Your Source for Allergy Immunotherapy Treatment Sets
Edge Pharmacy Services is the leading provider of compounded subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) treatment sets. Our dedicated team of experts review every order for antigen-saving recommendations and to identify cross-reactive allergens. If your office or hospital pharmacy is struggling with USP 797 compliance, EDGE can provide a cost-effective and comprehensive solution to meet the needs of your patients.
Compounding Compliance is Essential
- FDA-Registered 503B Outsourcing Facility
- Licensed by state boards of pharmacy
- Compliant with CGMP and USP 797
- Only US-licensed extracts utilized
Every Treatment Set is Tailored to the Patient's Needs
- Immunotherapy treatment sets come in customized formulations, dosages, and strengths
- Compounding capabilities for complex, multiple-antigen orders
- Expert review of every order for antigen-saving recommendations
- Cross-reactive allergens identified
We Offer Improved Efficiency and Regulatory Compliance
- STAT Rx option for orders in 24 – 48 hours
- Free up valuable staff time
- Minimal staff training required
- Lower or eliminate extract inventory management and costs
- Regulatory compliance made easy
NEW PROPOSED USP 797 REVISION FOR ALLERGENIC EXTRACT COMPOUNDING
On July 27 USP released a new proposed revision to the 797 sterile compounding guidelines. In particular, there are substantial changes being implemented to allergy immunotherapy treatment set compounding. In order to be in compliance with the revised USP 797, facilities engaging in the compounding of allergy treatment sets will need to essentially meet all of the testing, qualification, cleaning, and documentation requirements of the full USP 797 required of all other sterile compounding activities. Some specific examples include:
- Either an ISO Class 5 PEC or a dedicated allergenic extracts compounding area (AECA)
- Smooth, impervious, non-shedding preparation surfaces, free from cracks and crevices
- Surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the AECA must be cleanable and must be kept clean
- Cleaning logs
- In an AECA, all work surfaces where direct compounding is occurring must be cleaned and disinfected at the beginning and end of each shift of compounding and between each prescription set
- Access to AECA during compounding restricted to authorized personnel
- Temperature and humidity controls within the compounding space
- SOPs describing all aspects of the compounding process
- Annual written exams for compounding personnel
- Fingertip and thumb sampling
- Successful completion of media-fill testing
- Personnel training records, competency assessments, and qualification records
- Refrigerator temperature logs
- Investigations and corrective actions
As a result of these stringent requirements, it will become very difficult for allergy practices to put in place the necessary facilities, personnel, and processes to remain in compliance. Edge Pharmacy Services helps health systems, hospitals, and clinics continue to offer these valuable services while maintaining compliance with compounding regulations. In addition to just compliance, however, the benefits of outsourcing treatment set compounding results in substantial improvements to clinic efficiency, reduced logistics and inventory of extracts, and more accurate dosages because of the high standards placed on FDA regulated Outsourcing facilities. As the only FDA registered 503B Outsourcing facility offering allergy treatment set compounding, Edge is in a unique position to help hospitals and allergy practices make this transition with easy ordering and full time dedicated sales staff including experienced allergy pharmacists that help with every detail.
State and Federal Regulations for Allergy Compounding
Section 17.10: Allergen Extracts as CSPs states, "If the prescription set is prepared in a State-licensed pharmacy or Federal facility, or in a physician's office, it is prepared in accordance with USP Chapter <797>."
Section 17.10: Allergen Extracts as CSPs states, "A pharmacy shall prepare allergen extracts in an ISO 5 Classified Area located within an ISO Class 7 buffer room or ISO Class 8 DCR."
"The United States Pharmacopeia Chapter 797 ("USP 797") governs the compounding of all sterile products. Thus, all those engaged in sterile compounding in all situations are required to adhere to and comply with the requirements of USP 797."
"For low-risk with greater than twelve hour beyond use date, allergen extracts, medium and high-risk sterile compounded drugs as defined in United States Pharmacopeia Chapter <797> , the prescriber shall comply with United States Pharmacopeia Chapter <797> , USP 38 - NF 33, or any official supplement thereto."
Please call us or register below for more information on our allergy immunotherapy program.
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