C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 207—REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE › Subpart A—General

21 C.F.R. § 207.3

Bulk drug substance

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Bulk drug substance, as referenced in sections 503A(b)(1)(A) and 503B(a)(2) of the Federal Food, Drug, and Cosmetic Act, previously defined in § 207.3(a)(4), means the same as “active pharmaceutical ingredient” as defined in § 207.1.

[81 FR 60212, Aug. 31, 2016, as amended at 86 FR 17061, Apr. 1, 2021]
Notes of Decisions
Cited in 4 cases, 1990–2016 · leading case: United States v. Baxter Healthcare Corp., & Glaxo Specialties, Inc., a Corp., Intervenor/defendant-Appellant, 901 F.2d 1401 (7th Cir. 1990).
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United States v. Baxter Healthcare Corp., & Glaxo Specialties, Inc., a Corp., Intervenor/defendant-Appellant, 901 F.2d 1401 (7th Cir. 1990). · cites it 2× “§ 360 (a), 21 C.F.R. §§ 207.3 (a)(8), 210.3(b)(12), and 21 C.”
United States v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014). “To qualify as a “bulk drug substance,” an item must be “represented for use in a drug,” 21 C.F.R. § 207.3 (a)(4), and appellants point to no evidence in the record even suggesting that MSCs are held out for use in Carticel, or any other drug for that matter.”
United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla. 2011). · cites it 2× “, 21 C.F.R. § 207.3 (a)(4) (defining "bulk drug substance” as "any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug .”
AvKARE, Inc. v. United States, 125 Fed. Cl. 11 (Fed. Cl. 2016). “” 21 C.F.R. § 207.3 (a)(8); see also id. §§ 207.”
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