The Association for the Advancement of Blood & Biotherapies (AABB) has released its first edition of Cell and Gene Therapy Standards for Pharmacy, a milestone designed to strengthen safety and quality for cell and gene therapy (CGT) products managed by pharmacies. The new standards take effect October 1, 2025, and are now available for purchase through the AABB Store.
Closing a Critical Gap in Pharmacy Standards
Cell and gene therapies are rapidly reshaping the treatment landscape, offering new hope for patients with rare and complex conditions. With dozens of CGTs already approved — and many more advancing through the pipeline — pharmacies are becoming essential players in ensuring these high-value therapies are stored, handled, and dispensed safely.
Until now, there were no dedicated standards tailored to the unique requirements of CGTs within pharmacy settings. AABB, drawing on its decades of expertise in quality systems, convened a committee of academic, hospital, and industry experts to address that gap.
The result is a new set of standards that provide clear, practical guidance for pharmacies across the full lifecycle of CGT product management: receipt, storage, handling, and dispensing. The aim is simple but vital — protect product integrity, advance patient safety, and help pharmacies build operational readiness for a new era of therapies.
What Pharmacies Can Expect
The standards are available in both print and digital formats, with a companion guidance document to support implementation. Pharmacies may also apply for AABB Accreditation under this program, signaling their commitment to meeting rigorous quality and safety benchmarks in cell and gene therapy management.
By establishing these standards now, AABB is providing pharmacies with a roadmap to prepare for the increasing volume and complexity of CGTs entering the market.
AABB’s National Role in Quality Standards
AABB has been setting standards that define quality and safety for the blood and biotherapies field since 1957. Today, its standards are applied in accredited facilities across more than 50 countries, providing a common framework for advancing quality worldwide.
Each edition of AABB Standards is shaped by expert committees and a public comment process, ensuring they reflect best medical practices, scientific evidence, and regulatory requirements. The release of the Cell and Gene Therapy Standards for Pharmacy extends that legacy, positioning AABB as a national leader in ensuring the safe integration of CGTs into clinical care.
“This is an important next step for the field,” said an AABB spokesperson. “By creating standards specific to pharmacies, we are ensuring that as the science evolves, the systems supporting patients evolve with it.”
Why It Matters
For patients, these standards mean greater assurance that their cell and gene therapies will be handled with the highest levels of safety and quality. For pharmacies, they provide a clear framework to manage risk, ensure compliance, and build trust with patients, providers, and regulators.
And for the broader healthcare ecosystem, AABB’s move represents a significant step in bridging the gap between scientific innovation and patient access. By setting standards that are practical, nationally recognized, and internationally relevant, AABB is helping create the infrastructure needed to support the growth of CGTs across the United States.
As CGTs shift from rare-disease breakthroughs to more mainstream therapies, pharmacies of all sizes will need to adapt. With AABB’s new standards in place, they now have a nationally recognized playbook to guide them.
For more information or to purchase the new standards, visit the AABB Standards & Accreditation page.
