§353a. Pharmacy compounding — Inbound Citations
21 U.S.C. § 353a
Cited by 4 provisions in release 119-102.
Citations to 21 U.S.C. § 353a as a whole
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(2) expressing concerns that a compounding pharmacy may be acting contrary to section 353a of this title.
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(2) the Secretary makes a determination that a pharmacy is acting contrary to section 353a 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.