The Manufacturer’s intent for these human cellular tissue products (HCT/Ps) is that they are regulated under 21 CFR 1271.10 under section 361 of the PHS Act. This includes following the June 2020 guidance document by the Food and Drug Administration (FDA), regulatory considerations for human cells, tissues, and cellular/tissue-based products: minimal manipulation and homologous use in context to the manufacturing and intended use of structural tissues regulated under section 361 of the PHS Act.
ORDERING PROTOCOL – Orders ship out on dry ice from the lab Monday-Thursday for next day delivery. They do not ship out on Friday. Paid orders sent to the lab on Friday will be shipped out on Monday for Tuesday delivery. PLEASE DETERMINE YOUR DESIRED DELIVERY DATE WHEN SENDING IN YOUR ORDER AND ALLOW 72 HOURS PROCESSING TIME PRIOR TO THE DELIVERY DATE IN ORDER TO RECIEVE YOUR ORDER ON TIME. FOR EXAMPLE, IF YOU’D LIKE THE PRODUCT DELIVERED ON THURSDAY, PLEASE PLACE YOUR ORDER BY 10AM MST ON MONDAY. THIS WILL ALLOW OUR TEAM AMPLE TIME TO PROCESS YOUR ORDER, INVOICE YOU, AND SUBMIT THE ORDER TO THE LAB FOR SHIPMENT. OUR TEAM SUBMITS ORDERS BY 10AM MST DAILY TO THE LAB.
SHIPMENTS & DELIVERY – Biologic products must be delivered to and signed for by a
licensed medical practitioner with an approved account or the medical practitioner's
assigned designee for that location.