The need for stricter contamination-control practices and procedures for the compounding of sterile pharmaceutical preparations has long been a topic of discussion in the pages of CleanRooms. But, as of January 1, 2004, good advice and recommendations have been transformed into the first official and enforceable sterile preparation compounding requirement in the U.S.-the United States Pharmacopeia (USP) Chapter 797.
USP Chapter 797 is considered a national requirement, and pharmacies and pharmacists are certain to be subject to inspection against these standards by State Boards of Pharmacy, FDA, and other healthcare organizations. The American Society of Hospital Pharmacists (ASHP) now “strongly encourages” pharmacists to contact their respective boards of pharmacy for information on state enforcement criteria and activities for 797.
The ASHP also observes that “persons who compound sterile preparations should exercise their professional judgment to obtain the education and training necessary to prove their competence in managing sterile compounding facilities and in sterile compounding processes and quality assurance,” and that such education and training are available from a variety of sources.
One of these sources is certainly CleanRooms magazine and the CleanRooms Contamination Control Technology (CCT) conferences and exhibitions. Experts on contamination control and the ramifications of USP 797, such as Doug Theobald with Controlled Contamination Services LLC, and Hank Rahe of Containment Technologies Group, are regular contributors to CleanRooms, providing a wealth of specific information and guidance. (See Hank’s column this month on page 12.) But, in addition, every issue of the magazine contains the very latest information on all aspects of the science of contamination control, how to best implement it, and the most efficient and cost-effective tools and equipment available. CleanRooms also provides a direct connection to the critical standards activities of the Institute of Environmental Sciences (IEST) through this important organization’s own monthly contribution to the publication.
It is critical that this information get into the hands of the host of medical practitioners now in immediate need-many of whom have little or no experience with the technology or the industry that stands ready to provide it. While many mainstream hospital pharmacy professionals are readers of the publication and are aware of the broader contamination-control community, there are certainly a greater number who are not.
We at CleanRooms certainly encourage the addition of more pharmacists and pharmacy technicians to our readership, and will continue to provide the information and advice they will need to meet their growing regulatory and technology requirements. Likewise, we encourage you to lead them to us by passing along a copy of the magazine (additional copies available upon request), directing them to our Web site (www.cleanrooms.com), or suggesting they attend the next CleanRooms CCT show in Boston next March. As a current reader of this publication, you can help your fellow professionals, as well as your industry, by simply spreading the word of the existence of these resources.