Six ways a product can be made, and what each one means for your practice. Pricing unlocks with your NPI — understanding does not.
Made for one named patient, by a licensed compounding pharmacy. Not for office stock.
Catalogue comingOpen lane →503B OutsourcingNo patient neededOffice stock, no patient name neededBatch-made by an FDA-registered outsourcing facility. This is what legitimate office stock runs on.
Catalogue comingOpen lane →PUO + RUONo patient neededPractitioner use · research useResearch-use labelling and a supplier trade term. Neither confers approved-product status.
Catalogue comingOpen lane →CosmeticNo patient neededAppearance, not treatmentNo premarket approval — but a drug claim reclassifies it as a drug, whatever the label says.
Catalogue comingOpen lane →Biologic — AcellularNo patient neededHCT/P, no living cellsAcellular HCT/Ps under Part 1271. Section 361 or 351 turns on manipulation and use.
Catalogue comingOpen lane →Biologic — CellularNo patient neededLiving cells — highest scrutinyLiving cells. Usually a section 351 biologic needing an approved BLA or an active IND.
Catalogue comingOpen lane →Lane summaries are educational orientation, not legal advice. Confirm any classification against current FDA guidance and your state board before you order.
