Safety and Standardization in Labeling and Repackaging

Packaging and labeling are believed to be the cause of 33% of medication errors1 and poor label design is cited as a potential cause.2

In 2016, the FDA released guidelines for safe labeling and repackaging acknowledging that improper repackaging of drug products can cause serious adverse events stating, “Because labeling, packaging, and nomenclature have been identified as key system elements that have great influence on medication use, any weaknesses or failure in the design of these elements can cause medication errors that lead to patient harm.”

There are a number of best practices, regulatory, and professional agencies that specify important recommendations regarding labeling and repackaging. Two of our applications were built specifically for labeling and repackaging: RxPACK™ and the RxTOOLKIT® Label Solutions Library include key safety features aligned directly with these recommendations.

Label Design and ISMP

In 2010, the ISMP acknowledged that poor pharmacy label design is directly associated with the increased risk for error and established guidelines for safe medication labeling and design.3 These guidelines include specific recommendations regarding layout, fonts, language, warnings, etc.

Most pharmacy labeling solutions on the market today leave you on your own to figure out how to correctly design and print labels. This can cost valuable time and money!

Using the RxTOOLKIT Label Solutions Library ensures you are using up-to-date professionally designed label templates that follow all of the ISMP guidelines.

We also provide full service training and support. This includes helping you determine which templates you need to get started or designing a new one to meet your exact parameters. We will also help you navigate the many choices for quality printers and label stock.

Standardization of Process and ISMP

The ISMP directly recommends implementation of standardized and mindful drug labeling practices as part of an overall strategy to improve medication adherence and reduce inadvertent medication errors.3

RxPACK™ gets your staff on the same page by establishing a standardized process for verification and documentation. It also pairs seamlessly with the RxTOOLKIT Label Solutions Library to provide easy to find, consistent, and professionally designed label templates. Combining these solutions increases compliance, uniformity, and efficiency while lowering the potential for error.

Expiration Dates and USP

USP General Chapter 795 provides standards for compounding quality non-sterile preparations including provision of general guidelines for assigning beyond-use dates to non-sterile preparations. They specify the expiration date “not exceed (1) 6 months from the date of repackaging; or (2) the manufacturer’s expiration date; or (3) 25% of the time between the date of repackaging and the expiration date shown on the manufacturer’s bulk article container of the drug being repackaged, whichever is earlier.”

Our label templates directly follow USP recommendations and automatically calculate the expiration date even for source ingredients or products.

Logbooks and State Law

Whenever a product or compounded product is packaged for distribution, best practices (and some state laws) require that all information, including for source ingredients, must be documented including: expiration date(s) for final product and source ingredient(s), NDC number, lot number, and preparer’s initials. Typically this information is stored in large binders, making it difficult to store and reference.

With RxPACK™, all relevant information is automatically cataloged and stored in a HIPAA compliant digital logbook. Users can easily find and reference any data element including information on source ingredients.

We recently launched a new site to showcase the many benefits of RxPACK™ and the RxTOOLKIT Label Solutions Library. These tools can help you increase safety and efficiency, and establish standardization and quality control within your labeling and repackaging processes. Please visit for more information and to check out the new site.



[1] Aspden P, Wolcott J, Bootman L, Cronenwett L, editors. Preventing medication errors. Washington DC: Institute of Medicine of the National Academies; 2006. [2] The variability and quality of medication container labels.Shrank WH, Agnew-Blais J, Choudhry NK, Wolf MS, Kesselheim AS, Avorn J, Shekelle P Arch Intern Med. 2007 Sep 10; 167(16):1760-5. [3]

Chuck DiTrapano RPh

Chuck DiTrapano RPh

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About RxToolKit

RxToolKit was founded by an experienced infusion pharmacist to act as a virtual pharmacist. RxToolKit’s flagship software solutions include RxWorkFlow and RxELearning which are web-based applications designed to reduce medication errors, enhance clinical competencies, increase patient safety, and improve clinical outcomes.

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