21 CFR 316.1 - Scope of this part.
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(a) This part implements sections 525, 526, 527, and 528 of the act and provides procedures to encourage and facilitate the development of drugs for rare diseases or conditions, including biological products and antibiotics. This part sets forth the procedures and requirements for:
(2) Allowing a sponsor to provide an investigational drug under a treatment protocol to patients who need the drug for treatment of a rare disease or condition.
(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
[57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35132, June 12, 2013]
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.