Food

Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507

Resources

How to Comment

The comment period opens October 20, 2017.

Submit electronic comments on http://www.regulations.gov to docket number FDA-2017-D-6133.

Submit written comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2017-D-6133

Questions?

For questions regarding this draft document as it relates to our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2166.

For questions regarding this draft document as it relates to our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals,” contact the Center for Veterinary Medicine (CVM) at 240-402-6246.

Contains Nonbinding Recommendations
Draft - Not for Implementation

October 2017

This guidance is being distributed for comment purposes only.

The purpose of this guidance is to help establishments and facilities subject to Title 21 of the Code of Federal Regulations (21 CFR) part 117 (part 117) or 21 CFR part 507 (part 507) determine whether they are “solely engaged” in certain activities. Establishments and facilities “solely engaged” in certain activities are exempt from some or all requirements in parts 117 or 507.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration's (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

Download
Draft Guidance for Industry:
Application of the “Solely Engaged”
Exemptions in Parts 117 and 507
(PDF: 55KB)

Table of Contents


This guidance has been jointly prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition, the Office of Surveillance and Compliance in the Center for Veterinary Medicine, and the Office of Foods and Veterinary Medicine in the Office of the Commissioner at the U.S. Food and Drug Administration.

Page Last Updated: 07/06/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English