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Made effective in 2019, USP 800 introduces multiple new requirements for pharmacies. Introducing multiple new requirements for pharmacies, the new legislation is intended to protect pharmacists, nurses, pharmacy technicians, and others from the potential carcinogenic and teratogenic effects of hazard drugs (HDs).
Your business is to develop and deliver safe and effective pharmaceuticals to the marketplace. Our business is to provide you with durable, hygienic interior finishes that will support your work.
Protect your personnel with a safer environment to handle chemotherapy medications and other hazardous drugs by achieving USP 797 + USP 800 compliance with Altro’s hygienic floor and wall system.
If you act last-minute to comply with the new legislation, you risk a slew of disruptive effects, including increased costs, inopportune facility downtime, federal litigation, and more. Minimize your risk by taking early, proactive steps to be compliant with USP 800.
Standards for compounding sterile preparations help promote patient safety and prevent harm
USP (United States Pharmacopeia) 797 is a comprehensive regulation applying to institutions within healthcare and pharmaceutical industries where sterile compounds are prepared, stored and dispensed. The purpose of the regulation is to prevent infections in patients using pharmaceutical products, as well as to protect pharmacy staff members that are ordinarily exposed to pharmaceutical products.
The legislation affects facilities in which sterile products are prepared or compounded according to the manufacturer’s labeling and instructions.
Typical facilities affected by USP 797
Requirements of floors and walls
Areas must meet a range of ISO Cleanroom compliance for the area they will be installed
Information, updates and resources for the safe handling of hazardous drugs
In March of 2014 the United States Pharmacopeial Convention proposed new general chapter referred to as USP 800. This new chapter applies to all personnel that compound hazardous drug (HD) preparations, as well as all places where hazardous drugs are prepared, stored, transported and administered in order to protect healthcare workers, patients and the environment.
In the nearly two years since its initial publication in draft form, USP 800 has undergone periods of public comment and revision. Following these revisions, the chapter was approved and became effective for compounding and pharmaceutical facilities in 2019.
Due to provisions, USP 800 is being legally enforceable and may subject pharmacies to both state board and FDA inspections.
This means facilities must comply with the requirements of USP 800 or they risk being shut down until these standards are met.
Path to compliance
Whether you’re looking to build a cleanroom or a negative-pressure compounding area, Altro can help. Altro manufactures products that can help facilities achieve USP 800 compliance.
We offer a floor and wall solution that is seamless, non-shedding, and heat-weldable. Our solution offers the right amount of hygiene and performance and is well suited for USP regulated facilities.
Floors and walls in clean facilities are constantly exposed to a barrage of aggressive chemicals. Surfaces see everything from decontaminants to germicidal cleaners and disinfectants. It is important your facility is furnished with materials that will stand up to these powerful agents.
We have tested our floor and wall products against many of the commonly used chemicals: such as sodium hypochlorite, phenolic disinfectants, and germicidal cleaners like Preempt and Simple Green D. You’ll see the results here. For a full report, please visit our website.
Even with this, it is still very important that maintenance teams are well educated on how to properly care for the floor and walls in a facility.
Steps to reduce staining
