Identify the entities that perform the work
Ask which legal entity provides clinical care, which pharmacy dispenses, which facility prepares a product if applicable, and which company coordinates the service. A distributor or platform's brand name may differ from the licensed entity. Record addresses, professional contacts and the contract counterparty. Confirm whether more than one partner can serve an order and how substitutions in the partner network are approved and disclosed.
This is an educational due-diligence framework. Healthcare counsel, clinical leadership and pharmacy professionals should validate requirements and product-specific questions. A completed vendor questionnaire is useful evidence of a review process, but it cannot guarantee a partner's future conduct or eliminate regulatory, quality or service risk.
Check authority and destination coverage separately
FDA's BeSafeRx materials describe signs of a safer online pharmacy, including state licensure, a prescription requirement and access to a licensed pharmacist. They also provide links to state license databases. Verify the relevant pharmacy records directly and keep a dated copy or reference. Have the pharmacy and counsel confirm destination-specific permissions and restrictions for your arrangement.
For the prescribing side, confirm the clinical entity, clinician type and state service coverage. Ask how credentials and changes are maintained, who owns clinical review and how questions reach a licensed professional. Use the state availability register to ensure clinical authorization and pharmacy service coverage are both satisfied before enabling a route.
Source context: FDA: Considering an Online Pharmacy?, FDA: Locate a State-Licensed Online Pharmacy, HHS: Licensing Across State Lines
Keep registration, approval and marketing claims distinct
If a partner refers to FDA registration, ask what registration means for the specific facility and service. FDA's outsourcing-facility registration guidance states that registration does not indicate FDA approval or that the facility complies with requirements. Match the exact facility to the current FDA record where relevant. Do not turn a registration entry into a broad product-quality endorsement.
FDA states that compounded drugs are not FDA-approved and are not reviewed by the agency for safety, effectiveness or quality before marketing. If compounding is part of the service, clinical and legal specialists should assess the current product-specific circumstances. Founder copy should not call a compounded drug FDA-approved or describe it as interchangeable with an approved product without appropriate support and review.
Source context: FDA: Questions and Answers on Outsourcing Facility Registration, FDA: Understanding the Risks of Compounded Drugs
Review public records without inventing a verdict
Review applicable state discipline records and FDA inspection, recall or enforcement information. FDA publishes compounding inspection and action resources. Record what you checked, what you found and what you asked the partner to explain. An inspection observation, warning letter, recall and final enforcement outcome are different documents. Have qualified reviewers interpret the relevant context and response.
A record that requires explanation should create a documented follow-up, not an unsupported public allegation or a casual dismissal. Ask for the affected facility, scope, corrective actions and current status. If a material question remains unanswered, pause the commercial decision for that route. Avoid claiming that an empty search result proves there is no risk.
Source context: FDA: Compounding Inspections, Recalls and Other Actions
Test the service handoffs before traffic
Walk through a delayed order, damaged package, clinical question, wrong address and product complaint using dummy data. Record which partner owns each response and how support confirms receipt. Ask who communicates with the patient, which channel is appropriate and which information the brand may share. Have clinical and pharmacy leads approve escalation scripts; support should not improvise treatment or dispensing guidance.
Document notice of service changes, capacity limits and interruptions in the operating agreement. Connect these commitments to the continuity plan. Recheck the evidence when a facility, coverage area, product category or partner changes. The strongest due-diligence file supports an ongoing relationship with clear review triggers, rather than a folder that is closed on signature day.
Partner evidence and follow-up file
Create one file per clinical entity and dispensing or preparing facility. Each unresolved question needs an owner and a decision date before the affected service is released.
On small screens, scroll the table sideways to view every column.
| Evidence category | Request or primary check | Decision to record |
|---|---|---|
| Entity identity | Legal name, address, counterparty and facility role | Which entity performs each function |
| Professional authority | Current primary licenses and relevant registrations | Reviewed service and destination scope |
| Product representations | Product source, status and approved marketing wording | What the brand may accurately say |
| Public record review | Applicable discipline, inspections, recalls and responses | Reviewer assessment and open follow-ups |
| Operating handoff | Named clinical/pharmacy contacts and interruption procedure | Escalation path and evidence of response |
Before you move forward
- Verify the exact licensed and contracted entities.
- Check clinical and pharmacy coverage independently.
- Distinguish facility registration from product approval.
- Record public findings and qualified follow-up assessments.
- Test complaint and interruption handoffs before launch.
Sources and scope
Source check: October 10, 2026. Primary sources support the rules and vendor descriptions cited above. Worksheets are original planning tools, not provider commitments or forecasts. Requirements can change; confirm current terms for your program.
- FDA: Considering an Online Pharmacy?
Supports pharmacy license, prescription and pharmacist-contact checks. Checked October 10, 2026.
- FDA: Locate a State-Licensed Online Pharmacy
Links to primary state pharmacy verification records. Checked October 10, 2026.
- HHS: Licensing Across State Lines
Supports review of state authorization for the clinical side of a partnership. Checked October 10, 2026.
- FDA: Questions and Answers on Outsourcing Facility Registration
Explains that registration is not FDA approval or a finding of compliance. Checked October 10, 2026.
- FDA: Understanding the Risks of Compounded Drugs
Supports the distinction between compounded drugs and FDA-approved products. Checked October 10, 2026.
- FDA: Compounding Inspections, Recalls and Other Actions
Provides primary public records for qualified partner-review follow-up. Checked October 10, 2026.