Compounding and Manufacturing
Over the last several months, there have been numerous
communications as to the definition of compounding
versus manufacturing. South Dakota Codified Law 36-
11-2(5) defines compounding “as the preparation, mixing,
assembling, packaging or labeling of a drug or drug
device as a result of a practitioner’s prescription drug
order or an initiative based on the pharmacist/patient/
practitioner relationship in the course of professional
practice,” eg, patient-specific. Manufacturing on the
other hand, as defined by the National Association of
Boards of Pharmacy® is “preparation of non-patient specific
products where the primary focus is on the product;
not the patient.” Organizations that are manufacturing
must be permitted by Food and Drug Administration.
Source found here
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