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Four Challenges to USP 797 Compliance & Standardization

As compounding pharmacies face increasing regulatory attention and inspection frequency, more pharmacies are looking to achieve compliance with USP Chapter 797 standards. According to the 2014 annual survey of compounding pharmacies conducted by CriticalPoint, a few areas remain challenging.1

Below are the four issues that remain most troublesome for hospital pharmacies that compound sterile products all had compliance rates below 50%:

  1. Documented confirmation by all employees (both male and female) of reproductive age that they understand the risks of handling hazardous compounded sterile products (CSPs) at 42%. The percentage has risen from 23.9% in 2011, but the low rates demonstrate not only compliance issues with USP 797, but also federal Occupational Safety and Health Administration (OSHA) right-to-know laws.2

  1. Completion of at least three successful gloved fingertip/thumb sampling procedures on both hands by all staff performing compounding, as well as the supervising pharmacist, prior to being permitted to compound sterile products for humans. A result of 0 CFUs must be recorded for a sampling procedure to be considered successful. While the percentage of facilities that comply with this item has risen from less than 30% to more than 46% since 2011, it continues to be an area where hospital pharmacies could substantially improve.

  1. Proper labeling of all reusable cleaning and disinfection materials such as mop handles and mop heads with location of use and development of policies and procedures for maintenance of reusable items to ensure repeated use does not compromise the environment. Compliance with labeling requirements has risen almost 10 points, from 37.6% to 47% between 2011 and 2014. Study directors Kate Douglass, Eric S. Kastango and Peter Cantor note that since the chapter was first written, advances in cleaning and disinfection supplies and equipment have made reusable materials less common and eliminated the need for labeling in many cases.

    For instance, most mops today feature changeable mop heads and replaceable mop head covers. However, buckets used for mixing cleaning solution for use inside the primary engineering control (compounding hood/isolator) still must be labeled so that these buckets are not inadvertently used to mix cleaning solutions used on floors, ceilings or walls.

  1. Pharmacists must have a “detailed written policy and procedure on all aspects of surface sampling and viable air sampling.” This policy and procedure should include preparation of plates, labeling of plates (according to the Environmental Sampling Plan), reading plates, and documentation of results. There should be a procedure for sending these plates to certified contracted microbiology lab if applicable. The study directors commented that compliance with part of Chapter 797 that related to the Environmental Sampling Plan remains low at 48.4%, up from 41.5% in 2011.

    The directors speculated that many pharmacies rely on certification professionals to ensure compliance, particularly with viable air sampling requirements, but urged pharmacies to create their own Environmental Sampling Plan that reflects their areas of greatest risk. They also recommended that all compounders use bacterial and fungal specific media for all risk levels, even though the USP 797 chapter currently only requires both media in high-risk compounding environments.

What has your pharmacy done to ensure compliance in these four areas?


  1. Douglass K, Kastango ES, Cantor P. The 2014 USP Chapter <797> Compliance Survey. Pharmacy Purchasing & Products. October 2014: Cleanrooms & Compounding; 11(10): 6.

  2. Kastango E, Power LA, Kienle PC. Discussion Guide: An Update On Protecting Health Care Practitioners and Patients from Hazardous Drugs. ASHP Advantage. March 31, 2015.

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