Repackaged drug definition

Repackaged drug means any drug removed from the manufacturer's original package and placed in different packaging.
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Repackaged drug means a drug product that is transferred by pharmacy personnel from an original manufacturer’s container to another container properly labeled for subsequent dispens- ing.
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Repackaged drug means a drug product that is transferred by pharmacy personnel from an original manufacturer's container to another container properly labeled for subsequent dispensing.
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Examples of Repackaged drug in a sentence

  • Regulatory Framework for Repackaging Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs.

  • Repackaged drug products supplied through co-ops, franchises, or other sources not readily available to other providers shall not be used.

  • Repackaging of Radiopharmaceuticals248249 Outsourcing facilities sometimes receive a prescription or order for a radiopharmaceutical250 product that differs from an approved radiopharmaceutical only in that it has been repackaged.251 Repackaged drug products are not eligible for the exemptions provided under section 503B of252 the Act.

  • Repackaged drug products supplied through co-ops, franchises, or other sources not readily available to other providers shall not be used to estimate provider acquisition cost.

  • Repackaged drug products are subject to the premarket approval, misbranding, adulteration and drug supply chain security provisions of the FD&C Act.


More Definitions of Repackaged drug

Repackaged drug means a drug product which that is transferred by pharmacy personnel from an original manufac- turer’s container to another container properly labeled for subsequent dispensing.
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Related to Repackaged drug

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Covered drug means any prescription drug that:

  • cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epi­ dermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;

  • Generic Drug means a Prescription Drug that is medically equivalent to a Brand Name Drug as determined by the FDA. It meets the same standards as a Brand Name Drug for purity, safety, strength and effectiveness and is manufactured and sold under its chemical, common, or official name.

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Brand Name Drug means a Prescription Drug that has been given a name by a manufacturer or distributor to distinguish it as produced or sold by a specific manufacturer or distributor and may be used and protected by a trademark.

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

  • Legend drug or "prescription drug" means any drug or device that has been determined to be unsafe for self- medication or any drug or device that bears or is required to bear the legend:

  • FDCA shall have the meaning ascribed to such term in Section 3.1(hh).

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Drug addiction means a disease characterized by a

  • Legend drugs means any drugs which are required by state

  • Invalid Drug Test means the result of a drug test for an oral fluid specimen that contains an unidentified adulterant, or an unidentified substance, that has abnormal physical characteristics, or that has an endogenous substance at an abnormal concentration preventing the laboratory from completing or obtaining a valid drug test result.

  • Counterfeit drug means a drug that, or the container or

  • Prescription drug means any drug required by federal law or regulation to be dispensed only

  • FD&C Act means the United States Federal Food, Drug and Cosmetic Act, as amended.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • 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;

  • Packaged means bottled, canned, cartoned, or securely wrapped.

  • low protein modified food product means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a Practitioner for the dietary treatment of an inherited metabolic disease, but does not include a natural food that is naturally low in protein; and

  • Drug means (i) articles or substances recognized in the official United States Pharmacopoeia

  • 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.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”