Functional & Integrative Medicine

Fitting one more vendor into an existing portfolio

If your practice already manages multiple vendor relationships, consider holding a biologics vendor to the same documentation and verification standard already applied to other regulated suppliers rather than treating it as a special case.

Compare documentation requirements across current vendor relationships to spot any gaps before the first order.

• Consider applying existing vendor-management standards to the biologics category
• Compare documentation requirements across current vendor relationships
• Avoid treating biologics sourcing as an exception to normal vendor review
• Decide who is responsible for managing the vendor account

Checking storage capacity before scaling orders

If your practice operates on a membership or panel model, a known patient panel size can support more predictable inventory planning than unscheduled walk-in volume. Confirm storage capacity, freezer or shelf-stable, before scaling order size to panel growth.

Revisit the forecast periodically as the panel changes, and check storage limits again before each adjustment.

• If applicable, forecast inventory needs against a known patient panel
• Check storage capacity before scaling order size
• Revisit forecasts periodically as patient volume changes
• Avoid scaling orders based on panel size alone without a storage check

Account verification across a provider team

If more than one licensed provider works under one practice, decide which provider's NPI verifies the purchasing account and document an internal request process for other providers to use inventory.

Keeping the audit trail centralized under one verified account, with each provider's role documented, can simplify both ordering and recordkeeping.

• Decide which licensed provider's NPI verifies the purchasing account
• Document an internal request process for other providers
• Keep the audit trail centralized where practical
• Document each provider's role in the purchasing process

Reviewing patient education content with counsel

Any material referencing biologics, whether labeled education or marketing, carries the same regulatory risk and benefits from the same review by counsel before publication. Limit content to documented sourcing and testing facts rather than describing what a product does.

FDA states there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351, and purchase and clinical-use decisions belong to the physician and their own regulatory counsel.

These products are not FDA approved or licensed for any disease or condition. Information here is for licensed healthcare professionals and is not medical or legal advice.

• Review patient education materials with the same scrutiny as marketing
• Limit content to documented sourcing and testing facts
• Avoid describing what any product does in educational materials
• Have counsel review new education content before publication