Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:43
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 43
Character Range: 39440–40853

43  Storage and transportation

     Human skin
 (1) Immediately following collection and prior to processing, human skin must be:
 (a) stored as follows:
 (i) at less than 10°C in a suitable storage medium; or
 (ii) as otherwise validated by the manufacturer to prevent microbial proliferation and to ensure the quality, safety and efficacy of the human skin product manufactured using the human skin; and
 (b) transported in a manner that ensures the relevant storage conditions specified in paragraph (a) are maintained during transportation.

     Human skin products
 (2) Human skin products must be stored as follows:
 (a) at less than minus 40°C for not more than 5 years after collection of the human skin; or
 (b) at 2°C to 8°C for not more than 14 days after collection of the human skin; or
 (c) if stored in greater than 75% glycerol solution—at 2°C to 8°C for not more than 2 years after the collection of the human skin; or
 (d) in accordance with conditions that are validated on the basis of validated data or documented evidence from relevant scientific literature, including justified time and temperature specifications, to ensure the quality, safety and efficacy of the products.
 (3) Human skin products must be transported in a manner that ensures the relevant storage conditions specified in subsection (2) are maintained during transportation.

Part 7—Standard for human amnion products