Orphan Products Laws and Regulations

Orphan Drugs:

• Orphan Drug Act of 1983
• Orphan Drug Regulations (21 CFR 316) (Revised April 2004)
• Federal Register Final Rule (December 29, 1992)
• Tax Credit (Section 45C of the Internal Revenue Code)
• User Fee Waiver

Humanitarian Use Devices and Humanitarian Device Exemption:

• Safe Medical Devices Act of 1990
• Food and Drug Administration Modernization Act of 1997
• Current HUD/HDE Regulations (21 CFR 814 Subpart H)
• Federal Register Final Rule- Nov 3, 1998
• Federal Register Final Rule- June 26, 1996