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CBER - Questions and Answers for Roll-Out of Good Tissue Practice (GTP) Final Rule |
 | | At this time, and with two minor exceptions [1271.150 (c) and 1271.155], the regulations in subparts D and E are not being finalized with respect to reproductive HCT/Ps described in 1271.10 and regulated solely under section 361 of the PHS Act and the regulations in part 1271. |
 | | We are leaving the docket to the GTP rule open and we are asking interested parties to submit comments on communicable disease risks associated with reproductive HCT/Ps and appropriate regulation to minimize those risks. |
 | | Current good tissue practice (CGTP) is the requirements in subparts C and D of 21 CFR part 1271 that govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps, including but not limited to all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution. |
| www.fda.gov /cber/rules/gtpq&a.htm (1507 words) |
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