Saturday, May 14, 2016

Proposed Revisions to USP 797 - Overview and Current Status

This article is an overview, including current status, of the proposed revisions to USP 797.

Brief History of USP 797 and the Current, Proposed Revisions:

USP 797 was first published in 2004.

The last official revision to USP 797 became official on June 1, 2008.

The Compounding Expert Committee of USP began a new set of revisions in July 2010, and on September 25, 2015, USP issued a set of proposed revisions to USP 797 for public comment. The public comment period ran through January 31, 2016.

Currently, as of May 14, 2016, USP is evaluating the comments received through the public comment process.

You can download the proposed revisions that were published on September 25, 2015, from the following link:

Key Components of the Proposed Revisions per USP:

According to USP (per, the major revisions of the General Chapter include:

1. Reorganization of existing sections and placement of procedural information in boxes

2. Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2) distinguished primarily by the conditions under which they are made and the time within which they are used.

3. Removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings

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Sunday, May 8, 2016

Pharmacy Design Commission in Ohio Awarded to Bernstein & Associates, Architects

Pharmacy design architect Bernstein & Associates, Architects ( has been selected to provide pharmacy design services for a new, USP 797 compliant compounding suite for a hospital pharmacy in Ohio. See

Pharmacy design consulting services include: pharmacy programming, pharmacy planning, pharmacy design, pharmacy architecture, pharmacy engineering, and pharmacy equipment planning.

About Bernstein & Associates, Architects (
Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm’s founding in 1990. This architecture firm has an international reputation for pharmacy planning, pharmacy design and pharmacy construction, and has designed over (25) hospital pharmacies in the last 5 years, which have included USP 797 compliant pharmacy design and construction. The firm’s principal — William N. Bernstein, AIA — is a well-known architect of pharmacies. He has written extensively on pharmacy design and construction including USP 797 compliant pharmacies.

For more information about pharmacy design and usp797 architectural and engineering design, please see the pharmacy design page for Bernstein & Associates, Architects:

Additional ways to follow Bernstein & Associates, Architects, include:
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For more information about healthcare and hospital design and construction, including pharmacy design, pharmacy equipment planning, planning for pharmacy automation equipment, and pharmacy construction, contact Bernstein & Associates, Architects at:
New York (Headquarters)

Bernstein & Associates, Architects
1201 Broadway – #803
New York, NY 10001
T: 212-463-8200
F: 888-214-0670
Also in Hartford, Princeton, Charlottesville, and Los Angeles