21 CFR 201.1 - Drugs; name and place of business of manufacturer, packer, or distributor

Cite as21 CFR 201.1
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15 practice notes
  • Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...that is necessary to enable safe and proper administration of the drug (for example, the labeling specified in Sec. Sec. 201.1 and 201.5 (21 CFR 201.1 and 201.5)), including all text, tables, and Domestic. For the purposes of registration and listing under this proposal, and when used to mo......
  • Part II
    • United States
    • Federal Register August 29, 2006
    • August 29, 2006
    ...that is necessary to enable safe and proper administration of the drug (for example, the labeling specified in Sec. Sec. 201.1 and 201.5 (21 CFR 201.1 and 201.5)), including all text, tables, and Domestic. For the purposes of registration and listing under this proposal, and when used to mo......
  • U.S. v. Baxter Healthcare Corp., Nos. 89-2087
    • United States
    • United States Courts of Appeals. United States Court of Appeals (7th Circuit)
    • June 6, 1990
    ...engaged in "manufacturing." Gov't's Brief, pp. 42-43. It cites 21 U.S.C. Sec. 360(a), 21 C.F.R. Secs. 207.3(a)(8), 210.3(b)(12), and 21 C.F.R. Sec. 201.1(b)(10). These statutory and regulatory sections, however, do not define "manufacturing" as such. They are all related to matters peripher......
  • White v. Weiner
    • United States
    • Superior Court of Pennsylvania
    • July 10, 1989
    ...other than the manufacturer, [386 Pa.Super. 122] packer or distributor may be identified on the label of a drug or drug product." 21 C.F.R. § 201.1(h)(1); see also id. § 201.1(a). The label must bear the following information: "description, clinical pharmacology, indications and usage, cont......
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9 cases
  • U.S. v. Baxter Healthcare Corp., Nos. 89-2087
    • United States
    • United States Courts of Appeals. United States Court of Appeals (7th Circuit)
    • June 6, 1990
    ...engaged in "manufacturing." Gov't's Brief, pp. 42-43. It cites 21 U.S.C. Sec. 360(a), 21 C.F.R. Secs. 207.3(a)(8), 210.3(b)(12), and 21 C.F.R. Sec. 201.1(b)(10). These statutory and regulatory sections, however, do not define "manufacturing" as such. They are all related to matters peripher......
  • White v. Weiner
    • United States
    • Superior Court of Pennsylvania
    • July 10, 1989
    ...other than the manufacturer, [386 Pa.Super. 122] packer or distributor may be identified on the label of a drug or drug product." 21 C.F.R. § 201.1(h)(1); see also id. § 201.1(a). The label must bear the following information: "description, clinical pharmacology, indications and usage, cont......
  • McNeil Pharmaceutical v. Hawkins, No. 94-CV-1346
    • United States
    • District of Columbia Court of Appeals of Columbia District
    • December 23, 1996
    ...understand, since it is not apparent on the face of the statute, that the statute is supplemented in great detail by the regulations of 21 C.F.R. §§ 201.1-201.316 (1990). Although these regulations were submitted 686 A.2d 585 to the jury, lay jurors would be unable to assess how the regulat......
  • Pernix Ir. Pain Dac v. Alvogen Malta Operations Ltd., Civil Action No. 16-139-WCB
    • United States
    • United States District Courts. 3th Circuit. United States District Court (Delaware)
    • August 24, 2018
    ...drug for those indications, as dictated by FDA regulations that govern both labeling and advertising for all prescription drugs. See 21 C.F.R. §§ 201.1 – 201.327 (labeling); id. § 202.1 (advertising).In an effort to speed up the approval process for generic drugs, the Hatch-Waxman Act provi......
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2 firm's commentaries
  • Par vs. USA - Off-label Promotion And The First Amendment
    • United States
    • Mondaq United States
    • February 20, 2012
    ...speech concerning off-label use. 32 CFR 201.100(c)(1) is invalid as contrary to 21 USC §353(b)(2). FDA's definition of labeling 21 CFR § 201.1(1)(2) is invalid as contrary to 21 USC § 321(m). Enter a preliminary injunction during the pendency of this case prohibiting enforcement of the fore......
  • Pharma Ruling Broadens Gov't Drug Procurement Options
    • United States
    • JD Supra United States
    • February 26, 2020
    ...United States’ and so are ‘U.S.-made end products’ whether or not they meet the other requirements of ‘domestic end products.’” [10] 21 C.F.R. § 201.1(b). ...

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