Frequently Asked Questions




USP <797> FAQs


What is USP <797>?

USP <797> is a chapter in a book, specifically chapter <797> in the United States Pharmacopoeia (USP). The title of the chapter is Pharmaceutical Compounding – Sterile Preparations. In the past, compliance with guidelines for sterile pharmaceutical compounding was voluntary. USP <797> set the first enforceable standards for sterile compounding. The primary objectives of the chapter are ensuring sterility and accuracy of compounded sterile preparations or CSPs.

Who has been responsible for development of <797> guidelines?

An expert committee of healthcare professionals from many practice settings was established by the USP to develop the guidelines for Chapter <797>. A draft document was developed and comments have been collected regarding the Chapter. The process is designed to incorporate diverse views and opinions. The guidelines first became effective January 1, 2004, but this is a dynamic document that is still being reviewed and updated. Revised guidelines were published on the USP Web site on December 3, 2007 (http://www.usp.org/products/797Guidebook/), and become official in June, 2008.

Who is affected by USP <797>?

Anyone – in any practice setting – involved with sterile compounding. Physicians, nurses, pharmacists, dentists, technicians – anyone who compounds sterile medications or pharmaceutical products – are subject to <797>. Your state professional board has either reviewed, or is reviewing, chapter <797>. Regulations may be passed affecting how your profession practices sterile compounding.

What is the scope and intent of USP <797>?

Chapter <797> deals with the pre-administration manipulations for sterile compounding in specific areas such as the whole arena of compounding, transportation and storage of sterile compounds. It is important to note that the IV drug administration itself is not covered by <797>, other than some basic issues about handling the preparation once it leaves the pharmacy. However, that does not absolve the healthcare practitioner from putting appropriate beyond-use dating (BUD) on products due to the chemical or physical characteristics of the drug.

Does USP <797> require construction of a sophisticated cleanroom?

No. The short answer is that <797> requires sterile mixing in a properly maintained laminar airflow hood (ISO Class 5 – also known as Federal Standard Class 100, or a maximum of 100 particles per cubic foot) situated in a relatively clean room (ISO Class 7 – also known as Federal Standard Class 10,000). In other words, sterile compounding must take place in a controlled area that meets a defined level of cleanliness under dynamic conditions. For most pharmacies, this is neither a difficult, nor unreasonable expectation.

What is required for sterile preparation areas?

The following basic production and process controls are required for all sterile preparation production areas:
  • ISO Class 5 air quality in the direct compounding area or DCA.
  • Environmental controls and procedures on topics as diverse as air quality in the buffer areas, procedures for the area entry, materials movement and storage, gowning, hair covers, hand washing, personnel behavior, area clearance between batches etc.
  • Housekeeping procedures
  • Visual controls
  • Microbial and particulate monitoring

Note that there are separate recommendations for safe handling of hazardous drugs that should be reviewed and addressed prior to undertaking a facility redesign.

Can a pharmacy become USP <797> compliant simply by purchasing a compounding aseptic isolator(s) or CAI?

Isolators alone will not ensure compliance with USP <797>. Using an isolator for sterile compounding addresses only part of the requirements for USP <797>. Issues such as process validation, training, BUD determination, product quality maintenance after the CSP (compounded sterile preparation) leaves the pharmacy, caregiver training, patient monitoring, QA program, etc. remain the same as for products compounded in standard laminar flow hoods.

Is environmental monitoring required for <797> compliance?

Yes, a comprehensive environmental monitoring program must be in place to identify trends, or points of failure, before they become critical. The intent is to address potential failures in the process when the issues are smaller and less significant. A properly constructed environmental monitoring program demonstrates that your engineering controls, cleaning procedures and overall employee training and work practices have resulted in an appropriate compounding environment that consistently maintains acceptably low microbial levels.

What types of environmental monitoring programs are involved?

Air and surface sampling are two simple examples. There are numerous vendors that supply products to help fulfill this requirement.

What are some examples of quality assurance programs required by <797>?

  • A QA plan formalized in writing. The best start is a written, procedurally accurate and current policy and procedure manual. The document should include personnel and position descriptions. Baxa Corporation provides a number of the written policy and procedures to support USP <797> compliance with its products.
  • Descriptions of specific monitoring and evaluation activities, reporting and evaluation of results and identification of follow-up activities when thresholds are exceeded. It is important that individual responsibilities for each aspect of the program are delineated.
  • Adequate employee training and validation of employee competency might be the most important variable in the entire <797> compliance process. Media fills to validate aseptic technique are a part of this step.

What are some examples of quality assurance practices required by <797>?

  • Routine disinfection and quality testing of the direct compounding environment
  • Visual confirmation of personnel processes such as gowning, etc.
  • Review of orders and packages of ingredients to assure correct identity and amounts of ingredients
  • Visual inspection of the compounded sterile preparation
  • A media-fill test procedure performed at least annually for each person

Is sterility testing required to establish BUD (beyond use dating, aka ‘expiration dates’) for compounded sterile preparations?

No. USP <797> has default maximum BUD times depending on the risk level and storage conditions of the compounded preparation. <797> only requires that there is ‘justification’ from ‘appropriate literature sources’ or direct testing for the BUD decisions that fall outside the maximum default times. Otherwise, BUDs can be assigned as described in the Chapter. Sterility and stability testing are required if the BUD exceeds the maximum default periods.

What are the maximum default BUD times?

These vary by risk level and storage conditions and may be updated through the USP revision process:
  • Low Risk Level maximums, without sterility testing, are 48 hours at room temperature, 14 days refrigerated and 45 days frozen.
  • Medium Risk Level maximums are 30 hours at room temperature, nine days refrigerated and 45 days frozen. The refrigerated time is being changed to nine days to help home care pharmacies ship a one week supply.
  • High Risk Level maximums are 24 hours at room temperature, three days refrigerated and 45 days frozen.

Is there a category of ‘immediate use’ that is exempt from <797> compliance?

Yes, this category is revised from the original guidelines and there are significant restrictions in the definition of immediate use. In worse than ISO Class 5 air, simple aseptic transfer or no more than three commercially manufactured packages of sterile, non-hazardous products from the manufacturers’ original containers and not more than two entries into any one container or package of sterile infusion solution and administration begins within one hour. No hazardous drugs fall into this category.

Does outsourcing IV preparation remove the institution from USP <797> compliance?

No, the healthcare facility is responsible for ultimate product quality. It is critical to verify that any outsourced IV products have been prepared under <797>-compliant conditions. In addition, facilities need to comply with USP <797> for any preparations that cannot be supplied through outsourcing. Common examples include individualized doses, those subject to last-minute changes, short-expiration drugs, some antineoplastics and other expensive and specialized drugs.

What does USP <797> say about patient and caregiver training?

There must be a formalized program that includes:
  • Understanding of the therapy being provided
  • Handling and storage of the compounded sterile product
  • Appropriate administration techniques
  • Use and maintenance of any infusion device involved
  • A plan for appropriate follow-up for issues regarding the compounded products

Are there requirements for maintaining product quality and control once the compounded sterile preparation leaves the pharmacy?

Yes, written policies and procedures are required for:
  • Packaging, handling and transport of chemo toxic and hazardous preparations
  • Use and storage of the ingredients and final products
  • Compounded sterile preparation administration on topics such as hand washing, aseptic technique, site care, etc.
  • Education and training of patients and caregivers

Where can I get additional expert training about USP <797> and specific help on how to become compliant?

There are numerous professional and commercial organizations with products and services to help. The ASHP Web site (www.ashp.org) has a compounding resource center offering written materials on compliance. Baxa Corporation has a unique opportunity through its STAR (Skills Training, Academics and Resources) Center® located at its Denver-area headquarters. There, two and one-half day hands-on USP <797> classes are offered in a purpose-built pharmacy training facility. Industry experts teach small classes offering real-life solutions for USP <797> compliance. Please see www.baxa.com/starcenter for more information.

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