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title 21
Food and Drugs
chapter I-i4
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
part 316
PART 316—ORPHAN DRUGS
subpart D
Subpart D—Orphan-drug Exclusive Approval
Subpart D. Subpart D—Orphan-drug Exclusive Approval
§ 316.31 - Scope of orphan-drug exclusive approval.
§ 316.34 - FDA recognition of exclusive approval.
§ 316.36 - Insufficient quantities of orphan drugs.
