What is the procedure outlined in the Interim Final Rule for petitioning FDA for an exemption from 100 percent identity testing requirement?
First, the IFR notes that the FDA will not consider a manufacturer’s petition until after the FDA CGMP compliance date for that company and suggests that a manufacturer who may want to submit a petition could begin immediately to gather the data and information needed to support the petition for exemption. The petition must include the scientific rationale, supported by data and information, that the alternative to the 100 percent identity testing will demonstrate that there is no material decrease of assurance, compared to the assurance provided by 100 percent identity testing, when the dietary ingredient is sourced from one or more suppliers identified in the petition. The FDA will considered such petitions under 10.30 (21 CFR 10.30), the citizen petition process. The petition must include: The action requested (a request for an exemption from requirements of 21 CFR 111.75(a)(1)(i); A statement of grounds (this is the section that outlines your scientific rationale and supporting dat
Related Questions
- What is the procedure outlined in the interim final rule (IFR) for petitioning FDA for an exemption from 100 percent identity testing requirement?
- What is the procedure outlined in the Interim Final Rule for petitioning FDA for an exemption from 100 percent identity testing requirement?
- How will FDA enforce this interim final rule during the comment period?
