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Seven Tips to Help You Avoid Cross-Contamination During Unit-Dose Drug Repackaging

Posted on August 12, 2021

Originally posted on April 05, 2018

Updated August 2, 2021 

While the COVID-19 pandemic has contributed to medication shortages, the FDA acknowledges that drug shortages can occur almost any time, due to factors such as manufacturing delays, quality issues, or discontinuations. In fact, the FDA now offers a Drug Shortages Mobile App to receive notifications within selected therapeutic categories.

As a result of pandemic-related shortages, some hospitals and health systems have opted to establish a combination of in-house and outsourced unit-dose drug repackaging to ensure supply availability and to keep costs in check. Regardless of which approach a facility chooses, cross-contamination remains a vitally important consideration for every hospital's unit-dose repackaging strategy.

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What Is Unit-Dose Repackaging and What Does It Mean for Your Hospital or Health System?

Posted on February 01, 2021

In its simplest form, unit-dose repackaging means placing every individual medication dose into its own package, labeled and bar-coded. The pharmacist must repackage a bulk shipment of drugs (for example, a bottle of 100 tablets) into 100 separate doses. Sound simple? Maybe, but think about everything that’s involved in that process.

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How to Combat Unit-Dose Drug Costs with Third-Party Drug Repackaging

Posted on October 07, 2020

Unit-dose medication packaging has been a standard practice for hospital pharmacies since the late 1960s. Since then, pharmaceutical manufacturers and wholesalers have consolidated, resulting in fewer unit-dose drugs being available to hospital pharmacies. This directly caused price increases on unit-dose products, frequent backorders and more limited options.

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In-House vs. Outsourced Unit-Dose Repackaging: Which is Better?

Posted on February 18, 2019

In today’s health care environment, it’s important to ensure that patients get the best care possible. This can include spending time with the patient to understand his or her needs. It also includes prescribing, dispensing and administering the right drug in the right dose at the right time.

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FDA Label Changes for Vitamins A, D and E

Posted on October 18, 2018

The U.S. Food and Drug Administration (FDA) now requires that manufacturers change their product labels from international units (IU) to metric units of measurement — micrograms (mcg) or milligrams (mg). This comes as a result of the FDA’s final rule, “Food Labeling: Revision of the Nutrition Supplement Facts Labels,” published on May 27, 2016.

Pharmacies can expect to start seeing these label changes come through on all over-the-counter (OTC) fat-soluble vitamin A, D and E products. We understand that this change can be difficult when trying to determine the metric equivalent for IUs. For a safer transition to metric labeling, Safecor Health will begin including both the IU and metric measurements on its labels, when possible.

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How to Optimize Pharmacy Staffing through Repackaging

Posted on June 13, 2018

Health care is an ever-changing industry. The fluctuation in technology alone can be hard enough to keep track of, but modern medical institutions also must deal with rapidly increasing costs and ever-shrinking resources. This is especially true of hospital pharmacies where tighter budgets can stretch staff thin and it can be difficult to optimize pharmacy staffing.

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Trending Hospital Pharmacy Challenges from HCP Spring 2018

Posted on May 09, 2018

Highlights about Our Time at the Event

In case you missed it, the HCP Spring 2018 Hospital Pharmacy Conference kicked off in Atlanta, GA last week – April 30 – May 2, 2018. Our Safecor Health team participated in the Reverse EXPO and accredited educational sessions. Hearing from other hospital pharmacy directors provided valuable insight on trending topics and challenges in the industry.

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Three Hidden Savings of Outsourced Repackaging

Posted on March 28, 2018

For many hospitals, in-house repackaging often seems like the most cost-effective way to package drugs into unit-dose. Unfortunately, with limited resources, hospital pharmacies don’t always have the time needed to focus on packaging. To offset staff time spent on packaging, many pharmacies purchase whatever is available in commercial unit-dose. Unfortunately, many of those unit-dose purchases have a significant cost premium versus bulk bottles.

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How Does USP General Chapter <800> Affect Medication Repackaging?

Posted on February 15, 2018

The National Institute for Occupational Safety and Health (NIOSH) developed USP General Chapter <800> to better protect all workers, patients and general public who may potentially come in contact with hazardous drugs. Many hospitals are keeping this top of mind as they try to understand how these requirements impact their pharmacy operations. If your hospital pharmacy currently repackages hazardous drugs in-house, you may need to implement new steps and process changes to be compliant with USP <800> (official December 2019).

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Is Your Pharmacy Ready to Meet FDA Unit-Dose Repackaging Guidelines?

Posted on January 14, 2018

Here’s a checklist to help you determine if your hospital pharmacy would comply with upcoming FDA unit-dose repackaging guidelines.

Do you have stability studies to justify your expiration dating (beyond-use date) on repackaged drugs?

  • FDA July 2020 guidance states six months dating (or 25 percent of the remaining manufacturer expiration date, whichever is less) in the absence of a risk-based approach to stability studies for oral solids.
  • The FDA has not given any guidance on allowable expiration dating for repackaged oral liquids.

Do you know what class of packaging materials you use?

  • USP Class A materials can support one year dating with stability studies.
  • USP Class B materials can only support six months dating.
  • USP Class D materials can only support 30 days dating.

Does your pharmacy’s unit-dose packaging process comply with cGMP requirements?

  • Proposed FDA guidelines ensure packaging and dating consistency regardless of location.
  • Cleaning validation to prevent cross-contamination.
    • Did you know? Many high-speed oral solid packagers use a common chute resulting in a high chance of cross-contamination among drugs dispensed.
  • Packaging materials must comply with FDA guidelines for water vapor and light transmission.
  • Canisters in packaging machines should be proven as capable to protect the stability of the product while in storage. Canisters would be considered a container closure system and comply with USP requirements for light resistance.

Do you have a separate quality team overseeing your packaging operation?


If you answered “NO” to any of these questions, here’s what it could mean for your pharmacy:

More packaging. More labor. Shorter dating. More waste. Higher costs.

Proposed changes in pharmacy packaging requirements could have a significant impact on your operations and budget. Shorter dating and more regulations could mean more time spent on packaging, more waste due to shorter dating, more personnel needed for packaging and higher costs.

As the world of hospital pharmacy unit-dose repackaging changes, will you be ready?

Lower your risk. Improve medication safety. Extend your dating. Reduce your waste.

Contact us today to learn how Safecor Health can help.

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