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Regulations last checked for updates: May 16, 2025
Title 16 - Commercial Practices last revised: May 12, 2025
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Title 16
Chapter II
Part 1702 -
§ 1702.1 - Purpose and policy.
§ 1702.2 - Procedural requirements and recommendations.
§ 1702.3 - Substantive requirements.
§ 1702.4 - Petitions with insufficient or incomplete information.
§ 1702.5 - Failure to supply adverse information.
§ 1702.6 - Trade secrets and other confidential information.
§ 1702.7 - Justification for the exemption.
§ 1702.8 - Human experience data.
§ 1702.9 - Relevant experimental data.
§ 1702.10 - Human experimental data involving the testing of human subjects.
§ 1702.11 - Product specifications.
§ 1702.12 - Packaging specifications.
§ 1702.13 - Labeling and packaging samples.
§ 1702.14 - Marketing history.
§ 1702.15 - Petitions alleging the incompatibility of child resistant packaging with the particular substance petitioned for exemption.
§ 1702.16 - Petitions requesting an exemption for a drug or a new drug.
§ 1702.17 - Granting petitions.
§ 1702.18 - Denying petitions.
§ 1702.19 - Effect of filing petition.
authority:
15 U.S.C. 1471
(4), 1472, 1474, 1269(a), 2079(a);
21 U.S.C. 371
(a)
source:
45 FR 13064, Feb. 28, 1980, unless otherwise noted.
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