[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.12]

[Page 106]
 
                        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]