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(a) You must make and keep records required under this subpart N in accordance with subpart P of this part.
(b) You must make and keep the following records:
(1) Written procedures for fulfilling the requirements of this subpart N.
(2) Any material review and disposition decision on a returned dietary supplement;
(3) The results of any testing or examination conducted to determine compliance with product specifications established under § 111.70(e); and,
(4) Documentation of the reevaluation by quality control personnel of any dietary supplement that is reprocessed and the determination by quality control personnel of whether the reprocessed dietary supplement meets product specifications established in accordance with § 111.70(e).
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 321 - Definitions; generally
§ 342 - Adulterated food
§ 343 - Misbranded food
§ 371 - Regulations and hearings
§ 374 - Inspection
§ 381 - Imports and exports
§ 393 - Food and Drug Administration
§ 264 - Regulations to control communicable diseases
Title 21 published on 10-May-2017 03:43
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 111 after this date.
The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.
The Food and Drug Administration (FDA or we) is announcing three one-day public meetings in different regions throughout the United States to provide importers and other interested persons an opportunity to have an in-depth discussion on the implementation of the FDA Food Safety Modernization Act (FSMA) import safety programs ( i.e., foreign supplier verification programs (FSVPs) for importers of food for humans and animals, accreditation of third-party certification bodies, and FDA's Voluntary Qualified Importer Program (VQIP)). During these meetings, participants and key FDA subject matter experts will discuss the next phase of FSMA implementation related to import safety programs, which includes establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance. The purpose of the regional outreach public meetings is to continue the dialogue with the importer community on FSMA and elicit ideas that will help to inform FDA and our stakeholders on how to continue to work together to successfully comply with FSMA mandates and regulations.
The Food and Drug Administration (FDA or we) is announcing a public meeting entitled “FDA Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation.” The public meeting will provide importers and other interested persons an opportunity to discuss import safety regulations and programs, including final rules for foreign supplier verification programs (FSVPs) for importers of food for humans and animals (the FSVP final rule) and accreditation of third-party certification bodies (the third-party certification final rule). Participants will also be briefed on the status of FDA's Voluntary Qualified Importer Program (VQIP), which is still in development. Additionally, the public meeting will provide importers and other interested persons an opportunity to discuss FDA's comprehensive planning effort for the next phase of the FDA Food Safety Modernization Act implementation relating to import safety programs, which includes establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance.
The Food and Drug Administration (FDA) is adopting a regulation on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The regulation requires importers to verify that food they import into the United States is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA). The regulation will help ensure the safety of imported food.