PART 329—NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371, 379aa. Source: 79 FR 33089, June 10, 2014, unless otherwise noted. § 329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act. (a) Reporting requirements. (b) Contents of reports. (1) Patient information. (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. (2) Adverse event. (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 patient history, including preexisting medical conditions. (3) Suspect medical product(s). (i) Name; (ii) Dose, frequency, and route of administration used; (iii) Therapy dates; (iv) Diagnosis for use (indication); (v) Whether the product is a combination product as defined in § 3.2(e) of this chapter; (vi) Whether the product is a prescription or nonprescription product; (vii) Whether adverse drug event abated after drug use stopped or dose reduced; (viii) Whether adverse drug event reappeared after reintroduction of drug; (ix) Lot number; (x) Expiration date; (xi) National Drug Code (NDC) number; and (xii) Concomitant medical products and therapy dates. (4) Initial reporter information. (i) Name, address, and telephone number; (ii) Whether the initial reporter is a health care professional; and (iii) Occupation, if a health care professional. (5) Responsible person (as defined in section 760(b) of the FD&C Act) information. (i) Name and contact office address; (ii) Telephone number; (iii) Report source, such as spontaneous; (iv) Date the report was received by responsible person; (v) Whether the ICSR is a 15-day report; (vi) Whether the ICSR is an initial report or followup report; and (vii) Unique case identification number, which must be the same in the initial report and any subsequent followup report(s). (c) Electronic format for submissions. (2) The responsible person may request, in writing, a temporary waiver of the requirements in paragraph (c)(1) of this section. These waivers will be granted on a limited basis for good cause shown. FDA will issue guidance on requesting a waiver of the requirements in paragraph (c)(1) of this section. (d) Patient privacy.