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."
Therapeutically equivalent drug products means drug products that contain the same active
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...

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

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 Product means a product that includes a device for delivery or at least one active ingredient other than a Licensed Product.

  • 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.

  • 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:

  • 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.

  • 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.

  • 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”).

  • 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.