21 U.S.C. § 379aa — Serious adverse event reporting for non-

Page 628 TITLE 21—FOOD AND DRUGS § 379s § 379s. Preemption for labeling or packaging of cosmetics (a) In general Except as provided in subsection (b), (d), or (e), no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is other- wise not identical with, a requirement specifi- cally applicable to a particular cosmetic or class of cosmetics under this chapter, the Poison Pre- vention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.). (b) Exemption Upon application of a State or political sub- division thereof, the Secretary may by regula- tion, after notice and opportunity for written and oral presentation of views, exempt from sub- section (a), under such conditions as may be pre- scribed in such regulation, a State or political subdivision requirement for labeling or pack- aging that— (1) protects an important public interest that would otherwise be unprotected; (2) would not cause a cosmetic to be in viola- tion of any applicable requirement or prohibi- tion under Federal law; and (3) would not unduly burden interstate com- merce. (c) Scope For purposes of subsection (a), a reference to a State requirement that relates to the pack- aging or labeling of a cosmetic means any spe- cific requirement relating to the same aspect of such cosmetic as a requirement specifically ap- plicable to that particular cosmetic or class of cosmetics under this chapter for packaging or labeling, including any State requirement relat- ing to public information or any other form of public communication. (d) No effect on product liability law Nothing in this section shall be construed to modify or otherwise affect any action or the li- ability of any person under the product liability law of any State. (e) State initiative This section shall not apply to a State re- quirement adopted by a State public initiative or referendum enacted prior to September 1, 1997. (June 25, 1938, ch. 675, § 752, as added Pub. L. 105–115, title IV, § 412(d), Nov. 21, 1997, 111 Stat. 2376.) Editorial Notes REFERENCES IN TEXT The Poison Prevention Packaging Act of 1970, re- ferred to in subsec. (a), is Pub. L. 91–601, Dec. 30, 1970, 84 Stat. 1670, which is classified principally to chapter 39A (§ 1471 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1471 of Title 15 and Tables. The Fair Packaging and Labeling Act, referred to in subsec. (a), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§ 1451 et seq.) of Title 15, Commerce and Trade. For complete classi- fication of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title. PART G—SAFETY REPORTS § 379v. Safety report disclaimers With respect to any entity that submits or is required to submit a safety report or other in- formation in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or in- formation shall not be construed to reflect nec- essarily a conclusion by the entity or the Sec- retary that the report or information con- stitutes an admission that the product involved malfunctioned, caused or contributed to an ad- verse experience, or otherwise caused or contrib- uted to a death, serious injury, or serious ill- ness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or con- tributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness. (June 25, 1938, ch. 675, § 756, as added Pub. L. 105–115, title IV, § 420, Nov. 21, 1997, 111 Stat. 2379.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title. PART H—SERIOUS ADVERSE EVENT REPORTS § 379aa. Serious adverse event reporting for non- prescription drugs (a) Definitions In this section: (1) Adverse event The term ‘‘adverse event’’ means any health- related event associated with the use of a non- prescription drug that is adverse, including— (A) an event occurring from an overdose of the drug, whether accidental or intentional; (B) an event occurring from abuse of the drug; (C) an event occurring from withdrawal from the drug; and (D) any failure of expected pharma- cological action of the drug. (2) Nonprescription drug The term ‘‘nonprescription drug’’ means a drug that is— (A) not subject to section 353(b) of this title; and Page 629 TITLE 21—FOOD AND DRUGS § 379aa (B) not subject to approval in an applica- tion submitted under section 355 of this title. (3) Serious adverse event The term ‘‘serious adverse event’’ is an ad- verse event that— (A) results in— (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under sub- paragraph (A). (4) Serious adverse event report The term ‘‘serious adverse event report’’ means a report that is required to be sub- mitted to the Secretary under subsection (b). (b) Reporting requirement (1) In general The manufacturer, packer, or distributor whose name (pursuant to section 352(b)(1) of this title) appears on the label of a non- prescription drug marketed in the United States (referred to in this section as the ‘‘re- sponsible person’’) shall submit to the Sec- retary any report received of a serious adverse event associated with such drug when used in the United States, accompanied by a copy of the label on or within the retail package of such drug. (2) Retailer A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufac- turer or packer of the nonprescription drug to submit the required reports for such drugs to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such drug that are reported to the retailer through the address or telephone number described in section 352(x) of this title. (c) Submission of reports (1) Timing of reports The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in section 352(x) of this title. (2) New medical information The responsible person shall submit to the Secretary any new medical information, re- lated to a submitted serious adverse event re- port that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new informa- tion is received by the responsible person. (3) Consolidation of reports The Secretary shall develop systems to en- sure that duplicate reports of, and new med- ical information related to, a serious adverse event shall be consolidated into a single re- port. (4) Exemption The Secretary, after providing notice and an opportunity for comment from interested par- ties, may establish an exemption to the re- quirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health. (d) Contents of reports Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modi- fied by the Secretary for nonprescription drugs, and may be accompanied by additional informa- tion. (e) Maintenance and inspection of records (1) Maintenance The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years. (2) Records inspection (A) In general The responsible person shall permit an au- thorized person to have access to records re- quired to be maintained under this section, during an inspection pursuant to section 374 of this title. (B) Authorized person For purposes of this paragraph, the term ‘‘authorized person’’ means an officer or em- ployee of the Department of Health and Human Services who has— (i) appropriate credentials, as deter- mined by the Secretary; and (ii) been duly designated by the Sec- retary to have access to the records re- quired under this section. (f) Protected information A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under sub- section (c)(2), or an adverse event report volun- tarily submitted to the Secretary shall be con- sidered to be— (1) a safety report under section 379v of this title and may be accompanied by a statement, which shall be a part of any report that is re- leased for public disclosure, that denies that the report or the records constitute an admis- sion that the product involved caused or con- tributed to the adverse event; and (2) a record about an individual under sec- tion 552a of title 5 (commonly referred to as the ‘‘Privacy Act of 1974’’) and a medical or similar file the disclosure of which would con- stitute a violation of section 552 of such title 5 (commonly referred to as the ‘‘Freedom of Information Act’’), and shall not be publicly disclosed unless all personally identifiable in- formation is redacted. (g) Rule of construction The submission of any adverse event report in compliance with this section shall not be con- strued as an admission that the nonprescription Page 630 TITLE 21—FOOD AND DRUGS § 379aa–1 drug involved caused or contributed to the ad- verse event. (h) Preemption (1) In general No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a man- datory system for adverse event reports for nonprescription drugs, that is different from, in addition to, or otherwise not identical to, this section. (2) Effect of section (A) In general Nothing in this section shall affect the au- thority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivi- sion. (B) Personally-identifiable information Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Sec- retary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not— (i) be made publicly available pursuant to any State or other law requiring disclo- sure of information or records; or (ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary. (C) Use of safety reports Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner in- consistent with subsection (g) or section 379v of this title. (i) Authorization of appropriations There are authorized to be appropriated to carry out this section such sums as may be nec- essary. (June 25, 1938, ch. 675, § 760, as added Pub. L. 109–462, § 2(a), Dec. 22, 2006, 120 Stat. 3469.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 1 year after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109–462, set out as an Effective Date of 2006 Amendment note under section 352 of this title. MODIFICATIONS Pub. L. 109–462, § 2(b), Dec. 22, 2006, 120 Stat. 3472, pro- vided that: ‘‘The Secretary of Health and Human Serv- ices may modify requirements under the amendments made by this section [enacting this section and amend- ing sections 331 and 352 of this title] in accordance with section 553 of title 5, United States Code, to maintain consistency with international harmonization efforts over time.’’ GUIDANCE Pub. L. 109–462, § 2(e)(3), Dec. 22, 2006, 120 Stat. 3472, provided that: ‘‘Not later than 270 days after the date of enactment of this Act [Dec. 22, 2006], the Secretary of Health and Human Services shall issue guidance on the minimum data elements that should be included in a serious adverse event report described under the amendments made by this Act [see Short Title of 2006 Amendment note set out under section 301 of this title].’’ Pub. L. 109–462, § 3(d)(3), Dec. 22, 2006, 120 Stat. 3475, enacted provisions substantially identical to those en- acted by Pub. L. 109–462, § 2(e)(3), set out above. § 379aa–1. Serious adverse event reporting for di- etary supplements (a) Definitions In this section: (1) Adverse event The term ‘‘adverse event’’ means any health- related event associated with the use of a die- tary supplement that is adverse. (2) Serious adverse event The term ‘‘serious adverse event’’ is an ad- verse event that— (A) results in— (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under sub- paragraph (A). (3) Serious adverse event report The term ‘‘serious adverse event report’’ means a report that is required to be sub- mitted to the Secretary under subsection (b). (b) Reporting requirement (1) In general The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to section 343(e)(1) of this title) appears on the label of a dietary supplement marketed in the United States (referred to in this section as the ‘‘responsible person’’) shall submit to the Secretary any report received of a serious ad- verse event associated with such dietary sup- plement when used in the United States, ac- companied by a copy of the label on or within the retail packaging of such dietary supple- ment. (2) Retailer A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufac- turer or packer of the dietary supplement to submit the required reports for such dietary supplements to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such die- tary supplement that are reported to the re- tailer through the address or telephone num- ber described in section 343(y) of this title. (c) Submission of reports (1) Timing of reports The responsible person shall submit to the Secretary a serious adverse event report no