Industry Developments
Recently, NASH received a note from the payer industry regarding international sourcing compliance following a federal court case in Maryland. It is important to know that the court order and litigation are specific to certain plan sponsors and third-party vendors rather than a general industry prohibition on international specialty drug sourcing.
However, we recognize the importance of prescription sourcing compliance and want to provide clarity on our approach to drug sourcing. In addition, we want to underscore our commitment to patient safety, legal compliance, and transparency.
NASH does not facilitate or support the importation of specialty drugs into the U.S. in violation of U.S. law. We are aware of the complex and evolving legal framework surrounding international prescription sourcing and are committed to aligning our practices with both FDA guidance and federal compliance expectations.
At NASH, patient safety is our highest priority. We work exclusively with licensed, accredited, and compliant international pharmacy partners to ensure the authenticity, safety, and traceability of every medication. Each product dispensed through our partner network:
- Is authentic and manufacturer sealed
- Originates from FDA-inspected or equivalently regulated facilities
- Follows Good Manufacturing Practices (GMP) and rigorous quality controls
- Is distributed through secure, verified supply chains with tamper-evident packaging and temperature integrity
In addition, our high standards of pharmacy practice reflect our dedication to providing safe, affordable access to care without compromising on legal or ethical standards.
The Maryland federal case underscores the legal sensitivities around international specialty drug sourcing. Generally, federal law prohibits individuals from importing prescription medications into the United States unless limited, narrowly defined conditions are met. These exceptions are reserved for rare and regulated circumstances, such as when:
- The drug treats a serious condition for which no U.S. alternative exists.
- The product is not promoted commercially in the U.S.
- It poses no unreasonable safety risk, and
- The imported quantity does not exceed a three-month supply.
Because these conditions are highly specific and case-dependent, NASH ensures that all programs, partnerships, and data practices remain compliant with applicable laws and regulations. NASH remains steadfast in its mission to enhance access to compliant, transparent, and patient-centered specialty pharmacy solutions. We are continuously monitoring the legal landscape and working closely with partners to ensure that our policies align with both federal standards and the highest ethical expectations.
Patient Safety, Drug Affordability, and Regulatory Compliance
Our focus remains on patient well-being, drug affordability, and regulatory compliance. We fully support ongoing industry efforts to clarify regulatory frameworks and promote safe, transparent access to prescription medications.
NASH is committed to:
- Ensuring complete legal and regulatory compliance in all sourcing and data-sharing activities.
- Partnering only with licensed, reputable entities that meet U.S. and global quality standards.
- Providing patients and clients with accurate information grounded in current law and best practices.
Evolving Legal Landscape
As the legal and regulatory environment evolves, we will continue to communicate proactively and transparently with our partners and clients. At NASH, patient health and trust remain our highest priorities. We’re proud to help patients access the medications they need safely, affordably, and with full peace of mind.
Visit our specialty pharmacy page to learn more about how NASH ensures Seamless Access. Smarter Drug Savings.
Disclaimer: this communication is provided for informational purposes only and does not constitute legal advice. NASH encourages readers to consult with qualified legal counsel or compliance professionals regarding specific questions about prescription sourcing, importation, or applicable federal regulations.
About the Author
Michael “Mike” Agostino is a registered pharmacist and a seasoned entrepreneur in the healthcare industry. Currently, Mike is the CEO Network of Advanced Specialty Healthcare (NASH). Throughout his thirty-year career, Mike has been a founder, co-founder, and/or key contributor to the formation of several companies including Vivid Clear Rx, Turning Point, and Hy-Vee Pharmacy Solutions. Mike also served as President and co-owner of Amber Specialty Pharmacy and Hy-Vee Pharmacy Solutions, located in Omaha, NE. LinkedIn