21 C.F.R. § 201.58 Waiver of labeling requirements.
Title 21 - Food and Drugs
An applicant may ask the Food and Drug Administration to waive any requirement under §§201.56, 201.57, and 201.80. A waiver request must be submitted in writing to the Director (or the Director's designee), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or, if applicable, the Director (or the Director's designee), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200 North, Rockville, MD 20852–1448. The waiver must be granted or denied in writing by the Director or the Director's designee. [71 FR 3996, Jan. 24, 2006]
Title 21: Food and Drugs
PART 201—LABELING
Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin
§ 201.58 Waiver of labeling requirements.
