Beyond use dating for compounded pharmaceuticals

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Today, compounding has made a resurgence because of many drug shortages in recent years; the need for customized drug formulations as a result of allergies; special dosage forms for pediatric patients, geriatric patients, and special needs populations; and the movement toward specialty and personalized medicines.

Today’s compounding pharmacy practice includes sterile preparations and nonsterile preparations.

Physical reference standards also are called for in monograph tests as well as in some general chapters.

USP’s standards are developed or revised by the Council of Experts and its Expert Committees, a volunteer, expert standards-setting body.

The Compounding Quality Act of DQSA established two sections that established clearly differentiated types of compounding facilities: Section 503A set forth “Traditional Compounders” and Section 503B established “Outsourcing Facilities.” For further information on this law, see Power Pak’s Current Topics in Sterile Compounding: The Drug Quality and Security Act. USP’s standards were recognized as the official compendia for drugs marketed in the United States in the 1906 Pure Food and Drugs Act and the 1938 FD&C Act and its amendments.

In the United States, standards of strength, quality, purity, packaging, labeling, and naming of medicines are developed by the USP. The FDA typically enforces USP-NF standards via the adulteration and misbranding sections of the FD&C Act.

For compounding, the Compounding Expert Committee comprises experts in the fields of sterile and nonsterile compounding for human and animal drugs, microbiology, infection control, and analytical chemistry.

All new or revised USP standards undergo a formal public review and comment process.

Sterile compounding evolved primarily in hospitals in the 1960s and 1970s.USP’s standards for compounded medicines include monographs for bulk drug substances used in compounded preparations; monographs for compounded preparations (primarily nonsterile), six general chapters including USP has nearly 200 compounding preparations monographs in the official USP-NF, primarily for nonsterile preparations.Compounding preparation monographs include formulations and quality parameters for individual preparations and comprise formulas (ingredients and quantities), directions to correctly compound the preparation, packaging and storage information, p H, beyond-use dates (BUD) based on stability studies, and assays (for most monographs).General Chapter describes the “conditions and practices to prevent harm, including death, to patients that could result from 1) microbial contamination (nonsterility), 2) excessive bacterial endotoxins, 3) variability in the intended strength of correct ingredients, 4) unintended chemical and physical contaminants, and 5) ingredients of inappropriate quality in compounded sterile preparations (CSPs).” The revisions proposed in 2015, while not finalized, are intended to “reflect new science and evidence based on updated guidance documents, best practices, and new learnings from investigations; respond to stakeholder input received...; and to clarify topics that are frequently queried and misconstrued.” is designed to protect health care personnel who handle hazardous drugs as well as to increase the safety in the physical environments in which hazardous drugs are prepared.It “...describes practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection.

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