Compounded drug definition

Compounded drug means any drug subject to:
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Compounded drug means a drug that is created by combining one or more active pharmaceutical ingredients, and one or more inactive ingredients, to meet specific patient medical needs that cannot be met with FDA-approved prescription drugs, FDA- approved non-prescription drugs, or other drugs commercially available in the marketplace.
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Compounded drug means a sterile or nonsterile compounded formulation for dispensing or administration pursuant to a prescription, that is prepared for a patient with needs that cannot be met by a commercially available prescription drug.
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Examples of Compounded drug in a sentence

  • Compounded drug products are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality.

  • Compounded drug products can serve an important role for patients whose clinical needs cannot be met by an FDA-approved drug product, such as a patient who has an allergy and needs a medication to be made without a certain dye, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form that is not otherwise available, or for appropriate pediatric or weight-based dosing.

  • Compounded drug preparations shall not be offered to other entities for resale.

  • Compounded drug product should be produced for a specific individual and not on a large scale.• United States Pharmacopoeia (USP)o Drug should be compounded in compliance with the USP Chapter <795> using bulk drug substances as defined in 21 CFR 207.3(a)(4), that comply with applicable USP standardsor National Formulary monograph if one exists.

  • The Direct Clearing Customer or Guarantee Agent shall provide the details of a valid account within Nasdaq Dubai to Nasdaq Dubai for the purpose of transferring the assets in the Segregated Clearing Account prior to the closing out of same, subject to Rule 12.4.2.

  • Compounded drug claims must be submitted via the POS System using the appropriate compounding indicator code of “2” in field NCPDP D.0 406-D6 with each ingredient cost submitted by the particular quantity of the NDC and with the applicable Level of Effort (LOE) code in field 474-8E of the NCPDP D.0 format describing the amount of time/work required to produce the compounded drug.

  • Streets in these communities are often designed to be fairly wide also for the convenience of moving the houses in and out.

  • Compounding, Generally7778 Compounded drug products serve an important role for patients whose clinical needs cannot be79 met by an FDA-approved drug product such as for a patient who has an allergy and needs a80 medication to be made without a certain dye contained in an FDA-approved drug product, or an81 elderly patient or a child who cannot swallow a pill and needs a medicine in a liquid form that is82 not available in an approved product.

  • Compounding, Generally6566 Compounded drug products serve an important role for patients whose clinical needs cannot be67 met by an FDA-approved drug product, such as a patient who has an allergy and needs a68 medication to be made without a certain dye, an elderly patient who cannot swallow a pill and69 needs a medicine in a liquid form that is not otherwise available, or a child who needs a drug in a70 strength that is lower than that of the commercially available product.

  • Compounded drug preparations -Pharmacist/Patient/Prescriber Relationship.


More Definitions of Compounded drug

Compounded drug means a drug that is created by combining two or more active pharmaceutical ingredients to meet specific patient medical needs that cannot be met with FDA- approved prescription drugs, FDA-approved non-prescription drugs, or other drugs commercially available in the marketplace. A “compounded drug” does not include a drug prepared by mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer.
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Compounded drug means a product that is created by combining two or more active or inactive pharmaceutical ingredients to meet specific patient medical needs that cannot be met with FDA-approved prescription drugs, FDA-approved non-prescription drugs, or other drugs commercially available in the marketplace inclusive of kits designed for ease of compounding such products.
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Compounded drug means a drug that is created by combining two or more active pharmaceutical ingredients to meet specific patient medical needs that cannot be met with FDA-approved prescription drugs, FDA-approved non-prescription drugs, or other drugs commercially available in the marketplace.
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Compounded drug means a combination preparation of the active ingredients of which are
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Compounded drug means a sterile or nonsterile compounded
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Compounded drug means a prescription drug that has been prepared by a pharmacist who mixes or adjusts drug ingredients to customize a medication to meet a patient’s individual needs.
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Related to Compounded drug

  • Compounded SOFR means the compounded average of SOFRs for the applicable Corresponding Tenor, with the rate, or methodology for this rate, and conventions for this rate being established by the Calculation Agent in accordance with:

  • Compounded Daily SOFR means, in relation to a Floating Rate Interest Period, the rate of return of a daily compound interest investment (with SOFR as reference rate for the calculation of interest) during the related Observation Period and will be calculated by the Calculation Agent on the related Interest Determination Date as follows: Where:

  • Compounded Daily SONIA means with respect to an Interest Accrual Period, the rate of return of a daily compound interest investment during the Observation Period corresponding to such Interest Accrual Period (with the daily Sterling overnight reference rate as reference rate for the calculation of interest) and will be calculated by the Calculation Agent (or such other party responsible for the calculation of the Rate of Interest, as specified in the Final Terms or Pricing Supplement) on the relevant Interest Determination Date, as follows, and the resulting percentage will be rounded, if necessary, to the fifth decimal place, with 0.000005 being rounded upwards: Where:

  • SOFR Compounded Index means the Compounded Daily SOFR rate as published at 15:00 (New York time) by Federal Reserve Bank of New York (or a successor administrator of SOFR) on the website of the Federal Reserve Bank of New York, or any successor source; and

  • Compounded Daily XXXXX means the rate of return of a daily compound interest investment (with the daily Sterling Overnight Index Average as the Reference Rate for the calculation of interest) and will be calculated by the Principal Paying Agent (or such other party responsible for the calculation of the Rate of Interest, as specified in the applicable Final Terms Document) on the Interest Determination Date, as follows, and the resulting percentage will be rounded if necessary to the fourth decimal place, with 0.00005 being rounded upwards: where:

  • Compounded Daily €STR means, with respect to any Interest Period, the rate of return of a daily compound interest investment (with the daily euro short-term rate as reference rate for the calculation of interest) as calculated by the Calculation Agent as at the relevant Interest Determination Date in accordance with the following formula (and the resulting percentage will be rounded if necessary to the nearest fifth decimal place, with 0.000005 being rounded upwards):

  • Covered drug means any prescription drug that:

  • Compounded Daily Reference Rate means, with respect to an Interest Period, the rate of return of a daily compound interest investment in the Specified Currency (with the applicable Reference Rate (as indicated in the relevant Final Terms and further provided for below) as the reference rate for the calculation of interest) and will be calculated by the Calculation Agent on the Interest Determination Date, as follows, and the resulting percentage will be rounded, if necessary, to the fifth decimal place, with 0.000005 being rounded upwards:

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

  • SONIA Compounded Index means the index known as the SONIA Compounded Index administered by the Bank of England (or any successor administrator thereof);

  • SONIA Compounded IndexEnd means the SONIA Compounded Index Value on the date falling “p” London Business Days prior to (i) in respect of an Interest Accrual Period, the Interest Payment Date for such Interest Accrual Period, or (ii) if the Notes become due and payable prior to the end of an Interest Accrual Period, the date on which the Notes become so due and payable; and

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

  • SONIA Compounded IndexStart means, with respect to an Interest Accrual Period, the SONIA Compounded Index determined in relation to the day falling the Relevant Number of London Banking Days prior to the first day of such Interest Accrual Period; and

  • 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."

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Daily Non-Cumulative Compounded RFR Rate means, in relation to any U.S. Government Securities Business Day during a Floating Rate Interest Period for a Loan (or any part of it), the percentage rate per annum determined by the Facility Agent in accordance with the methodology set out in Schedule 15B (Daily Non-Cumulative Compounded RFR Rate) or in any relevant Compounding Methodology Supplement.

  • 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:

  • Compound means the taking of two or more ingredients and fabricating them into a single

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

  • 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.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • SBI 1 Year MCLR Rate means 1 year Marginal Cost of Funds Based Lending Rate (MCLR) fixed by State Bank of India (SBI) / any replacement thereof by SBI for the time being in effect applicable for 1 year period, as on 1st April of the respective financial year in accordance with regulations and guidelines of Reserve Bank of India. In absence of such rate, any other arrangement that substitutes such rate as mutually agreed to by the Parties.

  • controlled drug means an article or substance prescribed under a regulation to be a controlled drug.

  • Legend drugs means any drugs which are required by state

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

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.