§ 207.21 When must initial registration information be provided?

(a) Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug or an animal feed bearing or containing a new animal drug at such establishment.

(b) Registrants must register each foreign establishment before a drug or an animal feed bearing or containing a new animal drug manufactured, repacked, relabeled, or salvaged at the establishment is imported or offered for import into the United States.

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Warning letters citing § 207.21

1 FDA warning letters since 2017 cite this section :

• A.I.G Technologies, Inc. 5 Dec 2017

FDA guidance that cites § 207.21

• CVM GFI #201 SECG for The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 29 Jul 2014
• Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide: Guidance for Industry 6 Dec 2012
• FDA Oversight of PET Drug Products -- Questions and Answers 3 Dec 2012
• Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide): Guidance for Industry 15 Nov 2012
• Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective: Guidance for Industry 21 Jun 2011
• Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide 17 Aug 2010
• Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing 1 Jun 2009

Amendment history

Federal Register documents that created or amended this section.

• 81 FR 60212 31 Aug 2016