Congressional Bill of the 113th Congress. H.R.3204 – Drug Quality and Security Act. “To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes.”
The fact is, no one really knows just yet what the new law will mean. However, be assured that if your group is a medium or high risk facility and produces large volumes of sterile products, you are in the crosshairs of the U.S. FDA.
H.R.3204, signed into law by the president in November 2013, gives back the power to the FDA it relinquished to the states earlier. This new law will allow the FDA to inspect sterile compounding pharmacies in the same manner pharmaceutical drug companies are inspected and reviewed by them now.
What this means for sterile compounders is increased monitoring, SOPs, tracking, and documentation of practices.
Continuously monitoring the facility’s environmental conditions is first on the list of things the FDA will require. That means the temperature, humidity, pressure, and particles in the sterile compounding area’s critical locations. Though continuous monitoring is commonplace in pharmaceutical facilities, for most pharmacies this will mean a required upgrade.
The continuous monitoring of critical sites allows for issues to be found sooner rather than later. Monitoring of the critical areas should include setting limits on the system to alarm if the conditions exceed the parameters or do not fall within the assigned range. For example, temperature and humidity spikes can spur the growth of microbial CFUs, which in turn can cause contamination in compounding products. Spikes for short periods of, say, three to four hours usually would not be considered alarming; however, longer timelines or up to a day should trigger additional monitoring of viable samples. Additional monitoring of products produced during these events could be warranted.
Room pressurization is very critical in preventing infiltration of outside contaminates from non-filtered or non-sterile cleaned areas. Even short-term failures or reverse room pressurization could cause facility contamination. Performing additional terminal cleanings, re-certification of the facility, and microbial viable air sampling could be needed to verify compliance if a failure is recorded.
Continuous particle counting in critical areas is not required under USP-797 guidelines. However, the FDA feels that non-viable particulate counting should be monitored continuously in ISO-5 clean zones. I recommend that if you are going to have FDA inspectors at your facility checking your monitoring systems, offer more as opposed to less— performing risk assessments of critical area monitoring and sharing this information with them during the inspection. Be proactive not reactive, anticipating their requests in facility design, operation, and monitoring; go farther than is required in an effort to stay ahead of the curve the FDA uses, to assess your compliance.
These continuous monitors must also have SOPs associated with them— which calls for calibration at regular intervals. The logical time frame would be during the certification of the sterile compounding facility’s environmental systems.
Be aware that your facility must register with the FDA, but it is not required. Doctors, hospitals, and other entities will be required to use only FDA-approved facilities for sterile compounding to be reimbursed by insurance companies, Medicare, or the ACA. Refusal to do what is recommended will ultimately lead to failure!
The author would like to acknowledge the contributions to this article by Courtland Imel, Ceutical Labs, Farmers Branch, Texas.
Rick Meyer is President of Superior Laboratory Services Inc. He has 35 years’ experience in the construction, design, installation, consulting, repair, certification, and maintenance of labs, cleanrooms, and filtration systems. He has designed, built, consulted, and certified over 100 USP-797 facilities since 2004. In addition, Rick has tested/certified over 2,000 cleanrooms. He is a member of six IEST working groups, including HEPA leak testing, nano facility design, nano safety, and USP-797 facility design. www.slsi.net
This article appeared in the February 2014 issue of Controlled Environments.