21 C.F.R. § 203.12 An appeal from an adverse decision by the district office.
Title 21 - Food and Drugs
An appeal from an adverse decision by the district office involving insulin-containing drugs or prescription human drugs, other than biological products, may be made to the Office of Compliance (HFD–300), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. An appeal from an adverse decision by the district office involving prescription human biological products may be made to the Office of Compliance and Biologics Quality (HFM–600), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852 or the Office of Compliance (HFD–300), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, depending on the Center responsible for regulating the product. [64 FR 67756, Dec. 3, 1999, as amended at 69 FR 48775, Aug. 11, 2004; 70 FR 14980, Mar. 24, 2005]
Title 21: Food and Drugs
PART 203—PRESCRIPTION DRUG MARKETING
Subpart B—Reimportation
§ 203.12 An appeal from an adverse decision by the district office.
