Regulatory Text
21 C.F.R. § 4.100 — What is the scope of this subpart?
§ 4.100 What is the scope of this subpart? (a) This subpart identifies postmarketing safety reporting requirements for combination product applicants and constituent part applicants. (b) This subpart does not apply to investigational combination products, combination products that have not received marketing authorization, or to persons other than combination product applicants and constituent part applicants. (c) This subpart supplements and does not supersede other provisions of this chapter, including the provisions in parts 314, 600, 606, 803, and 806 of this chapter, unless a regulation explicitly provides otherwise.
Source: ecfr.gov · govinfo.gov — public domain
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Root-LD v1.0 · boisestandard.org
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BS-CFR21-SEC-8DCFB7
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REGULATION / FEDERAL-CFR-SECTION
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boisestandard.org
Citation
21 C.F.R. § 4.100
Corpus
CFR — Code of Federal Regulations
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✓ ACTIVE
Source
PRIMARY-SOURCE
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✓ TRUE
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b2771bb1487572d4...
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Pending — corpus passes queued
The regulatory text of 21 C.F.R. § 4.100 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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Title 21 — Food and Drugs
21 C.F.R. § 1.121 C.F.R. § 1.321 C.F.R. § 1.421 C.F.R. § 1.2021 C.F.R. § 1.2121 C.F.R. § 1.2321 C.F.R. § 1.2421 C.F.R. § 1.7021 C.F.R. § 1.7121 C.F.R. § 1.7221 C.F.R. § 1.7321 C.F.R. § 1.7421 C.F.R. § 1.7521 C.F.R. § 1.7621 C.F.R. § 1.7721 C.F.R. § 1.7821 C.F.R. § 1.7921 C.F.R. § 1.8021 C.F.R. § 1.8121 C.F.R. § 1.8321 C.F.R. § 1.9021 C.F.R. § 1.9121 C.F.R. § 1.9421 C.F.R. § 1.9521 C.F.R. § 1.9621 C.F.R. § 1.9721 C.F.R. § 1.9921 C.F.R. § 1.10121 C.F.R. § 1.22521 C.F.R. § 1.226
21 C.F.R. — public domain
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