Compounded drug definition

Compounded drug means any drug subject to:
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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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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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Examples of Compounded drug in a sentence

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

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

  • Compounded drug product may be distributed in or into Idaho in the absence of a patient specific prescription drug order to licensed practitioners in the usual course of professional practice by: ( )01.

  • Dr. Black presently is on campus spending time with the admissions department to review their current processes and functions.

  • Beginning January 1, 2021, your MAC may determine the payment category for any new home infusion drug additions to the DME LCD for External Infusion Pumps (L33794) as identified by the following Not-Otherwise-Classified (NOC) codes:- J7799 - Not otherwise classified drugs, other than inhalation drugs, administered through DME- J7999 - Compounded drug, not otherwise classified.

  • Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act guidance for industry.

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

  • Compounded drug products are exempt from certain provisions of the Food, Drug, and Cosmetic Act (FD&C Act) if they meet the conditions set forth in section 503A of the FD&C Act, including the requirements for premarket approval of new drug products, and current good manufacturing process (CGMP) requirements.

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


More Definitions of Compounded drug

Compounded drug means a drug that is created by combining two one or more active pharmaceutical ingredients, and/or 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. 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 sterile or nonsterile compounded
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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 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 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 (which may include compounding in arrears with a lookback and/or suspension period as a mechanism to determine the interest amount payable prior to the end of each Interest Period) being established by the Administrative 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:

  • Daily Compounded XXXXX means, for any day, XXXXX with interest accruing on a compounded daily basis, with the methodology and conventions for this rate (which will include compounding in arrears with a lookback) being established by the Administrative Agent in accordance with the methodology and conventions for this rate selected or recommended by the Relevant Governmental Body for determining compounded XXXXX for business loans; provided that if the Administrative Agent decides that any such convention is not administratively feasible for the Administrative Agent, then the Administrative Agent may (in consultation with the Borrower) establish another convention in its reasonable discretion; and provided that if the administrator has not provided or published XXXXX and a Benchmark Replacement Date with respect to XXXXX has not occurred, then, in respect of any day for which XXXXX is required, references to XXXXX will be deemed to be references to the last provided or published XXXXX. Any change in Daily Compounded SOFR due to a change in XXXXX shall be effective from and including the effective date of such change in XXXXX without notice to the Borrower.

  • Compounded Daily SONIA means, with respect to an Interest Accrual Period, the rate of return of a daily compound interest investment (with the daily SONIA 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 interest rate, as specified in the applicable Pricing Supplement) on the relevant Interest Determination Date, as follows, and the resulting percentage will be rounded if necessary to the fourth decimal place, with 0.00005 per cent being rounded upwards:

  • SOFR Compounded Index means the Compounded 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 reference rate as reference rate for the calculation of interest) and will be calculated by the Interest Determination Agent as at 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):

  • 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;

  • 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 applicable Final Terms and further provided for below) as the reference rate for the calculation of interest) and will be calculated by the Principal Paying Agent on the relevant Interest Determination Date, as follows, and the resulting percentage will be rounded, if necessary, to the Relevant Decimal Place:

  • 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

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • 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."

  • Cumulative Compounded RFR Rate means, in relation to a Loan (or any part of it) accruing interest at the Compounded Reference Rate, the percentage rate per annum determined by the Facility Agent in accordance with the methodology set out in Schedule 15C (Cumulative Compounded RFR Rate) or in any relevant Compounding Methodology Supplement.

  • 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.

  • 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.

  • Compounded Index means either the SONIA Compounded Index or the SOFR Compounded Index, as specified in the relevant Final Terms;

  • 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 any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Legend drugs means any drugs which are required by state