To ensure compliance and patient trust, your partner should be HIPAA Compliant. Confirm they adhere to the Health Insurance Portability and Accountability Act, including physical, technical, and administrative safeguards for handling PHI. Signing a Business Associate Agreement (BAA) is a requirement if your partner handles PHI in any capacity (ex. test registration, lab returns, patient labels). Use a secured data system that is encrypted, access controlled, and backed by detailed audit logs. Your partner’s staff must be trained on data privacy, HIPAA compliance, and incident response, as well as, have documentation to prove that they are trained.
For pet pharmaceuticals, HIPAA doesn’t apply, but similar principles of data security and confidentiality should still be in place, especially if collecting owner or vet prescription info.
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Serialization and track-and-trace capabilities
Make sure that there is documentation and standards in place for serialization and traceability. The system must support lot tracking, expiration dating, and recalls. The system should have real-time tracking and reporting dashboards for visibility. A validated inventory management system along with SOP’s, training, deviations and corrective actions must be part of the Quality Management System and audited regularly for certification.
Scalability and customization
As your needs evolve, make sure you look for partners that can scale during peak seasons or product launches. Make sure they can handle custom kitting, labeling, branded packaging, and multi-channel distribution.
Final word
When choosing a fulfillment partner for regulated health and pet products, don’t settle for a basic 3PL. Choose a provider who understands the unique challenges of healthcare logistics, including the sensitive handling of patient information. Be sure they treat your brand’s reputation as carefully as you do.
About the author: Michelle Keske is president of Diamond Fulfillment Solutions, a scalable fulfillment partner for emerging and established brands in a variety of industries. Diamond’s customizable services, including order fulfillment, kitting and assembly, freight transportation, subscription box fulfillment, and print-on-demand services. Diamond has highest levels of excellence in warehousing standards, including ISO, HIPAA, Rx Licenses, and FDA compliances.
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