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Change on the Horizon: USP Chapter 797 Changes Part 3: Beyond Use Dating, Recordkeeping and SOPs

By October 1, 2019C&A Blog

Part 3 of our series on the 2019 USP 797 Chapter changes is focused on Beyond Use Dating, Record Keeping and Standard Operating Procedures.

Beyond Use Dating (BUD)

The assignment of a Beyond Use Date (BUD) or Time takes into consideration the chemical and physical stability of the medication compound and the sterility or risk of microbial contamination of the medication product. This is based upon the safeguards implemented during the compounding process, storage conditions, aseptic processing and whether sterile ingredients are used as a starting point in the compounding process.  In the original USP Chapter 797, the foundation of assigning BUD categories were based upon the complexity of the compounding process. This resulted in three risk categories: Low, Medium and High. The assignment of the category was founded in the thought that the more ingredients and manipulations involved, the greater the risk of contamination and hence the shorter the BUD that was assigned.

The 2019 changes convert those 3 risk categories into two: Category 1 and Category 2.

Category 2 – BUD will apply provided the medication compound is prepared within a Clean Room Suite and will be assigned the proper BUD during the compounding process.   Category 2 timeframes provide the longest time periods but require compounding to be performed within an environment that meets the requirements of a Clean Room Suite.

Category 1 – BUD applies to all other compounded products.  Category 1 BUDs and times are as follows:

  • When stored at controlled room temperature of 20-25⁰ Celsius: < 12 hours
  • When stored under refrigeration of 2-8⁰ Celsius: < 24 hours

The BUD or Time must appear on the label.  The BUD or time is not designed to include the time it will take to administer the medication compound but is designed to define the date or time in which administration must begin.

Standard Operating Procedures (SOPs) and Recordkeeping

This series would not be complete without reinforcing the need for detailed record keeping and well-designed Standard Operating Procedures (SOPs), also known as Policies and Procedures.

Important tips on your SOPs:

  • They must be reviewed at least every 12 months by your organization’s designated person.
  • Review must ensure they reflect all current practices and procedures.
  • Your designated Medication Compounding person is the only person who can author changes to the SOP’s. Final approval of changes should flow through your Pharmacy and Therapeutics Committee as they have assigned responsibility to oversee all processes related to medication management.
  • Design a robust communication process that can be implemented when SOP changes are necessary. Remember to design your communication process to ensure the delivery of the pertinent information of the revision.  Organizations often use a one page” Just the Facts” type of communication that is electronically shared with staff.  This allows the organization to document acknowledgement of the communication.

Required SOPs

There are several required SOPs that must be defined to reflect current expectations. The following list provides information about the required SOPs:

  1. Aseptic Processes
  2. Staff Training Program
  3. Microbiological air and surface monitoring
  4. Cleaning and Disinfection activities including list of approved cleaning agent
    1. Frequency, process, method, locations and directions on how to perform
    2. SOP aligns with manufacturer instructions
  5. Personnel training and competency assessment program. Program to address remediation
  6. Environmental air and surface monitoring procedures and management of results
  7. Equipment management: calibration, verification and maintenance
    1. Maintenance of the RABS sleeves, gloves and gauntlet sleeves
    2. Cleaning procedures and frequencies
  8. Master Formulation Record and Compounding Record Management
    1. Process for reviewing, revising formulations
    2. Records must be readily retrievable for a minimum of 3 years after preparation
  9. Process for complaint management including investigation and corrective actions
  10. Garbing Requirements
    1. Order for garbing
  11. Temperature and Humidity Monitoring and Management
  12. Airborne particle and Surface sampling
    1. Process for sampling
    2. Sites for sampling, management of results
    3. Microbiological air sampling process when applicable
    4. Diagram of sampling locations
    5. Procedures for collecting samples
    6. Frequency of sampling
    7. Size of samples
    8. Time of day for sampling
    9. Action levels that will trigger corrective actions
  13. Incubator Management and Maintenance
    1. Temperature monitoring
  14. Compounding procedures
    1. selection, receipt, evaluation, handling, storage, and documentation of all CSP components, including all ingredients, containers, and closures.
    2. A description of the terminal sterilization and depyrogenation process, including the temperature, pressure (if applicable), duration, permissible load conditions for each cycle, and the use of biological indicators and endotoxin challenge vials (ECVs)
  15. Quality Assurance-Quality Control Program
    1. methods and equipment used by the facility. In addition, the SOPs must include a schedule and method for establishing and verifying the effectiveness of the terminal sterilization and depyrogenation methods selected, as well as the methods for maintaining and cleaning the sterilizing and depyrogenation equipment. A Master Formulation Record is a detailed record of procedures that describes how the CSP is to be prepared.
  16. Labeling procedures
  17. Roles, Duties and training of personnel
  18. Recall of “out of specification” dispensed products
    1. Disposition and Reconciliation
    2. Severity of problem determination
    3. Urgency of actions
    4. Documentation requirements


In summary, 797 Changes include two BUD categories, detailed record keeping, and the need for current policies and procedures that detail key functions while communicating important information to personnel, including annual review and authorization.


USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations June 2019

Patricia Cook

Author Patricia Cook

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