By Matt Martin, PharmD, PCCA Clinical Compounding Pharmacist

Are you done remodeling for USP <800>? Have you started? What is your board of pharmacy’s stance on it? What about other states you’re licensed in? How about the FDA’s take on USP <800>? How many times have you read the chapter? Do you have a full and nuanced understanding of it? Do you have questions about what it means to be compliant with various parts of the chapter? Have you selected the equipment you will need? Are you certain that the contractors you are working with have the appropriate knowledge of working with health care facilities and can build out or remodel your facility to the appropriate specifications? Do you have appropriate personal protective equipment lined up?

Is your pulse racing or sweat forming on your forehead as you read this list of questions? Let’s start with some basics.

Know Your Regulators

USP General Chapter <800> is scheduled to become official in the United States Pharmacopeia on December 1, 2019, along with substantially revised versions of General Chapters <795> and <797>. It is a busy year for changes to the guidelines provided by USP.

When USP chapters under <1000> become official, they can be enforced, but this is up to each regulatory entity that would have a role in enforcement. The United States Pharmacopeial Convention is not a regulatory body and does not enforce USP chapters. However, state boards of pharmacy are regulators and may enforce USP chapters. The state boards are making a range of choices about USP <800>, from rejecting it, to enforcing parts of it, to adopting all of it and expecting full compliance by December 1, 2019. If you don’t know what your state is doing, call your board of pharmacy and ask. You may also be able to reach out to your state’s pharmacists association to see what it knows about USP <800> enforcement in your state.

“The state boards are making a range of choices about USP <800>, from rejecting it, to enforcing parts of it, to adopting all of it and expecting full compliance by December 1, 2019.”

Beyond the boards of pharmacy, there are questions about what the FDA may do in regards to their inspections of pharmacies once USP <800> becomes official. As of the date of this publication, the FDA has not taken any official position on USP <800> and how they may use it in their inspections of pharmacies.

Read It, and Read It, and Read It

If you haven’t been reading up on USP <800>, you’re behind, but there’s no time like the present, so go get your copy from USP and start reading. You can access it for free . Seriously, after you’re done with this article, go get the chapter and read it several times. As you do, make sure to highlight the words “should” and “shall” in the document. When it comes to USP chapters, a “should” is a recommendation and a “shall” is a requirement.

Once you’ve been through it several times, you will likely have questions. USP has a webpage dedicated to frequently asked questions (FAQs) about this chapter. PCCA also has resources on our dedicated USP <800> page. PCCA members with Clinical Services access can also send their questions to the Clinical Services team here at PCCA so that we can discuss them.

“When it comes to USP chapters, a ‘should’ is a recommendation and a ‘shall’ is a requirement.”

Interpreting the Chapter

USP <800> defines hazardous drugs (HDs) as those on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016 . The NIOSH list divides hazardous drugs into different groups based on their classification.

One of the questions that has been raised at various conferences is whether or not USP <800> allows you to perform a risk assessment for NIOSH Group 2 and 3 APIs, and whether this excludes them from being required to be compounded in a negative pressure room. This is based on question 18 from the USP’s Chapter <800> FAQ. The question is, “Can the reconstitution, mixing, and diluting of Group 2 and 3 HDs on the NIOSH list be performed under an assessment of risk?” The answer USP provides is, “Yes. The reconstitution, mixing, and dilution of dosage forms of Group 2 and 3 HDs may be considered under an assessment of risk.”¹

Some take this to mean that they do not have to compound drugs in Groups 2 and 3 in a negative pressure room. However, I would note that when USP <800> discusses an “API,” it is referring to raw materials or chemicals used as active ingredients. Box 1 on page 2 of the chapter states that “any HD API” or “any antineoplastic requiring HD manipulation” on the NIOSH list must follow the requirements of USP <800>.² Based on this, all hazardous drug chemicals must follow the requirements of USP <800>, including the manipulation within a negative pressure room. Therefore, the statements as written do not allow an assessment of risk for Group 2 and 3 active pharmaceutical ingredients because the chapter states explicitly that “any HD API” on the NIOSH list must follow the requirements of USP <800>.

“Box 1 on page 2 of the chapter states that ‘any HD API’ or ‘any antineoplastic requiring HD manipulation’ on the NIOSH list must follow the requirements of USP <800>.²”

Start with the Right Plan

Pharmacies working with contractors in their area are finding wide variance in the proposals they are being provided to build “appropriate” facilities. The only thing worse than remodeling or building a facility is the opportunity to do it a second time if it isn’t done right the first time. This will likely prove even more costly than doing it correctly at first.

This is why Eagle has two engineers on staff who have been working with pharmacies ranging from a review of their build-out plans all the way up to managing their entire remodel or construction project. Would you like to have an experienced engineer talk about your plans directly with your chosen contractor? Jeff Gloyer and Chris Trotter are engineers at Eagle and can be a part of your team to help get your facility ready for USP <800> compliance. I would highly recommend using the services of these engineers. Eagle has also made this offering customizable on an hourly basis, so you can consult their engineers as much as you need without committing to a required minimum number of hours. Much the same as we would advocate for patients and prescribers to use pharmacists as the medication experts, I would encourage you to use the engineers at Eagle in the design of your remodel or new construction.

“The only thing worse than remodeling or building a facility is the opportunity to do it a second time if it isn’t done right the first time.”

As you work on your journey to USP <800> compliance, PCCA and Eagle stand ready to help you answer your questions, select appropriate equipment and PPE, and partner with you to aid in the design and execution of your remodel or new construction. PCCA members with Clinical Services access can call our Clinical Services team at 800.331.2498, and any compounding pharmacy can contact Eagle at 800.745.8916.

PCCA offers compounding pharmacies exclusive access to customizable, world-class cleanrooms by Nicos Group. For more information about Nicos cleanrooms, contact us at 800.331.2498.

Matt Martin , PharmD, is a Clinical Compounding Pharmacist at PCCA. He joined the PCCA Clinical Services department in September 2014. Matt graduated from Morehead State University with a BS in Chemistry in 2002, and received his PharmD from the University of Kentucky College of Pharmacy in 2006. Prior to joining the PCCA team, Matt worked in compounding pharmacy for more than eight years, and has experience with both sterile and non-sterile preparations.

A version of this article originally appeared in PCCA’s members-only magazine, the Apothagram.

References

1. United States Pharmacopeial Convention. (2017). FAQs: <800> hazardous drugs—Handling in healthcare settings. Retrieved from http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

2. United States Pharmacopeial Convention. (2017). <800> hazardous drugs—Handling in healthcare settings. Retrieved from http://www.usp.org/usp-chapter-800-download