Therapeutically equivalent drug products definition

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 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 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 1294 edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as 1295 the "Orange Book." 1296 "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 1298 distributor, or dispenser of the drug or device but does not take ownership of the product or have 1299 responsibility for directing the sale or disposition of the product. 1300 "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 1313 shall not include surgical or dental instruments, physical therapy equipment, X-ray apparatus, or glasses 1314 or lenses for the eyes. 1315 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 cont...
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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.

  • 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.

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

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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:

  • 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.

  • 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

  • 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.