves, powdered extract asis drug products. Betaine hydrochloride Bismuth subcarbonate Alkyl isoquinolinium bromide Bismuth subgallate Allantoin Black radish powder Benzalkonium chloride Blessed thistle (cnicus benedictus) Benzethonium chloride Buckthorn Boric acid Calcium gluconate Calcium undecylenate Capsicum Captan Capsicum, fluid extract of Chloroxylenol Carbon Colloidal oatmeal Cascara sagrada extract Cresol, saponated Catechu, tincture Ethohexadiol Catnip Eucalyptol Chamomile flowers Juniper tar Charcoal, wood Lauryl isoquinolinium bromide Chloroform Menthol Cinnamon oil Mercury oleate Cinnamon tincture Methylbenzethonium chloride Citrus pectin Methyl salicylate Diastase Phenol Diastase malt Phenolate sodium Dog grass Pine tar Elecampane Povidone-iodine Ether Resorcinol Fennel acid Sodium borate Galega Sodium salicylate Ginger Thymol Glycine Undecylenic acid Hydrastis canadensis (golden seal) (8) Digestive aid drug products—(i) Ap- Hectorite proved as of May 7, 1991. Horsetail Huckleberry Bismuth sodium tartrate Hydrastis fluid extract Calcium carbonate Hydrochloric acid Cellulase Iodine Dehydrocholic acid Iron ox bile Dihydroxyaluminum sodium carbonate Johnswort Duodenal substance Juniper Garlic, dehydrated Kaolin, colloidal Glutamic acid hydrochloride Knotgrass Hemicellulase Lactic acid Homatropine methylbromide Lactose Magnesium hydroxide Lavender compound, tincture of Magnesium trisilicate Linden Ox bile extract Lipase Pancreatin Lysine hydrochloride Pancrelipase Mannitol Papain Mycozyme Peppermint oil Myrrh, fluid extract of 39 VerDate Mar<15>2010 13:22 May 12, 2011 Jkt 223069 PO 00000 Frm 00049 Fmt 8010 Sfmt 8010 Y:\SGML\223069.XXX 223069 WReier-Aviles
Load more

Recommended publications
  • United States Patent 1191 Lll] 3,983,266 Bahls [451 Sept
    United States Patent 1191 lll] 3,983,266 Bahls [451 Sept. 28, 1976 [54] METHOD FOR APPLYING METALLIC 3.776.740 [2/1973 Sivcrz ct al. .......................... .. l06/l SILVER TO A SUBSTRATE OTHER PUBLICATIONS [75] Inventor: Harry Bahls, Wayne, Pa. lvanov et al., Chem. Abs. 43:2548c, I949, [73] Assignee: Peacock Laboratories, Inc., Philadelphia, Pa. Primary Examiner-Ralph S. Kendall [22] Filed: Oct. 9, I974 I 57] ABSTRACT [2!] ,Appl. No.: 513,417 High efficiency deposition of silver on the surface of a substrate is obtained by providing a solution contain [52] [1.8. CI ............................... .. 427/164; 427/165; ing reducible dissolved silver in the presence of an al 427/168; 427/424; 427/426; l06/l kali metal hydroxide and ammonia, all of which are [51] Int. CLZ. ......................................... .. C23C 3/02 applied to the substrate in the presence of an aqueous [58] Field of Search .............. .. l06/l; 427/l68. I69, solution of a moderating reducer containing :1 poly 427/165, I64, 426, 304, 125, 425 hydric alcohol of the formula CH2OH(CHOH),,C H,OH, where n is an integer from 1 to 6. Preferably [56] References Cited the polyhydric alcohol is sorbitol, and in a preferred UNITED STATES PATENTS embodiment a moderator is the form of a thio glycerol is present. 2,996,406 8/l96l Weinrich ........... ............ .. 427/168 3,772,078 ll/l973 Polichcttc ct al ................. .. l06/l X l5 Claims, No Drawings 3,983,266 1 Other objects and advantages of this invention, in METHOD FOR APPLYING METALLIC SILVER TO cluding the economy of the same, and the case with A SUBSTRATE which it may be applied to existing silver coating equip ment and apparatus, will further become apparent BRIEF SUMMARY OF THE INVENTION 5 hereinafter.
    [Show full text]
  • Biochemistry Lab (BT35L) Lab Manual
    Department of Biotechnology Sri Jayachamarajendra College of Engineering Mysuru-570006 Biochemistry Lab (BT35L) Lab Manual (Prepared by Dr. S. Nanjunda Swamy and Dr. M. N. Nagendra Prasad) INDEX 1. PREPARATION OF SODIUM ACETATE BUFFER 2. ESTIMATION OF GLUCOSE BY DNS METHOD 3. ESTIMATION OF SAPONIFICATION VALUE OF FATS/OILS 4. ESTIMATION OF ACID VALUE OF FATS/OILS 5. PREPARATION OF PHOSPHOTIDYL CHOLINE FROM EGG YOLK 6. LOWRY METHOD FOR PROTEIN ESTIMATION 7. ESTIMATION OF AMINO ACID BY FORMAL TITRATION 8. DETERMINATION OF ISOELECTRIC POINT OF GLYCINE (PI) 9. SEPARATION OF AMINO ACIDS BY CIRCLULAR PAPER CHROMATOGRAPHY 10. ESTIMATION OF IRON BY WONG’S METHOD Experiment No 1: PREPARATION OF SODIUM ACETATE BUFFER Aim: Preparation of sodium acetate buffer of 0.1M and 4.7 pH (25ml) Principle: Buffer is a solution used to maintain the pH of any biochemical reaction. Procedure: 1. Weigh about 0.205g of sodium acetate. Dissolve it in 15ml distilled water. 2. Dip the electrode of the pre calibrated pH meter in the above solution. 3. Add acetic acid of 0.5M drop by drop till the pH reaches 4.7. 4. Make up the solution to 25ml with distilled water. 5. Store the buffer in a sealed container. Experiment No 2: ESTIMATION OF GLUCOSE BY DNS METHOD Aim: To estimate the amount of glucose in the given ample by DNS method. Principle: This method tests for the presence of free carbonyl group (C=O), of the reducing sugars. The reaction involves the oxidation of this of free carbonyl group (aldehyde functional group present in, glucose and the ketone functional group in fructose) and simultaneous reduction of , 3,5-dinitrosalicylic acid to 3-amino,5- nitrosalicylic acid (a coloured molecule) under alkaline conditions.
    [Show full text]
  • Disposal of Solid Chemicals in the Normal Trash
    Disposal of Solid Chemicals in the Normal Trash Many solid chemicals can be safety discarded into the normal trash, provided they are in containers that are not broken or cracked and have tightly fitting caps. These chemicals are considered acceptable for ordinary disposal because they display none of the properties of hazardous waste, are of low acute toxicity, and have not been identified as having any chronic toxic effects as summarized in the National Institute of Occupational Safety and Health (NIOSH) “Registry of Toxic Effects of Chemical Substances”. Examples of chemicals acceptable for disposal as regular trash are listed below. To dispose of these chemicals, place the containers in a box lined with a plastic bag, tape the top of the box shut, write “Normal Trash” on the box and then place the box next to the lab trash container. Only solid forms of these chemicals can be disposed in this manner. Any questions about these chemicals or other chemicals that may be disposed of in the normal trash should be directed to the Hazardous Materials Technician (610) 330-5225. Chemicals Generally Acceptable for Disposal as Regular Trash Acacia powder, gum Detergent (most) Methyl salicylate Sodium carbonate arabic Cation exchange resins Methylene blue Sodium chloride Acid, Ascorbic Chromatographic Methyl stearate Sodium citrate Acid, Benzoic absorbents Nutrient agar Sodium dodecyl sulfate Acid, Boric Crystal violet Octacosane (SDS) Acid, Casamind Dextrin Parafin Sodium formate Acid, Citric Dextrose Pepsin Sodium iodide Acid, Lactic Diatomaceous
    [Show full text]
  • Dietary Supplements Compendium Volume 1
    2015 Dietary Supplements Compendium DSC Volume 1 General Notices and Requirements USP–NF General Chapters USP–NF Dietary Supplement Monographs USP–NF Excipient Monographs FCC General Provisions FCC Monographs FCC Identity Standards FCC Appendices Reagents, Indicators, and Solutions Reference Tables DSC217M_DSCVol1_Title_2015-01_V3.indd 1 2/2/15 12:18 PM 2 Notice and Warning Concerning U.S. Patent or Trademark Rights The inclusion in the USP Dietary Supplements Compendium of a monograph on any dietary supplement in respect to which patent or trademark rights may exist shall not be deemed, and is not intended as, a grant of, or authority to exercise, any right or privilege protected by such patent or trademark. All such rights and privileges are vested in the patent or trademark owner, and no other person may exercise the same without express permission, authority, or license secured from such patent or trademark owner. Concerning Use of the USP Dietary Supplements Compendium Attention is called to the fact that USP Dietary Supplements Compendium text is fully copyrighted. Authors and others wishing to use portions of the text should request permission to do so from the Legal Department of the United States Pharmacopeial Convention. Copyright © 2015 The United States Pharmacopeial Convention ISBN: 978-1-936424-41-2 12601 Twinbrook Parkway, Rockville, MD 20852 All rights reserved. DSC Contents iii Contents USP Dietary Supplements Compendium Volume 1 Volume 2 Members . v. Preface . v Mission and Preface . 1 Dietary Supplements Admission Evaluations . 1. General Notices and Requirements . 9 USP Dietary Supplement Verification Program . .205 USP–NF General Chapters . 25 Dietary Supplements Regulatory USP–NF Dietary Supplement Monographs .
    [Show full text]
  • Order in Council 1243/1995
    PROVINCE OF BRITISH COLUMBIA ORDER OF THE LIEUTENANT GOVERNOR IN COUNCIL Order in Council No. 12 4 3 , Approved and Ordered OCT 121995 Lieutenant Governor Executive Council Chambers, Victoria On the recommendation of the undersigned, the Lieutenant Governor, by and with the advice and consent of the Executive Council, orders that Order in Council 1039 made August 17, 1995, is rescinded. 2. The Drug Schedules made by regulation of the Council of the College of Pharmacists of British Columbia, as set out in the attached resolution dated September 6, 1995, are hereby approved. (----, c" g/J1"----c- 4- Minister of Heal fandand Minister Responsible for Seniors Presidin Member of the Executive Council (This pan is for adnwustratlye purposes only and is not part of the Order) Authority under which Order Is made: Act and section:- Pharmacists, Pharmacy Operations and Drug Scheduling Act, section 59(2)(1), 62 Other (specify): - Uppodukoic1enact N6145; Resolution of the Council of the College of Pharmacists of British Columbia ("the Council"), made by teleconference at Vancouver, British Columbia, the 6th day of September 1995. RESOLVED THAT: In accordance with the authority established in Section 62 of the Pharmacists, Pharmacy Operations and Drug Scheduling Act of British Columbia, S.B.C. Chapter 62, the Council makes the Drug Schedules by regulation as set out in the attached schedule, subject to the approval of the Lieutenant Governor in Council. Certified a true copy Linda J. Lytle, Phr.) Registrar DRUG SCHEDULES to the Pharmacists, Pharmacy Operations and Drug Scheduling Act of British Columbia The Drug Schedules have been printed in an alphabetical format to simplify the process of locating each individual drug entry and determining its status in British Columbia.
    [Show full text]
  • Official Journal of the European Communities No L 61/1
    18 . 3 . 95 EN Official Journal of the European Communities No L 61/1 I (Acts whose publication is obligatory) EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners THE EUROPEAN PARLIAMENT AND THE COUNCIL OF Whereas it is necessary to lay down strict rules for the THE EUROPEAN UNION, use of food additives in infant formulae, follow-on formulae and weaning foods, as referred to in Council Having regard to the Treaty establishing the European Directive 89/398/EEC of 3 May 1989 on the Community, and in particular Article 100a thereof, approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses ( 5 ), Having regard to the proposal from the Commission ( 1 ), and in particular Article 4(1 ) ( e ) thereof; Having regard to the opinion of the Economic and Social Whereas this Directive is not intended to affect rules Committee ( 2 ), relating to sweeteners and colours; Acting in accordance with the procedure laid down in Whereas, pending specific provisions pursuant to Council Article 189b of the Treaty ( 3 ), Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ( 6 ), Having regard to the Council Directive 89/107/EEC of and pursuant to Council Directive 90/642/EEC of 21 December 1988 on the approximation of the laws of 27 November 1990 on the fixing of maximum levels for the Member States concerning food additives authorized pesticide residues in and on certain products of plant
    [Show full text]
  • Potassium Sodium Tartrate MSDS # 592.00
    Material Safety Data Sheet Page 1 of 2 Potassium Sodium Tartrate MSDS # 592.00 Section 1: Product and Company Identification Potassium Sodium Tartrate Synonyms/General Names: Rochelle Salt. Product Use: For educational use only Manufacturer: Columbus Chemical Industries, Inc., Columbus, WI 53925. 24 Hour Emergency Information Telephone Numbers CHEMTREC (USA): 800-424-9300 CANUTEC (Canada): 613-424-6666 ScholAR Chemistry; 5100 W. Henrietta Rd, Rochester, NY 14586; (866) 260-0501; www.Scholarchemistry.com Section 2: Hazards Identification White crystalline powder, no odor. HMIS (0 to 4) Health 0 This material is not considered hazardous. Fire Hazard 0 Target organs: None known. Reactivity 0 This material is not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200) if used properly. Section 3: Composition / Information on Ingredients Potassium Sodium Tartrate (6381-59-5), >99% Section 4: First Aid Measures Always seek professional medical attention after first aid measures are provided. Eyes: Immediately flush eyes with excess water for 15 minutes, lifting lower and upper eyelids occasionally. Skin: Immediately flush skin with excess water for 15 minutes while removing contaminated clothing. Ingestion: Call Poison Control immediately. Rinse mouth with cold water. Give victim 1-2 cups of water or milk to drink. Induce vomiting immediately. Inhalation: Remove to fresh air. If not breathing, give artificial respiration. Section 5: Fire Fighting Measures When heated to decomposition, emits acrid fumes. 0 Protective equipment and precautions for firefighters: Use foam or dry chemical to extinguish fire. 0 0 Firefighters should wear full fire fighting turn-out gear and respiratory protection (SCBA). Cool container with water spray.
    [Show full text]
  • Additional Drug Coverage
    Additional Drug Coverage Additional prescription drug coverage Your plan includes extra coverage for certain drugs and supplies as shown below. This is not a complete list of prescription drugs and supplies covered by our plan. For a complete list, please call Customer Service toll-free at (866) 868-0609 (TTY: 711), 7 a.m. – 7 p.m. CT, Monday – Friday and 7 a.m. – 3 p.m. CT, Saturday. Lower-cost Medicare prescription drugs and supplies Your plan covers some of your Medicare prescription drugs and supplies at a $0 copay. If you have questions, call us toll-free at (866) 868-0609 (TTY: 711), 7 a.m. – 7 p.m. CT, Monday – Friday and 7 a.m. – 3 p.m. CT, Saturday. These drugs and supplies are part of your Medicare prescription drug coverage.1 Breast cancer preventive medications PEG-3350/NaCl/Na Bicarbonate/KCl TriLyte Anastrozole Exemestane Certain diabetic supplies for the Raloxifene administration of insulin Tamoxifen Insulin Syringes & Pen Needles Certain cholesterol-lowering medications Shingles vaccine Atorvastatin 10mg & 20mg Tablet Shingrix Lovastatin 10mg, 20mg & 40mg Tablet Zostavax Simvastatin 5mg, 10mg, 20mg & 40mg Tablet Tobacco cessation medications Certain colon prep products Buproban 150mg GaviLyte-C Chantix GaviLyte-G Nicotrol Inhaler PEG-3350/Electrolytes Nicotrol Nasal Spray Y0066_200527_081500_C Lower-cost non-Medicare over-the-counter drugs These drugs are covered in addition to the drugs in your plan’s drug list (formulary).2 Your plan covers these over-the-counter drugs at a $0 copay. Certain colon preparation products Tobacco cessation medications Bisacodyl Tablets Nicotine Gum Magnesium Citrate Solution Nicotine Lozenges Polyethylene Glycol Powder Nicotine Patches 1Information about the appeals and grievance process for these prescription drugs and supplies can be found in your Evidence of Coverage.
    [Show full text]
  • Non-Hazardous Chemicals
    OSU HAZARDOUS WASTE PROCESS DETERMINATIONM F ORRevision 10/12/2018 Written records are required to demonstrate compliance for all wastes, both hazardous and non-hazardous, that may reasonably be suspected of being hazardous waste. If you have any questions, please contact EH&S at (541)737-2273 or email us at [email protected] Please submit the completed Or save it and email to email address above. Generation Location: Generator Name: (generator any person, whose act or process produces a hazardous waste) Building: Room: Process Name: Contact Phone Number: Generation Process: (how was the waste created) Estimated Volume of Waste Generation: (per month)__________________________________________ mL Liter Gal other_______________ Attachments: (attach all applicable documentation describing the waste (e.g. Acceptable Generator Knowledge, SDS, SOP etc.) : List all hazardous constituents, the volume must equal 100% Chemical: Volume % Compound: Volume % 1 5. 2 6. 3 7. 4. 8. Physical State: Characteristics: (Select all that apply) Solid Flashpoint _________________ Solid w/freestanding or absorbed liquid pH __________________ Liquid (if liquid, indicate if the liquid is: Reactive to Air Single – Phase Reactive to Water Multi - Phase Reactive to pressure Other: ___________________ Oxidizer Toxic Radioactive Biological 1 OSU CHEMICAL WASTE PROCESS DETERMINATION FORM Draft Revision 01/23/19 This section is to be filled out by EH&S. Process: NOTE: • This determination must be reviewed annually and whenever there are process or raw material changes that could affect the waste. • This written documentation of Hazardous Waste Process Determination is required by Federal regulation to be retained until 3 years AFTER the waste is no longer being accumulated.
    [Show full text]
  • Tenncare Preferred Drug List (PDL)
    TennCare Preferred Drug List (PDL) Effective October 1, 2021 PA – Prior Authorization required, subject to specific PA criteria; QL – Quantity Limit (PA & NP agents require a PA before dispensing); B – Budgetary Reduction edit for utilization control (Standard NP PA criteria does not apply); ID – Class PA for patients with Intellectual or Developmental Disability Please note the following: • All agents must be prescribed by a provider with a Tennessee Medicaid Provider ID • Approval of NP agents requires trial and failure, contraindication, or intolerance of 2 preferred agents, unless otherwise indicated • With the exception of the “Branded Drugs Classified as Generics” list, TennCare is a mandatory generic program in accordance with state law (TCA 53-10-205). Approval of a branded product when a generic is available requires documentation of a serious adverse reaction from the generic via an FDA MedWatch form OR contraindication to an inactive ingredient in the AB-rated generic equivalent. Therapeutic Failure of an AB-rated generic equivalent may be considered for approval of branded products in the following high-risk medication classes: Anticonvulsants, Atypical Antipsychotics, HIV antivirals, Immunosuppressants, and Oncology Agents. • Unless otherwise noted, all agents listed on the PDL are referencing legend drugs which are prescription-required agents. Coverage of Over-the Counter (OTC) Products is listed at: https://www.optumrx.com/content/dam/openenrollment/pdfs/Tenncare/presciber/program-information/Covered%20OTC%20List.pdf Preferred
    [Show full text]
  • Sodium L(+)-Tartrate
    SODIUM L(+)-TARTRATE Prepared at the 7th JECFA (1963), published in NMRS 35 (1964) and in FNP 52 (1992). Metal and arsenic specifications revised at the 63rd JECFA (2004) (identical to those listed for potassium sodium L(+)-tartrate). An ADI of 0-30 mg/kg bw was established at the 17th JECFA (1973) and reconfirmed at the 21st JECFA (1977). SYNONYMS Sodium dextro-tartrate; INS No. 335 DEFINITION Chemical names Disodium L-tartrate, disodium (+)-tartrate, disodium (+)-2,3- dihydroxybutanedioic acid C.A.S. number 868-18-8 Chemical formula C4H4Na2O6 · 2H2O Structural formula Formula weight 230.8 Assay Not less than 99% after drying DESCRIPTION Transparent, colourless and odourless crystals FUNCTIONAL USES Sequestrant and stabilizer in meat products and sausage casings CHARACTERISTICS IDENTIFICATION Solubility (Vol. 4) One gram is soluble in 3 ml of water; insoluble to ethanol Test for tartrate (Vol. 4) Passes test Test for sodium (Vol. 4) Passes test PURITY Loss on drying (Vol. 4) Not more than 17% and not less than 14% (150o, 3 h) pH (Vol. 4) 7.0 - 7.5 (1 in 10 soln) Oxalate Add 5 drops of dilute acetic acid TS and 2 ml of calcium chloride TS to 10 ml of a 10% solution of sodium tartrate. No turbidity is produced within 1 h. Lead (Vol. 4) Not more than 2 mg/kg Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in Volume 4, “Instrumental Methods.” METHOD OF Weigh 1.500 g of the dried sample into a tared porcelain crucible, ignite ASSAY gently at first, until the salt is thoroughly carbonized, protecting the carbonized salt from contact with the flame at all times.
    [Show full text]
  • Solid Chemicals for the Normal Trash
    SOLID CHEMICALS FOR THE NORMAL TRASH Solid chemicals acceptable for disposal as regular trash are listed below: Acacia powder, gum arabic Calcium silicate Manganese sulfate Acid, Ascorbic Calcium sulfate Methyl red Acid, Benzoic Detergent (most) Methyl salicylate Acid, Boric Cation exchange resins Methylene blue Acid, Casamind Crystal violet Methyl stearate Acid, Citric Dextrin Nutrient agar Acid, Lactic Dextrose Octacosane Acid, Oleic Diatomaceous earth Parafin Acid, Phthalic Docosanoic acid Pepsin Acid, Salicycle Drierite (calcium sulfate, anhydrous) Peptone Acid, Silicic Ferric oxide Petroleum jelly Acid, Stearic Ferric phosphate Polyethylene, solid Acid, Succinic Ferric pyrophosphate Polystryene Acid, Tartaric Ferric sulfate Potassium acetate Acrylamide gels Ferrous ammonium sulfate Potassium bicarbonate Agar(s) Galactose Potassium bromide Albumen Geletin Potassium carbonate Alumina Gum arabic Potassium chloride Aluminum oxide Gum guaiac Potassium citrate Amino acids, naturally occurring Hexadecanol, 1- Potassium ferricyanide Ammonium bicarbonate Kaolin Potassium iodide Ammonium phosphate Lactose Potassium phosphate Ammonium sulfate Lanolin Potassium sodium tartrate Ammonium sulfamate Lauric acid Potassium sulfate Base, blood agar Lauryl sulfate Potassium sulfite Beef extract Lithium carbonate Potassium sulfocyanate Behenic acid Lithium chloride Pumice Bentonite Lithium sulfate Salts, naturally occurring Brain heart infusion Litmus Sand Bromphenol blue Magnesium carbonate Silica Broth, nutrient Magnesium chloride Silica gel, unused
    [Show full text]