Therapeutically equivalent drug products definition

Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."
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Therapeutically equivalent drug products means drug products that contain the same active
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Therapeutically equivalent drug products means drug products that contain the same active 1291 ingredients and are identical in strength or concentration, dosage form, and route of administration and 1292 that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration 1293 pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent 129412951296 edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book.""Third-party logistics provider" means a person that provides or coordinates warehousing of or other 1297 logistics services for a drug or device in interstate commerce on behalf of a manufacturer, wholesale 129812991300 distributor, or dispenser of the drug or device but does not take ownership of the product or have responsibility for directing the sale or disposition of the product."USP-NF" means the current edition of the United States Pharmacopeia-National Formulary. 1301 "Warehouser" means any person, other than a wholesale distributor, manufacturer, or third-party 1302 logistics provider, engaged in the business of (i) selling or otherwise distributing prescription drugs or 1303 devices to any person who is not the ultimate user or consumer and (ii) delivering Schedule VI 1304 prescription devices to the ultimate user or consumer pursuant to § 54.1-3415.1. No person shall be 1305 subject to any state or local tax by reason of this definition. 1306 "Wholesale distribution" means (i) distribution of prescription drugs to persons other than consumers 1307 or patients and (ii) delivery of Schedule VI prescription devices to the ultimate user or consumer 1308 pursuant to § 54.1-3415.1, subject to the exemptions set forth in the federal Drug Supply Chain Security 1309 Act. 1310 "Wholesale distributor" means any person other than a manufacturer, a manufacturer's co-licensed 1311 partner, a third-party logistics provider, or a repackager that engages in wholesale distribution. 1312 The words "drugs" and "devices" as used in Chapter 33 (§ 54.1-3300 et seq.) and in this chapter 131313141315 shall not include surgical or dental instruments, physical therapy equipment, X-ray apparatus, or glasses or lenses for the eyes.The terms "pharmacist," "pharmacy," and "practice of pharmacy" as used in this chapter shall be 1316 defined as provided in Chapter 33 (§ 54.1-3300 et seq.) unless the context requires a different meaning. 1317 § 54.1-3446. Schedule I. 1318 The controlled su...
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Examples of Therapeutically equivalent drug products in a sentence

  • Common Channel Signaling (CCS): A high speed packet switched communications network which is separate (out of band) from the public packets switched and message networks.


More Definitions of Therapeutically equivalent drug products

Therapeutically equivalent drug products means drug products that contain the same active 848 ingredients and are identical in strength or concentration, dosage form, and route of administration and 849 that are classified as being therapeutically equivalent by the United States Food and Drug Administration
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Related to Therapeutically equivalent drug products

  • Therapeutically equivalent means a drug product with the same efficacy and toxicity when administered to an individual as the originally prescribed drug as provided for in Section 39‑24‑40.

  • Therapeutic Equivalent means that a Covered Drug can be expected to produce essentially the same therapeutic outcome and toxicity.

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • Morphine equivalent dose means a conversion of various opioids to a morphine equivalent dose by the use of accepted conversion tables.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Replacement Product means electric generating capacity, capacity-related benefits, environmental attributes, Energy or other electric products from a generation resource other than the Facility that are provided or delivered to replace or substitute for Contract Capacity or Storage Capacity (or any Capacity-Related Benefit, Environmental Attribute, Other Electric Product, Contract Energy, or Storage Energy associated therewith), in each case, in whole or in part, pursuant to Section 4.6.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Therapeutic school means a residential group living facility:

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Generic Equivalent or "generically equivalent" means a drug that has an identical amount of the same active chemical ingredients in the same dosage form, that meets applicable standards of strength, quality and purity according to the United States pharmacopeia or other nationally recognized compendium and that, if administered in the same amounts, will provide comparable therapeutic effects. Generic equivalent or generically equivalent does not include a drug that is listed by the federal food and drug administration as having unresolved bioequivalence concerns according to the administration's most recent publication of approved drug products with therapeutic equivalence evaluations.