Primary Care

Starting with a trial order

If your practice has not sourced this category before, a smaller first order can serve as a test of documentation and shipping reliability rather than a stocking decision, giving staff time to build familiarity with receiving and filing before volume increases.

Revisit the vendor relationship after the trial order, based on how documentation and shipping performed, before deciding whether to scale up.

• Consider a smaller trial order before committing to regular stocking
• Use the trial order to evaluate documentation and shipping reliability
• Build staff familiarity with procedures before volume increases
• Revisit the vendor relationship after the trial order

Training staff before inventory arrives

If biologics is an unfamiliar category for your staff, consider a short training on what the product is, what documentation accompanies it, and what the practice does and does not claim about it, before the first shipment arrives.

Base training on the vendor's own documentation and the practice's regulatory review rather than general assumptions about the category, and repeat it when staff or procedures change.

• Train staff before the first shipment, not after
• Base training on vendor documentation and your own regulatory review
• Clarify what the practice does and does not claim about any product
• Repeat training when new staff join or procedures change

Deciding who holds the account

Decide who within the practice will hold and manage the vendor account, and document that arrangement, consistent with how the practice handles other regulated supplies.

Whatever the arrangement, keep a single point of accountability for documentation review and vendor communication while the practice is still building familiarity with the category.

• Decide and document who holds the vendor account
• Confirm who is authorized to communicate with the vendor on documentation
• Keep account verification current
• Revisit the arrangement as procedures become established

Confirming scope and referral questions with counsel

Whether a given product and intended use fit within a practice's scope, or whether a referral is more appropriate, is a determination for counsel and, where relevant, the state medical board, not a general assumption about the category.

A vendor's documentation addresses sourcing and testing; it does not address scope of practice, referral appropriateness, or regulatory classification.

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.

• Confirm scope-of-practice questions with counsel and the state board
• Treat vendor documentation as sourcing information, not scope guidance
• Consider whether a referral is more appropriate before adding a new category
• Revisit the scope determination if practice patterns change