USP 797 Compliance in 2009, (c) William N. Bernstein, LEED®AP, AIA, 19 October 2009

An interesting survey of USP 797 compliance in the United States in 2009 was recently published in Pharmacy Purchasing & Products magazine (www.pppmag.com). Published in the September 2009 issue feature entitled “State of Pharmacy Compounding”, the article provides a unique perspective on the level of USP 797 compliance as of today, and the expected level of USP 797 compliance in the future.

The survey looks at various areas of USP 797 compliance.

It begins with results of the most basic question: how many directors of pharmacy have read the USP 97 regulation: it has grown from 69% in 2008 to 84% in 2009.

Partial or full pharmacy compliance with USP 797 has also grown, although the language of the survey does not make clear the percentage of full vs. partial compliance. Pharmacies that meet “most or all” of the USP 797 regulations have grown from 60% in 2008 to 72% in 2009.

Full compliance with USP 797 is measured differently, with 65% of pharmacies projecting full compliance within two years.

Obviously, the approach of regulatory bodies towards USP 797 compliance is a critical factor in how pharmacies approach this subject.

According to the survey, 49% of hospitals reported being asked by state boards of pharmacy about USP 797 compliance in 2008. In 2009, that figure had grown to 59%.

Questions by JCAHO about USP 797 compliance also increased. The survey notes that 58% of facilities surveyed in the past two years by JCAHO noted questions by JCAHO about USP 797 compliance.

Finally, the survey makes note of the fact that 30% of hospitals reported a patient incident involving a compounding error during the past five years.  Although this statistic does not address the cause of the error, or whether those errors have decreased as USP 797 compliance has increased, the statistic is an important reminder of the need for safe practices in pharmacy operations.

In summary, there is a continuing improvement in USP 797 compliance in pharmacies in the United States, as well as increased focus on USP 797 compliance by state pharmacy boards and JCAHO.

About the Author:

William N. Bernstein, LEED®AP, AIA is the principal of Bernstein & Associates, Architects (www.bernarch.com) and president of Equipment Planning, Inc. (www.equipmentplanning.org). This architecture firm and equipment planning firm are well-known for pharmacy planning, pharmacy design and pharmacy architecture, including a sub-specialty in usp 797 compliant pharmacy design and construction. These pharmacy consulting firms have designed and equipment planned over twenty new pharmacies, pharmacy renovations, and pharmacy relocations in the past five years. The firm's principal --- William N. Bernstein, LEED®AP, AIA --- is a well known pharmacy architect and pharmacy equipment planner. He has written extensively on pharmacy design and pharmacy construction including usp 797 compliant pharmacies. Mr. Bernstein's pharmacy design articles can be found on www.pharmacydesign.org, and his usp 797 articles can be found on the usp 797 website www.usp797.org.

For more information about pharmacy planning, pharmacy design and pharmacy construction, contact Bernstein & Associates, Architects at:

Bernstein & Associates, Architects - PLLC

59 West 19th Street - 6A, NY, NY  10011

T: 212.463.8200

F: 212.463.9898

E: info@bernarch.com 

www.bernarch.com

For more information about pharmacy equipment planning, and pharmacy automation equipment specifications and planning, contact Equipment Planning, Inc. at:

Equipment Planning, Inc.

59 West 19th Street - 6A, NY, NY  10011

T: 212.463.08200

F: 212.463.9898

E: info@equipmentplanning.org 

www.equipmentplanning.org