USP Publishes Chapter <800>

On February 1, 2016, the U.S. Pharmacopeial Convention (USP) published a new chapter to be added to the United States Pharmacopeia-National Formulary USP-NF <800> Hazardous Drugs & Handling in Healthcare Settings focuses on reducing exposure to hazardous drugs for healthcare workers and the environment. This chapter will especially affect all healthcare professionals and institutions involved in the handling, storage, or administration of hazardous drugs.

USP 800 builds on chapters 795 and 797, which deal with non-sterile and sterile pharmaceutical compounding respectively. The thrust of the new regulation is that there really is no acceptable level of exposure to hazardous drugs, and all involved entities need to utilize proper systems, equipment, protection, and handling techniques when working with hazardous drugs (HD's).

Hazardous Drugs. Hazardous drugs include those linked to carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity.http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings. You may find a full list of hazardous drugs here. USP Chief Science Officer Dr. Jaap Venema notes that “Practitioners are frequently unaware of the scope of the risk or the measures that should be taken to reduce such risk. The new standard defines processes intended to minimize exposure to hazardous drugs in healthcare settings, thereby protecting healthcare workers as well as patients.

What the Changes Mean. USP <800> applies to both sterile and non-sterile compounding pharmacies. In many cases, previously acceptable environments will no longer be considered compliant methods of handling or storing HD's. Be sure to assess your facility’s setup and equipment for the updated regulations. Some of the major changes to be aware of involve the need for HD’s to never be stored, unpacked, and compounded in a positive pressure area. You should also especially verify whether or not the type of hood and venting you currently use for compounding is still appropriate for HD's.

Implementation. Although USP 800 became available February 1, 2016, official implementation of the new chapter will not take effect until July 1, 2018. These updated standards will require significant and costly changes in many facilities. Understanding this, USP has set a longer than normal time frame for implementing this new chapter.

What do I do Now? Ultimately, you need to be thoroughly versed in what is required of your facility. Our first suggestion is that you read the chapter in its entirety, because you will be held responsible for it whether you're aware of the regulations or not.

Don't wait until the last minute to get compliant; do it as soon as possible. These new regulations have been implemented for a reason: protect yourself, your workers, and your patients by incorporating them as you are able.

Finally, assess if making the required changes are feasible for you. If they are not, use this time to focus on ways to shore up other areas of your business so that if you decide to eliminate HD compounding from your services, you won't see a loss of stability. Talk with others in the industry to see their thoughts and their solutions.

If you have any questions or need any help getting your facility compliant, let us know how we can help!

Copy Availability. A copy of the First Supplement to USP 39–NF 34 may be obtained by subscription to the USP Compounding Compendium or USP-NF. http://www.usp.org/store/products-services/usp-compounding-compendium