In the ever-evolving landscape of healthcare, staying ahead of the curve is crucial for ensuring the best patient care. One such development that's poised to bring significant changes to allergy practices across the United States is the new USP 797 regulations. With its last revision released on November 1, 2022, and the anticipated implementation date set for November 1, 2023, USP 797 Section 21 is set to reshape the landscape for Allergists who mix patient-specific allergy extracts for subcutaneous immunotherapy (IT). As you delve into the key concepts surrounding these new regulations, understanding some basic terminology will help you to navigate these new requirements effectively so you can ensure that your allergy practice remains at the forefront of patient care.
USP, or the United States Pharmacopeia, is an organization with a rich history dating back to 1820. It was founded by physicians who were deeply concerned about the inconsistent quality of medications in the United States. Operating as a non-profit and independent scientific body, USP has a singular mission - to enhance public health through rigorous standards.
To successfully navigate the requirements of USP 797, you need to become familiar with some essential terms:
ISO (International Organization for Standardization): ISO is an international non-governmental organization that establishes standards for various industries and countries. Its name, derived from a Greek word meaning "equal," reflects its commitment to ensuring consistency across languages and borders.
AECA (Allergenic Extracts Compounding Area): AECA refers to a designated space with a visible perimeter that meets the necessary criteria for mixing allergenic extracts.
PEC (Primary Engineering Control): If you don't have an AECA, you'll need a PEC with an ISO class 5 ventilation hood, to maintain the required sterility.
CSP (Compounded Sterile Preparation): This term encompasses the standards and guidelines for maintaining cleanliness and ensuring sterilization during the preparation and administration of extracts, aligning with the rules for storing, making, and administering injections.
BUD (Beyond Use Date): The BUD for a prescription set must be no later than the earliest expiration date of any allergenic extract or diluent within that prescription set. It must not exceed one year from the date the prescription set is mixed or diluted.
SOP (Standard Operating Procedures): SOPs are sets of clear, written instructions for performing routine tasks. Strict adherence to these procedures is crucial for maintaining compliance with USP 797 regulations.
As the implementation date of USP 797 draws nearer, it's essential to equip yourself with the knowledge and understanding of these key terms and concepts. These terms will serve as your guide as you diligently prepare to meet the new standards on November 1, 2023.
You may like these too…
