Controlled SubstanceCompliance & Shipping ExpertCommunity
What we doHigh levels of compliance are vital to maintain public trust in life science
R&D. The work of the Controlled Substance Compliance & Shipping
expert group keeps its members up-to-date with current developments
in best practices, legislation and regulation.

Key Information
Chair CSC: Jessie Bin Song
Chair Shipping: Jack DeCicco
Project manager: Birthe Nielsen
Contact us: CSCS@pistoiaalliance.org
Goal of the Expert Community
To improve the understanding andinterpretation of controlled
substances and shipping legislation
around the world

Sponsors/partners

Controlled substance legislation has changed rapidly in recent years aslegislators respond to societal issues and concerns. For example,enhanced suspicious order monitoring requirements in response to theopioid epidemic, and ‘super generic’ definitions of the mid 2010s in an
attempt to manage the rapid increase in synthetic cannabinoid analogs.
Remaining compliant in this environment is an ever-growing challenge,
and consequences for breaches can be severe.

Pharmaceutical Research and Manufacturers of America(PhRMA) presented to the community on the evolving
landscape of U.S. Controlled Substances Regulations at bothfederal and state levels and gave examples of conflict between
state and federal laws and ongoing uncertainties.
Suspicious Order Monitoring (SOM) - IQVIA presented theproposed changes in SOM regulation and comments received
by the DEA.

Cross-border shipping is also in a very dynamic and legislated
environment and ties in very closely with aspects of Controlled
Substance logistics. Since the start of the pandemic there have been
many additional challenges in transporting Pharmaceutical R&D
materials. Pharma must ensure shipments are fully compliant with bothnational and international requirements. Mistakes cause delayed orrejected shipments which in turn have negative impact onpharmaceutical R&D timelines.

Specialty logistics service providers – Our members discussed
white-glove/ Tier 1 shipping providers, responsibility of tradecomplacence data and the types of shipments handled by these
service providers.

The Community focuses on tackling the challenges we face, developing
solutions, influencing regulations, and learning from each other to stay
current and compliant with legislations governing controlled substanceand shipping activities

Inspections and audits – The Compliance Group, Irelandpresented controlled drugs requirements in Ireland, Italy, andUK focusing on their audit and inspection experience. Thecommunity shared its own experiences in regulatory
inspections, internal audit programs, license applications andrenewals. This resulted in the formation for the group of arepository for summary legislation/inspection
focus/exemption/threshold for major jurisdictions.

The CSC & Shipping Expert Community has existed since 2013 making
this one of the Pistoia Alliance’s longest ongoing groups.
Biggest challenge for our members in CSC & Shipping compliance:
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To join the steering committee, weask for a $7K yearly contribution

The International Narcotics Control Board had a dialogue
with the community on the trends and risks of precursors andcollaboration with industry and international governments incontrols, tools used, and the 1988 Convention and Equipment
control in illicit drug manufacture.

The proper translation of the wording of regulations to theappropriate (sub)structural queries, is key to the accurate
detection of controlled substances.
Keeping current with the changing requirements worldwideand maintaining an effective and efficient approach tomaintain compliance.
Engaging with regulators and gaining an understanding of how
regulators operate and devise improved approaches to CScompliance.
Interpretation of ambiguous regulations. Where there isambiguity in legislation, trying to get meaningful and timely
engagement from regulators to understand exactly what ismeant and how this applies to scientific research.
Navigating and improving transport delays resulting from
Global Logistic Barriers (i.e., Covid-19 and Brexit)

Inventory management systems – BIOVIA presented theirsolution for inventory management, focusing on the controlled
substances application. Members benchmarked the inventory
management processes.

US Section 301 – Prof Henry Gao from Singapore Management
University and expert on Chinese law and international tradegave his views on the future status of the US/China tariffs thatcurrently are in place.

Who should join?
The expert communities are made up of major pharmaceuticalcompanies and specialist software providers. Knowledge andexperience sharing is entirely voluntary. This community provide
an open and safe environment for members to benchmark andshare experience in various areas of focus related to controlled
substance and compound shipping legislation and regulations
around the world.
The community works as a team to tackle the challenges andstrive to stay current with the changing environment.

Activities 2021/22
Brief overview of the main activities in 2021/2022Changes to HS
nomenclature & mislabeling issues - Expert Group members Scitegrity
presented on the Harmonized System that handles nomenclaturechanges and ChemAxon presented challenges in communicating withcustoms regarding mislabeled information.
ACMD barriers to research - the UK’s Advisory Council on the Misuseof Drugs recommended to change de-minimis limits for researchorganizations with compounds which fall under the synthetic
cannabinoids definition.
Brexit updates – Updates on the changes to Brexit-related regulations.

If you would like to join theCSC & Shipping Expert
communities, please get intouch with us
CSCS@pistoiaalliance.org

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The Pistoia Alliance is a global, not-forprofit alliance of life science
companies, vendors, publishers, andacademic groups that work together tolower barriers to innovation in R&D.

Our members collaborate as equals on
open projects that generate significant
value for the worldwide life sciences
community.

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