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FDA`s Acetaminophen Notice: A Snapshot of the Current Regulatory
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Compounding

Pharmaceutical compounding (done in compounding pharmacies) is the creation of a particular pharmaceutical product to fit the unique need of a patient. To do this, compounding pharmacists combine or process appropriate ingredients using various tools. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, to avoid a non-essential ingredient that the patient is allergic to, or to obtain the exact dose(s) needed or deemed best of particular active pharmaceutical ingredient(s). It may also be done for more optional reasons, such as adding flavors to a medication or otherwise altering taste or texture. Compounding is most routine in the case of intravenous/parenteral medication, typically by hospital pharmacists, but is also offered by privately owned compounding pharmacies and certain retail pharmacies for various forms of medication. Whether routine or rare, intravenous or oral, etc., when a given drug product is made or modified to have characteristics that are specifically prescribed for an individual patient, it is known as ""traditional"" compounding.Due to the rising cost of compounding and the shortage of drugs, many hospitals have shown a tendency to rely more upon large-scale compounding pharmacies to meet their regular requirement, particularly of sterile-injectable medications. When compounding is done on bulk production of a given formulation rather than patient-specific production, it is known as ""non-traditional"" compounding (which, as discussed below, is arguably not ""compounding"" but rather ""manufacturing""). This development raises concerns about patient safety and makes a case for proper regulatory control and monitoring.
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