Batch compounding definition

Batch compounding means the act of compounding multiple containers/doses of a drug product or other material with uniform character and quality, within specified limits, that are prepared in anticipation of physician/prescription drug orders or approved protocol/procedure based on routine, regularly observed prescribing patterns.
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Batch compounding means the act of compounding multiple containers/doses of a drug product or other material with uniform character and quality, within specified limits, that are
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Related to Batch compounding

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid, a quantity of soluble lead compound exceeding, when calculated as lead monoxide, five per cent of the “dry weight” of the portion taken for analysis. In the case of paints and similar products and other mixtures containing oil or fat the “dry weight” means the dry weight of the material remaining after the substance has been thoroughly mixed and treated with suitable solvents to remove oil, fats, varnish or other media.

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

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).