21 CFR 210.3 - Definitions
| Cite as | 21 CFR 210.3 |
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62 practice notes
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United States v. Bader, No. 10–1263.
...component that is intended to furnish pharmacological activity or other direct effect.’ ” Id. at 1154 n. 3 (emphasis added) (quoting 21 C.F.R. 210.3(b)(7)), while a “ ‘[d]rug product’ ”—a term that we analogized to “finished drug product”—“is defined as a ‘finished dosage form ... that cont......
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Summit Tech. v. High-Line Med. Instruments Co., No. CV 95-6491 ABC (SHx).
...opinion, the FDA had not "found conclusively that demulcents must be labelled as active or inactive ingredients within the meaning of 21 C.F.R. § 210.3(b)(7)." Sandoz, 902 F.2d at 230. 9 Plaintiff asserts that the various warning letters and the "Import Alert" (see Exhibit 18) indicate that......
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U.S. v. Baxter Healthcare Corp., Nos. 89-2087
...process, such as registration of producers, (21 U.S.C. Sec. 360(a); 21 C.F.R. Sec. 207.3(a)(8)) or good manufacturing practices, (21 C.F.R. Sec. 210.3(b)(12)), or labeling (21 C.F.R. Sec. 201.1(b)(10)). None can be considered an authoritative definition, for each is obviously intended for p......
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The More Things Change: Improvement Patents, Drug Modifications, and the FDA
...is some tolerability in the difference in the generic’s composition relative to the brand that would still allow bioequivalence. See 21 C.F.R. § 210.3(b)(2), (10); see also Janet Freilich, The Paradox of Legal Equivalents and Scientific Equivalence: Reconciling Patent Law’s Doctrine of Equi......
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31 cases
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United States v. Bader, No. 10–1263.
...component that is intended to furnish pharmacological activity or other direct effect.’ ” Id. at 1154 n. 3 (emphasis added) (quoting 21 C.F.R. 210.3(b)(7)), while a “ ‘[d]rug product’ ”—a term that we analogized to “finished drug product”—“is defined as a ‘finished dosage form ... that cont......
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Summit Tech. v. High-Line Med. Instruments Co., No. CV 95-6491 ABC (SHx).
...opinion, the FDA had not "found conclusively that demulcents must be labelled as active or inactive ingredients within the meaning of 21 C.F.R. § 210.3(b)(7)." Sandoz, 902 F.2d at 230. 9 Plaintiff asserts that the various warning letters and the "Import Alert" (see Exhibit 18) indicate that......
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U.S. v. Baxter Healthcare Corp., Nos. 89-2087
...process, such as registration of producers, (21 U.S.C. Sec. 360(a); 21 C.F.R. Sec. 207.3(a)(8)) or good manufacturing practices, (21 C.F.R. Sec. 210.3(b)(12)), or labeling (21 C.F.R. Sec. 201.1(b)(10)). None can be considered an authoritative definition, for each is obviously intended for p......
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United States ex rel. Campie v. Gilead Scis., Inc., No. 15-16380
...in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure of any function of the body." 21 C.F.R. § 210.3(b)(7).2 In addition to using the term FTC, relators use the term "API" to refer to "active pharmaceutical products" throughout their complaints......
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6 firm's commentaries
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Biogen Int'l v. Banner Life Sciences LLC (Fed. Cir. 2020)
...has a specific definition as "any component that is intended to furnish pharmacological activity or other direct effect," citing 21 C.F.R. § 210.3(b)(7). It also "must be present in the drug product when administered," citing Hoechst-Roussel Pharm., Inc. v. Lehman, 109 F.3d 756, 759 n.3 (Fe......
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Momenta v. Teva – Effective Claiming of Methods of Testing Drug Products
...as including ‘testing[] and quality control of drug products,’” were rejected by the court emphasizing that such definition applies to 21 C.F.R. § 210.3(b)(12)12 and not § 271(g). Regarding Amphastar’s infringement under § 271(g), based on the holding that the accused products were not “mad......
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FDA Obtains Consent Decree of Permanent Injunction Against Drug Repackager For Alleged CGMP and Labeling Violations
...CGMP regulations that the manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations. See 21 CFR 210.3(b)(12). The cessation of operations is not a defense to an FDA enforcement action. In this instance, Shamrock’s representatives informed the ......
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Federal Circuit Focuses On Active Ingredient, Not Active Moiety, For Scope Of Patent Term Extension
...is a term of art, defined by the FDA as “any component that is intended to furnish pharmacological activity or other direct effect,” 21 C.F.R. § 210.3(b)(7), and it “must be present in the drug product when administered.” Hoechst-Roussel Pharm., Inc. v. Lehman, 109 F.3d 756, 759 n.3 (Fed. C......
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4 books & journal articles
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The Statutory and Regulatory Scheme
...identifying differences between the two labels. An ANDA applicant can comply with the requirement for identical labeling 101. 21 C.F.R. § 210.3(b)(7) dor54588_01_ch01_001-028.indd 21 5/5/16 5:23 PM 22 by using for the generic a verbatim copy of the NDA drug labeling with necessary differenc......
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The More Things Change: Improvement Patents, Drug Modifications, and the FDA
...is some tolerability in the difference in the generic’s composition relative to the brand that would still allow bioequivalence. See 21 C.F.R. § 210.3(b)(2), (10); see also Janet Freilich, The Paradox of Legal Equivalents and Scientific Equivalence: Reconciling Patent Law’s Doctrine of Equi......
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Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials
...mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.” 21 C.F.R. § 210.3(b)(7) (2012). 370. It does not matter whether the chemical entity has been known or for how long. The question for the purposes of exclusivity ......
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Endnotes.
...substance to mean a component of a drug that is intended to furnish pharmacological activity in the diagnosis or treatment of disease, 21 CFR 210.3(a)(7); 314.3." See also "Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients", U.S. Department......
1 provisions
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Chapter 509, AB 5667 – AN ACT concerning prescription medications, supplementing Title 45 of the Revised Statutes, and amending P.L.2017, c.135
...for consumer drug disposal shall provide a method that renders the active ingredients in the prescription medication, as defined in 21 C.F.R. 210.3(b)(7)or as defined in a successor regulation, unusable so that the active ingredients cannot be transformed to a physical or chemical condition......