Code of Federal Regulations · Section
§ 35.49 — Suppliers For Sealed Sources Or Devices For Medical Use
10 C.F.R. § 35.49
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For medical use, a licensee may only use—
(a) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under 10 CFR Part 30 and 10 CFR 32.74 of this chapter or equivalent requirements of an Agreement State;
(b) Sealed sources or devices non-commercially transferred from a Part 35 licensee or an Agreement State medical use licensee.
(c) Teletherapy sources manufactured and distributed in accordance with a license issued under 10 CFR Part 30 or the equivalent requirements of an Agreement State.
Authorizing Statute
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Domestic distribution42 U.S.C. § 2111
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Establishment and transfers42 U.S.C. § 5841
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Authority and functions of Director44 U.S.C. § 3504