THE PCCA BLOG

USP 800: Is It Enforceable?

Wed, 10 Jan 2024 22:42:05 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services

Sections of the United States Pharmacopeia (USP) that don’t get enough attention are the General Notices. USP General Notices describe how the USP works. For example, this particular notice has shaped the applicability of USP 800:

“Applicable general chapters” means general chapters numbered below 1000 or above 2000 that are made applicable to an article through reference in General Notices, a monograph, or another applicable general chapter numbered below 1000.¹

Until recently, USP 800 was an official chapter within USP but wasn’t considered “compendially applicable” because it wasn’t referenced in the General Notices, a monograph or another applicable general chapter numbered below 1000. However, on November 1, 2023, revisions to USP Chapter 795 and Chapter 797 became official. USP 795 and 797 are applicable general chapters that reference USP 800, which make USP 800 compendially applicable and potentially enforceable.

To determine if USP 800 is enforceable in your practice, you need to know which state or states your pharmacy is licensed in and know the related state board of pharmacy requirements. In my review of state regulations, more than 30 states have language generally requiring compliance with USP when compounding. This general language would require compliance with USP 795, 797 and 800.

Alternatively, some states are not allowed to adopt items by reference in their regulations. In other words, some states cannot simply say, “Follow USP,” but are required to write their own regulations. Some of those states write regulations that closely mirror USP chapters, but those state regulations may differ from USP. A few states have requirements that are more stringent than USP 795, 797 and 800. Other states are still considering USP 800 and will make their decisions at some point in the future. Several states have also delayed enforcement of USP 795, 797 and 800 for one to two years.

A few resources may help you understand where your state board of pharmacy is on these topics, such as state board of pharmacy websites, newsletters and the “law book” of each state. Calling a state board of pharmacy or inspectors for information — notably with mixed results — may produce a productive result. Another resource available to members of the Alliance for Pharmacy Compounding (APC) is their Compilation of State-Adopted USP 795, 797 and 800 Rules. Please note that use of this resource requires APC membership.

If you’ve researched the potential enforcement of USP 800 where your pharmacy is licensed and found that it’s not currently being enforced, you may think that nothing needs to be done when compounding hazardous drugs. However, the FDA does.

The FDA releases its thoughts on a variety of topics through what they call guidance documents. The preface in the agency’s Guidance for Industry, Insanitary Conditions at Compounding Facilities states:

This guidance represents the current thinking of the Food and Drug Administration (FDA or the Agency) on this topic. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.

The guidance initially says that it’s not binding on the FDA or the public — which might make you think it’s not important — to the contrary, that guidance is a critical resource for understanding FDA’s thoughts and expectations during the agency’s inspections of compounding facilities, independent of whether or not any particular USP chapters are enforced by the state board of pharmacy. The guidance specifically calls out the handling of hazardous drugs, including sensitizing or highly potent drugs:

Handling bulk drug substances or drug products that are hazardous, sensitizing, or highly potent (e.g., hormones) with inadequate controls to prevent cross-contamination. This includes:

inadequate dedication, segregation, and containment (e.g., a powder-containment hood) of a suite, room, or piece of equipment based on risk;
inadequate cleaning of rooms, work surfaces, and equipment (e.g., utensils), including spills;
inadequate segregation of HVAC systems (as appropriate for the operation); and
inadequate control over the movement of personnel and materials.

Other federal agencies, including the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH), are involved in protecting compounding pharmacy staff from potential exposure to hazardous drugs.

USP 800 may or may not be enforced by your board or boards of pharmacy, despite being an official chapter that is now compendially applicable within the USP. Regardless of a board of pharmacy’s position, the FDA, OSHA and NIOSH are interested in preventing the potential for cross-contamination of hazardous, sensitizing and highly potent drugs on patients and compounding pharmacy staff.

The FDA rarely, if ever, references a USP chapter in inspection reports for compounding pharmacies. The state’s position on USP 800 does not affect the FDA’s approach to preventing insanitary conditions from existing in compounding facilities. Nor does the state’s position affect OSHA regulations.

Members with clinical services access may contact our Clinical Services team for help with compounding sterile and nonsterile formulations in compliance with USP Chapters 795, 797, 800 and the FDA’s Insanitary Conditions Guidance, as well as other compounding concerns.

References

United States Pharmacopeia. Online Subscription Required.

Modular Compounding Cleanroom 101

Wed, 18 Jan 2023 18:26:42 GMT

by Matt Martin, PharmD, BCSCP, PCCA Director of Clinical Services and Mike DeLisio, PCCA North American Sales Director

If you're thinking of integrating compounding services into your pharmacy, are new to compounding or are a seasoned professional who’s looking to expand, it's important to know regulatory standards are changing the compounding environment. Modular cleanrooms are a great way to implement or expand existing cleanrooms and address the ever-evolving compounding pharmacy regulations and standards.

Advantages of choosing a modular compounding cleanroom include:

Lower costs
Greater customization & flexibility
Can be built adjacent to existing walls within pharmacy lab
Shorter build time
Easier to clean and maintain pressure
Reduces risk of insanitary conditions related to appropriate materials of construction
Less “down” time
Easier to supply air and exhaust air if required
Fewer disruptions for pharmacy & customers

What is a modular cleanroom?

Generally speaking, a modular cleanroom provides a dedicated space for compounding medicines within an enclosed environment. Its purpose is to help prevent compounded medications from potential contaminants and protect compounders from potentially harmful chemicals (hazardous materials) when appropriate controls are included in the design of the room. As such, a compounding cleanroom requires a well-sealed area using non-porous, powder coated materials that won’t harbor chemicals or microbes.

Modular cleanrooms are built using prefabricated materials. Given the increased regulatory focus on maintaining sanitary conditions in cleanroom environments, materials used in prefabricated constructions must be able to sustain routine exposure to harsh cleaning, sanitizing, decontaminating, or sporicidal solutions, which can easily degrade walls, doors, ceilings, and floors when they are not made from suitable materials.

Careful consideration should also be given to the cleanroom’s design, which directly impacts staff efficiency and efficacy of meeting cleaning standards. For example, walls, floors and ceilings designed with rounded or coved corners are much easier to clean than those with angular corners. Ceilings designed with a T-grid system with removable vinyl coated panels are easily sanitized and help safeguard against hidden microbes and other potential contaminants.

The type of compounding performed by your pharmacy will determine the types and levels of controls needed in the cleanroom:

A cleanroom used to compound non-sterile preparations (CNSP, USP 795) require the fewest controls;
A cleanroom used for CNSP using hazardous materials (USP 795 + USP 800) increases controls;
A cleanroom used to compound sterile preparations (CSP, USP 797) adds significant controls;
A cleanroom used for CSP using hazardous materials (USP 797 + USP 800) need maximum controls.

Additional Considerations

On November 1, 2022, the United States Pharmacopeia (USP) published revisions to General Chapter 795, Pharmaceutical Compounding — Nonsterile Preparations (CNSPs), will be official and possibly enforceable in your state on November 1, 2023. The date also triggers potential enforcement of USP 800, which addresses CNSPs and CSPs using hazardous drugs.

USP 795 revisions define minimum schedules for cleaning and sanitizing nonsterile compounding area surfaces. Cleaning and sanitizing procedures also changed in Chapter 797 revisions, including environmental monitoring and cleaning processes for specific categories of compounded sterile preparations. The FDA also focuses on the quality of the compounding environment for both CNSPs and CSPs in their guidance, Insanitary Conditions at Compounding Facilities .

Cleanroom Providers

Given regulatory oversight and complexities, it’s vital to partner with an experienced and reputable cleanroom provider with:

Knowledge of regulatory & compounding industry standards
Recommendations to improve pharmacy workflow & minimize patient inconvenience
Experience in modular compound cleanroom installation for type(s) of compounding
Guidance and support throughout the build process
1. Immediate notification of delays in cleanroom construction materials or build time
2. Previous customer experience (i.e., testimonials, peer organizations, peer collaboration)
3. Foremen and installation crews familiar with all wall-system components & trained from A to Z to install modular compounding cleanrooms

Initial Steps

Decide type(s) of compounding service(s) your pharmacy will offer (including lab expansion)
Become familiar with USP Minimum Standards
1. USP 795 sets minimum standards for non-sterile compounded preparations
2. USP 797 sets minimum standards for sterile compounded preparations
3. USP 800 sets minimum standards for compounding preparations with hazardous materials
Contact your state board of pharmacy to learn state board requirements
Become familiar with FDA guidance

Helpful Resources

PCCA partnered with ISO 9001 certified Nicos to deliver seamless cleanroom design with expert support that exceed USP minimum standards. Learn more here.

Look for our forthcoming four-part Blog series on USP 795, 797 and 800 Revisions & Impacts, scheduled to begin February 13.

For those looking for USP implementation training, we partnered with the Alliance for Pharmacy Compounding (APC) to provide courses on quality, compliance and regulatory requirements.

PCCA offers additional resources to our members, including eLearning Compounding Training and multiple online webinars and training sessions . Members with Clinical Services may also contact our Clinical Services team for help with formulas and other compounding concerns.

The Top 5 Blog Posts of 2019

Wed, 11 Dec 2019 16:29:00 GMT

By PCCA

And just like that, The PCCA Blog is closing its first full calendar year in the world. Between January and November of 2019, we published 71 blog posts and attracted tens of thousands of readers just like you, many of whom have subscribed as well. Thank you to all of our readers and subscribers for making it a wonderful year. We’re grateful to be able to produce content that professionals in the pharmacy compounding industry find valuable. Below are some of our top-performing posts of the year, reflecting some of the biggest changes that our area of health care is experiencing along with the ever-present need for research-based clinical information.

1. Notable Changes in the New USP <795>
Even though implementation of the new USP General Chapter <795> has been delayed due to appeals, it is still crucial to have a full and nuanced understanding of it. In this post, PCCA Clinical Compounding Pharmacist Matt Martin, PharmD, addresses notable changes to the new USP guidelines and provides some considerations for implementation.

2. An Innovative Option for Hirsutism: Topical Metformin
Clinically, hirsutism “refers to women with excess growth of stiff, pigmented hair (known as ‘terminal hair’) in a male pattern,” explains PCCA Clinical Compounding Pharmacist Sara Hover, RPh, FAARM. But she has exciting news about a potential option for women with hirsutism as well.

3. Oral vs. Topical Estrogen: What the Literature Is Showing about Health Risk
Compounded bioidentical hormone replacement therapy (BHRT) is an important treatment option for women around the world. Colleagues and patients alike come to experts like Pamela Smith, Nat Jones and Sara Hover for guidance. In this two-part post, they cover this all-too-important topic in the BHRT conversation, showing what current literature says about the usage of oral vs. topical estrogen.

4. Upcoming Changes to PCCA Formulas per the New USP <795>, <797> and <800>
The new and revised USP chapters affect many aspects of compounding, including formulas. In this post, PCCA Director of Formulation Development Melissa Merrell Rhoads, PharmD, details the updates we’re planning to make to our formulas based on the new USP guidelines. Pro tip: Look at the types of updates we’re going to make to our formulas as a guide for changes you should consider in your own.

5. Notable Changes in the New USP <797>
The new USP General Chapter <797> implementation is delayed because of appeals just like USP <795>, and that gives compounders more time to become familiar with it. Let Dylan Herr, RA/QA Development Manager at Eagle, help with that. She understands that this version makes significant revisions to the old one, and in this post, she provides you with an overview of those changes and strategies for implementing them.

We’re hard at work planning more content for 2020 that we hope will help you serve patients and grow your business, so keep an eye on The PCCA Blog. If you like what you see, consider subscribing. We’ll send you email notifications when we publish new posts. And if you’re already a subscriber, sit back and relax. We’ll be in touch.

Upcoming Changes to PCCA Formulas per the New USP <795>, <797> and <800> (Part Two)

Wed, 06 Nov 2019 14:52:00 GMT

By Melissa Merrell Rhoads, PharmD, PCCA Director of Formulation Development

As I wrote in the first part of this article, on June 1, 2019, the United States Pharmacopeial Convention published revisions to the compounding Chapters <795> and <797> in the United States Pharmacopeia and National Formulary, which were set to become official on December 1. However, USP later announced that they would postpone that official date because of pending appeals to certain parts of the revised chapters. The revisions in USP <795> and <797> affect the beyond-use date (BUD) that can be applied to compounded formulations, among other standards.

Even though the date when the revised chapters become official is postponed, our Formulation Development department is working on updates to our formulas to be compliant with the new USP standards. We will complete these updates within our formulation database when we are notified of the new official date and contents of the Chapters <795> and <797>, and they will go into effect in our database on the day that they become official. Therefore, it will be important for PCCA members to download the latest versions of PCCA formulas after the date that the new chapters become official (which has not been announced yet), as there will be changes that should be noted and documented for master formulas.

Therefore, we wanted to announce what these future changes will look like. Below is a summary of the formula changes based on the latest version of USP Chapter <797> as it is written currently. We will make further changes as needed based on the appeals outcome, and we will announce those changes as well.

Changes Related to USP <797>
Sterilization Procedures
Section 10 of the revised USP Chapter <797> discusses sterilization and depyrogenation for compounded sterile preparations (CSPs). The method of sterilization plays a role in establishing the BUD for CSPs. The chapter establishes two categories for CSPs: aseptically processed, which are sterilized by filtration, and terminally sterilized, which are sterilized by steam heat (autoclaving) or dry heat. We will update PCCA formulas to reflect these compounding processes and provide specific instructions to render the preparations sterile.

BUDs
Section 14 of USP Chapter <797> discusses the parameters for establishing BUDs for CSPs. Table 11 of the chapter covers the parameters in detail, but the BUDs are based primarily on factors that affect the achievement and maintenance of sterility (risk of microbial contamination). The chapter assumes that CSPs will remain chemically and physically stable within the container-closure systems used. Chapter <797> does not provide specific direction on chemical stability, but requires that compounders consider the chemical and physical properties of the drug and/or its formulation as well as the compatibility of the container-closure system with the finished preparation. Since establishing a BUD per these new guidelines depends on multiple factors, our sterile formulas (outside of FormulaPlus formulas) will no longer assign a specific BUD, but will rather provide the relevant guidelines for compounders to determine the maximum BUD they will be able to assign based on whether sterility testing was performed and passed and the temperature at which the preparation will be stored.

According to USP Chapter <797>, a multiple-dose CSP must additionally pass antimicrobial effectiveness testing in accordance with USP Chapter <51>. After the multiple-dose CSP is dispensed, and upon initially entering or puncturing the container for the first time, “the multiple-dose container must not be used for longer than the assigned BUD or 28 days if supported by antimicrobial effectiveness testing results (see <51>) on the CSP, whichever is shorter.” As an alternative, compounders may dispense the preparation in smaller, sealed, single-use, sterilized and depyrogenated container-closure systems.

According to the new guidelines as they are currently written in USP Chapter <797>, there are no means to extend a BUD beyond the dates listed in Table 11. However, PCCA’s data on our sterile FormulaPlus formulas is still a valuable resource. Since USP <797> does not address chemical stability, these studied formulas provide documented chemical stability and therefore ensure the chemical and physical stability of the preparation. We have 12 sterile FormulaPlus formulas, and several are bracketed studies allowing for a broad range of active ingredient concentrations. PCCA members can view these in the FormulaPlus master list.

Given the significant changes in pharmacy compounding recently, it is as important as ever to ensure that compounders comply with the latest standards. We hope that the updates we will make to our formulas when the new USP <795> and <797> become official — as well as the change we’ve implemented for compliance with USP <800> — will help them do just that. If PCCA members with Clinical Services access have questions about any of these changes, they can contact our Clinical Services department.

Melissa Merrell Rhoads, PharmD, PCCA Director of Formulation Development, received her pharmacy degree from Mercer University in Atlanta, Georgia, in 1995. She currently is involved with and oversees the development and implementation of new formulas at PCCA. She had more than six years of compounding experience with pharmacies in Georgia and Florida prior to joining the PCCA staff in 2004. Her areas of interest include women’s health, veterinary and pain management compounding.

A version of this article previously appeared in PCCA’s members-only magazine, the Apothagram. PCCA members can find a more detailed description of these formula changes in the Fall 2019 issue.

Reference
United States Pharmacopeial Convention. (2019). General chapter <797> pharmaceutical compounding — Sterile preparations. In United States pharmacopeia and national formulary (USP 42nd ed. & NF 37th ed.). Rockville, MD: United States Pharmacopeial Convention, Inc.

Upcoming Changes to PCCA Formulas per the New USP <795>, <797> and <800> (Part One)

Mon, 04 Nov 2019 15:26:00 GMT

By Melissa Merrell Rhoads, PharmD, PCCA Director of Formulation Development

On June 1, 2019, the United States Pharmacopeial Convention published revisions to the compounding Chapters <795> and <797> in the United States Pharmacopeia and National Formulary, which were set to become official on December 1. These revisions affect the beyond-use date (BUD) that can be applied to compounded formulations, among other standards. On September 23, USP announced they were postponing the official dates of the revised chapters due to pending appeals to certain revisions of both chapters. With the revised chapters becoming official at some point in the near future, our Formulation Development department is hard at work planning updates to all of our formulas to be compliant with the new USP standards. We will complete these updates within our formulation database when we are notified of the new official date and contents of the Chapters <795> and <797>, and they will go into effect in our database on the day that they become official. Therefore, it will be important for PCCA members to download the latest versions of PCCA formulas after the date that the new chapters become official (which has not been announced yet), as there will be changes that should be noted and documented for master formulas.

Even with the delay in these standards, we wanted to announce what these future changes will look like. Below is a summary of the formula changes based on the latest version of USP Chapter <795> as it is written currently. We will make further changes as needed based on the appeals outcome, and we will announce those changes as well. Since USP Chapter <800> will become official on December 1, I have also highlighted a formula change that we have already implemented for PCCA formulas that contain an ingredient designated as a hazardous drug by the National Institute for Occupational Safety and Health. In the second part of this article, I summarize the formula changes we are planning to make based on the latest version of USP <797> as it is currently written.

Changes Related to USP <795>
Updated BUDs
Section 10.3 in the revised USP Chapter <795> sets parameters to consider when establishing BUDs for compounded nonsterile preparations (CNSPs). It states, “BUDs for CNSPs should be established conservatively to ensure that the preparation maintains its required characteristics to minimize the risk of contamination or degradation.” Following the guidelines shown below, we will update the BUDs of all PCCA formulas for CNSPs (excluding FormulaPlus™ formulas, which have extended BUDs compliant with USP <795>). We will also update the storage requirements listed in the formulas to comply with the chapter.

USP <795> established the BUDs listed below based on a CNSP’s ability to maintain chemical and physical stability and suppress microbial growth. The BUDs require packaging the CNSPs in tight, light-resistant containers. USP determined the BUDs by assessing the susceptibility to microbial contamination and the potential for active ingredient degradation in a CNSP through its water activity (Aw). Reduced water activity greatly assists in active ingredient stability and the prevention of microbial growth. Therefore, USP considers preparations with water activity above 0.6 (Aw > 0.6) to be aqueous and preparations with water activity equal to or less than 0.6 (Aw ≤ 0.6) to be nonaqueous (anhydrous). As a reminder, the BUDs below were established in USP <795> as it is currently written, and they may change depending on the outcome of the pending appeals.

Maximum Default BUDs in the New USP <795>

Non-preserved aqueous dosage forms: 14 days in refrigerator
Preserved aqueous dosage forms: 35 days at controlled room temperature or in refrigerator
Nonaqueous dosage forms: 90 days at controlled room temperature or in refrigerator
Solid dosage forms: 180 days at controlled room temperature or in refrigerator

USP Chapter <795> has also provided ways to extend BUDs beyond those listed above. If the United States Pharmacopeia and National Formulary has a compounded preparation monograph for the CNSP, the BUD must not exceed the one specified in the monograph. PCCA has quite a few of these formulas documented for our members review within our formulation database. They are cross-referenced and searchable by “USP monograph.”

Another means of extending a BUD up to a maximum of 180 days is by conducting a stability study using a stability-indicating assay for the active ingredient(s), the CNSP as a whole, and the type of container-closure that will be used. Additionally, Chapter <795> states that an FDA-registered laboratory should perform an antimicrobial effectiveness test (covered in USP Chapter <51>) when extending the BUD of a CNSP. In other words, the stability study must include assays for each of the individual active ingredients within the specific compounded formula and in the specific container noted, plus USP <51> testing.

This is where PCCA’s FormulaPlus program is so valuable: We have done all of this testing for PCCA members and have published over 135 nonsterile FormulaPlus formulas with extended BUDs. Many of these are bracketed formulas that allow compounders to use the data for a broad range of active ingredient concentrations and many formula options. FormulaPlus formulas are denoted in our database with the “BUD Study” designation and the FormulaPlus Symbol. PCCA members can view the FormulaPlus master list for the complete list of FormulaPlus-studied formulas.

Adding Physical Description
Sections 7.1 and 7.2 in the revised USP Chapter <795> list requirements for master formulation records and for compounding records. One of the noted items to document is the physical description for the final CNSP. We are adding this description to our formulations to help our members with these requirements. We will add physical descriptions to the majority of our existing formulas, and these will be included in all PCCA formulas in the future.

Changes Related to USP <800>
To help PCCA members comply with the requirements established in USP General Chapter <800>, we have added a note to all PCCA formulas that use an ingredient designated as a hazardous drug by the National Institute for Occupational Safety and Health. The note indicates that one or more ingredients in the formula is designated as a hazardous drug, and it also states that USP <800> provides guidelines for handling such substances.

If PCCA members with Clinical Services access have questions about any of these changes, they can contact our Clinical Services department.

A version of this article previously appeared in PCCA’s members-only magazine, the Apothagram. PCCA members can find a more detailed description of these formula changes in the Fall 2019 issue.

Reference
United States Pharmacopeial Convention. (2019). General chapter <795> pharmaceutical compounding — Nonsterile preparations. In United States pharmacopeia and national formulary (USP 42nd ed. & NF 37th ed.). Rockville, MD: United States Pharmacopeial Convention, Inc.

New Releases on PCCA Play — August 2019

Wed, 21 Aug 2019 14:34:00 GMT

By PCCA

PCCA Play is our educational media library exclusively for members. It offers tens of thousands of dollars’ worth of educational content available on desktop, tablet or smartphone. PCCA members can also access premium content through a subscription or a la carte rental.

PCCA Play includes everything from main-stage presentations at our live events to our recorded webinars, bringing PCCA members the information they need, when and where they need it.

Now Free
Here is a video that is now free on PCCA Play.

Quality and USP <800> Implementation
This video is a combination of two presentations from the 2017 PCCA Quality Symposium. In part one, Ross Caputo, PhD, Eagle President, covers essential quality assurance elements for compounding pharmacies. In part two, Jerra Banwarth, RPh, FIACP, PCCA Education and Training Manager, discusses USP <800> risk assessment steps in detail.

New Release (at a Great Price)
This new release on PCCA Play is available for just $95.00.

USP <797> — Is Your Pharmacy Ready?
PCCA Clinical Compounding Pharmacist Matt Martin, PharmD, and Eagle Vice President of Operations Megan Jeffrey Liotta, MS, share detailed information about how the revisions to USP General Chapter <797> may affect personnel qualifications, facilities and documentation in compounding pharmacies.

Members, stay tuned to PCCA Play: We’ll release our latest webinar recording on the revised USP <795> soon!

Why PCCA Chose Nicos, and Why You Should Too

Thu, 09 May 2019 18:32:00 GMT

Part of building the world’s best support network for compounding pharmacies is finding the right people to partner with. For us at PCCA, we wanted to find a cleanroom provider that we and our customers could trust. That is why we chose to partner with the Nicos Group. When it was time to renovate our chemical repackaging facility at PCCA, after careful deliberation, we chose Nicos. We believed Nicos would build a repacking area that met FDA regulations.

They did not disappoint.

In short, we trust Nicos to deliver a beginning to end cleanroom solution for your pharmacy. We know from personal experience that you can too.

That trust makes the compounding world a better, more reliable place for compounders and their patients.

Having a cleanroom that meets the upcoming USP <800> facility requirements is essential to the long-term success of compounding pharmacies in states that adopt the guidelines. That means being informed when considering what kind of cleanroom to build, but USP <800> can get dense and confusing when it comes to design elements and layout. To address that potential issue, Eagle’s own Jeffery Gloyer wrote an article that details crucial considerations you need to know when it comes to cleanroom design. After reading Jeffery’s article, head over to our USP <800> education page to get even more answers you’re looking for. No matter your comfortability with USP <800>, you can take comfort in this — with a Nicos Group cleanroom, you will have a facility that meets all your regulatory needs.

Not only does Nicos deliver customizable, world-class cleanrooms with high quality finishes applied to all surfaces as well as fully flush and coved joints for quick and effective cleaning, they help you through the entire process, providing:

Complete project management, including design, construction, support and installation
Detailed engineering documentation
Factory-trained installation crews led by professional engineers

Partners join hands when they see that working together can build better solutions for the clients they serve. We’re proud to be partners with the Nicos Group. Not only because they provide an excellent service and product, but because they are invested in empowering pharmacies with the very best cleanroom technology in the world.

PCCA Launches New Comprehensive USP <800> Educational Page

Mon, 22 Apr 2019 18:28:27 GMT

By PCCA

PCCA is excited to announce our updated and USP <800> educational page. This page is a one-stop resource that summarizes the United States Pharmacopeia general chapter <800>, providing pharmacy owners with what they need to know in order to become compliant with the new chapter for sterile and non-sterile compounding with hazardous drugs. The page’s seamless navigation provides quick and succinct answers to questions compounders have regarding the updated guidelines. We’ve built an experience that empowers pharmacists so that they have the knowledge they need to make the right choices for their pharmacies before the chapter becomes official on December 1, 2019. The experience begins by asking three simple questions:

Does USP <800> apply to me?
Do I need a copy of the USP <800> Compounding Compendium? Where can I get it?
Where do I go for common USP <800> questions?

Answers to Your Questions
Are you looking for an overall chapter summary? We have you covered. One of the pillars of our USP <800> educational page is the comprehensive frequently asked questions (FAQ) section, addressing everything from facility regulations, C-PEC information, venting requirements and compounding processes all the way down to storage regulations. Our FAQ has the answers you are looking for when it comes to getting clarity on USP <800>.

If the FAQ sheet is not your thing, slide over to our media page. There, you will find a complete USP <800> overview video as well as a video regarding quality in pharmacy and USP <800> implementation, both featuring Matt Martin, PharmD, of PCCA Clinical Services. Along with the USP <800> videos, Matt has also curated videos that give a summation of USP chapters <795> and <797>.

Lab and Clean Room Designs
No matter if your pharmacy compounds sterile or non-sterile medications with hazardous drugs, or both, there are several requirements that each pharmacy must take into consideration when outfitting or building their lab and clean room. When it comes to PCCA’s USP <800> facility information, our educational page covers everything from flooring to countertops, storage areas and more. For pharmacy owners looking to build a new clean room, PCCA is excited to introduce our partner, the Nicos Group. Nicos provides the most advanced clean room systems in the world today, and we are proud to recommend them to any pharmacy looking to update an existing clean room facility or build an entirely new one.

If your pharmacy is planning to put together a state-of-the-art clean room that will ensure the highest quality products for your patients, make sure to check out our Nicos Clean Room overview section!

Equipment and Services
New regulations sometimes means it’s time to update your equipment. Whether you need to update your powder containment units or personal protective equipment (PPE) — or a little bit of everything — the new USP <800> page is your portal to the highest quality options.

Excellent tools are most effective when used with experience, which is why we offer consultation via Eagle. Eagle comprises the best and brightest minds in compounding, and they are here to help with compliance and even with an FDA or state board of pharmacy inspection.

The Best Resource for USP <800> Readiness
USP chapter <800> is weighing on the mind of many pharmacists in the United States, but PCCA wants to make their PCCA wants to make your pharmacy’s transitional process as smooth and as easy as possible. When it comes to getting USP <800> compliant, it is truly a “measure twice and cut once” scenario. We care deeply about your pharmacy’s success, and our USP <800> educational page is just one more way we are providing the best compounding resources in the industry.

Have a question about USP <800> compliance that we haven’t covered in our FAQ? Leave a comment below and let us know!

Important Considerations for Cleanroom Design

Wed, 20 Feb 2019 15:01:33 GMT

By Jeffery Gloyer

When designing a cleanroom, there are many aspects to take into consideration. While regulations and guidelines such as USP chapters outline the minimum requirements for cleanroom design, they do not address all important elements. Many compounding pharmacies use the requirements stated in USP chapters <797> and <800> as the template for designing their cleanroom—often at the expense of a workflow that is operationally efficient and designed to minimize contamination risk. To help compounding pharmacies stay compliant and reduce risk without sacrificing efficiency, here are some of the aspects to consider when designing a cleanroom, as well as some recommendations that we at Eagle consider best practices.

Three-Room Design

The fundamental purpose of a cleanroom is to minimize the risk of contamination of compounded sterile preparations. In order to best achieve this goal, design considerations should address the number of personnel, the movements of personnel and supplies, and the activities that need to be performed in the classified areas. When all of these considerations are taken into account, best practices for cleanroom design often become more involved than the minimum requirements prescribed by USP regulations.

For example, while USP <797> only requires an ISO 7 buffer room adjacent to an ISO 8 ante room, many pharmacies do not consider the amount of space they will need for all activities and equipment in this area. Therefore, cleanrooms don’t always have sufficient space for pre-sterilization activities, such as weighing non-sterile powders, or for the placement of equipment, such as autoclaves, convection ovens and powder-containment enclosures. We typically recommend using a three-room design, which allows the segregation of aseptic processing, pre-sterilization procedures, and handwashing and gowning activities.

When employing a three-room design, we typically recommend a buffer area and two ante rooms. The ante room that is adjacent to unclassified areas serves as a gowning room, should contain a sink for handwashing, and should be a positive-pressure ISO 7 or 8 area. This room can be shared between hazardous and non-hazardous cleanroom suites, though if it is shared with the hazardous suite, it must meet the ISO 7 classification. The second ante room can be used for prep, such as weighing of powders and sterilization or depyrogenation of supplies and compounded sterile preparations.

Finally, there is the ISO 7 buffer area that contains the ISO 5 primary engineering control, such as a laminar-airflow workstation. This room should be adequate in size to accommodate the size of the primary engineering control. It is important to carefully consider the placement of equipment and supplies in this area as well, and the impact that they have on the ISO classification and on the HEPA-filtered airflow supplied by the primary engineering control. You can see an example of three-room design in Figure 1 below.

Negative- and Positive-Pressure Areas

When designing a cleanroom suite that meets USP <800> requirements for handling hazardous drugs, it is especially important to consider the activities that personnel will perform in these areas. USP <800> requires a negative pressure ISO 7 buffer room that is adjacent to a positive pressure ISO 7 ante area. Since the buffer room will maintain negative pressure relative to the ante room, the ante room must maintain ISO 7 air quality to prevent the influx of lower quality air into the buffer room. Similarly, the ante room must be positive pressure relative to adjacent, unclassified areas in order to prevent the influx of lesser quality air into the sterile suite.

However, pharmacies must also consider where they will perform pre-sterilization weighing of hazardous APIs. Personnel must handle hazardous drugs under negative pressure, so we strongly recommend a second ante room that is under negative pressure and has a containment primary engineering control, such as a powder-containment enclosure, that can be used for weighing non-sterile ingredients. This design results in an ISO 7 buffer room that is negative pressure relative to the adjacent ISO 7 prep area, which is negative pressure relative to the ISO 7 gowning room, which is positive pressure relative to unclassified areas. Figure 1 below shows an example of this.

Figure 1. An example of a cleanroom suite that uses three-room design with appropriate negative- and positive-pressure areas.

Maintaining Sanitary Conditions
The USP chapters also do not address all design considerations that are discussed in the FDA guidance document “Insanitary Conditions at Compounding Facilities.” This guidance document describes conditions—including cleanroom design elements—observed at compounding facilities that the FDA considers to be insanitary. Regardless of whether a facility qualifies for 503A or 503B exemptions from federal requirements, if they prepare compounded drugs under conditions that the FDA considers insanitary, then the compounded drugs are considered adulterated, and the facility may be subjected to regulatory actions or asked to recall their products.

Some of the insanitary conditions discussed in the FDA document that relate to cleanroom design are as follows:

Unsealed or loose ceiling tiles
Buffer rooms that contain ledges or overhangs that may collect dust
Water sources (sinks or drains) in buffer rooms, or floor drains in ante rooms
Equipment that is in close proximity to the ISO 5 primary engineering control and may affect airflow
Personnel gowning in unclassified areas
Inadequate pressure differentials between areas of higher and lower quality air
HEPA filters that are not sealed around their perimeters
HEPA air returns that are on the ceiling or located near the HEPA filter instead of near the floor
Production areas that are difficult to clean (e.g., equipment that is difficult to move or clean around, or that is particle-generating, or construction materials and surfaces that are porous, shedding or not easily cleanable)

These are just a few of the aspects that compounders should consider when designing a cleanroom facility. If you have any questions about cleanroom design, the Eagle engineering team can provide a range of consulting services. Please feel free to contact us at 800.745.8916.

Jeff Gloyer joined the Eagle team as an Engineer I in 2018. He has experience in working with multidisciplinary teams to implement the engineering design process, and he has led projects in many different sectors, including energy, automotive, semiconductor, aerospace, robotics and pharmaceutical industries. He also brings experience from working with cleanroom spaces for both the satellite and semiconductor manufacturing industries.

Pictured in banner: cleanroom facility by Nicos Group Inc. For more information about Nicos cleanrooms, contact your PCCA sales representative at 800.331.2498.

A version of this article was originally published in the winter 2019 issue of the Apothagram, PCCA’s members-only magazine

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