Overview of the Drug
Supply Chain Security Act
The Drug Supply Chain
Security Act (DSCSA) serves as a critical safeguard
for the pharmaceutical supply chain, aiming to ensure that all prescription
drugs can be traced from their origin to the consumer. Enacted in 2013, the DSCSA
is a federal law that requires the pharmaceutical industry to implement systems
to trace the distribution of prescription drugs.
Pedigree Requirements Under the DSCSA
Central to this act are the Pedigree Requirements outlined in
Section 503(e)(1)(A). These requirements mandate that each prescription drug be
accompanied by a detailed pedigree, which documents every prior sale, purchase,
or trade, including transaction dates and the names and addresses of all
parties involved in the chain of distribution. This meticulous documentation is
essential for preventing counterfeit medications from entering the supply chain
and protecting public health.
Medi-Cal
Appeals Highlight Compliance Challenges
However, several Medi-Cal administrative appeals currently being
defended by Marcarian Law Firm shed
light on significant shortcomings in the dissemination of information regarding
the DSCSA to pharmacy professionals. The cases involve retail pharmacies and
their pharmacists who are facing legal actions stemming from audits conducted
by the California Department of Healthcare Services related to alleged
noncompliance with the DSCSA.
Navigating an Evolving Legal and Regulatory Landscape
As the legal landscape surrounding the DSCSA continues to
evolve, Marcarian Law Firm remains at the forefront, actively monitoring these
developments and engaging in discussions about effective regulatory compliance.
Our mission is to bridge the gap between legal requirements and practical
implementation, ensuring that dedicated healthcare professionals have the
support they need to adhere to laws designed to protect public health.
Supporting
Healthcare Professionals and System Integrity
The integrity of our healthcare system hinges on clear
communication and equitable treatment for those who tirelessly serve their
communities, and we are proud to play a pivotal role in shaping the future of
healthcare regulation.
FAQs :-
1. Does Los Angeles have a drug problem?
Yes, Los Angeles faces serious drug issues, including opioid and fentanyl
abuse.
2.
Are drugs illegal in Los Angeles?
Many drugs are illegal, but some are decriminalized under California law.
3.
Is California a drug-free state?
No, California regulates certain drugs but is not a drug-free state.
4. What is a drug injury?
A drug injury is harm caused by unsafe, defective, or wrongly prescribed
medication.
