Compounded drug definition

Compounded drug means any drug subject to:

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.

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.

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 sterile or nonsterile compounded

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 combination preparation of the active ingredients of which are

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 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.

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.