Deciding who can place an order
If your group includes more than one physician or more than one location, decide whether every associate holds independent ordering authority or whether orders route through one accountable buyer. Either approach can work; the goal is a clear, written answer rather than an informal default.
Keep NPI verification current for whichever account or accounts the practice uses, and record which physician authorized each order so a compliance question can be answered by checking one record instead of reconstructing it from memory.
- Decide and document who may place orders under the verified account
- Keep NPI verification current for each ordering account
- Log which physician authorized each order
- Set a policy for whether visiting or locum surgeons may order directly
Documentation to request per lot
Before a lot reaches a procedure room, request the certificate of analysis, the donor eligibility summary, and the sterility testing record tied to that specific lot number. Each lot carries its own identifier and is held until internal release criteria are met, so documentation should be lot-specific, not generic to the product line.
If your practice already keeps implant logs for hardware, consider filing biologics documentation the same way, organized by lot number so any document can be retrieved within minutes.
- Request a certificate of analysis and donor eligibility summary per lot
- Confirm third-party sterility testing was completed before release
- File documentation by lot number, not by order date
- Ask how long the supplier retains records and how to request copies
Cold-chain and inventory logistics
Cryopreserved vial formats ship overnight on dry ice in validated containers and require storage at -80 degrees C. Confirm freezer capacity and build a receiving checklist that verifies the shipment arrived within temperature range before logging it into inventory.
Lyophilized formats do not require freezer storage, but still need a chain-of-custody record from receipt to use, including who handled the vial and when it was pulled from stock.
- Confirm freezer capacity before committing to cryopreserved formats
- Build a receiving checklist that checks shipment temperature on arrival
- Track lyophilized stock with the same lot-level rigor as cryopreserved stock
- Record chain of custody from delivery to removal from inventory
Confirming regulatory posture with counsel
Whether a specific intended use meets all applicable criteria in 21 CFR 1271.10 is a determination for the practice and its counsel, not the vendor. A vendor can supply documentation quickly; it should not be relied on for that determination.
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.
- Ask counsel which licensure and board requirements apply to your practice
- Review how a product's intended use maps to the HCT/P framework with counsel
- Set a document retention policy before the first order ships
- Evaluate vendors partly on how clearly they answer documentation questions
Frequently asked questions
What should an orthopedic practice request before opening a new vendor account?+
A sample certificate of analysis format, a sample donor eligibility summary, and a description of how lots are tracked from recovery through shipment. Pricing and clinical-use questions are separate from a documentation review and are available to verified accounts on request.
Does every physician in a group need a separate purchasing account?+
That is a decision for the practice to document. Some groups centralize purchasing under one administrator with physicians named as authorizing providers on each order; others verify accounts individually. Either way, record the decision in writing.
How should a cryopreserved shipment be logged on arrival?+
Confirm the dry ice shipping container held temperature during transit, record the lot number and arrival date, and move the vial into -80 degree C storage before updating inventory records.