Compounded drug definition

Compounded drug means any drug subject to:
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2
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.
Sample 1Sample 2

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 Claims should be submitted with the correct amount prescribed and with corresponding accurate quantities and days’ supply calculations.

  • 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.

  • 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.

  • Compounded drug products may be considered investigational in diagnoses that are used off- label or in formulations that do not have a confirmed FDA approval of use.

  • 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.

  • Compounded drug products are not FDA-approved, which means83 they have not undergone FDA premarket review for safety, effectiveness, and quality.

  • 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.


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.
Sample 1
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.
Sample 1
Compounded drug means a sterile or nonsterile compounded
Sample 1
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.
Sample 1
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.
Sample 1
Compounded drug means a combination preparation of the active ingredients of which are
Sample 1

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:

  • 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

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

  • 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 product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • 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.

  • 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.