[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.12]
[Page 103]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 203 PRESCRIPTION DRUG MARKETING--Table of Contents
Subpart B Reimportation
Sec. 203.12 An appeal from an adverse decision by the district office.
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]
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