Is Your Mixing Pharmacy Ready for the 2018 USP Regulations?

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Most people don’t think twice about the cleanliness of the Will your pharmacy be ready for 2018?pharmacy they use. Whether it’s a chain like Walgreens or a hospital’s internal pharmacy, they take for granted that the spaces are well maintained and under strict regulations. For the most part, this is the case, but 2018 will bring stricter regulations.

To be specific, July 1, 2018 is the deadline to meet the USP 797 & 800 standard changes. It may seem far away, but, considering the time and expense of design and construction, it’s rapidly approaching.

So what are the regulations, and how can you be prepared?

Sterile, cleanroom environments are essential for mixing drugs properly, and as the pharmaceutical industry advances, a lot of pharmacies are doing this in-house and without much regulation. These new mandates change that. To comply, any pharmacy that mixes drugs will need a cleanroom with pressures and anti-contamination measures. Essentially, ISO 14644 standards used for other cleanrooms will be applied to pharmacies, and mixing pharmacies must comply with the USP 797 and 800 standards.

If a new pharmacy is being constructed, it’s relatively easy to incorporate these changes into the design. If a standing pharmacy needs to be updated, that can be more difficult.

No matter your situation, Synergy can help. We can step in during the design phase of your project, give you a construction quote, and help you meet your Owner Project Requirements. Or we can help you navigate remodeling by conducting design reviews and onsite commissioning.

New regulations can be a pain in the neck to implement, but we can make it easier. July 1st, 2018 is the deadline. Will your pharmacy be ready?

Contact us today to find out how we can help you get compliance ready!