- What is USP 797?
- What testing is sanctioned by AIS to maintain USP 797 compliance?
- Do syringes need to be used by a certain date? Is a use by date documented on the syringe?
- What is infusion therapy?
- Where are we located?
- What is USP 797?
The United States Pharmacopeia, or USP, is a nongovernmental, scientific, organization responsible for setting standards for drug quality and related practices. The USP has compiled a book of regulations in which chapter 797 deals directly with the requirements for the preparation of sterile drugs to include: their environmental setting, equipment used, personnel, and the product itself.
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- What testing is sanctioned by AIS to maintain USP 797 compliance?
a. Environmental/Equipment Testing:
i. Certified ISO 5 Environmental Testing
1. Routine air microbial monitoring
2. Routine surface microbial monitoring
ii. Scheduled equipment testing and certification
b. Personnel:
i. Validation of technique
ii. Routine microbial monitoring of garb and gloves
iii. Continuing education training
c. Product:
i. Testing is performed on 100% of batches for sterility, potency, and pyrogen.
ii. All testing is performed by an independent, third party FDA registered lab in Houston, Texas.
iii. Routine pH and extended potency testing
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- Do syringes need to be used by a certain date? Is a use by date documented on the syringe?
Yes, after compounding, the medication should be injected into the implanted pump by the beyond-use date located on the syringe. USP 797 regulations call for a beyond-use date to be placed on every product; thus, a label is located on each syringe which indicates the beyond-use date. Keep in mind, the beyond-use date always refers to the date in which the medication must be placed in the implanted pump and not the expiration of the medication.
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- What is infusion therapy?
- Infusion therapy involves the administration of medication through a needle or catheter. It is prescribed when a patient’s condition is so severe that it cannot be treated effectively by oral medications. Typically, “infusion therapy” means that a drug is administered intravenously, but the term also may refer to situations where drugs are provided through other non-oral routes, such as intramuscular injections and epidural routes (into the membranes surrounding the spinal cord). “Traditional” prescription drug therapies commonly administered via infusion include antibiotic, antifungal, antiviral, chemotherapy, hydration, pain management and parenteral nutrition. Infusion therapy is also provided to patients for treating a wide assortment of often chronic and sometimes rare diseases for which “specialty” infusion medications are effective. While some have been available for many years, others are newer drugs and biologics. Examples include blood factors, corticosteroids, erythropoietin, infliximab, inotropic heart medications, growth hormones, immunoglobulin, natalizumab and many others.
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- Where are we located?
- 132 Fairmont Street Suite B Clinton, MS 39056
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