Aseptic Enclosures, Sterile Air & Containment Equipment
To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards.
Identify High-Risk Compounding Practices and Develop Strategies to Reduce Risks, pharmacy staff should develop strategies to reduce risk of compounding sterile products (CSPs) in the practice setting.
Pharmacies around The United States are in various stages of planning and implementing facility and operational changes to meet the requirements of USP 800. The mile markers are slipping by, but wherever you are on the road to compliance, we helped out by listing the 3 most important steps in achieving USP Compliance.
All sterile compounded drug products from Pharma D Solutions are being voluntarily recalled due to a potential contamination risk at the pharmacy, according to a company press release.
The last couple of years we have recorded a serious upswing and increase of use of automated IV preparation systems. Their popularity is directly linked to their ease of use since they combine barcode scanning and Digital image capture to ensure safer and more efficient compounding processes. With the increase of use of such technology we’ve seen an increase in the risks and sources of contamination of compounded products when prepared with an IV automation workflow machine. Currently there are many TPN compounder manufacturers on the market, such as Epic, Baxter, Baxa, MedKeeper, Omnicell, ICU medical and many other players in this segment. We’ve been carefully monitoring the responses regarding these types of machinery whenever there was an inspection by the FDA at a facility that houses and uses such technology. Pretty much all oversights noticed issues with the proper placement of the IV compounder in the working area; issues that either exposed the operator to risks or cases where the technician contaminated the product.
Although most pharmacy personnel will say that the highest risk of exposure to hazardous drugs is during the compounding process, we feel that there is an even greater risk of exposure to hazardous materials during shipping and receiving.
Whenever new standards or regulations are put in place, it’s important to understand who developed them, what they are, and why they were developed. The goal of the United States Pharmacopoeia (USP), the organization behind USP <800>, is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” This same organization also sets standards for general pharmacy practice.
While all three chapters address cleanrooms, USP <795> is the first (of two) to have its revisions made public and, accordingly, provides facility owners with the first opportunity to provide public comment or seek clarification. Section four of the Proposed Revision to GC <795>, which covers Buildings and Facilities, states:
Under the FCDA Act, outsourcing facilities register with, and are regulated and inspected by FDA as 503B outsourcing facilities. An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP requirements.
USP Compounding General Chapters are now available for public comment. The USP team has scheduled an Open Microphone session for September 5, 2018. During the Open Microphone session, USP will highlight changes in the proposed revised standard and answer stakeholder questions about the approach and methodology of the revision.
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