Blogs

USP recently released a timeline for public comments and proposed revisions to USP 795 and 797. The public comment period for <795> will occur between March 30 and July 31, 2018 and July 27 through Nov 30, 2018 for <797>. See more details about the timeline and the revisions on their website. http://www.usp.org/compounding/updates-on-standards…Read More

USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. Free Download of USP General Chapter <800> The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs. General Chapter <800> describes requirements…Read More

"Pharmacy compounding continues to play an important role in helping patients and providers advance public health. But these practices must adhere to the modern rules that Congress recently enacted, including in the Drug Quality and Security Act, to enhance the safety and sterility of these medicines. The FDA is fully committed to implementing these requirements in a way that preserves the legitimate practice of pharmacy and promotes access to these important drugs while protecting patients,” said FDA Commissioner Scott Gottlieb, M.D. “Our 2018 Compounding Policy Priorities Plan lays out a comprehensive work plan for how we will implement key aspects of this important law, including making changes to some proposed policies to better ens…Read More

Come visit Travis Cleanair in Orlando at the 2017 ASHP Midyear Clinical Meeting & Exhibition! TCA is a proud exhibitor at this year’s ASHP Midyear Clinical Meeting &amp; Exhibition in Orlando, Florida on December 4 th , 5 th and 6 th . Find out what’s new at TCA and get all your questions answered at Booth #853. The ASHP Midyear Clinical Meeting &amp; Exhibition is a can’t-miss show for pharmacy professionals. As an exhibitor at this show, Travis Cleanair will have the opportunity to make connections with current and prospective customers, offer valuable industry knowledge and meet face-to- face with more than 20,000 pharmacy professionals who are shaping the industry today. In addition, this is a great chance to showcase …Read More

With the new revision of USP<797> on its way, many pharmacists are concerned about how these new regulations will affect their business. But what exactly has changed within the new revision? Among the most significant changes is the removal of low, medium, and high risk CSP categories. These designations have been replaced with category 1 and category 2 CSPs. The categories are now dictated by the BUD and the environment in which the product was compounded. The chart below shows the major differences between category 1 and 2 CSPs: Another major change within the new USP<797> revision is the frequency at which environmental and personnel viable monitoring must be done. Current USP<797> protocols state that media fill testin…Read More

Mississippi Baptist Medical Center (MBMC) is a 620-bed, full-service hospital located in Jackson, Mississippi. MBMC’s primary service areas include cardiology, oncology, and women’s services, with additional areas of expertise, such as specialty surgery, radiology, urology, and behavioral health. The pharmacy provides complete IV admixture services, compounding about 900 preparations per day, including total parenteral nutrition (TPN) and chemotherapy agents. When USP <797> was originally published in 2004, the problem MBMC and many other facilities faced was the chapter’s standards were a moving target and subject to change during the recently completed revision process. Even so, we were required to take interim measur…Read More

After input from stakeholders the FDA posted a notice announcing a change in inspections of 503 (A) Human Drug Compounding Facilities effective August 1, 2016. The investigations will consist of an initial assessment to see if the pharmacies are operating as a 503 (A) facility. If it is concluded that the facility is not operating as a 503 (A) facility the investigator will place the pharmacy on the list of non-compliance 483 and require the pharmacy to meet CGMP requirements. “The FDA investigators now will make a preliminary assessment regarding the firms compliance with certain conditions of section 503A before closing an inspection” as a response to the stakeholders input. To read the entire notice click here: http://www.fda.gov/dow…Read More

April 15th, 2016 The USP expert committee proposed a revision to USP 800, 5.3 FACILITIES AND ENGINEERING CONTROLS Compounding. The revision states that the C-SEC used for both sterile and non-sterile hazardous compounding would not need to be externally vented through HEPA filtration. The revision to USP 800 was set to be official May 26th, 2016. Click HERE to review the notice in full detail: http://www.usp.org/usp-nf/notices/hazardous-drugs-handling-healthcare-settings…Read More