Storage of Hazardous Drugs

USP<800> requires facilities to maintain a separate storage area for anti-neoplastic hazardous drugs that require manipulation other than counting or repackaging of a final dosage form.  This storage area must be a negative pressure room with 12 or more air changes per hour. An anti-neoplastic requiring refrigeration must be stored in a dedicated refrigerator inside a negative pressure room with 12 or more air changes per hour.

Non-neoplastic, reproductive risk only and final dosage forms of anti-neoplastic hazardous drugs may be stored with the general inventory.^1,6

Additional information regarding storage can be found on the USP website: USP <800> FAQ

Compounding

USP <800> outlines specific facilities and standards that are required when compounding hazardous drugs.  These requirements include using the proper ventilated device which is to be housed in a negative pressure area with 12 or more air changes per hour.  USP <800> does override a previous provision in USP<797> that allowed low volume of hazardous drug compounding to take place outside of a negative pressure area or in areas where non-hazardous drug compounding takes place. ^5,6

The chapter does provide provisions for compounding non-neoplastic hazardous drugs. Per USP <800> “The facility can determine alternative containment strategies for dosage forms of other HDs, including manipulating (e.g., compounding/reconstituting) manufactured non-antineoplastic HDs.”  Based on this, if you are compounding a non-antineoplastic hazardous drug from a manufactured tablet, alternative containment strategies can be implemented.⁷

If a pharmacy performs regular compounding of hazardous drugs, USP<800> should be reviewed in more detail to ensure compliance with equipment standards and processes as well as your state’s rules and regulations.

Additional specific information regarding compounding can be found on the USP website:  USP<800> FAQ.

Receiving

USP <800> requires that the receipt and unpacking of anti-neoplastic hazardous drugs be completed in a negative-pressure or neutral-pressure area. In addition, storage of most hazardous drugs are required to be housed in a negative-pressure room with at least 12 air changes per hour.  However, some hazardous drugs such as capsules or film-coated tablets, may be kept with non-hazardous drugs if certain precautions are in place.¹⁰

Additional information regarding receiving can be found on the USP website: USP <800> FAQ

Additional Resources

USP Compounding Compendium

Michigan Pharmacists Association: The Future Impact Of USP 800 In The Health Care Setting (T)

Pharmacy Times Continuing Education: Gathering Momentum Towards Safer Work Environments: The Role of the Nurse and Pharmacist in Improving the Practice of Safe Handling of Hazardous Drugs

Resources

1. US Pharmacopeial Convention. (2016). Frequently Asked Questions: <800> Hazardous Drugs—Handling in Healthcare Settings. Retrieved from http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings
2. Bruckart, JL. USP<800>: How Your Pharmacy Can Prepare. National Community Pharmacists Association website. December 2016http://www.ncpa.co/issues/APDEC16-USP_800__How_Your_Pharmacy_Can_Prepare.pdf. Accessed March 2017.
3. Demler, T. (2015) USP<800> and Hazardous Drugs. US Pharmacist website. August 18, 2015. https://www.uspharmacist.com/article/usp800-and-hazardous-drugs Accessed March 2017. Accessed March 2017
4. Aguero,D. and Marge,K. Developing a USP <800> Compliance Gap Analysis. Pharmacy Purchasing and Products website. January 2017 Vol 14, Page10. https://www.pppmag.com/article/1989/?search=usp800 Accessed March 2017
5. Traynor, K. Prepare Now for USP Standard on Handling Hazardous Drugs. American Society of Health System Pharmacists website https://www.ashp.org/news/2015/03/13/prepare_now_for_usp_standard_on_handling_hazardous_drugs Accessed March 2017.
6. Page,MR. (2016) USP<800>: Key Changes and Additions to USP<797> Pharmacy Times website. July 27,2016 http://www.pharmacytimes.com/publications/health-system-edition/2016/july2016/usp-800-key-changes-and-additions-to-usp-797?p=2 Accessed March 2017
7. Professional Compounding Centers of America website. USP<800> Frequently Asked Questions. http://www.pccarx.com/what-is-compounding/usp-800-frequently-asked-questions?highlight=WyJ1c3AiLDgwMCwidXNwIDgwMCJd Accessed March 2017.