On June 1, 2008, USP797 became official and enforceable. But why the merger with USP800 and impending date of December 1, 2019? USP797 brought a lot of confusion and budgetary constraints to the hospital/infusion pharmacy sector. Lack of clarity and exact expectations were surrounding the industry. It was a major change for pharmacy departments to go from compounding in LAFW to Cleanroom environments. Classifications and testing were unclear. Experts began popping up on every street corner.
Just when USP797 was getting underway and most hospitals adhering to the FDA regulation, here comes USP800. What does this have to do with compounding? The industry was just getting used to cleanroom classifications, testing, and protocols of gowning. The USP decided to merge the two with a pending official date of December 1, 2019.
We know that USP797 was created to protect patients from tainted sterile compounds. But what is USP800 for? After years of research and years of discovering preventable deaths, illnesses, and impairments could have been avoided with proper gowning, handwashing, and sterile compounding techniques, USP797 was developed and enforceable. This Federal mandate was intended to protect the consumer/patients from harm.
Whereas, USP800 is soley to protect the handlers of hazardous compounds. From delivery trucks, stock personnel, compounders, nurses in infusion sites, hospital rooms with chemotherapy patients, basically any area that has shipped, stored, processed, used, contained patients with injections of hazardous compounds must test for residue. USP800 is about ensuring personnelle safety and to track the residue that is left from such hazardous compounds. It is also to validate that hazardous compounds are being processed in negative pressure cleanroom environments. Isolating the hazards from contaminating individuals and CSP's is the focus.
USP797 is to protect the patients from contamination of sterile products. USP800 is to protect the workers from hazardous compounds.
While most facilities have been doing their best to adhere to USP797, USP800 is creating a bit of frustration and uncertainty in the sector. Don't trust just any consultant or cleanroom contractor to assist you with your facility. Ensure you are dealing with a company that has extensive experience, a reputable/approachable list of previous/current clients, and current knowledge. Working with a company with these qualities will save you time, money, and stress.
By December 1, 2019 all sterile compounders must:
1. Must a cleanroom to compound sterile preparations. Positive for non-hazardous and Negative for hazardous.
2. Must certify the cleanroom bi-annually (some major hospitals are also opting to implement a continuous particle monitoring system)
3. Must conduct viable air and surface testing bi-annually (air samples will possibly be monthly with surface quarterly)
4. Must have an SOP for gowning and handling.
5. Must have hazardous drug residual testing bi-annually
6. Must monitor and chart daily the temperature/humidity/pressure differentials
7. Must conduct viable glove testing regularly-Must certify technicians prior to compounding and regular verification of protocol throughout the year.
8. Must have a current list of hazardous compounds.
This may seem like a lot for the industry to handle. But, it was created to enforce current good manufacturing practices. Following regulations can save lives.
Any questions and assistance with your current cleanroom needs, don't hesitate to reach Cleanetics at firstname.lastname@example.org.