Once the revisions of <797> are approved, there is a minimum grace period of 6 months for pharmacies to comply.
In a presentation at the American Association of Pharmacy Technicians 2022 Annual Pharmacy Technician Convention, Brenda Jensen, CPhT, CNMT, MBA, founder of Compounding Consultants, LLC discussed the proposed changes to USP <797> and how it would affect pharmacies if they were in action. Once the revisions of <797> are approved, there is a minimum grace period of 6 months for pharmacies to comply.
Currently, sterile preparation includes didactic training with a quiz, first fingertip samples of gloves to be performed 3 times in a row without bacteria growing, a media fill test that mimics the most strenuous process, and a perceived competency test, which involves hand hygiene and clothing, aseptic technique, cleaning and disinfection. For low- and intermediate-risk compounders, these tests are annually and for high-risk compounders, every 6 months.
In addition, for antiseptic hand cleaning, Jensen said people often forget to clean under their fingernails.
“We are usually quite good at aseptically cleaning and disinfecting the hands of preparation surfaces, for which we have a checklist,” Jensen said in the presentation. “The number 1 correction plan I write for sterile pharmacies involves hand washing. The things we take for granted are the things that the regulators are hyper focused on. The specific part of that hand washing, for which I am writing these corrective actions, is cleaning the fingernails under running water.”
She also said to choose appropriate protective clothing, which should not be touched from the outside and should not touch the floor when a person puts it on. Current practices also include maintaining or achieving sterility of CSPs and personal protective equipment. Composite environments must be safe from contamination by radioactive, cytotoxic and chemotoxic drugs.
In addition, Jensen discussed identifying ingredients and aseptically maintaining sterile products, sterilizing high-risk CSPs, and labeling and inspecting CSPs for quality.
“It tells us that we are going to identify, identify, weigh and measure ingredients. This is often lacking for those high-risk compounders. Documentation about the training is often lacking,” Jensen said in the presentation.
The current chapter also said that individuals should be trained in the principles of filtering, unidirectional airflow. In addition, all personnel preparing hazardous drugs must be fully trained in storage, handling and disposal, including every piece of equipment.
In addition, all individuals must certify in writing that they understand the risk associated with handling hazardous drugs, including reproductive performance. Individuals should be trained in surface cleaning, disinfection sampling and assessment.
Jensen also noted that documentation is essential for this chapter.
As for proposed changes to USP <797>the handling of dangerous drugs is moved to USP <800>. In addition, it does not directly invoke identification, weighing, labeling or quality inspection of dangerous drugs, although it is all mentioned indirectly.
For those changes not included in the current chapter, the proposed changes include training on calculations, training on mixing, achieving apyrogenicity, documentation of CMPD processes, the movement of materials, and it requires more of a standard documentation.
In addition, the proposed chapter includes a master formula record (MFR) of the drug name, strength and dosage form, all ingredients, type and size of container sealing systems, best before dates (BUD) and storage requirements, quality control procedures and other information essential to preparing the medicine.
For the proposed chapter, the training is yearly for all categories, with the media fill training taking place every 6 months. For compounders dealing with Category 3 drugs, the media fill training is every 3 months.
For cleaning and disinfection training, the test should be done every 12 months.
Other changes include using categories to describe the drugs, rather than using high, medium, and low risk. Each drug is classified by environment and BUD.
Category 1 includes drugs prepared in an unclassified area with a BUD of 12 hours or less at room temperature of 24 hours in a cold state. Category 2 includes longer BUDs, but it must be assembled in a cleanroom setup, such as a hazardous negative buffer room. Category 3 drugs have strict guidelines for where to compound them, but also have longer BUDs.
Jensen noted that these proposed changes may also be reviewed again before they are final.
Reference
Jensen B. How Does the Proposed Review Affect USP <797> the training and competence evaluation of sterile preparation methods?. Raleigh-Durham, NC: AAPT 2022 Annual Convention for Pharmacy Technicians; July 22, 2022.