Is it wise to use commercial products in compounding? When doing so, can the pharmacist be assured of a quality preparation? Is it possible to meet the standards of United States Pharmacopeia (USP) Chapter <795>, Chapter <797>, and Chapter <1163> when using commercial products as the source of drugs? The answer to these questions is "sometimes, but not always." Commercial drug products are commonly used for compounding human drug preparations. However, pharmacists are placed in an interesting position because the federal government dictates that commercial products be used for veterinary compounding. However, doing so sometimes results in preparations that are outside USP standards and specifications.
Historically, pharmacists have used commercially available medications to prepare different dosage forms. The most common examples are the use of oral tablets and capsules to prepare oral liquids (solutions and suspensions) for pediatric patients and the use of injectable drugs to prepare intravenous admixtures. Even though U.S. Food and Drug Administration (FDA)-approved commercial products may be used, the final compounded preparation does not have FDA approval.
Considerations
Considerations concerning commercial product use include the following:
- Using commercial products as a source of active drugs usually will result in a higher prescription cost to the patient than would using bulk drug substances. This is especially true when injectables are used as the drug source.
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