Eliminate Risk: Ensure Your Multi-Dose Packages Are Compliant
Aug 01

Eliminate Risk: Ensure Your Multi-Dose Packages Are Compliant

One step toward eliminating risk in your pharmacy is ensuring multi-dose packages are compliant with USP standards.

Here, we've simplified two of the most important USP regulations along with providing insights into Medicine-On-Time's software.

Defining Compliance Packages

First, it’s important to know exactly how compliance packages are defined by the USP (U.S. Pharmacopeial Convention).

Compliance packages are defined in the USP standard 661. Standard 661  is listed as Containers, Plastics PF 32(4) Customized Patient Medication Packages (CPMP) on page 1176.

A CPMP, or multi-dose package, is a package prepared by pharmacists for a specific patient, comprising a series of containers. A pack contains two or more prescribed solid, oral dosage forms. Medication packs are labeled to indicate the day and time contents should be taken within each container.

The Basics about USP Standard

According to the USP Standard 661,  multi-dose packages must also comply with standard 671: Containers Permeation. This standards states how the CPMP must meet moisture permeation requirements for Class B containers. Multi-dose packages must be airtight and have no openings on the container’s edges to prevent moisture from seeping into individual dose cups.

From a regulatory standpoint, all state Boards of Pharmacy have either adopted the USP Guidelines for CPMP word-for-word or have added to the USP’s 661 standard. State Boards of Pharmacy have created a modified version of standard 671 for their specific state Board.

To learn more about multi-dose packaging standards, visit the Pharmacopeia’s USP, BP, EP website. They outline the labeling, packaging and record keeping requirements for multi-dose packages.

Your Advantage with Medicine-On-Time

We make compliance and adherence simple for pharmacies across the nation!

Medicine-On-Time ensures patient safety and regulatory compliance by adhering to the USP’s standards.

When marketing the Medicine-On-Time program, know your competition and make sure your customers are informed about Medicine-On-Time’s advantage for patient safety and regulatory compliance.

All multi-dose blister packages are not compliant with these important regulations. It is critical to know which multi-dose packages are compliant with USP standards and which are not when selecting a multi-dose service for your customers. Your business will avoid fines by complying with USP standards.

Record Keeping Requirements

Record keeping requirements are often overlooked by many pharmacists until it’s addressed in a surveyor’s inspection. It is important to note how Medicine-On-Time’s software has data recording capabilities to assure you’re updated on record keeping requirements.

Medicine-On-Time’s software will generate a printable USP record keeping report that can be presented to surveyors.

Contact Us!

If you are not familiar with the record keeping feature or the printable report in our software, please do not hesitate to contact our Customer Support Department at (800) 722-8824 Option 2, and they will be more than happy to show you these features.

Our goal at Medicine-On-Time is to ensure our pharmacy customers are compliant with their appropriate federal and state regulations. If you become aware that pharmacy or facility regulations in your state have changed and/or are going to change, please contact us. Your attentiveness will enable us to stay updated on changes and offer you guidance with new compliance regulations.

Works cited: All information regarding USP standards- Pharmacopeia.cn