February 3, 2022 - Blog (taken directly from State of Ohio: Board of Pharmacy Notice)
To address operational concerns raised by pharmacies and due to the continued community spread of COVID-19, the Board hereby adopts the following resolution on the enforcement of USP 800 and USP 825 as required by the Ohio Administrative Code:
The Board will be inspecting licensees to the standards set for the in OAC 4729:7-2 and 4729:5-6 beginning February 1, 2022. Board staff will be issuing written warnings to all licensees that are not yet compliant with these standards until August 1, 2022, after which time additional administrative action may occur. In addition to addressing or remediating any other noted violations in the written warning, licensees that are issued written warnings will be required to provide a written corrective action plan in accordance with rule 4729:5-3-03 that details the licensee's efforts to become compliant with these standards by the August 1, 2022 deadline.
Nothing in this resolution shall limit the Board from taking administrative action against a licensee that is engaged in the preparation of hazardous drugs or radiopharmaceuticals in a manner that presents a danger of immediate and serious harm to others.
For more information regarding the Board's hazardous compounding or nuclear pharmacy rules, please refer to the following resources:
August 18, 2021 - Blog
Auth. Bryan E. Clark
USP <800>, is the document published by The United States Pharmacopeia (USP) which describes practice and quality standards for handling Hazardous Drugs (HDs), including the receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations. While it is a large document that thoroughly covers all aspects of HD drug compounding, the purpose of this blog entry is to outline some of the sections and specific wording in USP 800 that we (Travis CleanAir) take into account when designing a Non-Sterile Hazardous room.
One of the more common rooms we’ve been requested to build by our clients in recent years is the Non-Sterile Hazardous Room (NSH Room); essentially a negative pressure secondary enclosure to contain hazardous materials as well as your hoods and other various equipment being used for non-sterile hazardous compounding. Reading through USP 800, you will see two important terms applying to this:
When compounding non-sterile HD’s, compounding must take place within a C-PEC located inside a C-SEC. Or in other words, a hood inside a room. The C-SEC itself must meet certain requirements for compounding HD’s, whether Non-Sterile or Sterile. These C-SEC room requirements are:
Your C-PEC, (Hood) used for Non-Sterile HD compounding has its own set of rules as well:
With those guidelines in mind, we can start to shape our NSH room design based on the client provided specifications. Additional information we require from our clients is covered in our initial Project Questionnaire, such information includes dimensions of usable space, types of compounding planned to be done in the workspace, number of hoods and hood types.
USP 800 Appendix 2 shows a whole page of simple example drawings of Sterile and Non-sterile rooms that leave much to the imagination.
Example: USP 800’s sample NSH room
At Travis Clean Air, all of our rooms are modeled in 3D from the initial drawing. This eliminates any misconceptions as to the scale or aesthetics of our cleanrooms, and allows us to have a full list of needed materials to build your cleanroom from the initial draw.
Example: One of our standard NSH designs shifting from top down 2D view used for design documents, to 3D front view
In order to keep our C-SEC negative per USP 800, our standard Non- sterile hazardous room includes an exhaust plenum in case the C-PEC loses power and fails to keep the room under negative pressure. As with everything else in our rooms, the size and location of the plenum is entirely customizable based on our client’s needs.
All Travis Clean Air rooms are designed with our client’s airflow needs in mind from our initial drawings to our final design documents. Whether it’s a USP 800 or USP 797 room, we guarantee you’ll pass certification. If you still have questions regarding an 800 compliant or any other cleanroom, we can work with you one on one to determine your requirements, and have a sample design based on your needs in a matter days.CONTACT US
March 11, 2018 - Blog
USP has now released the final version of USP 797and will be enforceable December 1, 2019 along with USP 800. Click below to download a free copy.
January 24, 2018
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 including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.
USP is announcing the intent to postpone the official date of General Chapter <800>. The purpose of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797>Pharmaceutical Compounding — Sterile Preparations, to provide a unified approach to quality compounding.
– September 29, 2017: Notification of intent to revise the official date of USP General Chapter <800>
– December 1, 2019: USP General Chapter <800> expected official date
To protect patients and healthcare workers from potential harm, USP General Chapters <800> Hazardous Drugs – Handling in Healthcare Settings and <797> Pharmaceutical Compounding – Sterile Preparations were developed to provide a complete set of standards for all healthcare workers to help ensure the safe handling of hazardous drugs throughout the healthcare system, including in the practice of compounding. The intent of the Expert Committee has always been to align these standards, providing a unified approach to quality compounding. The next revision to General Chapter <797> is anticipated to be published in the Pharmacopeial Forum 44(5) September/October 2018 for a second round of public comment. Both USP General Chapter <797> and USP General Chapter <800> are anticipated to become official on December 1, 2019. Sections of the revised <797> may have longer implementation dates that will allow time for adoption of the standard.
As we all move towards safer handling of hazardous drugs in the work place, USP strongly encourages early adoption and implementation of USP General Chapter <800> to protect the public health in all healthcare settings. We will continue to support our stakeholders through ongoing education and outreach.
Developing USP General Chapter <800>
Public Health Need
The need to help ensure a quality environment and to protect healthcare personnel from hazardous drugs has been a topic of concern for decades. Growing evidence highlights that acute and chronic health effects can occur due to occupational exposure to over 200 hazardous drugs used commonly in healthcare settings. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. The goals of these standards are to help increase awareness, provide uniform guidance to reduce the risk of managing hazardous drugs, and help reduce the risk posed to patients and the healthcare workforce.
USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard-setting progress.
The USP Compounding Expert Committee is responsible for the development of General Chapter <800>. Review their work plan and past meeting summaries. USP General Chapter <800> was published twice in the Pharmacopeial Forum for public comment. USP received over 1,300 comments from approximately 150 stakeholders during the second public comment period (Dec. 1, 2014, to May 31, 2015). All of the public comments were reviewed by the USP Compounding Expert Committee and many of them are incorporated in the final published chapter. Read the Compounding Expert Committee’s responses to the public comments in the Commentary (posted Feb. 1, 2016)
January 24, 2014 - Blog
“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 ensure we balance the need to preserve access to appropriately compounded drugs for patients whose needs cannot be met by FDA-approved products with our legal obligation to help protect patients from poor quality compounded drugs that could cause significant harm. For instance, we’re taking steps to make it more feasible for certain compounders to become outsourcing facilities by taking a risk-based approach to how we will implement good manufacturing requirements on these facilities. The goal is to make it more feasible, and lower cost, for a larger swath of pharmacies to transition to becoming outsourcing facilities. Many of these policy priorities are well underway, including three final guidance documents announced today. Other policies will be rolled out over the course of the coming year. The FDA’s compounding program is a priority for the agency given its profound public health importance. I look forward to soon sharing more on how we will continue to build on these efforts as part of our public health mission.”
The U.S. Food and Drug Administration today issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement certain key aspects of the Drug Quality and Security Act (DQSA) and other provisions of the law relevant to compounders. DQSA put in place more robust oversight of compounders and enabled closer federal and state collaboration. It also established a clear legal framework that provides for compounding to meet patients’ medical needs, while also giving the FDA tools to promote the quality of compounded products – which have not undergone FDA premarket review for safety, efficacy and manufacturing controls – and address unlawful compounding practices that threaten public health. Significantly, the law created a new category of compounders, called outsourcing facilities, which may engage in larger-scale, nationwide distribution under additional FDA oversight.
The 2018 Compounding Policy Priorities Plan specifically details how the FDA will:
address manufacturing standards for outsourcing facilities
regulate compounding from bulk drug substances
restrict compounding of drugs that are essentially copies of FDA-approved drugs
solidify the FDA’s partnership with state regulatory authorities
provide guidance on other activities that compounders undertake.
As part of its implementation of the plan, the FDA today issued two final guidance documents explaining the agency’s policies on the “essentially a copy” provisions of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. For example, the guidance documents describe the characteristics of drugs that may be considered “essentially a copy” and the FDA’s policies regarding prescriber review of changes between compounded drugs and commercially available or approved drugs to determine whether they produce a significant or clinical difference for individual patients.
The FDA today also issued a final guidance on mixing, diluting, or repackaging biological products, which describes the conditions under which the agency does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. These policies are intended to minimize public health risks, while preserving access to these products for patients who have a medical need for them.
For more information:2018 Compounding Policy Priority PlanCompounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic ActCompounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic ActMixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Link to the original article on the FDA website found below.
November 7, 2017- Blog
Come visit Travis Clean Air in Orlando at the 2017 ASHP Midyear Clinical Meeting & Exhibition!
TCA is a proud exhibitor at this year’s ASHP Midyear Clinical Meeting & Exhibition in Orlando,
Florida on December 4th , 5th and 6th . Find out what’s new at TCA and get all your questions answered at
The ASHP Midyear Clinical Meeting & Exhibition is a can’t-miss show for pharmacy professionals.
As an exhibitor at this show, Travis Clean Air 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 TCA’s custom cleanroom suite.
TCA’s own educated staff will be working the booth and available to answer any questions you
may have. Travis Clean Air’s booth is number 853. For more information, visit the ASHP site, or contact
Travis Clean Air at 970-203- 0516.
September 7, 2016 - Blog
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 testing and fingertip testing of all compounding personnel must be done either annually or semi-annually – depending on the risk level. New USP revisions call for these test to be done by all personnel quarterly, regardless of the category designation of the product. The frequency at which viable air sampling must be done has also increased. Although air sampling for cleanroom certification remains semi-annually, air sampling to evaluate air cleanliness must be done monthly by the pharmacist. This inherently creates issues for pharmacists that have not previously had to do their own air sampling. In addition to monthly viable air sampling, monthly surface samples must also be taken within each area of the cleanroom.
Many other smaller changes have been made within the USP<797> revision. For example, master formulation records must be kept for all manipulations made of any compounds, including non-sterile manipulations and dilution processes. A new concept called “in-use time” has also been introduced in the revision which regulates the amount of time that a sterile product can be used once opened or pierced.
Although the new regulations will require more testing and documentation to comply with regulations, the FDA is hoping that implementation of the revised USP<797> will reduce illness and death associated with sterile compounding. With the implementation of these new regulations in the now foreseeable future, pharmacists must begin preparing to comply with the new USP standards. Since environmental and personnel monitoring must be done monthly by the pharmacist, a suitable supplier of media and laboratory services is necessary. LAB 797 offers quality media and laboratory services – including speciation of all viable organisms recovered. Revision of internal SOPs is also crucial to comply with these changes. Although a specific release date has not been set by USP and the FDA, pharmacists are encouraged to begin considering these new regulations now – inherently saving time and stress when the official revision is published.
For more information on USP 797 and updated revisions release dates, check out USP’s website
September 7, 2016 - Blog
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 measures toward compliance and achieve full compliance by January 2008. Having to meet the deadline, but not knowing what the final standards would be presented MBMC with a significant dilemma. With this in mind, we decided to develop a cleanroom that met the most stringent standards under consideration by the USP.
Cleanroom Construction Roadblocks
At the time, our cleanroom would have required major renovations to meet <797> standards. The ceilings, walls, and floors needed to be upgraded, but the primary roadblock to new construction was our pneumatic tube station, located in our anteroom. The station was clearly incompatible with <797>, but it was cost-prohibitive to relocate. At a minimum, we were looking at a major remodeling of the anteroom and the loss of extensive – and expensive – custom anteroom cabinetry. After looking at multiple options, we decided a modular cleanroom offered a solution of known quality with the flexibility to meet future <797> standards at a cost that would not wreak havoc on our budget. The modular design allowed us to avoid “immovable” obstacles while customizing the cleanroom to the available space and incorporating a major portion of our existing anteroom cabinetry into a new staging area.
Selecting a Modular Cleanroom
We looked at quite a few modular cleanroom manufacturers and found their offerings to be mostly equal in quality, as they often utilized the same base components. We found Travis Clean Air’s modular acrylic cleanroom to be the equal of any product in the mid-priced spectrum, and because of our high compounding volume, we particularly liked its large pass-through chamber. That said, we were ultimately sold by the quality of their people and customer service. Their expertise was apparent, their attention to meeting our specific needs was first rate, and their installation team was highly qualified.
In the fourth quarter of 2007, we installed a 27×12-foot positive-pressure modular cleanroom in our main pharmacy and a 14×14-foot negative-pressure modular cleanroom in our Hederman Cancer Center pharmacy. Almost no structural changes to the pharmacies were required, as we designed the cleanrooms around existing components and equipment that would have been expensive to relocate.
While the entire process took about three months, including the demolition of our existing IV room and the installation of HVAC hookups, Travis Clean Air installed the actual cleanrooms in one week. Since most institutions cannot just stop preparing IV solutions during construction, Travis Clean Air installed a temporary cleanroom in our main pharmacy, which allowed us to continue compounding throughout the installation. This added service made the process as painless as possible for our staff and patients.
Features and Equipment
In the main pharmacy cleanroom, we installed laminar airflow hoods and an automated TPN compounder, and in our oncology satellite, we installed
externally exhausted biological safety cabinets. Both cleanrooms feature a wireless phone, an intercom system, a digital clock, and sensors for the continuous monitoring of temperature and humidity. All of our cleanroom furniture is stainless steel and on casters. Both cleanrooms and anterooms have been certified to meet ISO Class 6 specifications by ENV Services, an independent cleanroom certifier. The anteroom is used primarily for garbing, and supplies are passed into the cleanroom through a pair of acrylic pass-throughs.
The use of a modular cleanroom, as opposed to a traditional cleanroom, has changed our workflow, but the impact has been smaller than we expected. The three workstations in our main cleanroom and two in our oncology satellite have been more than sufficient to meet our compounding volume. Our modular cleanrooms have further ensured the quality and safety of our compounded sterile preparations, while providing us with a flexible vehicle for meeting future regulatory requirements. We believe Travis Clean Air’s cleanrooms will provide us with economical service for many years to come.
About the Writer:
George H. Milstead, RPh, is the director of pharmacy for Mississippi Baptist Medical Center in Jackson, Mississippi, where he has worked since 1973. He holds a BS in pharmacy from the University of Mississippi.
Purchasing & Products
As Seen In
May 2008 Vol. 5 No. 5
By George H. Milstead, RPh
Reprinted with permission from Pharmacy Purchasing & Products, Vol. 5 #5.
©2008 Ridgewood Medical Media, LLC, Ho-Ho-Kus, NJ. All rights reserved.
September 6, 2016 - Blog
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.
June 6, 2016 - Blog
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.
July 8, 2015 - Blog
If you’re thinking of installing clean rooms in your business, you are likely simply concerned with complying to safety laws and regulations. However, there are several benefits – aside from safety benefits – to installing a modular clean room:
Modular clean rooms are adaptable. Travis Clean Air’s clean rooms are modular and mobile – which means freedom in the programming and design of your clean rooms. Since our clean rooms are modular, room configurations can change or expand to meet the changing and expanding needs of your business.
Moreover, if your business moves, you can take your modular clean rooms with you to your new location. There, you’ll be able to reassemble and readapt the structure to a new environment.
Additionally, if you’re moving large equipment into, out of, or through a clean room, disassembly is possible! Walls can be maneuvered, rearranged, and reassembled to move furniture or equipment throughout your facilities.
Our clean rooms are sleek, minimalistic, and stylish. We provide clean rooms with several windows – which means you get the feeling of an open environment, even when the room is sealed. You’ll be anything but claustrophobic in our modular clean rooms.
Since clean rooms isolate environmental conditions, they can act like a thermos. Clean rooms hold temperatures longer than open air rooms, and you may notice a drop in your heating and cooling bills.
If your business is ready to install clean rooms, feel free to contact Travis Clean Air. We’re modular clean room specialists and experts, and we’ve got experience under our belt.
Contact us if you’re curious about our clean rooms, or if you’d like to begin discussing a project!
October 30, 2014 - Blog
Here at Travis Clean Air, we’re really excited about the new USP 800 Clean Rooms. We are not only fully committed to serving your clean room needs by providing the best possible clean room solutions out there today, but we’re also totally committed to backing up the clean rooms with excellent customer service. We first assess your needs, then we find ways to accommodate your space, we help you select color and design, and then we build your clean room to exact specifications right here in our Loveland, Colorado facility. After that, we deliver the clean room directly to you to ensure proper and safe installation.
There are a few changes that come with the USP 800 Clean Rooms. Here’s what you can expect:
Compounding supervisor. With the introduction of the USP 800 clean rooms, pharmacy staff and administration will have new responsibilities. USP 800 requires that a specific person be assigned as the compounding supervisor. This person will be responsible for developing and carrying out specific procedures as well as faculty compliance and overall monitoring.
Separation of hazardous drugs. Now the compounding and manipulation of hazardous drugs must be performed in a C-PEC within a separate room. The goal here is additional personnel protection.
Co-Mingling of non-antineoplastic hazardous drugs. USP 800 allows drugs non-antineoplastic hazardous drugs to be co-mingled with non-hazardous drugs if the pharmacy policy allows. Note that the permitted co-mingled drug must not be manipulated other than for counting.
Implementing an USP 800 clean room is easier than you think!
Call us today and let us help you!