21 C.F.R. § 1271.330 Applicability.
Title 21 - Food and Drugs
The provisions set forth in this subpart are being implemented for nonreproductive HCT/Ps described in §1271.10 and regulated solely under section 361 of the Public Health Service Act and the regulations in this part, and for the establishments that manufacture those HCT/Ps. HCT/Ps that are drugs or devices regulated under the act, or are biological products regulated under section 351 of the Public Health Service Act, are not subject to the regulations set forth in this subpart.
Title 21: Food and Drugs
PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart E—Additional Requirements for Establishments Described in § 1271.10
§ 1271.330 Applicability.