21 CFR 1.377 - What definitions apply to this subpart?

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§ 1.377 What definitions apply to this subpart?
The definitions of terms that appear in section 201 of the act (21 U.S.C. 321) apply when the terms are used in this subpart. In addition, for the purposes of this subpart:
Act means the Federal Food, Drug, and Cosmetic Act.
Authorized FDA representative means an FDA District Director in whose district the article of food involved is located or an FDA official senior to such director.
Calendar day means every day shown on the calendar.
Food has the meaning given in section 201(f) of the act (21 U.S.C. 321(f)). Examples of food include, but are not limited to, fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or components of food, animal feed, including pet food, food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food, dietary supplements and dietary ingredients, infant formula, beverages, including alcoholic beverages and bottled water, live food animals, bakery goods, snack foods, candy, and canned foods.
Perishable food means food that is not heat-treated; not frozen; and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 calendar days under normal shipping and storage conditions.
We means the U.S. Food and Drug Administration (FDA).
Working day means any day from Monday through Friday, excluding Federal holidays.
You means any person who received the detention order or that person's representative.

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-05-29; vol. 79 # 103 - Thursday, May 29, 2014
    1. 79 FR 30716 - Administrative Detention of Drugs Intended for Human or Animal Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective June 30, 2014.
      21 CFR Parts 1 and 16

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.

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 1 after this date.

  • 2014-09-29; vol. 79 # 188 - Monday, September 29, 2014
    1. 79 FR 58524 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; supplemental notice of proposed rulemaking.
      Submit either electronic or written comments on the proposed rule by December 15, 2014 Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 15, 2014 (see the “Paperwork Reduction Act of 1995” section of this document).
      21 CFR Parts 1, 16, and 117