NFC World: “The two companies [Thinfilm and Jones Packaging] are collaborating to integrate Thinfilm’s NFC OpenSense technology into paperboard pharma packaging and establish key manufacturing processes for production on Jones’ high speed lines.†In addition “the work…will also include the integration of ferrite shield labels with the NFC OpenSense tags. This will enable NFC to function on metalized packaging such as blisters …â€
Pretty cool stuff. By using NFC in the packaging, the simple tap of an NFC-enabled phone will allow you to authenticate the product, as well as track individual items. Would be neat to tie this into IV labels somehow.
This year’s ASHP Midyear Clinical Meeting was held at the Ernest N. Morial Convention Center in New Orleans, Louisiana on December 6 through December 10, 2015. For many, the Midyear Meeting is about the latest in clinical advances, but for me, it’s an opportunity to see all the new pharmacy automation and technology. And the best place to see the latest and greatest technology is in the exhibit hall.
Below you will find my thoughts on what I saw while roaming the exhibit hall. By no means is this an exhaustive list, but rather items that I think are worth mentioning and thinking about.
PHARMACY CLEAN ROOM
“Sterile compounding is a significant but perilous core pharmacy process in dire need of improvement.†– ISMP Jan 2015
The pharmacy clean room (a.k.a. iv room) continues to get a lot of attention, and rightly so. With the introduction of USP Chapter <800> and proposed changes to USP Chapter <797>, the clean room is on everyone’s mind. This year’s exhibit hall was a direct reflection of this.
The clean room automation and technology space is It was bound to happen. Over the past few years, several vendors have introduced products designed to help pharmacists with compounding sterile products or meeting clean room regulatory requirements.
Aesynt is now part of Omnicell and CareFusion is part of BD. BD has had more time to ramp up their messaging and it was obvious in their exhibit this year.
The Plus Delta Technologies booth was empty. Plus Delta’s products include PD, a medication tracking system, and IVTtrac, a semi-automated iv workflow management system. It is unclear whether the company has been sold, has gone belly up, or is simply keeping a low profile
APOTECA was not present in the Midyear Exhibit Hall this year. If you recall, APOTECA is the company responsible for APOTECAchemo, a robot for compounding hazardous drugs. Last year about this time they introduced APOTECAps, a semi-automated iv workflow management system. The company was conspicuously absent.
There was a good number of booths offering clean room consulting. More than I’ve seen in past years.
Aesynt – previously McKesson Automation, now part of Omnicell – was focused on data analytics in the clean room with two new products: REINVENT and Formulary Tool Kit (FTK). I wrote about REINVENT after the ASHP Summer Meeting in Denver. FTK is a tool designed to help pharmacies extend BUD in the cleanroom.
BD and Baxter seem to be running parallel races. Baxter had a press release at the meeting that focused on DoseEdgeBD did the same for Cato. Baxter will be pushing their Epic integration in the coming year.
Baxter was showing off their DoseEdge scales for the first time ever at a Midyear event. DoseEdge has had gravimetric functionality for quite some time, but the concept has never been popular with their customers. Apparently that has all changed. Based on conversations with insiders, this appears to be a direct result of pressure from BD’s gravimetric-centric approach.
Imaging platform and scales from DoseEdge (left) and BD Cato (right)
MedKeeper showed off a new booth at Midyear with Verification front and center. Verification is MedKeeper’s semi-automated iv workflow management system. Something that caught my eye while I was in the MedKeeper booth was the images captured by Verification. They’re really quite good. I was especially surprised to find that some of the images I was looking at were taken from outside an isolator. That’s right, the device was mounted outside the isolator, thus limiting the hardware in the hood.
Verification by MedKeeper – images shown on screen taken from outside an isolator
Talyst had Talyst IV Room on display. Talyst IV Room is part of the company’s mobile inventory management solution and offers users the ability to build IV kits utilizing barcode scanning for verification, as well as the ability to track sterile preparations throughout the compounding process.
Talyst IV Room product on display
Grifols introduced a new hazardous drug compounding hybrid robot, Kiro Oncology. Kiro is a bit different from previous robots as it uses two robotic arms to compound sterile preparations. It’s an interesting concept.
Kiro Oncology robot from Grifols
Compounding robots were out in full force: Aesynt with v.STATION, ARxIUM with RIVA, and Grifols with Kiro Oncology.
RFID-ENABLED TECHNOLOGY
RFID-enabled technology was more prevalent at this year’s ASHP Midyear than I can recall in previous years. Booths that had RFID-enabled products on display were typically busy, and the people in those booths were engaged in conversation.
Does this mean that pharmacy has finally turned the corner on RFID? Perhaps, but the technology still has some barriers, both real and perceived to overcome. It is clear to me, however, that RFID has niches in pharmacy and vendors are finding those niches.
Three booths that I thought were particularly busy were MEPS Real-Time, Inc., Kit Check and FFF Enterprises.
MEPS Real-Time, Inc. was showing off their Intelliguard RFID system, which includes an RFID-enabled medication tray management system, controlled temperature cabinets (CTCs) – both refrigerated and room temperature – and a virtual logbook for tracking medication trays.
Kit Check had their “Little Blue Box†scanning station in the booth, which is part of their RFID-enabled medication tray management system. In addition, Kit Check was showing off their RFID-enabled Anesthesia Check system, which I thought was pretty cool. The design is well thought out and offers some nice functionality.
FFF Enterprises is a distributor of plasma products, vaccines, biopharmaceuticals, and biosimilars. Part of their product line includes Verified Inventory Program-Consignment (VIPc), which includes RFID-enabled refrigerators that offer automatic track and replenishment for their product line. Cardinal Health does something similar.
SencorpWhite was on hand with a small booth providing information on their RFID capable carousels. They didn’t have a physical carousel in the booth as in previous years, but instead opted for literature and a looping video to support their product offering.
PharMEDium announced that they will be making pre-filled syringes with RFID tags embedded in the labels. This is big, but the announcement went unnoticed by many. I wouldn’t have known about the move had I not been speaking to one of the vendors mentioned above. I verified this with one of the PharMEDium executives and was informed that the RFID-enabled pre-filled syringes will not be proprietary to any single company, and will be made available to anyone looking for pre-filled syringes with embedded RFID tags.
COLD CHAIN TECHNOLOGY
It has been clear for quite some time that refrigeration is going to be important for the next generation of pharmaceuticals, including biologicals. Pharmacies will need to invest in and utilize better security, as well as real-time monitoring for temperature, humidity, and inventory.
The exhibit hall was full of vendors offering real-time monitoring. Have a data connection, i.e. “the internet� If so, then you have everything you need to use many of these systems. Vendors are offering cloud-based storage of information, which means anytime, anywhere access to data. Real-time monitoring and alerts mean that pharmacy directors will have peace of mind that their pricey inventory is in date, properly stored, and in stock. It’s a win-win.
All the major pharmaceutical grade refrigerator vendors had a presence in the exhibit hall: Helmer, Follett, Migali Scientific. Not to mention seeing many other vendors with one of these brands in their booth. Partnerships and alliances appear to be the most efficient method of ensuring that you can offer a refrigerated solution to your customers.
Some items that I felt were particularly interesting in the cold chain area:
RFID-enabled refrigerators. See the section on RFID for more detail.
The Evolve line of pharmacy-grade refrigerators from Phononic were quite impressive. These refrigerators are powered by SilverCoreâ„¢ Technology. They have no compressor, meaning they have no mechanical parts, run quiet, use less electricity, and generate less heat. The refrigerators use solid-state heat pump technology coupled with a non-hazardous, non-toxic refrigerant. In addition, the units provide alerts for temperature, door, battery, memory, loss of Wi-Fi, and loss of power. Check the image below showing the solid-state “pumpâ€.
Phononic compressor-free refrigeration technology
Vaccine Smart-Fridge. I wrote about this back in September. The Smart-Fridge is an interesting concept. The system offers single-point access to vaccines, providing real-time alerts on inventory shortages and temperature. Automated temperature monitoring ensures that things stay within their appropriate temperature range, and analytics and historical dispensing data are collected and made available to the user.
STRIP PACKAGING FOR AMBULATORY CARE
Strip packagers have been around for a long time. They were popular in acute care for a while, but not so much anymore. However, there appears to be renewed interest in the technology for use in ambulatory care pharmacy, especially as a method of improving medication adherence. I spoke to several strip packaging vendors that are seeing renewed interest in the technology. Most attribute this to the introduction of strip packaging as a medication adherence platform made popular by recent coverage of PillPack.
DYNALABS DVxâ„¢ Onsite Drug Verification System. DVx allows users to quickly and easily verify drug identity and strength (concentration) in real-time. The demo was impressive. The representative that I spoke with said that DYNALABS currently had a limited reference library, but were adding new drugs all the time.
ScriptCenter by Asteres. Think of ScriptCenter as something similar to the Amazon Locker model. Pharmacies fill medications, place them in the ScriptCenter kiosk, and allow users to pick them up at their convenience. Kind of an ATM-style solution to medication refill pickup. The system sends messages to patients when their prescription is loaded and ready. Users can pay with credit card or payroll deduction. You can even load OTCs into ScriptCenter. I spoke to Dana Darger, Director of Pharmacy at Regional Health in Rapid City, SD about ScriptCenter. He has been using the unit to provide employees with 24/7 access to medication refills. So far he’s been pretty happy with the results. Dana commented that ScriptCenter has helped alleviate congestion in the outpatient pharmacy as well as give hospital employees easy access to their refills.
ScriptCenter by Asteres
Cactus Smart Sink. I wrote about the Cactus Smart Sink while attending Midyear. The Smart Sink is a pharmaceutical waste disposal container that renders its contents “unrecoverable, non-retrievable and unusableâ€. It’s small and unassuming. I thought it was pretty slick.
Swisslog Nexus Station. One has to wonder how a tube station can be exciting. Well, if you’ve ever worked in a pharmacy where items are queued up due to volume, then you’ll appreciate the Swisslog Nexus Station. The Nexus allows users to load up to five tubes at a time in a Lazy Susan-like configuration. Tubes can be loaded as non-secure or secure and the Nexus will keep track. Much more efficient than a “one-up†tube station.
Nexus Station by Swisslog
A PDF version of this report may be downloaded here.
Like many others, I received a press release from BD while attending the 2015 ASHP Midyear Clinical Meeting in New Orleans. The press release touted the introduction of “a simplified way for hospitals to manage intravenous (IV) medication to help improve safety and reduce wasteâ€. The press release goes on to explain how BD has combined their technology with that of CareFusion, which they acquired last year.
I didn’t think much of it at the time. I get lots of these throughout the year, especially during conferences like ASHP Midyear. I always approach them with a heavy dose of skepticism, and for good reason. Announcements like these often describe a Picasso when in reality you’re getting something closer to Dogs Playing Poker.
However, Medgadget Tweeted about BD’s “simplified comprehensive IV management†earlier today. I found that interesting as it didn’t really seem to fit Medgadget’s typical fare. When I clicked on the link in the Medgadget Tweet I was taken to the official BD press release. Hmm.
Here’s the plan laid out by BD in the press release:
Starting in the IV room of a hospital pharmacy, BD Cato™ Medication Workflow Solutions have been integrated with the CareFusion SmartWorks platform to seamlessly integrate with pharmacy IT systems to receive IV orders. Throughout the medication preparation process, the BD Cato System helps detect potential errors optimize drug utilization, simplify preparation steps and improve documentation compliance.
If preparing hazardous drugs, clinicians may use a closed system drug transfer device (CSTD), and BD’s Hazardous Drug Safety portfolio of solutions can help minimize the risk of hazardous drug exposure for health care workers and patients through products like the BD PhaSealâ„¢
After the medication has been safely prepared and is ready to deliver to the patient floor, the Track and Deliver module of Pyxis® ES Link enables the pharmacy and nurses to see exactly where the medication is during transport and when and where it is delivered. This helps nurses better manage their time and reduces calls to the hospital pharmacy inquiring about status and whereabouts of medication.
Once the medication makes it to the patient bedside, the Alaris® System with bi-directional electronic medical record (EMR) interoperability bridges the gap between an EMR and an infusion pump. With only one additional barcode scan to a nurse’s workflow, the pharmacist-verified physician’s order can pre-populate the Alaris System, reducing manual keystrokes and infusion programming errors.
EMR interoperability also enables automated documentation back to the patient’s EMR, where the nurse validates the data in the EMR and commits it to the patient record, eliminating the need for manual documentation and ensuring that documentation is complete and accurate. In addition, Alaris® Viewer Suite for Charge Capture takes all of the data from the Alaris System and displays it in a patient-specific report, making it easier for billers and coders to make an accurate claim for reimbursement.
Finally, through Pyxis ES Link, a nurse can submit an IV refill request that will be displayed in the Med View Dashboard and enable pharmacists to proactively plan for IV replenishment needs, reducing the risk of interrupted therapy and waste. The refill order is sent to the BD Cato Medication Workflow Solutions and the process begins again.
The concept is interesting, but before passing ultimate judgment I need to see the entire process at a live site. I will contact BD next week to see if I can get more information and find a customer using the entire system.
Acute care pharmacies generate a lot of pharmaceutical waste, and it’s not always clear what you should do with it.
Yesterday I came across The Cactus Smart Sink while roaming through the exhibit hall at ASHP Midyear. The Smart Sink is a pharmaceutical waste disposal container that renders its contents “unrecoverable, non-retrievable and unusable”.
Some key features of The Smart Sink include:
A two cartridge system, one for liquid waste and one for solid waste, including patches.
It runs on batteries
Has a small footprint, measuring only 15.5†W x 12.5″ H x 9.5†D.
Uses audible alarms and alert lights to notify users when cartridges are full, have expired, or when the unit has been accessed.
I thought the it was pretty cool. Obligatory video below.
I’ve made a few changes to my technology travel bag from last year.
My loadout for ASHP Midyear 2014 consisted of a Lenovo Yoga 2 Pro ultrabook, a Microsoft Surface Pro 3, and a Samsung Galaxy S5 smartphone.
I’ve since sold my Surface Pro 3 (SP3) and replaced my Galaxy S5. The SP3 was a great machine, but at the time I felt that I needed a better mobile keyboard experience. In hindsight, it was the wrong move. I used the SP3 to take handwritten notes, mark up PDFs, etc, and I desperately miss the active digitizer and pen support. I hope to remedy that problem with a Surface Pro 4 at some point in the near future.
My Galaxy S5 was a great phone. It went everywhere I went for more than a year, at times acting as my only “computerâ€. I used it for obvious things like calls, text messages, emails, etc – as well as to play games, listen to music, take photos, check my social media feeds, and so on. I’ve recently replaced it with a Samsung Note 5.
This year’s ASHP Midyear loadout will include:
Yoga 2 Pro– Same as last year. The Y2P will act as my primary workhorse. I will be using it to compose blog posts and manage photos and videos that I capture while walking around the exhibit hall. The only difference from last year is an upgrade from Windows 8.1 to Windows 10.
Toshiba Encore 2 Write – Remember above when I said that I missed having a Windows tablet with active digitizer and pen support? Well, the Encore 2 Write is my solution for the time being. The Write will likely go with me everywhere I go while I’m at Midyear. It’s small and light enough that I can carry it around, it offers great pen support for note taking, and has just enough horsepower to be productive. It does not replace the SP3, but it’ll do for now.
Note 5 – I’ve been wanting to try a Note for a while. Finally pulled the trigger, and I don’t regret it for a second. The Note 5 is big, beautiful, well made, fast, the screen is crystal clear and bright, the camera is second to none, the pen experience is phenomenal, and the battery life is good. What can I say, the Note 5 is the best smartphone I’ve ever owned. Period. I’ll be using it to manage my calendar, make calls, send texts, read and respond to emails, etc. I will also be using it to take photos and videos when possible. Not to mention that I’ll be using it to take handwritten notes. It’s possible that I will leave the Write in my room and try to go it alone with the Note 5. I see no reason why I shouldn’t try.
In addition to the three machines above, I’ll also be carrying various cables, adapters, and external chargers for my smartphone.
And there you have it, my ASHP Midyear 2015 technology loadout.
Tomorrow morning I’ll catch a flight from LAX to New Orleans for the 50th ASHP Midyear Clinical Meeting and Exhibition. The annual ASHP Midyear Meeting is the largest gathering of pharmacists in the country. Over a period of five days, more than 20,000 pharmacists from all over the world will gather to discuss everything from new approaches to therapy, to trending topics like IoT, wearables, and new technologies. It’s a great opportunity to learn a great many things.
Over the years, my focus at the Midyear Meeting has changed. When I was a practicing clinician, I spent all my time in sessions trying to pick up every last little clinical crumb. However, I’ve become less interested in clinical content and more interested in pharmacy operations and technology. As a result, I attend fewer and fewer educational sessions each year, instead opting for more time in the exhibit hall. That trend will continue this year. I will slowly wind my way through the exhibit hall evaluating products, looking for new technologies, and sniffing out new practice trends. I will attend a few sessions on topics covering things like USP <797> and USP <800>, automation and technology, practice changes, etc., and I will be following up with all the companies covered in In The Clean Room to see if there have been any significant changes from a year ago, but for the most part the exhibit hall will be my primary focus.
I will do my best over the next several days to keep you up to date as to what I’ve seen and my thoughts on anything “newâ€.
Midday Symposia – There are some good CE opportunities here.
Cardinal Health educational programs – I mention this here because there are two programs that I’m interested in attending: 1) Hazardous Drugs: USP, NIOSH, and OSHA Oh, My! on Tuesday, December 8 at 3:00 – 5:00 PM; and 2) Preparing for USP Chapter <800> Now is the time to get ready on Wednesday, December 9, at 11:30 AM – 1:00 PM.
Vestigo is web-based Investigational Drug Service (IDS) software made by the McCreadie Group, Inc., a privately held pharmacy software company out of Ann Arbor, Michigan. The McCredie Group is a small boutique company that builds software for niche markets like IDS.
I’ve worked in pharmacies that have an IDS, and let me just say that there’s a lot of record keeping involved and attention to detail is important. One would think that the “the drug†would be the most important thing, but that’s not really the case. Records, logs, and traceability are key.
Anyway, one of the products offered by the McCreadie Group is Vestigo. I’ve come across the product in pharmacies while traveling, but never really given it much attention. Because it’s such a niche product I couldn’t even tell you who they’re competing against.
Don’t go Googling for information on Vestigo, because you’re probably not going to find much. The company has done a pretty good job of not marketing their product and keeping relevant information off the internet. Not sure how that’s possible in this day and age, but I wasn’t able to find more than some old reference articles and press releases.
I have verified with the company that they will be at the 50thASHP Midyear Clinical Meeting and Exhibition in New Orleans in early December. I’m interested enough in the product to drop by their booth and have a look. Until then, here’s what the McCreadie Group site has to say about Vestigo:
Vestigo increases IDS safety and compliance…
Protocols structured in a logical and safe manner
Product selection limited to drugs used for the current protocol
Automated checks for expired products and IRB approvals
Patient management functions prevent dispensing to patients not enrolled
Accurate, electronic drug accountability records
High-quality, safe labels with barcodes
Built-in workflow for safe practices
Logging and audit trails required for HIPAA and 21 CFR Part 11 compliance
…and improves IDS efficiency and reduces costs
Electronic protocol managementFully automated protocol billing (increases revenue and reduces the cost of generating the bill
Electronic inventory management including tracking patient-specific items, returns and destructions
Reduced paperwork and handwriting
Integrated dispensing with automatic label generation
Extensive reporting to track operations, workload and financials
So if you’re in the market for an IDS solution, you might give Vestigo a look and request a demo.
EMR & EHR: “Of all the things that irrationally inflate health costs, one of the top concerns is people who just don’t take their prescribed medications. Medication adherence doesn’t sound like a high-tech issue, but a lot of interesting technologies are being thrown at the problem…. At the recent Connected Health Conference I talked to several companies taking on the difficult adherence problem from different angles. Medisafe aids patients in self-monitoring, Insightfil creates convenient packaging that groups pills the ways patients take them, and Dose doles out medication at prescribed times.† – The author goes on to describe some of the technology. The content is worth a few minutes of your time.
Here’s the thing, technology may not be the solution.
@JFahrni or we could take the time & explain to pts how to/importance of taking their meds. Not sure these solve the root issue
There’s no question that medication adherence is a problem. How big is the problem? Well, according to an article in The American Journal of Medicine, 28% of new prescriptions never get filled, and among patients who do fill their prescriptions, adherence rates are less than 50%. The New England Healthcare Institute NEHI in 2009 [PDF] estimated that the cost of non-adherence was about $290 billion annually. It’s probably well over $300 billion now, but the number I see in most presentations is $290 billion. Hey, it’s a good, scary number.
Medication adherence, or non-adherence as the case may be, not only complicates things for patients but for the entire healthcare system.
The problem is well defined, i.e. people aren’t taking their medications properly, but the solution has eluded healthcare for a long time. That’s likely because the reasons for non-adherence vary widely and have been debated and discussed as long as I’ve been a pharmacist. Have we made progress? It’s hard to say. I suppose it all depends on your definition of progress. We have lots of medication adherence tools at our disposal; reminder systems, mobile applications, smart medication organizers, alert systems for medication bottles, and so on. I suppose that could be considered progress.
All these toys have a place in medication adherence, but the fundamental problem goes well beyond their scope. Medication adherence is a multi-faceted problem with roots in psychological behavior, socioeconomic background, and demographics.
However, one thing that people seem to overlook is that the contact point for most patients and their medications is a pharmacist. According to a recent report published by the National Community Pharmacy Association (NCPA), “the biggest predictor of medication adherence was patients’ personal connection (or lack thereof) with a pharmacist or pharmacy staff.â€
A patient’s introduction to medication use should begin by developing a relationship with a pharmacist at the point of care, whether that’s a hospital or a community pharmacy. In hospitals, patients should speak with a pharmacist upon admission, and again upon discharge. No patient should ever leave the hospital without speaking to a pharmacist or without medications in hand.
This is an oft-overlooked opportunity within healthcare systems. For hospitals that don’t have the resources to speak with every incoming and outgoing patient, look to your local community pharmacies. Find community pharmacies in the area that are willing to partner with the healthcare system to provide bedside medication delivery and consultation, thus beginning the process of building a working relationship between patient and pharmacist. As the patient moves from the hospital back into their daily routine, the relationship with their pharmacist will continue to grow. The payoffs are huge, especially for those patients with chronic diseases like diabetes, asthma, hypertension, hypercholesterolemia, and so on.
Not all patients are willing or able to be compliant, but some are, and those are the ones we hope to reach. Using a cost for non-adherence of $300 billion annually, a conservative positive impact of 10% could add up to more than #30 billion a year in savings, not to mention the positive impact on a patient’s quality of life.
Bottom line, get a pharmacist involved early and often. Medication adherence, it’s what we do.
Someone asked me the other day where they could read up on what’s going on in the world of pharmacy sterile compounding. It’s a good question. The simple answer is to get your hands on a copy of the USP Compounding Compendium and read it over and over again. That’s where I started. Unfortunately, that will make you about $150 lighter in the wallet. Not to mention that it’s not the most entertaining of documents.
ASHP offers several training courses that include written material as well as video. I’ve gone through many of them myself. They’re good, but expensive. You can see a list of them here.
I’ve found Pharmacy Practice News and Pharmacy Purchasing & Products to have lots of good, timely content pertaining to sterile compounding. The best part about these two publications is that they provide free access after a one-time registration process.
If you’re just looking for general reading material, a Google search for sterile compounding, compounded sterile preparations (CSPs), primary engineering controls, beyond-use dating (BUD), USP <797>, or pharmacy compounding will give you more than you can handle.
Anyone else have any recommendations for where to find information on sterile compounding? If you do, feel free to leave a comment below.
USP <800> is still in draft form. The official date of the chapter has not yet been determined and is dependent on several factors, but expect it to become official some time in mid to late 2016. And while USP <797> is in the process of being updated, the current version is still the one everyone has to live with.
Information contained in USP <800> is in addition to information found in USP Chapter <797> Pharmaceutical Compounding – Sterile Preparations and USP Chapter <795>Â Pharmaceutical Compounding – Nonsterile Preparations.
In its current iteration, USP <797> and USP <800> requirements for hazardous drugs (HDs) differ. However, HD compounding in the upcoming revision to <797> will be harmonized with Chapter <800>. Actually, it looks like USP will simply defer all HD compounding to USP <800>, which makes sense.
Until all the USP Chapters are on the same page, here are some highlighted differences between Chapters <800> and <797>:
Requirement of compounding supervisor
Applies to sterile as well as non-sterile compounding
No longer allowed to store, unpack, or manipulate HDs in positive pressure areas
Elimination of exemption that allowed low volumes of HDs to be compounded in a non-negative pressure room. All quantities of HDs must be compounded in a separate, negative pressure room
C-SCAs may be used to compound low- and medium-risk HDs
CSTDs are recommended for compounding and required for administration
Perhaps the greatest impact will come from elimination of the current USP <797> exemption for small volumes of HDs to be compounded in a positive pressure room. USP <800> handles this by allowing low- and medium-risk HDs to be compounded in a containment segregated compounding area (C-SCA). C-SCA is a new concept, and is defined as “a separate, negative pressure room with at least 12 air changes per hour (ACPH) for use when compounding HDs. Low- and medium-risk HD compounded sterile preparation (CSP) may be prepared in a BSC or compounding aseptic containment isolator (CACI) located in a C-SCA, provided the beyond-use date of the CSP does not exceed 12 hours“.
