Sec. 2. Definition of medical food for purposes of Orphan Drug Act
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/bill/117/hr/56/ih/section-2A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 5(b)(3) of the Orphan Drug Act ( 21 U.S.C. 360ee(b)(3) ) is amended to read as follows: The term medical food means a food which— is formulated to be consumed or administered enterally, including tube feeding and oral intake, and dispensed upon a written prescription of a practitioner licensed under the laws of the State in which such practitioner practices to administer drugs; and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, including conditions of inborn errors of metabolism, based on recognized scientific principles, are established by medical evaluation; or in the case of an individual for whom the prescribing physician determines the individual has failed on traditional therapies or determines continuing the traditional therapy is inappropriate for the patient due to comorbidities or severe side effects that endanger the health of the individual— has been shown to provide clinical benefit in well-controlled peer-reviewed clinical trials to patients with a disease or condition specified in clause (i); and is determined by the prescribing physician to be a safer therapeutic option or the only effective clinical option for the individual. .
Section 5 of the Orphan Drug Act ( 21 U.S.C. 360ee ) is amended— by redesignating subsection
(c)as subsection (d); and by inserting after subsection
(b)the following: Medical foods shall be eligible for a National Drug Code number. .
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Sec. 2
Definition of medical food for purposes of Orphan Drug Act
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