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Here Are A Few Helpful Tips To Keep In Mind When Staying Compliant With The New USP<800> Guidelines

While the rollout has been a long time coming, on December 1st, 2019, the new USP<800> standards for safe handling of hazardous materials were implemented. USP<800> is an enforceable chapter but is actually much wider in scope when compared to other chapters as it applies to sterile and non-sterile compounding practices as well as administration of these drugs to patients. These new standards are in place to make the handling of hazardous drugs safer and to minimize the risk of exposure to healthcare personnel and patients alike. It is important that you are aware of all the new standards and practices and prepared to comply with them. Below is a list of steps you can take to ensure you are in compliance with the new regulations.

Do An Audit Of Your Current Procedures and The Hazardous Drugs You Use
To start, it would be advised that any hospital, pharmacy or other medical center do a full audit of it’s current procedures in regards to the handling and dispensing of hazardous drugs. Start by examining the operating procedures and administrative controls and identify anything that may need to be changed or added to be in compliance with USP . In addition, you should also do a full audit of the hazardous drugs that you use in your facility on a regular basis so that you can ensure you have all of the necessary environmental and refrigeration equipment in place for the proper storage of these drugs. While USP will incorporate many of the same guidelines contained in chapter , many of the standards will be higher, so starting with a full internal audit will help prepare you for the next steps.

Make and Maintain Detailed Lists
One of the key areas that USP focuses on is the outlining of responsibilities of personnel as well as the various protective equipment required for handling these hazardous drugs. In addition, it details the guidelines for receiving, storing, compounding, administering and disposing of these hazardous drugs. By creating checklists and procedural lists for you and your personnel to follow, you will do a much better job of ensuring the proper procedures are followed and the proper protective equipment and products are used in the handling of these hazardous drugs.

Make Sure You Have Dedicated Storage Space
Another change that will be implemented in the USP requirements will be the need for additional storage space for hazardous drugs. While not every hazardous drug may need to be stored separately from the rest of your stock, the National Institute for Occupational Safety and Health does provide a list of drugs that will require additional space to assist in planning for just how much space will be needed. Another requirement will be the need for certain drugs, for example antineoplastic drugs that require manipulation to be stored in a negative-pressure room. These rooms should also contain dedicated refrigeration units to store any of these drugs that may require refrigeration, and they will also be required to have at least 12 air changes per hour.

Always Keep A Full Stock Of Gloves and Cleaning Supplies On Hand
USP will require that personnel “double glove”, or wear two pairs of gloves on each hand, during the administering and disposal of any hazardous drugs, so it is imperative that your facility maintain a full stock of gloves on hand at all times. In addition, personnel will also be required to double glove during the disposal of any protective equipment that may have been used during the handling of hazardous drugs or the cleaning of areas where these drugs were prepared, compounded or administered. In addition, it is best practice to ensure you have an adequate supply of cleaning products on hand at all times to ensure compliance with all new environmental controls. This also includes the cleaning of areas where drugs are prepared, compounded, administered and disposed of.

The goal of USP is to improve the overall safety for patients and personnel alike, so as there will be changes required in some of your procedures and practices, it is advised that your facility begin preparing for these improvements as soon as possible. Our customer service representatives are standing by to answer your questions Contact us today toll-free at 800.722.7865. We look forward to hearing from you!