Medical professionals only prescribe compounded medications in situations where the commercial form of the drug fails to address the patient’s specific needs. If you have any questions about the formulation of your compounded medication, or why you need a compounded drug product, speak with your doctor or medical professional who prescribed the item. If you are apprehensive about taking a compounded medication, ask your prescriber to consider the commercial version of the drug and whether or not this could be an appropriate option for you. You may also ask your prescriber to provide any evidence that the compounded item will produce a better outcome than the commercial item.
Standards for drug compounding are also published by the United States Pharmacopeial (USP) Convention. USP is a private, nonprofit agency designed to establish definitions for the chemical purity of medications and set practice standards. Specifically, the USP guidelines pertain to identity, quality, potency, and purity of the medications, supplements, and food items involved in drug compounding. Such guidelines are distinctly relevant to compounding pharmacists.
USP General Chapter <797> is a nationally recognized set of guidelines that define the accepted practices for processing, testing, and verifying all compounded sterile drugs. It outlines instructions for avoiding microbial contamination and other problematic variances in compounded products. USP 797 guidelines apply regardless of location (may include hospitals or community pharmacies) or the types of medical professionals practicing compounding (pharmacists, pharmacy technicians, nurses, etc.).
USP General Chapter <800> is the updated set of USP guidelines for procedure and quality standards of hazardous drug handling. The purpose of this update is to reduce exposure of health care providers to hazardous drugs. Such efforts encourage employee safety, patient safety, and environmental protection. Released on February 1, 2016, USP 800 guidelines will be officially enacted on July 1, 2018. The existing list of drugs classified as hazardous can be located on the website for the National Institute for Occupational Safety and Health (NIOSH).
Observance of USP guidelines is required nationally as the minimum standard of operation in pharmacies.
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