By now, you have probably heard about USP 797 or simply 797. If you are at all involved in anesthesia, you are also probably generally aware of what 797 is all about. But it’s a big issue with many facets, so regardless, you may be wondering when, what, who, where and how this will affect your ASC. Here is a brief overview of 797 and the impact it will have on daily operations within ASCs.
By now, you have probably heard about USP 797 or simply 797. If you are at all involved in anesthesia, you are also probably generally aware of what 797 is all about. But it’s a big issue with many facets, so regardless, you may be wondering when, what, who, where and how this will affect your ASC. Here is a brief overview of 797 and the impact it will have on daily operations within ASCs.
When?
USP 797 went through its final revision approval in December. The new standard becomes official June 1.
What is it, who will it affect, and where will it be implemented?
The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. USP sets standards for the quality of drug products and works with healthcare providers to help them meet the standards.1 The USP is a large book of standards and monographs broken into chapters (eg., chapter 797). Chapters 1 through 999 are enforceable standards that describe how certain functions and processes are to be performed. Chapters 1000 and higher are guidelines describing certain standards of practice and other processes and topics and are informational. Until Jan. 1, 2004, the chapter describing how sterile products are to be handled was in Chapter 1206; after that date, Chapter 1206 became Chapter 797, making it an enforceable standard of practice. It can be enforced by the state boards of pharmacy and the Food and Drug Administration. Pharmacies, ASCs, hospitals, doctors’ offices and anywhere sterile products are handled have been implementing the new standards into practice over the last four years. Surveyors and inspectors have been aware of the new standards and have been trying to help facilities make necessary changes. Beginning June 1, these new standards will be used by surveyors to inspect against.
Chapter 797 will affect anyone or any facility that handles injectables and other products that require sterility. This includes injections, aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues, irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.2
The requirements of 797 focus much more now than in the past on employee training, ongoing re-evaluation of employee aseptic technique, and documentation of training achieved. While facilities are a major focus of the chapter, it is clear that people are the main source of contamination of sterile products. Proper training and the use of best standards of
practice will help ensure patients’ safety.
Facility design and air quality are major factors in preventing contamination of sterile products. Wiping vials and proper hand hygiene are important in helping prevent contamination of products. Additionally, preparing products in an environment that meets minimum levels of air quality is an important consideration that 797 mandates.
How will this affect my facility?
If your facility is preparing products that require sterility when administered or applied to a patient then it is recommended that you have a copy of 797 (www.usp.org) and review the standards thoroughly. One of the more commonly asked questions is expiration dating of multiple-dose and single-dose vials once they are opened. The following is a direct excerpt from USP 797:
Opened or needle-punctured single-dose containers, such as bags,
bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 (maximum of 3,520 particles up to 0.5 microns in size per cubic meter of air) air quality, and any remaining contents must be discarded. Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture. Opened single-dose ampules shall not be stored for any time period. Multiple-dose containers (e.g., vials) are formulated for removal of portions on multiple occasions because they usually contain antimicrobial preservatives. The beyond-use-date (BUD) after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days unless otherwise specified by the manufacturer.2
Conclusion
USP 797 is in place to describe conditions and practices to prevent harm, including death, to patients that could result from microbial contamination, excessive endotoxins, variability in the intended potency of ingredients, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations (CSPs). The revisions that have been made over the last several years and will now be enforced on June 1 are significant and necessary.
Chapter 797 can seem overwhelming. There will definitely have to be extensive modification and review of policies and procedures to ensure your facility can satisfy the 797 standards. Some facilities may have procedures in place that already satisfy the majority of the requirements outlined. Others may decide that it is not worth the time and expense necessary to change procedures and update facilities to satisfy 797. In that case, you should consider outsourcing those procedures covered by 797.
Dr. Williamson is the CEO of JCB Labs (www.jcblabs.com). Contact him at
brian@jcblabs.com for further information on this issue.
1 [No author listed.] U.S. Pharmacopeia Web Site, 2008, www.usp.org.
2 The United States Pharmacopeial Convention, 2007, <797> Pharmaceutical Compounding — Sterile Preparations.
By now, you have probably heard about USP 797 or simply 797. If you are at all involved in anesthesia, you are also probably generally aware of what 797 is all about. But it’s a big issue with many facets, so regardless, you may be wondering when, what, who, where and how this will affect your ASC. Here is a brief overview of 797 and the impact it will have on daily operations within ASCs.
When?
USP 797 went through its final revision approval in December. The new standard becomes official June 1.
What is it, who will it affect, and where will it be implemented?
The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. USP sets standards for the quality of drug products and works with healthcare providers to help them meet the standards.1 The USP is a large book of standards and monographs broken into chapters (eg., chapter 797). Chapters 1 through 999 are enforceable standards that describe how certain functions and processes are to be performed. Chapters 1000 and higher are guidelines describing certain standards of practice and other processes and topics and are informational. Until Jan. 1, 2004, the chapter describing how sterile products are to be handled was in Chapter 1206; after that date, Chapter 1206 became Chapter 797, making it an enforceable standard of practice. It can be enforced by the state boards of pharmacy and the Food and Drug Administration. Pharmacies, ASCs, hospitals, doctors’ offices and anywhere sterile products are handled have been implementing the new standards into practice over the last four years. Surveyors and inspectors have been aware of the new standards and have been trying to help facilities make necessary changes. Beginning June 1, these new standards will be used by surveyors to inspect against.
Chapter 797 will affect anyone or any facility that handles injectables and other products that require sterility. This includes injections, aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues, irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.2
The requirements of 797 focus much more now than in the past on employee training, ongoing re-evaluation of employee aseptic technique, and documentation of training achieved. While facilities are a major focus of the chapter, it is clear that people are the main source of contamination of sterile products. Proper training and the use of best standards of
practice will help ensure patients’ safety.
Facility design and air quality are major factors in preventing contamination of sterile products. Wiping vials and proper hand hygiene are important in helping prevent contamination of products. Additionally, preparing products in an environment that meets minimum levels of air quality is an important consideration that 797 mandates.
How will this affect my facility?
If your facility is preparing products that require sterility when administered or applied to a patient then it is recommended that you have a copy of 797 (www.usp.org) and review the standards thoroughly. One of the more commonly asked questions is expiration dating of multiple-dose and single-dose vials once they are opened. The following is a direct excerpt from USP 797:
Opened or needle-punctured single-dose containers, such as bags,
bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 (maximum of 3,520 particles up to 0.5 microns in size per cubic meter of air) air quality, and any remaining contents must be discarded. Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture. Opened single-dose ampules shall not be stored for any time period. Multiple-dose containers (e.g., vials) are formulated for removal of portions on multiple occasions because they usually contain antimicrobial preservatives. The beyond-use-date (BUD) after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days unless otherwise specified by the manufacturer.2
Conclusion
USP 797 is in place to describe conditions and practices to prevent harm, including death, to patients that could result from microbial contamination, excessive endotoxins, variability in the intended potency of ingredients, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations (CSPs). The revisions that have been made over the last several years and will now be enforced on June 1 are significant and necessary.
Chapter 797 can seem overwhelming. There will definitely have to be extensive modification and review of policies and procedures to ensure your facility can satisfy the 797 standards. Some facilities may have procedures in place that already satisfy the majority of the requirements outlined. Others may decide that it is not worth the time and expense necessary to change procedures and update facilities to satisfy 797. In that case, you should consider outsourcing those procedures covered by 797.
Dr. Williamson is the CEO of JCB Labs (www.jcblabs.com). Contact him at
brian@jcblabs.com for further information on this issue.
1 [No author listed.] U.S. Pharmacopeia Web Site, 2008, www.usp.org.
2 The United States Pharmacopeial Convention, 2007, <797> Pharmaceutical Compounding — Sterile Preparations.