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Categories of Compounding
The categories of compounding are intended to provide an understanding among compounders when different forms of preparations are compounded. It is to be understood that there are levels of training associated with each category. In the categories of compounding described below, certain criteria were used to determine the overall classification.
Manufacturing involves the production, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction of the drug from substances of natural origin or by means of chemical or biological synthesis. Manufacturing also includes (1) any packaging or repackaging of the substance(s) or labeling or relabeling of containers for the promotion and marketing of such drugs or devices; (2) any preparation of a drug or device that is given or sold for resale by pharmacies, practitioners, or other persons; (3) the distribution of inordinate amounts of compounded preparations or the copying of commercially available drug products; and (4) the preparation of any quantity of a drug product without a licensed prescriber/patient/licensed pharmacist/compounder relationship.
A compounder is a
professional authorized by the state to perform compoundingUSP29
pursuant to a prescription order by a licensed prescriber.