The USP 800 Compliance Timeline

The two most common questions I get as a consultant that specializes in the design of USP <800> compounding rooms are, “How much is it going to cost” and “How much time will it take?” The “cost” question is riddled with too many unknowns for me to answer in this blog post, so I will address the time equation. I recently presented on the topic of “Building a Plan for Compliance” at the American College of Apothecaries (ACA) annual conference in Florida and will also give a similar variation of this presentation again at Compounders on Capitol Hill (CCH) in June in Washington D.C. It’s such an interesting question that I knew it deserved a quick blog post for those of you not traveling to conferences this season.

After working through quite a few USP <800> design projects I decided to build a GANNT chart that itemizes a fairly comprehensive list of the intricate tasks needed for USP <800> compliance.  A GANNT chart is a very useful project management tool that lists project tasks and estimates/tracks time. GANNT charts are commonly used in the construction and engineering industry and certainly applicable for our USP <800> compliance project. It’s such a simple and effective tool I wanted to share it with everyone, so you can download it HERE.

Pharmacists are busy people and a lot of you are also entrepreneurs, just trying to find enough time to run the business day after day. On any given day you wear different hats that include tasks like patient consults, accounts payable, accounts receivable, human resources (a multifaceted animal), etc., so who has time to manage a seemingly overwhelming compliance project? My goal for the past three years as a consultant has been to help demystify some of this compliance stuff and so I encourage you to download the GANNT chart and start taking bites out of the proverbial elephant. Trust me, the best way to accomplish USP <800> compliance is in small manageable bites.

Let’s just walk through a couple of the main issues involved in the USP <800> compliance project and assigned timelines. The reason why I want to do this is to help you understand that the additional seventeen-month time extension for compliance, which was originally June 2018, is now December 2019. The time extension is one that we should take advantage of! Based on historical information I can tell you that the absolute minimum time you should anticipate for completing total USP <800> compliance is seven months. There has only been one exception to the rule that I know of and that project was completed in six months, but already had a great deal of the engineering infrastructure in place. Additionally, that pharmacy hired consultants to write the hazardous drug standard operating procedures (SOPs). However, for the sake of this conversation we should assume that your facility is not already equipped with all the conveniences that aforementioned pharmacy had and that we are starting your project somewhat from scratch.

• The first task on the GANNT chart is “design consulting”. During this 6 to 10-week phase we start looking at your facility layout and how we can dedicate a separate space specifically to hazardous drug handling. Do we divide a current compounding room by simply adding a wall and additional plumbing? Do we take over another space like an unused office or reallocate the storage room somewhere else because the proximity to existing plumbing? How much air do we need and what engineering controls are necessary to achieve negative pressure? Since there are quite a few unknowns during this design consulting phase we may also have conversations with your team that include a local general contractor (GC), and/or HVAC contractor, and/or architect engineering firm. Only about half of the projects we design have a contracting team already involved during this design-consulting phase. If not, no big deal because based on this linear process of communication we conclude the design phase with some drawings and construction specifications for the GC and/or architect and/or others involved so we can get everyone talking the same language and moving in the same direction. Setting the collaborative direction for the contracting team sets a path forward for establishing a budget, which is the original question we couldn’t specifically answer in this blog being, “How much is this going to cost?”

There are other tasks defined on the GANNT chart, like writing HD SOPs and the hazardous communication program, and employee training modules, that run at a somewhat linear and overlapping pace with the design/construction phase timeline.  Setting the wheels in motion for the defined tasks will create a positive momentum. The key is to create action and the GANNT chart will definitely help with accountability and progress.

• After the design-consulting phase there is a solid plan that sets the foundation for the hard parts, mostly planning and construction. Hopefully you already have a relationship with a local general contractor and/or HVAC contractor. If not, then I recommend you reach out to your network of friends and other business professionals (e.g. your accountant, your mechanic, your neighbor, etc.) and ask for recommendations. The construction business has forever operated on “referrals” and this is a good place to start.  Once you have established a local general contractor, you might discover based on local building rules that you will need to apply for a building permit. Sometimes applying for a building permit requires a set of drawings, which may incur you to find a local architect.

There is so much more we can say about the process but as you can see there are quite a few moving parts to coordinate. Please don’t let that overwhelm you to a point where you hind in inaction. The takeaway from this short blog is to follow the GANNT and set the process in motion. There may be other pieces that aren’t specifically called out on the GANNT that you find you have to deal with. In that case, set a task and timeline and stick to the process. USP <800> planning doesn’t have to seem overwhelming if you manage it properly and in small manageable pieces. If we can be of further help along your journey, don’t hesitate to reach out and ask. We are here to help!

 

Bryan Prince

Bryan.prince@encoresci.com

800-454-2304

Schedule a FREE 30-minute consultation here.