Building a sterile compounding space in California – Regulatory Hurdles

For almost a year, I’ve been working as a ‘Pharmacy Project Manager’ on a large healthcare system project to bring all their pharmacy sterile compounding spaces — a.k.a. Cleanrooms, SCA’s, C-SCA’s, etc. — into compliance with USP General Chapters <797> and <800>. Some areas have been remodeled while others have simply been scrapped in favor of a completely new space.

The time on this project has been one of the highlights of my 20-plus year career. I’ve learned so much in such a short period. You think you know something until you have to start doing it day in and day out. It’s only then that you realize you know nothing. Here I am a year later and my knowledge base on sterile compounding has increased tenfold. It’s been a great experience.

One of the things that I learned early on in this position is that no pharmacy project in California is easy. There are several state and local agencies that have to be involved. And as one might expect, when government agencies get involved, the paperwork, time, money spent, and frustration can escalate quickly.

The process for remodeling or building a new sterile compounding area, at least in California, involves at least three agencies: the Office of Statewide Health Planning and Development (OSHPD), the California State Board of Pharmacy (BoP), and the California Department of Public Health (CDPH).

In a nutshell:

Office of Statewide Health Planning and Development (OSHPD): Part of the OSHPD mantra is to “ensure hospital buildings are safe”. They’re basically the organization that looks at your architectural and engineering plans and says yea or nay. My experience has mostly been nay on first glance followed by weeks of back and forth until all parties are satisfied. It’s an interesting process, to say the least. It’s also time-consuming.

OSHPD is a real stickler when it comes to anchoring equipment in place in case of an earthquake — noting that California has only had a few major quakes in the past few hundred years. A majority of our quakes are small and cause no damage. But don’t tell that to OSHPD. Their anchoring requirements are, shall we say robust; read that as overkill. The buildings around the anchored equipment will come crashing down long before the equipment will budge an inch. Just sayin’.

OSHPD is the first organization to sign off on a project. Once the plans are approved, a building permit may be issued and construction may begin. Once construction is complete, OSHPD inspects the area, and if everything meets code, they sign off and provide a Certificate of Occupancy (C of O) for the space.

I honestly don’t know a whole lot about OSHPD. The process is mostly handled by the architects, the project engineers, and the construction folks. I get informed with progress and sometimes provide snippets of information, but for me, the overall process is magic behind the curtains.

California State Board of Pharmacy (BoP): The BoP is responsible for ensuring that every pharmacy, or part of a pharmacy, conforms to the requirements set forth by the California Lawbook for Pharmacy. The BoP process starts with submission of an application, license sterile compounding or satellite pharmacy. The BoP reviews the document and either requests changes, which happens a lot, or approves the application and assigns an analyst. The analyst assigns an inspector to the project and a new set of back and forth begins. The inspector often asks for a lot of paperwork before their inspection: copy of sterile compounding PnP, testing and certification results for the room and hood, culture results, “QA” and competency results for staff, cleaning logs, etc. Once the inspector is satisfied with the paperwork — noting that each inspector is different and may ask for different things — they schedule a visit.

Assuming the BoP inspection goes smoothly, which is a hit and miss, the inspector will clear the site for licensing. Unfortunately, the inspector doesn’t actually license the space. All they do is notify the analyst assigned to your case that the space has been cleared for licensing. The actual license isn’t official until a new license number is assigned and posted to the BoP website. This can take anywhere from 2-6 weeks after the inspection. The BoP says “2 weeks” but I’ve found that to be inaccurate in almost all cases so far. The fastest I’ve had approval has been two weeks. The longest has been more than six weeks. If you haven’t heard from the BoP in two weeks, I recommend sending them a nudge, “hey, remember us?”.  It seems to help.

I recommend submitting your application to the BoP at least a couple of months before construction is complete.

California Department of Public Health (CDPH): If one were to assume that CDPH is a single organization, one would be only partly correct. For pharmacy projects, the organization is actually broken into multiple groups, each with its own set of requirements and approval processes for every single pharmacy sterile compounding project in California.

There’s the CDPH Central Application Unit (CAU), which works with each facility to ensure all necessary paperwork is in order: an HS Form 200 application form, along with a bunch of other paperwork like the OSHPD C of O and Form STD 850 Fire Safety Certificate. It’s quite a process. However, I’ve found that the CDPH CAU is easy to work with. They’re a friendly bunch that appears to want to help.

And there’s the CDPH Pharmaceutical Consultant Unit (PCU). As far as I can tell, the existence of the PCU in an official capacity is new. At least it feels new. The PCU requires its own laundry list of paperwork. Seriously, it’s a huge list of stuff.  The list includes the C of O for the space, even though the CAU requires it before they notify the PCU inspector; all sterile compounding PnP; temperature, pressure, and cleaning logs; a copy of the pharmacy plans, including HVAC system layout — even though this has already been approved by the engineers at OSHPD; test results for the room and hoods; employee competencies and QA testing; high-resolution photos of the space — even though CDPH PCU has no way to receive files this size and can’t use a file sharing service like Dropbox, Google Drive, or OneDrive from Microsoft.

Given my experience with the CDPH PCU, it’s difficult for me to understand their existence. They do almost exactly the same thing as the BoP. See above. It’s a duplication of efforts, to say the least. And in my humble opinion, the PCU doesn’t appear to provide any benefit to the overall health of the project. It doesn’t really matter as going through the PCU for approval of the space is required, so that’s what we do. Fortunately, the PCU inspectors are typically pretty easy to work with. They demand a lot but typically work with you to get it done.

The entire CDPH process is a bit convoluted. Once the CAU has everything they need for your new pharmacy sterile compounding area, i.e. they have all the paperwork, they notify the PCU that you’re clear for inspection. The PCU inspector contacts the facility via email or phone and works with them to schedule a field inspection. The inspector comes out, inspects the space, and if it’s good to go — almost never in my experience — they clear the space for use. However, the PCU clearance doesn’t mean you can use the space. The PCU inspector must first notify the local CDPH office with a “recommendation” to approve the space for use. The local office reviews the PCU inspectors report and if they agree with the inspector’s recommendation, which they always do, they notify the inspector of the approval. The inspector then notifies the facility that they’re good to go. Simple, right? Riiiight.

I recommend submitting your CAU application 4-6 months in advance of your construction completion date. I recommend contacting the PCU 2-3 months out. It’s better to be on their radar.

Final Thoughts

Building a new sterile compounding space is expensive, time-consuming, and disruptive. Even with the best planning, the regulatory processes in California are going to make you want to pull your hair out and scream. But there’s nothing you can do about it. I’ve found that being informed about the process is the best weapon in your arsenal, and can only help you in the long run. Get educated on the process. Reach out to all the agencies involved and find out what you have to do well in advance of your project. And don’t be afraid to reach out to the inspectors — BoP and CDPH PCU — because they’re there to help you.

Mobile compounding units, a.k.a. sterile compounding trailers

Image owned by Jerry Fahrni, Pharm.D. Taken June 28, 2018

Construction on pharmacy cleanrooms is at an all-time high in California. Every hospital I know is either renovating a sterile compounding area —  cleanroom or SCA — or building a new one. Why? Because of USP General Chapter <800>, of course. Never have I seen so little cost so much. That little 19-page document has sent shock waves throughout the pharmacy world and created more chaos than anything I’ve witnessed in my 20 plus year career. Whether or not the changes called for in the new chapter will improve patient care and worker safety remains to be seen. That’s a blog post for another time.

As pharmacies begin renovating existing sterile compounding areas, or building new ones, there may be a time when they find themselves without a suitable area to make Compounded Sterile Preparations (CSPs). Some pharmacies have the physical space and financial resources to build new sterile compounding areas without vacating their existing space. Others do not.

For those that don’t, there are few options. They can potentially get someone else to handle their CSP production while under construction, or they could give everything an immediate-use BUD. Neither is a great option, but options they are.

Enter the Mobile Sterile Compounding Unit (MSCU) built by Germfree — aka Mobile Compounding Unit (MCU), “Pharmacy Trailer”, “Rx Trailer”, “the trailer” or as the manufacturer likes to call it, “Rental Compounding Trailer”. I prefer MCU.

The MCU is basically a semi-truck trailer with a fully functional pharmacy cleanroom inside. Germfree describes it as a “turnkey rental pharmacy/cleanroom for hospital facility renovations”.  I wouldn’t go as far as to call it turnkey, but it’s close.

The Germfree MCU has three distinct work zones:

1) ISO Class 7/8 anteroom with a small area for personnel to don Personal Protective Equipment (PPE). The area has lockers for storing PPE, a hand washing sink, and a gowning bench.

2) ISO Class 7 Negative Pressure Buffer Room (HD room) with Class II, Type A Biological Safety Cabinets, storage space, and integrated refrigerator and freezer. Preparation areas are all stainless steel.

3) ISO Class 7 Positive Pressure Buffer Room (non-HD room) with Laminar Airflow Workstations, storage and integrated refrigerator and freezer. As with the HD room, preparation areas are stainless steel.

The trailer has a dedicated HVAC system for temperature and humidity control, an auxiliary generator should you require emergency power, on-board fresh water to provide for a sink, a gray water tank to collect water for disposal, data ports for computers and phones, and a host of cameras with a digital video recorder (DVR) for security.

I’ve had the opportunity in my current position to oversee the implementation of a MCU from purchase to fully-operational cleanroom. I’m a few weeks from signing off on the project. Only a bit of regulatory paperwork remains.

During my time with the MCU I’ve formed some opinions, which I present to you here.

Pros:

  • Ready-to-use, sort of. While it takes a little bit of work to get a MCU up and running, they truly are close to being a “turnkey cleanroom”.
  • ISO compliant HD and non-HD buffer rooms. Unlike an SCA, there is no limitation to what can be made in the MCU. It is fully capable of handling any type of CSP.
  • Self-contained, mostly. Once the MCU is tied to water and electricity, pharmacy personnel can work as if they were in any other pharmacy cleanroom.
  • It’s quicker and cheaper than many remodels. I don’t mean to say that MCUs are inexpensive, but I would wager that the cost is less than most major pharmacy remodels or the cost of building a completely new cleanroom.
  • The MCU is nice. Regardless of how you feel about the idea, one thing is for sure, the Germfree MCUs are nice and well-built. Honestly, the HD and non-HD buffer rooms inside the trailer are nicer than many pharmacy cleanrooms I’ve been in. Don’t take my word for it, go visit one yourself.
  • Same hoods that you find in the pharmacy. The same Germfree BZ and BBF hoods you find in pharmacy cleanrooms can be found in the MCU.
  • Lease or buy. Depending on your needs, Germfree offers both.

Cons:

  • One-year maximum use in California. This has nothing to do with Germfree but rather the state I live in. California will only give permission to use these trailers for 12 months. This seems a bit silly to me. Don’t people use trailers as permanent homes? I believe so. As mentioned above, the MCUs from Germfree are nicer than some cleanrooms I’ve been in. Meh, when in Rome…
  • Requires a “flex” or “alternate means of compliance (AMOC)” from state agencies, at least in California. It’s a bit of extra paperwork.
  • Regulatory scrutiny, again California specific. All the state agencies — OSHPD, CDPH, Board of Pharmacy — have taken an aggressive approach to these trailers, which makes getting them up and running a bit of a hassle. Be prepared to do a lot of extra paperwork, including extended policies and procedures, additional trailer-specific training and training, and so on.
  • Requires water, electricity, and internet. This is where calling the trailer self-contained becomes strained. Yes, the trailer has a fresh-water tank and a generator, but those are temporary solutions. Should you need the trailer for an extended period, you will have to find more permanent water and electricity options.
  • Gray water tank. Water used to wash hands has to go somewhere. In this case, it’s a gray water holding tank. Obviously, the tank has to be emptied when it gets full. Depending on how prolific your CSP production is, that could be more than once a week.
  • No restroom. Cross your legs or leave the trailer because there is no bathroom.
  • Customer support/service. I’m sure this will improve over time, but it’s been less than optimal.
  • Limited availability. Apparently, it takes a while to build an MCU, so if you’re in the market for one you should look into it as soon as possible.

USP Announces Intent to Postpone Official Date of USP Chapter <800>

In a notice posted last Friday, USP announced its intention to postpone the official date of USP Chapter <800> — Hazardous Drugs — Handling in Healthcare Settings.

According to the notice: “The intent 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. 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 and is expected 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. ”

The original date for USP <800> to take effect was July 1, 2018.

This is good news for many as the July 1, 2018 date has created chaos in pharmacies across the country as they attempt to update their cleanrooms to become compliant. With that said, it’s a bit irresponsible for USP to wait this long to announce the postponement. Many acute care pharmacies are in the middle of lengthy and expensive cleanroom renovations.

Not to mention that many state boards of pharmacy have hung their hats on USP <800>. For example, California has already made significant changes to their regulations around hazardous drug compounding. As I’ve written previously, California made significant — and reckless — changes. Unfortunately, this postponement of USP <800> will make matters worse. It’ll be interesting to see how the California Board of Pharmacy handles the postponement.

Compounding Today: state board of pharmacy concerns with USP <800>

Each Friday the CompoundingToday Newsletter faithfully appears in my inbox. The newsletter features commentary by Lloyd V. Allen, Jr., Ph.D., RPh, Editor-in-Chief of the International Journal of Pharmaceutical Compounding. Dr. Allen is a legend in the pharmacy compounding world for both sterile and non-sterile products. He was someone that I looked up to during my early years as a pharmacist; still do, as a matter of fact.

Long before USP <795> and <797> existed, he was preaching the gospel of proper compounding technique and the need for specialized training. Truly a visionary man ahead of his time. I hope to meet him in person someday.

So it should come as no surprise that I take seriously every thought and opinion he has. In last week’s Compounding Newsletter, Allen tackled an interesting topic with some thoughtful commentary.

From the newsletter:

Numerous state boards of pharmacy have concerns about United States Pharmacopeia (USP) Chapter <800> Hazardous Drugs-Handling in Healthcare Settings.

– The official chapter goes beyond the walls of the pharmacy and into healthcare settings, including physician offices, clinics, hospitals, treatment centers, etc. where state boards of pharmacy don’t generally have authority for enforcement.

– The requirements of <800> are very strict and extremely costly; many smaller pharmacies will no longer be able to serve their patients who depend upon compounded medications so they will simply cease compounding patient-specific medications, including some hospitals.

– There are some aspects of <800> that should be the burden of manufacturers and distributors, not pharmacies. As an example, no package should be delivered to a pharmacy contaminated with hazardous drug (HD) contents on the package surfaces that exposes pharmacy personnel upon opening. This is the responsibility of the manufacturer and distributor…

– Many of the requirements of <800> are based upon “opinion” and not necessarily upon science as demonstrated by documented, prospective studies.

It’s interesting to note that USP <800> extends into all areas where HD’s may be used, including physician offices. Where will that oversight come from? Will pharmacies be held accountable?

Dr. Allen has always been an advocate for “the little guy” and been cognizant of the balance between practical regulation and overbearing regulation. This is clear in his assessment of many areas within USP <800>. While I don’t necessarily agree with everything he says, I believe that his commitment to pharmacy practice and patient care deserve our attention. As he states, it is possible that the new regulation will simply be too much for some, resulting in the closure of compounding facilities. The greater concern, at least for me, is what impact the new requirements will have on hospital pharmacies where budgets drive change. A shift in budgetary requirements will likely mean that important projects will be postponed or canceled in favor of meeting USP <800>. The untoward consequences could be felt for years to come.(2)

Dr. Allen’s zinger about the lack of science is understandable and shared by many, but I don’t believe that prospective studies are always necessary to begin a process. For example, would you really want a 10-year pilot study showing that healthcare workers in the U.S. exposed to HDs are 10 times more likely to die of cancer than those that don’t before implementing these guidelines?(1) No, of course not. As I’ve said many times before, some fields – clean room procedure and pharmacy technology, for example – cannot be studied and scrutinized in the same manner as therapeutics. We simply can’t wait 5-10 years to change operational practices. With that said, USP <800> probably goes too far too fast in certain aspects of the regulation. Only time will tell whether the new guidelines will have the same impact as USP <797> did back when they were introduced.

Dr. Allen goes on to state: “As state boards of pharmacy have options other than accepting USP <800> in its entirety… The purpose of this document is to simply provide a resource from which state boards of pharmacy can “pick and choose” items to include for their respective state.” While this may be true, it is one area where I disagree with Allen. Giving each state the ability to “pick and choose” how to implement and use USP <800> makes things incredibly difficult. California, for example, has made a complete mess out of their new regulations. Other states will do the same, creating chaos. In Allen’s scenario, moving ten feet across a state boundary could mean following a completely different set of rules. How does that make sense? I recommend developing USP <800> to a point that everyone can live with and use it. Period.

I encourage you to read through the most recent issue of the CompoundingToday Newsletter. I also recommend that you “click subscribe” as well. The information is good and thought-provoking.

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  • This is a fictitious example.
  • As my friend and colleague, Ray Vrabel likes to say, the clean room is “clean, but deadly”, referring to the fact that we spend all our money on regulation and virtually nothing on technology to improve safety.

NIOSH puts the brakes on the CSTD vapor containment protocol

Pharmacy Practice News: “The National Institute for Occupational Safety and Health (NIOSH) held a meeting today in Cincinnati to discuss a universal closed-system drug-transfer device (CSTD) testing protocol, which is being developed… The new protocol will test both physical barrier systems, which block the intake of environmental contaminants or the unintended release of hazardous drugs into the environment; and air-cleaning systems, which clean or filter vapors to prevent the unintended release of drug or the intake of environmental contaminants… NIOSH released a draft test protocol last year to evaluate the efficacy of physical barrier–type CSTDs to see whether they prevented hazardous drugs from escaping the closed system. After hearing from the public and meeting with various stakeholders, NIOSH was asked to develop a new performance test protocol for air-cleaning CSTDs. Instead of developing a completely new protocol, NIOSH decided to develop a universal one that addressed both types of systems.

Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs”. The idea is admirable, but the testing method adopted by the protocol left some CSTD manufacturers on the outside looking in, and they let the CDC know about it. Feel free to drop by the protocol comment site for clarification.

Apparently the comments made an impact because NIOSH is going back to the drawing board to try and come up with a universal protocol to meet the testing needs for all CSTD systems. However, one has to wonder if the damage is already done. For the past several months pharmacies have been making decisions on which CSTD to use based on information in the draft vapor containment protocol. Right or wrong, that’s the truth of the matter. I have to believe that some of the companies in this space have been irreparably harmed. Only time will tell.

Deactivation, Decontamination, Cleaning, and Disinfection of sterile HD compounding areas

USP <800> has an entire section dedicated to deactivation, decontamination, cleaning, and disinfecting areas that are used for compounding sterile hazardous drugs (HDs).

The chapter calls for:

  • Establishing written procedures
  • Training personnel
  • Using appropriate personal protective equipment (PPE) resistant to cleaning agents. This includes the use of two pairs of chemo gloves and impermeable disposable gowns
  • Using eye protection and face shields required if splashing is likely
  • Using respiratory protection if warranted
  • Using wetted wipes and not spray bottles to deliver agents for deactivation, decontamination, and cleaning
  • Proper disposal of all materials used

Deactivation – Renders the compound inert or inactive. Residue from deactivation must be removed through decontamination (see below). There is no single method for deactivating all known compounds.

Decontamination – Inactivating, neutralizing, or physically removing HD residue from non-disposable surfaces via wipes, pads or towels. This includes work surfaces and under work trays where residue may collect.

Cleaning – Process to remove contaminants – organic and inorganic material – from objects and surfaces using water, detergents, surfactants, solvents, and/or other chemicals. Cleaning may not be performed while compounding activities are occurring.

Disinfection – Process of inhibiting or destroying microorganisms. Required for surfaces where sterile compounding occurs.

Most of the above is common sense. While it may seem complicated, most pharmacies will simply purchase kits designed to walk them through the process. An example of a kit used to meet USP <800> requirements is WipeDown 1-2-3 by Valtek Associates. I’m sure there are others as well.

The WipeDown 1-2-3 product description can be seen below. Notice that the kit contains numbered packets designed to walk you through the process, i.e. Packet #1 – deactivation, Packet #2 – decontamination, Packet #3 – disinfecting/cleaning. Pretty straightforward.

WipeDown 1-2-3 is a sterile 3 step application wipe kit, that when used in sequence, provides deactivation, decontamination, and disinfection/cleaning of sterile compounding surfaces from most hazardous drugs. WipeDown 1-2-3 satisfies both USP compounding sterile preparations and USP hazardous drugs – handling in healthcare settings.
Each Sterile WipeDown 1-2-3 kit includes:

  • Packet #1 – HYPO-CHLOR®, 5.25% Sodium Hypochlorite for deactivation
  • Packet #2 – THIO-WIPE, 2% USP Thiosulfate for decontamination
  • Packet #3 – ALCOH-WIPE®, 70% USP Isopropyl Alcohol for disinfecting/cleaning

Surface sampling for equipment used for preparing sterile HDs

USP Chapter <800> HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS is organized into the following main sections:

  1. Introduction and Scope
  2. List of Hazardous Drugs
  3. Types of Exposure
  4. Responsibilities of Personnel Handling Hazardous Drugs
  5. Facilities and Engineering Controls
  6. Environmental Quality and Control
  7. Personal Protective Equipment
  8. Hazard Communication Program
  9. Personnel Training
  10. Receiving
  11. Labeling, Packaging, Transport, and Disposal
  12. Dispensing Final Dosage Forms
  13. Compounding
  14. Administering
  15. Deactivating, Decontaminating, Cleaning, and Disinfecting
  16. Spill Control
  17. Documentation and Standard Operating Procedures
  18. Medical Surveillance

And of course the glossary and appendices.

Section 6 – Environmental Quality and Control covers wipe sampling for HD surfaces. According to Section 6, wipe sampling of HD surfaces should be performed initially to establish a baseline/benchmark and then at least every 6 months, or more often as needed, to verify containment.

Areas that should be sampled include:

  • Interior of the C-PEC and equipment contained in it
  • Pass-through chambers
  • Surfaces in staging or work areas near the C-PEC
  • Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area)
  • Areas immediately outside the HD buffer room or the C-SCA
  • Patient administration areas

Emphasis is mine.

For the interior of C-PECs and equipment contained in it, that means that pharmacies using an IV robot or IV workflow management system (IVWMS) for sterile HD compounding must sample inside the robot as well as all the hardware tied to the IVWMS. This includes cameras, scales, barcode scanners, and even touchscreen computers both inside and adjacent to the hood. I don’t think most pharmacies are doing this.

As far as pass-through chambers go, this includes refrigerators and dual-sided carousels attached to HD compounding areas. Again, I don’t think most pharmacies are doing this.

There is currently no standard for acceptable limits for HD surface contamination. However, USP <800> lists the following common marker HDs that can be assayed: cyclophosphamide, ifosfamide, methotrexate, fluorouracil, and platinum-containing drugs. I don’t think I’ve ever been in a hospital pharmacy larger than 100 beds that doesn’t have a patient receiving at least one of thsse drugs.

If any measurable contamination is found, the facility must identify, document, contain the cause of contamination, and come up with a way to fix it, which may include something as simple as re-evaluating work practices, re-training personnel, performing thorough deactivation, decontamination, and cleaning, or something as difficult as improving engineering controls, i.e. hoods and buffer rooms.

So remember folks, make sure you’re performing appropriate surface sampling on your technology in and around your hoods.

USP Chapter <800> Terminology

USP <800> Hazardous Drugs – Handling In Healthcare Settings introduces not only new rules around hazardous drug compounding, but some new terminology/vocabulary as well. Most of the terminology doesn’t address unique items, but rather how items are described when handling hazardous drugs (HDs).

USP Chapter <800> refers to “containment” primary and secondary engineering controls (C-PECs and C-SECs). Think of C-PECs and C-SECs as the USP Chapter <800> equivalent of PECs and SECs found in USP Chapter <797>.

C-PECs are commonly referred to as “hoods” and C-SECs are synonymous with “buffer area” or “buffer room”. Simply put, C-SECs are the rooms where C-PECs must be placed to perform sterile HD compounding.

USP Chapter <800> introduces the concept of a containment segregated compounding are (C-SCA), which is an area where limitations are placed on compounding, such as what type of HD compounding may take place as well as maximum BUDs allowed.

As USP Chapter <800> covers nonsterile HD compounding as well as sterile compounding, most of you may not be familiar with the concept of a Containment Ventilated Enclosure (CVE).

When discussing USP Chapter <800> it’s important that we’re all on the same page. Sometimes new terminology can create confusion, so I recommend you educate yourself sooner rather than later.

Summary: 
C-PEC (Containment Primary Engineering Control) - A ventilated device designed and operated to minimize worker and environmental exposure to HDs by controlling emissions of airborne contaminants

C-SEC (Containment Secondary Engineering Control) - The C-SEC is the room in which the C-PEC is placed. It incorporates specific design and operational parameters required to contain the potential hazard within the compounding room, e.g., restricted access, barriers, special construction technique, ventilation, and room pressurization are components of the secondary control strategy

C-SCA (Containment Segregated Compounding Area) - A type of C-SEC with nominal airflow and room pressurization requirements related to HD compounding. HD compounding in the C-SA is limited for use with a BSC when preparing low- or medium-risk level CSPs with 12-hour or less BUDs, preparing CSPs in a CACI that meets <797> requirements, or preparing non-sterile HDs in a C-PEC.

CVE (Containment Ventilated Enclosure) - A full of partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants (through HEPA filtration) and prevent their release into the work environment.

Containment Supplemental Engineering Control - Containment Supplemental Engineering Control basically refers to  closed system drug-transfer devices (CSTDs*) and provide adjunct controls to offer an additional level of protection during compounding or administration.

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*A closed system drug-transfer device (CSTD) is a device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. There’s still quite a bit of controversy around the definition of these devices.

JerryFahrni.com Podcast | Episode 12: Pharmacy IV room discussion with Ray Vrabel, PharmD

Show Notes:
Host: Jerry Fahnri, Pharm.D.

Jerry and Ray talk about the pharmacy IV room, specifically where we’ve been, where we’re at, and where we’re headed. Topics include workflow, the impact of USP <797> on pharmacy iv room operations, and thoughts on currently available iv workflow management system technologies.

You can learn more about Ray at his LinkedIn Profile here.

Items discussed in podcast:
Current setup:
Blue Microphones Yeti USB Microphone – Blackout Edition
Dragonpad Pop Filter
Sony MDR-V150 Headphones

CPhA releases statement on USP <800> and pending California regulation

CPhA recently sent out an alert notifying members of upcoming California State Board of Pharmacy adoption of USP <800> guidelines. You can read about it here.

California isn’t planning to adopt the entirety of USP <800>, but what they have decided to adopt will become enforceable on January 1, 2017. “The proposed California BOP regulations adopt certain requirements for engineering controls consistent with USP <800>, but the regulations do not adopt USP<800> in its entirety.  Specifically, the new regulations only apply to antineoplastic agents identified by NIOSH as hazardous.“ That’s interesting. I wish they’d just adopt the whole thing and get it over with. This is going to create a lot of confusion, especially with the proposed date of January 1, 2017. As it stands now, USP <800> isn’t supposed to be enforceable until July of 2018. Guess California has other plans.

However, it’s not all bad. Pharmacies can apply for an exemption if the meet the necessary requirements. From the alert: “… [this is] particularly concerning for compounding pharmacies because the proposed regulations have an effective date of January 1, 2017.  As explained in further detail below, pharmacies compounding hazardous drugs will not be required to comply with the USP <800> provisions on January 1, 2017 … The BOP regulations have a proposed effective date of January 1, 2017, but the BOP included a process for pharmacies to apply for a waiver from the above requirements when compliance requires physical construction or alteration and the pharmacy needs additional time beyond the implementation date to complete the upgrades.  The BOP will require that good cause be demonstrated and it is recommended that pharmacies compounding hazardous drugs develop a plan and begin implementing steps necessary to come into compliance with the above BOP requirements“. There’s always a loophole in there somewhere. So if you have to do construction or any major renovations to comply with USP <800>, you have a bit of a reprieve. Just make sure you apply for the waver.

People are going to be scrambling.