Complying with CBP regulations: Country-of-origin labeling for prescription and OTC drugs

Simplifying compliance with automated data

A first-of-its-kind, cloud-hosted capability for CoO data, the Medi-Span Country of Origin solution delivers manufacturer CoO details for prescription and over-the-counter (OTC) drugs at the NDC level, enabling automated labeling that reduces manual entry, lowers the risk of missing required details, and promotes consistent compliance across locations. Built on Digital Architect, Wolters Kluwer’s centralized API platform for health content, the solution is part of a broader ecosystem that gives organizations a consistent, secure way to access multiple APIs as their needs evolve.
The Medi-Span Country of Origin solution allows both single NDC lookup and bulk data retrieval to support the needs of:

1. Retail pharmacies
2. PBMs with mail order pharmacies
3. Specialty pharmacies
4. Pharmacy software developers

1. Retail pharmacy compliance at the point of sale

Problem: A retail pharmacy chain with hundreds of locations has not yet implemented the new CoO labeling requirements. Labeling system updates and the need for pharmacists to manually enter CoO data for prescription and OTC drugs have so far posed too big a challenge to overcome. That means many chain locations are out of compliance and subject to penalties.

Solution: By integrating the Country of Origin solution into the pharmacy’s existing software, pharmacists can instantly retrieve refreshed CoO data for an NDC. This reduces manual processes, promotes compliance with CBP regulations, and allows pharmacists to focus on patient care rather than administrative tasks.

2. Mail-order pharmacy compliance for PBMs

Problem: A PBM with a large mail-order prescription service ships thousands of prescriptions daily, and the manual process of verifying CoO data for bulk orders is not scalable. It is leading to delays in order fulfillment or even noncompliance, which can result in penalties during regulatory audits.

Solution: The Country of Origin API solution supports both bulk data retrieval and individual NDC lookup, so integrating it into their mail-order system allows the PBM to automate CoO labeling for large volumes of prescriptions without slowing down operations. The scalable cloud-hosted platform supports trustworthy, compliant results, even during peak order periods.

3. Specialty pharmacy import validation

Problem: A specialty pharmacy that imports high-cost, life-saving medications is struggling to validate CoO data for regulatory audits. The lack of a centralized, reliable source for CoO information increases the risk of noncompliance or delays in getting critical medications to patients.

Solution: The Country of Origin API solution provides a centralized, cloud-hosted source for CoO data. The pharmacy can retrieve trusted CoO data for imported drugs, supporting compliance with CBP regulations.

4. Pharmacy software integrators supporting clients’ labeling data needs

Problem: A pharmacy software integrator is receiving urgent requests from its users to add CoO labeling functionality to their systems. However, building and maintaining this data in-house from scratch is cost-prohibitive and would delay their ability to meet client needs.

Solution: The Country of Origin API solution offers a plug-and-play integration for which systems providers can trust the Medi-Span data. They know the Medi-Span editorial team has direct relationships with drug manufacturers to support timely updates. Additionally, the Digital Architect Developer Portal provides all the documentation, specs, and tools needed for fast implementation, allowing the integrator to quickly and cost-effectively deliver CoO labeling functionality to their clients, strengthening their competitive edge and customer satisfaction.

In order to avoid fines and other consequences of noncompliance, relevant stakeholders within the healthcare supply chain need to add CoO labeling to their workflow. Offering clear labeling that provides the transparency both the government and consumers are looking for is only part of the equation. It is equally important to implement data solutions that are reliable and are regularly updated to support ever-changing regulations.

Speak with a specialist to learn more about Medi-Span’s Country of Origin cloud-based API solution.