Compounded drug definition

Compounded drug means any drug subject to:
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.
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.

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

Related to Compounded drug

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

  • Legend drugs means any drugs which are required by state