DSCSA Compliance

We operate under the Drug Supply Chain Security Act (DSCSA) framework applicable to 3PLs. We have submitted our annual 3PL licensure report to FDA via CDER Direct and follow FDA’s DSCSA guidance for trading partners.

Trading partners may verify our FDA annual reporting status by searching our legal name (Active CS LLC dba 1SALERX) in FDA’s Check Licensure database (search by company name and facility address).

Note: DSCSA recognizes authorized trading partners when both FDA annual reporting and applicable state 3PL licensing are satisfied. Our Florida 3PL permit is not yet issued; we will update this page once granted and will not conduct any activities in Florida that require an active 3PL permit until issuance.

We are registered in CDER NextGen and prepared to submit Form FDA 3911 for any product determined illegitimate, and to notify affected trading partners. We will file 3911 and notify impacted parties within 24 hours of such determination, consistent with FDA guidance.

We maintain procedures and systems to support interoperable, electronic, package-level product tracing and to provide timely responses to investigation/verification requests under DSCSA.

We keep written SOPs covering: identification and quarantine/segregation of suspect/illegitimate product; investigation workflows and decision criteria; Form 3911 submission and partner notifications; recalls/market actions; traceability responses; and record retention

We maintain records sufficient to demonstrate DSCSA compliance (including 3911 submissions, notifications, and tracing/investigation responses) for legally required periods.

We may use qualified subcontractors and carriers. When engaged in DSCSA-covered activities on our behalf, they operate under controls and procedures aligned with our SOPs and DSCSA obligations.

We may suspend or refuse services where verification indicates DSCSA-related risk (e.g., failure to meet trading-partner verification expectations or to cooperate with investigations/notifications).

DSCSA has no FDA “badge,” certification, or approval program. We do not claim FDA approval and do not use the FDA logo. Our public statements are limited to the DSCSA steps implemented above and how to verify our FDA annual reporting status.

Go to FDA’s Check Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers database and search Active CS LLC to view our WDD/3PL Annual Reporting status.