Stramonium Preparations: 21 CFR, part 250

Transcription

1 Specific Requirements for certain products in US Specific requirements for certain drugs in US Opthalmic Preparations :21 CFR, part 200, subpart C gn=div5&view=text&node=21: &idno=21) sets out the requirements for ophthalmic preparations and dispensers. Aqueous based drug products for oral inhalation:21 CFR, part 200, subpart C gn=div5&view=text&node=21: &idno=21) lays down the requirements for aqueous-based drug products for oral inhalation. Thyroid Containing drug preparations:21 CFR, part 250 down requirements for thyroid-containing drug preparations intended for treatment of obesity in humans. Stramonium Preparations: 21 CFR, part 250 down requirements for Stramonium preparations. amyl nitrite inhalant:21 CFR, part 250 down requirements for Amyl nitrite inhalant as a prescription drug for Amphetamine & Metamphetamine inhalers:21 CFR, part 250 down requirements for Amphetamine and methamphetamine inhalers regarded as prescription drugs. Drugs containing "coronary vasolidators": 21 CFR, part 250 down requirements for Drug preparations intended for human use containing certain coronary vasodilators. Gelsemium containing preparations: 21 CFR, part 250 down requirements for Gelsemium-containing preparations regarded as prescription drugs. Potassium Permanganate Preparations: 21 CFR, part 250 down requirements for Potassium permanganate preparations as prescription drugs. Preparations for the treatment of Pernicious anaemia:21 CFR, part 250 down requirements for Preparations for the treatment of pernicious anemia. Hexachlorophene:21 CFR, part 250 down requirements for Hexachlorophene, as a component of drug and cosmetic products. Investigational New Drug: 21 CFR, part 312 gn=div5&view=text&node=21: &idno=21) contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the FDA of investigational new drug applications (IND's). Radio Pharmaceuticals:21 CFR, part 315 gn=div5&view=text&node=21: &idno=21) apply to radiopharmaceuticals intended for in vivo administration for diagnostic and monitoring use. They do not apply to radiopharmaceuticals intended for therapeutic purposes. Orphan Drugs:21 CFR, part 316 gn=div5&view=text&node=21: &idno=21) sets out the requirements for Orphan Drugs. OTC drugs containing alcohol:21 CFR, part 328 gn=div5&view=text&node=21: &idno=21) sets out requirements for OTC drugs intended for oral ingestion that contain alcohol. OTC Human Drugs:21 CFR, part gn=div5&view=text&node=21: &idno=21) sets out requirements for OTC human drugs. OTC antacids:21 CFR, part 331 gn=div5&view=text&node=21: &idno=21) sets out requirements for OTC antacid products. Antiflatulent OTC drugs:21 CFR part 332 gn=div5&view=text&node=21: &idno=21) sets out requirements for antiflatulent products for over-thecounter

2 OTC antifungal drug products:21 CFR, part 333, subpart B gn=div5&view=text&node=21: &idno=21) lays down the labeling requirements for over-the-counter antifungal drug products. OTC antidiarrheal drugs:21 CFR, part 335 gn=div5&view=text&node=21: &idno=21) sets out the labeling requirements for antidiarrheal drug OTC anti-emetic drugs:21 CFR, part 336 gn=div5&view=text&node=21: &idno=21) sets out the labeling requirements for antiemetic drug products for over-the-counter OTC night time sleep aid drugs:21 CFR, part 338 gn=div5&view=text&node=21: &idno=21) sets out the labeling requirements for nighttime sleep-aid drug OTC stimulant drugs:21 CFR, part 340 gn=div5&view=text&node=21: &idno=21) lays down the requirements for stimulant drug products for overthe-counter OTC cough, cold, allergy, bronchodilator, and anti asthmatic drug:21 CFR, part 341 gn=div5&view=text&node=21: &idno=21) lays down the labeling requirements for cold, cough, allergy, bronchodilator, and antiasthmatic drug products for overthe-counter OTC internal analgesic, antipyretic, and antirheumatic drug products:21 CFR, part 343 gn=div5&view=text&node=21: &idno=21) lays down the labeling requirements for internal analgesic, antipyretic, and antirheumatic drug products for over-thecounter Labeling requirements for OTC anorectal drug products: 21 CFR, part 346 gn=div5&view=text&node=21: &idno=21) sets out the labeling requirements for anorectal drug products for over-the-counter OTC skin protectant drug products: 21 CFR, part 347 ( 00a4b294cdc40b4a901c8a &rgn=div5&view=text &node=21: &idno=21) lays down the labeling requirements for skin protectant drug products for over-thecounter OTC external analgesic drugs:21 CFR, part 348 gn=div5&view=text&node=21: &idno=21) lays down the labeling requirements for external analgesic drug OTC Opthalmic drug products: 21 CFR, part 349 gn=div5&view=text&node=21: &idno=21) lays down the labeling requirements for opthalmic drug OTC antiperspirant drug products: 21 CFR, part 350 gn=div5&view=text&node=21: &idno=21) lays down the labeling requirements for antiperspirant drug OTC sunscreen drug products: 21 CFR, part 352 gn=div5&view=text&node=21: &idno=21) lays down the labeling requirements for sunscreen drug OTC anticaries drug products: 21 CFR, part 355 gn=div5&view=text&node=21: &idno=21) lays down the labeling requirements for anticaries drug Anthelmintic, cholesystokinetic & deodorant drug products for internal use: 21 CFR, part 357 gn=div5&view=text&node=21: &idno=21) lays down the labeling requirements for anthelmintic drug products, cholesystokinetic drug products & deodorant drug products for internal use. Drugs for wart removers, ingrown toe-nail relief, corn and callous remover, pediculicide, control of dandruff, seborrheic, dermatitis & psoriasis: 21 CFR, part 358 gn=div5&view=text&node=21: &idno=21) lays down labeling requirements for drugs for wart removers, ingrown toe-nail relief, corn and callous remover, pediculicide, control of dandruff, seborrheic, dermatitis & psoriasis. Animal Drugs:21 CFR, part 500, subpart C & D gn=div5&view=text&node=21: &idno=21) lay down the labeling requirements for animal drugs.

3 New Animal Drugs:21 CFR, part 510 gn=div5&view=text&node=21: &idno=21) sets out the labeling requirements for new animal drugs. New Animal drugs for investigational use: 21 CFR, part 511 gn=div5&view=text&node=21: &idno=21) lays down the requirements for new animal drugs for investigational use. Oral Dosage Form New Animal Drugs:21 CFR, part 520 gn=div5&view=text&node=21: &idno=21) sets out labeling requirements for oral dosage form new animal drugs. Implantation or injectable dosage form new animal drugs:21 CFR, part 522 ( 00a4b294cdc40b4a901c &rgn=div5&view=text &node=21: &idno=21) sets out labeling requirements for implantation or injectable dosage form new animal drugs. Ophthalmic and topical dosage form new animal drugs:21 CFR, part 524( =text&node=21: &idno=21) sets out labeling requirements for ophthalmic and topical dosage form new animal drugs. Intramammary dosage forms :21 CFR, part 526( =text&node=21: &idno=21) sets out labeling requirements for intramammary dosage forms. Dosage form new animal drugs:21 CFR, part 529( =text&node=21: &idno=21) sets out the specifications, approval procedures, conditions of use, indications for use and limitations for certain dosage form new animal drugs. Drugs intended for anilams:21 CFR, part 530 gn=div5&view=text&node=21: &idno=21) sets out the extralabel use for drugs intended for animals. Tolerances for residues of new animal drugs in food :21 CFR, part 556( =text&node=21: &idno=21) sets out the tolerances for residues of new animal drugs in food. Iron containing drugs and supplements ( Sets out labeling requirements for iron containing drugs and supplements. For more information on the same please visit: Human Drugs and biologics: ( ) Container closure systems for packaging human drugs and biologics. Biologics products: 21 CFR, part 601 gn=div5&view=text&node=21: &idno=21) sets out the licensing requirements for all biologics products. Allergens:21 CFR, part 680 gn=div5&view=text&node=21: &idno=21) sets out manufacturing standards and testing requirements for allergenic products. Drugs for internal use containing mineral oil: 21 CFR, subpart G part 302, drugs for internal use which contain mineral oil. Drugs containing wintergreen oil: 21 CFR, part 201, subpart G, part 303, ), sets out labeling requirements for drug preparations containing significant proportions of wintergreen oil. Tarric acid & barium enema preparations: 21 CFR, part 201, subpart G, part ) lays down the labeling requirements for Tarric acid & barium enema preparations. Isoproterenol inhalation preparations: 21 CFR, part 201, subpart G, part 305, ) lays down the labeling requirements for Isoproterenol inhalation preparations. Potassium salt preparations for oral ingestion: 21 CFR, part 201, subpart G, part 306 potassium salt preparations intended for oral ingestion by man.

4 Sodium phosphate: 21 CFR, part 201, subpart G, part ) lays down the labeling requirements for sodium phosphates. Ipecac syrup: 21 CFR, part 201, subpart G, part 308, Ipecac syrup for OTC sale. Acetophenetidin: 21 CFR, part 201, subpart G, part 309, acetophenetidin Phenindione: 21 CFR, part 201, subpart G, part 310 Phenindione intended for Magnesium sulfate heptahydrate: 21 CFR, part 201, subpart G, part 312, Magnesium sulfate heptahydrate. Estradiol: 21 CFR, part 201, subpart G, part 313, Estradiol. Drug preparations containing salicylates: 21 CFR, part 201, subpart G part 314, ) lays down the labeling requirements for drug preparations containing salicylates. Drugs for sore throats: 21 CFR, part 201, subpart G, part 315, ) lays down the labeling requirements OTC drugs for minor sore throats. Drugs with thyroid hormone activity for human use: 21 CFR, part 201, subpart G, part ) lays down the labeling requirements for Drugs with thyroid hormone activity for Digitalis and related cardiotonic drugs for human use in oral dosage forms: 21 CFR, part 201, subpart G, part 317, ) lays down the labeling requirements for Digitalis and related cardiotonic drugs for human use in oral dosage forms. Drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances: 21 CFR, part 201, subpart G, part 320, drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances. OTC drug products containing internal analgesic/antipyretic active ingredients: 21 CFR, part 201, subpart G, part 322, ) sets out alcohol warning labeling requirements for OTC drug products containing internal analgesic/antipyretic active ingredients. Specific Requirements for Electronics in US Diagnostic X-Ray system Flight guidance system Ozone depleting substances Water heaters, Boilers, Storage tanks Air Conditioners and heat pumps Air Conditioners (HS 8415) and heat pumps (HS 8418) Central air conditioner & heat pumps N-Propyl bromide Link TBT\000Diagnostic XRay - G.TBT.N.USA.29.doc TBT\000Flight Guidance Systems - G.TBT.N.USA.75.doc TBT\000Ozone Depleting Substances - G.TBT.N.USA.116.doc TBT\Ozone Depleting Substances - G.TBT.Notif doc TBT\Ozone Depleting Substances - G.TBT.Notif doc TBT\000Water Heaters - G.TBT.Notif doc TBT\Air Conditioners and Heat Pumps - G.TBT.Notif doc TBT\Air Conditioners Heat Pumps - G.TBT.N.USA.3.doc TBT\Central Air C Heat Pumps - G.TBT.Notif doc TBT\CFC Substitute - G.TBT.N.USA.45.doc

5 Clothes washers Electronic products Electronic motors Fluorescent Lamp ballast Refrigerant Spectrum devices TBT\Clothes Washers - G.TBT.Notif doc TBT\Diagnostic and Xray devices - G.TBT.N.USA.29.doc TBT\Electric Motors - G.TBT.Notif doc TBT\Florescent Lamp Ballast - G.TBT.Notif doc TBT\Refrigerant - G.TBT.N.USA.108.doc TBT\Spectrum Devices - G.TBT.N.USA.7.doc Product Code Product (US ele) Nature of Measure Description of Measure Date of Notification Notification No 8415/ Air Conditioners and Heat Pumps TBT Department of Energy proposes 15-Aug-00 G/TBT/Notif.00/364 regulations to implement the standards and test procedures for establishing the energy efficiency of Air Conditioners and Heat Pumps 8419 Refrigerant (HS Chapter: 8419) TBT In pursuance of the US Environment Protection Agency's proposal to amend the regulatory text for the definitions of refrigerant and technician and the prohibition against venting substitute refrigerants /01jan /edocket.access.gpo.go v/2005/ htm /01jan /edocket.access.gpo.g ov/2005/pdf/ pdf 19-Apr-05 G/TBT/N/USA/ Electric motors (HS Chapter ) TBT Efficiency labelling requirements and compliance certification requirements for motors by the Deaprtment of Energy Fluorescent Lamp Ballasts (HS Chapter 8539) TBT The Department proposes to amend the energy conservation standard for fluorescent lamp ballasts for commercial and industrial applications as recommended in the joint proposal and announce a public hearing General Measure (Labelling) TBT The country of origin is only necessary to be in close proximity to the name of the other geographic location on the imported article if the name of the other geographic location may mislead or deceive the ultimate purchaser as to the actual country of origin of the imported article , Refrigerators, refrigerator-freezers, and freezers(hs TBT Proposal for Comment with regard to Chapter , ) energy conservation Wireline telephones (HS Chapter ) TBT All wireline telephones in the workplace, confined settings (for example hospitals, nursing homes) and hotels and motels to be hearing aid compatible and have volume control. 8415/8418 Air Conditioners (HS Chapter 8415) (ICS ) and Heat Pumps (HS Chapter 8418) TBT Change in test procedures to ascertain energy efficiency standards. The efficiency standards however remain unaltered Water Heaters (HS Chapter 8419) TBT Proposed test for rating of instantaneous water heaters, the installation requirement for heat pump water heaters supplied without tanks, and the definition of heat pump water heater.(notice for public comments) 8451 Clothes Washers (HS Chapter 8451) TBT Energy conservation standards 8421/ 8422 Consumer Products TBT Energy Conservation Program for Consumer Products: Test Procedure for Clothes Washers and Reporting Requirements for Clothes Washers, Clothes Dryers and Dishwashers 8501 Electric motors (HS Chapter 8501) TBT Test Procedures, Labeling, and Certification Requirements for Electric Motors.(Draft for Comments) 8506 Batteries TBT An invite to commment on the rule prohibiting the deceptive use of Leakproof, Guaranteed Leakproof, etc., as descriptive Of dry cell batteries 8415/8418 Central Air Conditioners & Heat Pumps TBT Announcement of a Public Hearing on the proposal to amend the energy conservation standards for residential central air conditioners and heat pumps to require them to be more energy efficient, /841919/841720/ Consumer Products TBT Proposes amendments to the existing rukes to clarify the water heater, kitchen range, oven, and microwave, and clothes washer test procedures for energy efficiency. 8419/8516/8403/8404/ Water heaters, boilers, and storage tanks TBT Test Procedures and Efficiency Standards for Commercial Water Heaters, Hot Water Supply Boilers and Unfired Hot Water Storage Tanks 18-Dec-96 G/TBT/Notif Mar-00 G/TBT/Notif.00/ Dec-95 G/TBT/Notif Aug-95 G/TBT/Notif Mar-96 G/TBT/Notif Feb-01 G/TBT/N/USA/3 18-Nov-97 G/TBT/Notif Oct-00 G/TBT/Notif.00/497 6-May-96 G/TBT/Notif Jul-98 G/TBT/Notif Sep-97 G/TBT/Notif Oct-00 G/TBT/Notif.00/ Apr-95 G/TBT/Notif Aug-00 G/TBT/Notif.00/367