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United States • Title 21 CFR • Part 329

Part 329 — PART 329—NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

This part outlines postmarketing reporting requirements for serious adverse drug events for nonprescription human drug products under section 760 of the FD&C Act. It specifies the content of these reports, including patient information, adverse event details, suspect product information, initial reporter details, and responsible person information. Reports must be submitted in an electronic format, with provisions for temporary waivers. Patient privacy is to be maintained by using identification codes instead of names and addresses.

What this part covers

Mandates reporting of serious adverse drug events for nonprescription products under section 760 of the FD&C Act.
Specifies required information for Individual Case Safety Reports (ICSRs), including patient details, adverse event description, suspect product information, and reporter/responsible person data.
Requires electronic submission of reports, with guidance to be issued by the FDA.
Allows for temporary waivers of electronic submission requirements upon written request and good cause.
Emphasizes patient privacy by prohibiting the inclusion of names and addresses, and instead requiring unique patient identification codes.
Details the content for patient information, adverse event description, suspect medical product details, initial reporter information, and responsible person information.
Defines the electronic format requirements for submissions, emphasizing FDA's ability to process, review, and archive.
Clarifies that patient names, healthcare professional names, hospitals, and geographical identifiers are not releasable to the public.

Sections in Part 329

§ 329.100

Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act.

Reporting requirements.(a) Reports of serious adverse events required by section 760 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must include the information specified in this section, as applicable. Except as provided in paragraph (c)(2) of this section, these reports must be submitted to the Agency in electronic format as described in paragraph (c)(1) of this section. Contents of reports.(b) For purposes of reporting serious adverse events under section 760 of the FD&C Act, an individual case safety report (ICSR) constitutes the MedWatch form required to be submitted by section 760(d) of the FD&C Act. ICSRs include the following information: Patient information.(1) (i) Patient identification code; (ii) Patient age at the time of adverse drug experience, or date of birth; (iii) Patient gender; and (iv) Patient weight. Adverse event.(2) (i) Outcome attributed to adverse drug event; (ii) Date of adverse drug event; (iii) Date of ICSR submission; (iv) Description of adverse drug event (including a concise medical narrative); (v) Adverse drug event term(s); (vi) Description of relevant tests, including dates and laboratory data; and (vii) Other relevant…

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