§353b. Outsourcing facilities — Inbound Citations
21 U.S.C. § 353b
Cited by 7 provisions in release 119-102.
Citations to 21 U.S.C. § 353b as a whole
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(1) The resale of a compounded drug that is labeled “not for resale” in accordance with section 353b of this title.
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(3) The failure to report drugs or adverse events by an entity that is registered in accordance with subsection (b) of section 353b of this title.
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(13) The term “product” means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 360eee–1 of this title, does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42, imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 360ddd of this title), homeopathic drugs marketed in accordance with applicable guidance under this chapter, or a drug compounded in compliance with section 353a or 353b of this title.
Citations to §353b(b)
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(1) An outsourcing facility shall remit the establishment fee due under this section in a fiscal year when submitting a registration pursuant to section 353b(b) of this title for such fiscal year.
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(A) An outsourcing facility shall not be considered registered under section 353b(b) of this title in a fiscal year until the date that the outsourcing facility remits the establishment fee under this subsection for such fiscal year.
Citations to §353b(d)(4)
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(3) The term “outsourcing facility” has the meaning given to such term in section 353b(d)(4) of this title.