By Michelle Keske

As the demand for at-home healthcare solutions and pet medications grows, manufacturers and brands must choose fulfillment partners that can not only deliver reliable service but also meet strict regulatory, quality, logistical, operational and privacy requirements. Whether you’re distributing in-home diagnostic tests, FDA-regulated medical devices, or pet pharmaceuticals, selecting the right fulfillment company is critical to protecting your brand and ensuring patient safety. Here is a typical list of requirements in the United States to use as you vet a proper fulfillment partner.

Regulatory compliance is non-negotiable

Your fulfilment partner must hold the appropriate licenses and certifications to handle your products. Ensure they understand the requirements for packaging and transporting in-home test kits (ex. blood and urine). For pharmaceuticals, you must be registered with DEA, have Rx State Licenses, and are compliant with the FDA Drug Supply Chain Security and follow Good Manufacturing Practices. For medical devices, you must have an FDA registration and license, and be compliant with 21 CFR Part 820 under Quality System Regulations.

Storage and handling
A good fulfillment partner will have Good Distribution Practices that are documented, followed, and audited. Depending on your product requirements, temperature and environmental controls may be important (ex. refrigeration, temperature control, humidity control). The warehouse will automatically monitor and keep readings of these details throughout the day, and can respond quickly if something is out of calibration. You want the fulfillment center to share with you their security protocols that prevent theft, diversion, or contamination. The provider must have systems for inventory control, expiration, tracking, as well as, traceability and recalls.

Experience with regulated products
Ask about their experience fulfilling in-vitro diagnostics kits (IVDs), human-use medical devices, as well as, prescription and OTC pet pharmaceuticals. A partner that understands labeling requirements, medical privacy laws, (ex. HIPAA), and veterinary compliance will help reduce your risk of costly delays or regulatory issues.

Data privacy & patient information handling
When distributing in-home blood and urine tests or managing lab returns, fulfillment partners may come into contact with Protected Health Information (PHI). Mishandling this data not only erodes trust – it also exposes your brand to serious legal and financial risk.

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