Year: 2018

guidelines on quality assurance for pharmacy prepared sterile products

  guidelines on quality assurance for pharmacy prepared sterile products that can be compounded (i.e., prepared from component ingredients) if needed, including capsules or tablets, products like creams and gels that are used on the skin, and medications that are injected into the skin, muscle or vein using a syringe or infusion. Hospitals use a …

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USP 800 Checklist: Priority Areas to Address

  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. This could include: Outsourcing high-volume CSPs to 503B facilities …

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Three things to consider when upgrading to meet USP 800

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.     …

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Pharma D Solutions voluntarily recalls all sterile compounded drugs

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 drugs affected by the recall include any compounded at the pharmacy within the past 12 months, which were distributed nationwide and directly to customers and medical …

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The Risks of Automated Compounding of IV Products

The Risks of Automated Compounding of IV Products

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 …

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Reducing Risks of Exposure to HDs

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. Under the current regulations as well as the upcoming USP <800> the hazardous materials are usually ordered …

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What is USP ?

  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, …

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Updated Compounding Rules Could Affect Cleanroom Design

  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: Compounding facilities must have …

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503B Audits and Services

        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 …

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USP Compounding General Chapters Now Available for Public Comment

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.   To register please follow this link …

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