USP 800

by Ashley Builta, Pharm.D., MPA fellow of association management and business development

The goal of United States Pharmacopeia (USP) 800 is to provide protection for all health care workers dealing with hazardous drugs (HDs) at all stages. HDs are defined as those drugs on the National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, last updated in 2012, published by the Centers for Disease Control and Prevention. Drugs on this list include antineoplastic agents, hormones, antivirals and immunosuppressant agents.

The scope of 800 is wider than 797 or 795, encompassing the entirety of sterile and non-sterile HDs in the health care system from delivery and unpacking to final administration to the patient. The emphasis of USP 800 is on containment of HDs and their potential effects on health care workers to as low a limit as reasonably possible (ALARA). After USP 800 is approved, the language in 795 and 797 will be “harmonized” to reflect the new chapter.

Major recommendations in USP 800 are as follows:

• “HDs shall not be stored, unpacked, compounded or otherwise manipulated in an area that is positive pressure.”
• All handling, storage and compounding of HDs should be done in a negative pressure area, separate from non-HDs with separate engineering controls, called Containment Segregated Compounding Area (C-SCA) and Containment Secondary Engineering Control (C-SEC).
• UNLESS: the HD is a non-antineoplastic agent in a final-coated dosage form. Storage of these agents could be with non-HDs as long as they are well labeled. These agents may also be counted and transferred from the manufacture container to another container without the negative pressure requirements. USP recommends a dedicated set of counting supplies be used for these HDs.
• When compounding HDs, two pairs of gloves will be worn and the outer gloves changed every 30 minutes or they become damaged or contaminated. Goggles should be worn or full eye and face protection, as needed.
• Surgical masks do not provide adequate protection from HDs and should not be worn during compounding or administering drugs. A N95 respirator should be worn. When administering HDs, the person should wear two pairs of gloves and a gown.
• Employers will ensure that health care workers who are exposed to HDs are routinely monitored as part of a medical surveillance program. 

Recently, the American Pharmacists Association, International Academy of Compounding Pharmacists, National Association of Chain Drug Stores, National Alliance of State Pharmacy Associations, National Community Pharmacists Association and Specialty Sterile Pharmaceutical Society submitted a joint letter to USP requesting that the chapter be numbered above <1000>. By doing this, the chapter becomes a general information chapter, providing information on best practices rather than making these changes mandatory.

USP is accepting comments on proposed chapter 800 up until July 31, 2014. To submit a comment, include your comment with the line number(s) corresponding with your comment(s) to CompoundingSL@usp.org. The full proposed wording for USP can be found here, and includes line numbers.

These proposed changes will have a substantial and financially large impact on the pharmacy profession. Michigan Pharmacists Association strongly encourages all members to read the proposed USP chapter 800 and submit their comments by the July 31 deadline.