21 CFR 207.3 - Definitions
| Cite as | 21 CFR 207.3 |
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24 practice notes
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Public Health Security and Bioterrorism Preparedness and Response Act of 2002;
Food facilities registration,
...as defined by the FD&C Act. This interpretation is consistent with the drug, biologics, and device registration regulations in 21 CFR 207.3(a)(11) and (b), 607.3(i) and (j), and 807.3(h) and (Comment 93) One commenter asks how FDA intends to ensure that a person identifying itself as a ......
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Separate Parts In This Issue
Part VI
Health and Human Services Department, Food and Drug Administration,
...as defined by the FD&C Act. This interpretation is consistent with the drug, biologics, and device registration regulations in 21 CFR 207.3(a)(11) and (b), 607.3(i) and (j), and 807.3(h) and (Comment 93) One commenter asks how FDA intends to ensure that a person identifying itself as a ......
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United States v. Regenerative Scis., LLC, No. 12–5254.
...be enough to bring the Mixture within § 353a. 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 ......
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U.S. v. Baxter Healthcare Corp., Nos. 89-2087
...are all related to matters peripheral to the drug manufacturing 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 a......
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5 cases
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United States v. Franck's Lab, Inc., Case No. 5:10–cv–147–Oc–32TBS.
...not refer to size, volume, or quantity; rather, it refers to the raw chemical materials used in the compounding process. See, e.g., 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, proce......
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United States v. Regenerative Scis., LLC, No. 12–5254.
...be enough to bring the Mixture within § 353a. 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 ......
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U.S. v. Baxter Healthcare Corp., Nos. 89-2087
...are all related to matters peripheral to the drug manufacturing 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 a......
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United States v. Franck's Lab, Inc., Case No. 5:10-cv-147-Oc-32TBS
...not refer to size, volume, or quantity; rather, it refers to the raw chemical materials used in the compounding process. See, e.g., 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, proce......
Request a trial to view additional results