New Comprehensive USP <800> NIOSH Packaging Program
Letco implemented a new packaging program on July 1, 2019, to help compounding pharmacies comply with USP guidelines for receiving and unpacking products on the NIOSH hazardous drugs list.
Under Letco’s new packaging program, when a pharmacy orders chemicals on the NIOSH hazardous drug list, those products are separated and placed into an impermeable sealed bag to easily segregate and identify them upon receipt. A round purple sticker along with a packing slip is affixed to the outside of the package, both indicating NIOSH products are inside. These visual indicators quickly communicate to the pharmacy the need to follow their standard operating procedures for receiving and handling hazardous drugs (in compliance with USP ) to reduce the risk of airborne contamination.
Letco implemented these shipping enhancements well in advance of the December 2019 USP <800> deadline to provide pharmacies the opportunity to adjust or develop their own standard operating procedures before the new regulations take effect.
Gabe Peluso - Letco's Vice President, OperationsCompounding pharmacies now have peace of mind knowing we’ve taken extra steps to make it easy to receive, identify, and safely unpack shipments containing NIOSH-listed products. This is yet another example of how Letco provides value to our customers every day.
In addition to the new packaging program, Letco offers compliance services and programs to assist compounding pharmacies with the evolving requirements issued by the USP and the FDA, including:
Compounding Support Services
Staffed by industry-leading compounding experts and provided free of charge to customers, Letco’s Compounding Support Services team provides formulas, technical support, and real-time advisory services on a range of topics, including USP <800> compliance. During 2018 alone, Letco’s Compounding Support Services team responded to more than 28,000 customer inquiries.
Regulatory Solutions Program
Letco provides a wide range of regulatory consulting services, including pharmacy process and compliance audits; standard operating procedure development; and staff training to ensure compounding pharmacies are meeting or exceeding regulatory requirements and consistently delivering safe products to consumers.
Complying with new regulations and best practices can be challenging for compounding pharmacies. Letco helps customers protect their businesses by anticipating and staying ahead of regulatory and industry changes, enabling them to focus on patient care while taking advantage of compounding as a profit center.
What does the USP/ NIOSH packaging program look like, and how should pharmacies handle shipments from Letco with items on the NIOSH hazardous drugs list?
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