USP <800>: Key Changes and Additions to USP <797>

JULY 27, 2016
Michael R. Page, PharmD, RPh
Hazardous drug contamination is an issue of vital importance for specialty pharmacists. Abundant evidence has shown links between the handling of hazardous drugs (HDs) and increased risks for cancer, teratogenicity, and reproductive problems.

The risks surrounding the handling and manipulation of HDs have been recognized since the late 1970s, with more than 17 guidelines for HDs published over more than 30 years by 6 organizations and government agencies. However, despite the meticulous attention focused on drug safety, HD handling regulations continue to change.1-7

Although the US Pharmacopeial Convention (USP) addressed HDs in a 2008 update to USP <797> for the issue of compounding sterile parenteral HDs, the update fell short due to a lack of guidance for nonparenteral products. As a result, in March 2014, USP published a proposed set of guidance known as USP <800> that dealt with HD handling in health care settings.

In the nearly 2 years since its initial publication in draft form, USP <800> has undergone periods of public comment and revision. As of February 1, 2016, USP <800> is approved and final.3,7-9

Enforceability and Key Changes 
Due to provisions of USP numbered below 1000 being legally enforceable, following the adoption of these rules by individual state boards, USP <800> may subject pharmacies to both state board and FDA inspections.

Like USP <797> and USP <795>, the provisions of proposed USP <800> deal with product transport, product storage, compounding, preparation, and administration of parenteral products. However, USP <800> builds on earlier regulations by focusing on HDs and occupational safety.

The regulations require HD storage and preparation in areas separate from non-HDs and will eliminate the practice of compounding small volumes of HDs in areas where non-HDs are routinely prepared, which is allowed under USP <797>.

In another important change, USP <800> requires the administration of HDs with the use of closed-system transfer devices (CSTDs) to minimize HD exposure to nurses who administer these drugs to patients.5,7-9

The new requirements in USP <800> may pose major implementation challenges for pharmacists and pharmacy managers, as certain provisions may require pharmacies to change workflow patterns and make major purchasing decisions. In addition, limited financial resources may pose an important challenge to implementation of USP <800> regulations.

It is important to be familiar with the provisions of these proposed regulations and to take early steps to reduce implementation difficulties later on.

USP <797>: Adoption of and Compliance With Existing Regulations 
Although compliance with USP <797> has improved over time, current legislation governing sterile product compounding is a patchwork of state-specific regulations with wide variations between jurisdictions.

Despite the fact that USP <797> is a legally enforceable standard irrespective of state-specific legislation, only about half of state regulations specifically reference USP <797> in sterile compounding rules.4,8

In a nationwide survey conducted in 2014, two-thirds of respondents from 719 pharmacies throughout the United States and Canada reported handling HDs. Several reasons were cited by respondents for a lack of full USP <797> compliance (Figure 1).

State pharmacy boards, including the state boards of California, Florida, Minnesota, and Texas, have conducted inspections ensuring compliance with USP <797> standards in hospitals. Partially as a result of this increased regulatory oversight, between 2011 and 2014, self-reported compliance rates with USP <797> increased from 73.9% to 81.3% for sterile products and from 71.3% to 75.4% for hazardous drugs (Figure 2).