# 16 CFR § 1702.3: Substantive requirements

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-16-1702.3

## Section

- **Citation:** 16 CFR § 1702.3
- **Heading:** Substantive requirements
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 16—Commercial Practices > CHAPTER II—CONSUMER PRODUCT SAFETY COMMISSION > SUBCHAPTER E—POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS > PART 1702—PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS › PETITION PROCEDURES AND REQUIREMENTS

## Text

(a) A petition filed under this part shall include the information required by this part, or a satisfactory explanation for the absence of the information. As provided by § 1702.4, a petition which is not complete may be closed. To be considered complete, a petition shall include the following:
(1) A statement of the justification for the exemption in accordance with § 1702.7,
(2) All reasonably available human experience data, reasonably available relevant experimental data (both human and animal), product and packaging specifications, labeling, and marketing history, in accordance with §§ 1702.8 through 1702.14,
(b) As used in this regulation, “reasonably available” information is data in the petitioner's possession; data that has previously been generated by the petitioner, and data that is obtainable from such sources as: Reports from Poison Control Centers; reports of adverse reactions that have been submitted to the petitioner; the medical, pharmacological, and toxicological literature; and information required by the FDA for an Investigational Exemption for a New Drug (IND) or a New Drug Application (NDA).

## Nearby sections

- [16 CFR § 1700.1 § 1700.1 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1700.1.md)
- [16 CFR § 1700.2 § 1700.2 Authority.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1700.2.md)
- [16 CFR § 1700.3 § 1700.3 Establishment of standards for special packaging.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1700.3.md)
- [16 CFR § 1700.4 § 1700.4 Effective date of standards.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1700.4.md)
- [16 CFR § 1700.5 § 1700.5 Noncomplying package requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1700.5.md)
- [16 CFR § 1700.14 § 1700.14 Substances requiring special packaging.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1700.14.md)
- [16 CFR § 1700.15 § 1700.15 Poison prevention packaging standards.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1700.15.md)
- [16 CFR § 1700.20 § 1700.20 Testing procedure for special packaging.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1700.20.md)
- [16 CFR § 1701.1 § 1701.1 Special packaging for substances subject to a standard that are distributed to pharmacies to be dispensed pursuant to an order of a licensed medical practitioner.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1701.1.md)
- [16 CFR § 1701.3 § 1701.3 Applicability of special packaging requirements to hazardous substances in large size containers.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1701.3.md)
- [16 CFR § 1702.1 § 1702.1 Purpose and policy.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1702.1.md)
- [16 CFR § 1702.2 § 1702.2 Procedural requirements and recommendations.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1702.2.md)
- [16 CFR § 1702.3 § 1702.3 Substantive requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1702.3.md)
- [16 CFR § 1702.4 § 1702.4 Petitions with insufficient or incomplete information.](https://www.frixlaw.com/law-library/statutes/ecfr-16-1702.4.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-16-1702.3. Check the current official text before relying on it. Not legal advice.