§364. Definitions — Inbound Citations
21 U.S.C. § 364
Cited by 304 provisions in release 119-102.
Citations to 21 U.S.C. § 364 as a whole
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(ii) The falsification of a report of a serious adverse event submitted to a responsible person (as defined under section 364, 379aa, or 379aa–1 of this title) or the falsification of a serious adverse event report (as defined under section 379aa or 379aa–1 of this title or required under section 364a(a) of this title) submitted to the Secretary.
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(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to the limitations established in section 350c(d) of this title. In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies. In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter. No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data (other than data relating to new drugs, antibiotic drugs, devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 355(j) of this title). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.
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(a) The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or section 387e(h) of this title and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 360j(f) of this title, or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 355 of this title or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title, or is a controlled substance subject to an order under section 360bbb–8d of this title, or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article or1 (5) such article is being imported or offered for import in violation of section 331(cc) of this title, then any such article described in any of clauses (1) through (5) shall be refused admission, except as provided in subsection (b) of this section. If it appears from the examination of such samples or otherwise that the article is a counterfeit drug or counterfeit device, such article shall be refused admission. With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission. If such article is subject to a requirement under section 364a, 379aa, or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in section 364, 379aa, or 379aa–1 of this title) has not complied with a requirement of such section 364a, 379aa, or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 364a, 379aa, or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug, device, or tobacco product refused admission under this section, if such drug, device, or tobacco product is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug, device, or tobacco product under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug, device, or tobacco product. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, device, or tobacco product, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug, device, or tobacco product after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee. Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act [21 U.S.C. 951 et seq.].
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(b) Pending decision as to the admission of an article being imported or offered for import, the Secretary of the Treasury may authorize delivery of such article to the owner or consignee upon the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury. If it appears to the Secretary of Health and Human Services that (1) an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be brought into compliance with this chapter or rendered other than a food, drug, device, or cosmetic, or (2) with respect to an article described in subsection (a) relating to the requirements of section 364a, 379aa, or 379aa–1 of this title, the responsible person (as defined in section 364, 379aa, or 379aa–1 of this title) can take action that would assure that the responsible person is in compliance with section 364a, 379aa, or 379aa–1 of this title, as the case may be, final determination as to admission of such article may be deferred and, upon filing of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection, the Secretary may, in accordance with regulations, authorize the applicant, or, with respect to clause (2), the responsible person, to perform such relabeling or other action specified in such authorization (including destruction or export of rejected articles or portions thereof, as may be specified in the Secretary’s authorization). All such relabeling or other action pursuant to such authorization shall in accordance with regulations be under the supervision of an officer or employee of the Department of Health and Human Services designated by the Secretary, or an officer or employee of the Department of the Treasury designated by the Secretary of the Treasury.
Citations to §364(1)
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(d) The responsible person shall receive reports of adverse events through the domestic address, domestic telephone number, or electronic contact information included on the label in accordance with section 364e(a) of this title.
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(1) The responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or distributed by such person received by such person, for a period of 6 years, except that a responsible person that is considered a small business for the purposes of section 364h of this title, who does not engage in the manufacturing or processing of the cosmetic products described in subsection 364h(b) of this title, shall maintain such records for a period of 3 years.
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(g) A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (b)(2), or an adverse event report, or any new information, voluntarily submitted to the Secretary shall be considered 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 released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and(2) a record about an individual under section 552a of title 5 (commonly referred to as the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would constitute 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 information is redacted.
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(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 released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and
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(1) Nothing in this section shall affect the authority 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 subdivision.
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(2) Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—(A) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or
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(4) The submission of any report in compliance with this section shall not be construed as an admission that the cosmetic product involved caused or contributed to the relevant adverse event.
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(a) Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.
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(a) No State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement for cosmetics that is different from or in addition to, or otherwise not identical with, any requirement applicable under this subchapter with respect to registration and product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation.
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(c) Nothing in the amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022, nor any standard, rule, requirement, regulation, or adverse event report shall be construed to modify, preempt, or displace any action for damages or the liability of any person under the law of any State, whether statutory or based in common law.
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(1) The term “adverse event” means any health-related event associated with the use of a nonprescription 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 pharmacological action of the drug.
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(3) The term “serious adverse event” is an adverse 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 subparagraph (A).
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(2) A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer 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.
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(1) 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.
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(f) A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered 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 released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and(2) a record about an individual under section 552a of title 5 (commonly referred to as the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would constitute 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 information is redacted.
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(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 released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and
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(g) The submission of any adverse event report in compliance with this section shall not be construed as an admission that the nonprescription drug involved caused or contributed to the adverse event.
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(1) No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for nonprescription drugs, that is different from, in addition to, or otherwise not identical to, this section.
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(A) Nothing in this section shall affect the authority 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 subdivision.
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(B) Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary 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 disclosure of information or records; or
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(1) The term “adverse event” means any health-related event associated with the use of a dietary supplement that is adverse.
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(2) The term “serious adverse event” is an adverse 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 subparagraph (A).
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(2) A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer 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 dietary supplement that are reported to the retailer through the address or telephone number described in section 343(y) of this title.
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(1) 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.
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(f) A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered 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 released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and(2) a record about an individual under section 552a of title 5 (commonly referred to as the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would constitute 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 information is redacted.
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(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 released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and
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(g) The submission of any adverse event report in compliance with this section shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event.
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(1) No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for dietary supplements, that is different from, in addition to, or otherwise not identical to, this section.
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(A) Nothing in this section shall affect the authority 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 subdivision.
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(B) Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary 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 disclosure of information or records; or
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(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.
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(v) Carrying out section 355(k)(5) of this title (relating to adverse event reports and postmarket safety activities).
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(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.
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(i) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;
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(ii) developing and using improved adverse event data-collection systems, including information technology systems; and
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(I) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;
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(II) developing and using improved analytical tools, adverse event data-collection systems, including information technology systems, to assess potential safety problems, including access to external databases; and
Citations to §364(2)
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(g) If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for1 safety, as defined in section 364d(c) of this title.
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(a) The responsible person shall submit to the Secretary any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person.
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(1) The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person.
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(1) The responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or distributed by such person received by such person, for a period of 6 years, except that a responsible person that is considered a small business for the purposes of section 364h of this title, who does not engage in the manufacturing or processing of the cosmetic products described in subsection 364h(b) of this title, shall maintain such records for a period of 3 years.
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(f) If the Secretary has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event required to be reported under this section, the Secretary may request in writing a list of such ingredients or categories of ingredients in the specific fragrances or flavors in the cosmetic product, from the responsible person. The responsible person shall ensure that the requested information is submitted to the Secretary within 30 days of such request. In response to a request under section 552 of title 5, information submitted to the Secretary under this subsection shall be withheld under section 552(b)(3) of title 5.
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(4) The submission of any report in compliance with this section shall not be construed as an admission that the cosmetic product involved caused or contributed to the relevant adverse event.
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(a) The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards, in accordance with section 361 of this title. Any such regulations shall be intended to protect the public health and ensure that cosmetic products are not adulterated. Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing practices prescribed by the Secretary under this paragraph1 during an inspection conducted under section 374 of this title.
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(A) Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after December 29, 2022.
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(B) Every person that owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity or 60 days after the deadline for registration under subparagraph (A), whichever is later.
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(3) If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such facility.
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(D) all brand names under which cosmetic products manufactured or processed in the facility are sold; and
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(E) the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.
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(1) For each cosmetic product, the responsible person shall submit to the Secretary a cosmetic product listing, or ensure that such submission is made, at such time and in such manner as the Secretary may prescribe.
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(2) The responsible person of a cosmetic product that is marketed on December 29, 2022, shall submit to the Secretary a cosmetic product listing not later than 1 year after December 29, 2022, or for a cosmetic product that is first marketed after December 29, 2022, within 120 days of marketing such product in interstate commerce. Thereafter, any updates to such listing shall be made annually, consistent with paragraphs (4) and (5).
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(3) The Secretary shall provide for an abbreviated process for the renewal of any cosmetic product listing under this subsection with respect to which there has been no change since the responsible person submitted the previous listing.
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(A) Each such cosmetic product listing shall include—(i) the facility registration number of each facility where the cosmetic product is manufactured or processed;(ii) the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;(iii) the applicable cosmetic category or categories for the cosmetic product;(iv) a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient; and(v) the product listing number, if any previously assigned by the Secretary under subsection (d).
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(i) the facility registration number of each facility where the cosmetic product is manufactured or processed;
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(ii) the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
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(iii) the applicable cosmetic category or categories for the cosmetic product;
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(iv) a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient; and
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(B) A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.
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(5) A responsible person that is required to submit a cosmetic product listing shall submit any updates to such cosmetic product listing annually.
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(d) At the time of the initial registration of any facility under subsection (a)(1) or initial listing of any cosmetic product under (c)(1),1 the Secretary shall assign a facility registration number to the facility and a product listing number to each cosmetic product. The Secretary shall not make such product listing number publicly available.
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(1) The Secretary may suspend the registration of a facility if the Secretary determines that a cosmetic product manufactured or processed by a registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans and the Secretary has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.
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(A) notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and
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(6) If the registration of the facility is suspended under this section, no person shall introduce or deliver for introduction into commerce in the United States cosmetic products from such facility.
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(a) A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.
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(1) The term “adequate substantiation of safety” means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
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(2) The term “safe” means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.
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(a) Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.
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(b) The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after December 29, 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.
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(2) A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that—(A) contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and(B) is in conformity with the requirements of the Secretary for cosmetics labeling under this chapter and section 1453(a) of title 15.
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(a) If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such cosmetic product, and to any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. This subsection shall not be construed to extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).
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(a) Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.
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(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
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(2) Cosmetic products that are injected.
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(3) Cosmetic products that are intended for internal use.
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(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
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(a) Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.
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(b) A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of subchapter V shall not be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title, with respect to such cosmetic products.
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(b) Nothing in the amendments to this chapter made by the Modernization of Cosmetics Regulation Act of 2022 shall be construed to preempt any State statute, public initiative, referendum, regulation, or other State action, except as expressly provided in subsection (a). Notwithstanding subsection (a), nothing in this section shall be construed to prevent any State from prohibiting the use or limiting the amount of an ingredient in a cosmetic product, or from continuing in effect a requirement of any State that is in effect at the time of enactment of the Modernization of Cosmetics Regulation Act of 2022 for the reporting to the State of an ingredient in a cosmetic product.
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(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to the limitations established in section 350c(d) of this title. In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies. In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter. No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data (other than data relating to new drugs, antibiotic drugs, devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 355(j) of this title). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.
Citations to §364(3)(A)
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(a) The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards, in accordance with section 361 of this title. Any such regulations shall be intended to protect the public health and ensure that cosmetic products are not adulterated. Such regulations may allow for the Secretary to inspect records necessary to demonstrate compliance with good manufacturing practices prescribed by the Secretary under this paragraph1 during an inspection conducted under section 374 of this title.
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(b) In establishing regulations for good manufacturing practices under this section, the Secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply. Such regulations shall include simplified good manufacturing practice requirements for smaller businesses, as appropriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses, and may include longer compliance times for smaller businesses. Before issuing regulations to implement subsection (a), the Secretary shall consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the Secretary.
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(A) Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after December 29, 2022.
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(B) Every person that owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity or 60 days after the deadline for registration under subparagraph (A), whichever is later.
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(2) A person required to register a facility under paragraph (1) shall renew such registrations with the Secretary biennially.
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(3) If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such facility.
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(5) The Secretary shall provide for an abbreviated registration renewal process for any person that owns or operates a facility that has not been required to submit updates under paragraph (4) for a registered facility since submission of the most recent registration of such facility under paragraph (1) or (2).
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(A) the facility’s name, physical address, email address, and telephone number;
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(C) the facility registration number, if any, previously assigned by the Secretary under subsection (d);
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(D) all brand names under which cosmetic products manufactured or processed in the facility are sold; and
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(E) the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.
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(i) the facility registration number of each facility where the cosmetic product is manufactured or processed;
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(6) A responsible person may submit product listing information as part of a facility registration or separately.
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(d) At the time of the initial registration of any facility under subsection (a)(1) or initial listing of any cosmetic product under (c)(1),1 the Secretary shall assign a facility registration number to the facility and a product listing number to each cosmetic product. The Secretary shall not make such product listing number publicly available.
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(1) The Secretary may suspend the registration of a facility if the Secretary determines that a cosmetic product manufactured or processed by a registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans and the Secretary has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.
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(A) notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and(B) an opportunity, within 5 business days of the notice provided under subparagraph (A), for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration.
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(A) notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and
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(B) an opportunity, within 5 business days of the notice provided under subparagraph (A), for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration.
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(6) If the registration of the facility is suspended under this section, no person shall introduce or deliver for introduction into commerce in the United States cosmetic products from such facility.
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(a) If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such cosmetic product, and to any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. This subsection shall not be construed to extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).
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(a) Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.
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(b) The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.(2) Cosmetic products that are injected.(3) Cosmetic products that are intended for internal use.(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
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(a) Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.
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(b) A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of subchapter V shall not be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title, with respect to such cosmetic products.
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(B) A memorandum of understanding under subparagraph (A) between the Secretary and another Federal department or agency is effective only in the case of examinations or inspections at facilities or other locations that are jointly regulated by the Secretary and such department or agency.
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(3) In the case of food packed in the Commonwealth of Puerto Rico or a Territory the Secretary shall attempt to make inspection of such food at the first point of entry within the United States when, in his opinion and with due regard to the enforcement of all the provisions of this chapter, the facilities at his disposal will permit of such inspection.
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(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to the limitations established in section 350c(d) of this title. In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies. In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter. No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data (other than data relating to new drugs, antibiotic drugs, devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 355(j) of this title). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.
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(A) bearing on whether the infant formula manufactured or held in the facility inspected meets the requirements of section 350a of this title, or
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(A) Any records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C), shall, upon the request of the Secretary, be provided to the Secretary by such person, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such person. The Secretary’s request shall include a sufficient description of the records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.
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(A) The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], enter sites and facilities specified in subparagraph (C) in order to inspect such records or other information.
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(i) The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with—(I) developing an application or other submission to the Secretary under this chapter or the Public Health Service Act related to marketing authorization for a product described in paragraph (1);(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or(III) holding any records or other information described in subparagraph (B).
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(i) Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including—(I) permitting the Secretary to record or copy such information for purposes of this paragraph;(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred.
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(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred.
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The Secretary of Health and Human Services shall conduct inspections consistent with the authority under section 374 of this title of facilities in which foods are manufactured, processed, packed, or held—
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(1) to ensure that the entities operating the facilities comply with practices to reduce or eliminate cross-contact of a food with residues of major food allergens that are not intentional ingredients of the food; and
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(A) Information concerning the inspection of a facility may be provided to a foreign government if—(i) the Secretary reasonably believes, or the written agreement described in paragraph (2) establishes, that the government has authority to otherwise obtain such information; and(ii) the written agreement executed under paragraph (2) limits the recipient’s use of the information to the recipient’s civil regulatory purposes.
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(a) The Secretary, in consultation with the Administrator of the General Services Administration, shall enter into contracts for the design, construction, and operation of a consolidated Food and Drug Administration administrative and laboratory facility.
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(c) In carrying out this section, the Secretary shall have the power, in connection with real property, buildings, and facilities, to accept on behalf of the Food and Drug Administration gifts or donations of services or property, real or personal, as the Secretary determines to be necessary.
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(4) with the consent of the applicable executive department or independent agency, use the information, services, and facilities of such department or agencies in carrying out this section;
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(C) The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary’s review of pending human drug applications and supplements.
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(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies, and
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(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor.
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(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies;
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(C) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, premarket reports, and supplements.
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(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
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(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.
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(C) The inspection of animal drug establishments and other facilities undertaken as part of the Secretary’s review of pending animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.
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(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
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(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
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(C) The inspection of generic new animal drug establishments and other facilities undertaken as part of the Secretary’s review of pending abbreviated applications, supplemental abbreviated applications, and investigational submissions.
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(A) the responsible party for each domestic facility (as defined in section 350d(b)1 of this title) and the United States agent for each foreign facility subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year;
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(B) the responsible party for a domestic facility (as defined in section 350d(b)1 of this title) and an importer who does not comply with a recall order under section 350l of this title or under section 350a(f) of this title in such fiscal year, to cover food recall activities associated with such order performed by the Secretary, including technical assistance, follow-up effectiveness checks, and public notifications, for such year;
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(i) with respect to domestic facilities (as defined in section 350d(b)1 of this title), 1 or more inspections conducted under section 374 of this title subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this chapter, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction; and
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(B) If a domestic facility (as defined in section 350d(b)1 of this title) or an importer becomes subject to a fee described in subparagraph (A), (B), or (D) of subsection (a)(1) after the maximum amount of fees has been collected by the Secretary under subparagraph (A), the Secretary may collect a fee from such facility or importer.
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(5) The term “contract manufacturing organization facility” means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.
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(A) The term “facility”—(i) means a business or other entity—(I) under one management, either direct or indirect; and(II) at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and(ii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing.
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(C) If a business or other entity would meet the definition of a facility under this paragraph but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.
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(9) The term “human generic drug activities” means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:(A) The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions.(B) The issuance of—(i) approval letters which approve abbreviated new drug applications or supplements to such applications; or(ii) complete response letters which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.(C) The issuance of letters related to Type II active pharmaceutical drug master files which—(i) set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or(ii) document that no deficiencies need to be addressed.(D) Inspections related to generic drugs.(E) Monitoring of research conducted in connection with the review of generic drug submissions and drug master files.(F) Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities:(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.(iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies) insofar as those activities relate to abbreviated new drug applications.(v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities).(G) Regulatory science activities related to generic drugs.
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(11) The term “prior approval supplement” means a request to the Secretary to approve a change in the drug substance, drug product, production process, quality controls, equipment, or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.
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(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
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(i) such submission contains information concerning the manufacture of an active pharmaceutical ingredient at a facility by means other than reference by a letter of authorization to a Type II active pharmaceutical drug master file; and
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(A) Facilities identified in at least one generic drug submission that is approved to produce a finished dosage form of a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject to fees as follows:(i) Each person that owns a facility which is identified in at least one generic drug submission that is approved to produce one or more finished dosage forms of a human generic drug shall be assessed an annual fee for each such facility.(ii) Each person that owns a facility which is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such generic drug submission, shall be assessed an annual fee for each such facility.(iii) Each person that owns a facility identified in at least one generic drug submission that is approved to produce both one or more finished dosage forms subject to clause (i) and one or more active pharmaceutical ingredients subject to clause (ii) shall be subject only to the fee attributable to the manufacture of the finished dosage forms for that facility.
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(i) Each person that owns a facility which is identified in at least one generic drug submission that is approved to produce one or more finished dosage forms of a human generic drug shall be assessed an annual fee for each such facility.
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(ii) Each person that owns a facility which is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such generic drug submission, shall be assessed an annual fee for each such facility.
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(iii) Each person that owns a facility identified in at least one generic drug submission that is approved to produce both one or more finished dosage forms subject to clause (i) and one or more active pharmaceutical ingredients subject to clause (ii) shall be subject only to the fee attributable to the manufacture of the finished dosage forms for that facility.
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(C) Twenty percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a contract manufacturing organization facility shall be equal to twenty-four percent of the fee for a facility that is not a contract manufacturing organization facility. The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions.
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(D) Six percent shall be derived from fees under subsection (a)(4)(A)(ii) (relating to active pharmaceutical ingredient facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States, including its territories and possessions.
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(ii) for each such ingredient that is manufactured at more than one such facility, the total number of such additional facilities; and
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(1) Each person that owns a facility described in subsection (a)(4)(A) or a site or organization required to be identified by paragraph (3) shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year.
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(2) At a minimum, the submission required by paragraph (1) shall include for each such facility—(A) identification of a facility identified in an approved or pending generic drug submission;(B) whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both;(C) whether or not the facility is located within the United States and its territories and possessions;(D) whether the facility manufactures positron emission tomography drugs solely, or in addition to other drugs;(F) whether the facility is a contract manufacturing organization facility.
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(A) identification of a facility identified in an approved or pending generic drug submission;
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(B) whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both;
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(C) whether or not the facility is located within the United States and its territories and possessions;
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(D) whether the facility manufactures positron emission tomography drugs solely, or in addition to other drugs;
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(F) whether the facility is a contract manufacturing organization facility.
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(i) The Secretary shall place the facility on a publicly available arrears list, such that no new abbreviated new drug application or supplement submitted on or after October 1, 2012, from the person that is responsible for paying such fee, or any affiliate of that person, will be received within the meaning of section 355(j)(5)(A) of this title.
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(ii) Any new generic drug submission submitted on or after October 1, 2012, that references such a facility shall not be received, within the meaning of section 355(j)(5)(A) of this title if the outstanding facility fee is not paid within 20 calendar days of the Secretary providing the notification to the sponsor of the failure of the owner of the facility to pay the facility fee under subsection (a)(4)(C).
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(iii) All drugs or active pharmaceutical ingredients manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 352(aa) of this title.
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(B) The penalties under this paragraph shall apply until the fee established by subsection (a)(4) is paid or the facility is removed from all generic drug submissions that refer to the facility.
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(i) If an abbreviated new drug application or supplement to an abbreviated new drug application submitted on or after October 1, 2012, references a facility for which a facility fee has not been paid by the applicable date under subsection (a)(4)(C), the Secretary shall notify the sponsor of the generic drug submission of the failure of the owner of the facility to pay the facility fee.
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(ii) If the facility fee is not paid within 20 calendar days of the Secretary providing the notification under clause (i), the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of section 355(j)(5)(A) of this title.
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(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with human generic drug activities, is no less than $97,000,000 multiplied by the adjustment factor defined in section 379j–41(3) of this title applicable to the fiscal year involved.
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(1) Submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee under this section. Facilities that solely produce positron emission tomography drugs shall not be required to pay a facility fee as established in subsection (a)(4).
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(2) Facilities that produce positron emission tomography drugs or active pharmaceutical ingredients of such drugs are required to be identified pursuant to subsection (f).
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(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
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(C) The inspection of biosimilar biological product establishments and other facilities undertaken as part of the Secretary’s review of pending biosimilar biological product applications and supplements.
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(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of biosimilar biological product applications, is no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved.
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(h) Not later than 120 calendar days after each fiscal year in which fees are assessed and collected under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for such year, a summary description of entities paying the fees, a description of the hiring and placement of new staff, a description of the use of fee resources to support inspecting outsourcing facilities, and the number of inspections and reinspections of such facilities performed each year.
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(2) The term “contract manufacturing organization facility” means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.
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(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
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(6) The term “OTC monograph drug activities” means activities of the Secretary associated with OTC monograph drugs and inspection of facilities associated with such products, including the following activities:(A) The activities necessary for review and evaluation of OTC monographs and OTC monograph order requests, including—(i) orders proposing or finalizing applicable conditions of use for OTC monograph drugs;(ii) orders affecting status regarding general recognition of safety and effectiveness of an OTC monograph ingredient or combination of ingredients under specified conditions of use;(iii) all OTC monograph drug development and review activities, including intra-agency collaboration;(iv) regulation and policy development activities related to OTC monograph drugs;(vi) meetings referred to in section 355h(i) of this title;(vii) review of labeling prior to issuance of orders related to OTC monograph drugs or conditions of use; and(viii) regulatory science activities related to OTC monograph drugs.(B) Inspections related to OTC monograph drugs.(C) Monitoring of clinical and other research conducted in connection with OTC monograph drugs.(D) Safety activities with respect to OTC monograph drugs, including—(i) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;(ii) developing and using improved adverse event data-collection systems, including information technology systems; and(iii) developing and using improved analytical tools to assess potential safety risks, including access to external databases.(E) Other activities necessary for implementation of section 355h of this title.
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(ii) includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and
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(C) If a business or other entity would meet criteria specified in subparagraph (A), but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.
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(i) Each person that owns a facility identified as an OTC monograph drug facility at any time during the applicable period specified in clause (ii) for a fiscal year shall be assessed an annual fee for each such facility as determined under subsection (c).
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(i) For fiscal year 2026, the facility fees required under subparagraph (A) shall be due on the later of—(I) the first business day of June of such year; or(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year.
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(ii) For fiscal year 2027, the facility fees required under subparagraph (A) shall be due—(I) in a first installment representing 50 percent of such fee, on the later of—(aa) October 1, 2026; or(bb) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year; and(II) in a second installment representing the remaining 50 percent of such fee, on—(aa) February 1, 2027; or(bb) if an appropriations Act described in subclause (I)(bb) is not in effect on February 1, 2027, the first business day after enactment of such an appropriations Act.
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(iii) For fiscal year 2028 and each subsequent fiscal year, the facility fees required under subparagraph (A) shall be due on the later of—(I) the first business day on or after October 1 of the fiscal year; or(II) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees under this section for the fiscal year.
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(1) For each of the fiscal years 2026 through 2030, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—(A) the annual base revenue for the fiscal year (as determined under paragraph (2));(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));(C) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2));(D) additional direct cost adjustments (as determined under subsection (c)(3));(E) an additional dollar amount equal to—(i) $2,373,000 for fiscal year 2026;(ii) $1,233,000 for fiscal year 2027; and(iii) $854,000 for fiscal year 2028; and(F) in the case of a fiscal year for which the Secretary applies the one-time facility fee workload adjustment under subsection (c)(4), the dollar amount equal to such adjustment.
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(F) in the case of a fiscal year for which the Secretary applies the one-time facility fee workload adjustment under subsection (c)(4), the dollar amount equal to such adjustment.
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(II) the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the period of the preceding 3 fiscal years exceeds 1,625; and
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(III) with respect to facilities described in subclause (II), the average number of such facilities (expressed as a percentage) that appeared on the arrears lists pursuant to subsection (e)(1)(A)(i) over the period of the preceding 3 fiscal years is less than 30 percent.
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(I) the total facility revenue amount determined under subsection (b) for the fiscal year, exclusive of the adjustment under this paragraph for such fiscal year; and
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(II) the excess facility percentage described in clause (iii).
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(iii) The excess facility percentage described in this clause is—(I) the amount by which the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the preceding 3 fiscal years exceeds 1,625; divided by(II) 1,625.
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(I) the amount by which the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the preceding 3 fiscal years exceeds 1,625; divided by
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(B) publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.
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(2) include for each such facility, at a minimum, identification of the facility’s business operation as that of an OTC monograph drug facility.
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(ii) All OTC monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 352(ff) of this title.
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(B) information regarding registration of OTC monograph drug facilities and contract manufacturing organization facilities and payment of registration fees by such facilities, including—(i) the OTC monograph drug facilities and contract manufacturing organization facilities that were first registered under section 360(c) or 360(i) of this title in the fiscal year; and(ii) for each OTC monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section 379j–72(a) of this title in the fiscal year, whether the facility paid such fee;
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(ii) for each OTC monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section 379j–72(a) of this title in the fiscal year, whether the facility paid such fee;
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(a) The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or section 387e(h) of this title and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 360j(f) of this title, or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 355 of this title or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title, or is a controlled substance subject to an order under section 360bbb–8d of this title, or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article or1 (5) such article is being imported or offered for import in violation of section 331(cc) of this title, then any such article described in any of clauses (1) through (5) shall be refused admission, except as provided in subsection (b) of this section. If it appears from the examination of such samples or otherwise that the article is a counterfeit drug or counterfeit device, such article shall be refused admission. With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission. If such article is subject to a requirement under section 364a, 379aa, or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in section 364, 379aa, or 379aa–1 of this title) has not complied with a requirement of such section 364a, 379aa, or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 364a, 379aa, or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug, device, or tobacco product refused admission under this section, if such drug, device, or tobacco product is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug, device, or tobacco product under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug, device, or tobacco product. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, device, or tobacco product, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug, device, or tobacco product after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee. Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act [21 U.S.C. 951 et seq.].
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(II) If the denial of a request as described in subclause (I) is based on grounds other than an injunction proceeding pursuant to section 332 of this title, seizure action pursuant to section 334 of this title, or a recall designated Class I or Class II pursuant to part 7, title 21, Code of Federal Regulations, and is based on the facility being out of compliance with part 820 of title 21, Code of Federal Regulations, the Secretary shall provide a substantive summary of the specific grounds for noncompliance identified by the Secretary.
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(2) The Secretary shall request the Secretary of Treasury to remove an article held pursuant to paragraph (1) to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held.
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(1) If an article of food is being imported or offered for import into the United States, and the importer, owner, or consignee of the article is a person who has been debarred under section 335a(b)(3) of this title, such article shall be held at the port of entry for the article, and may not be delivered to such person. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.
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(1) 2 If an article of food is being imported or offered for import into the United States, and such article is from a foreign facility for which a registration has not been submitted to the Secretary under section 350d of this title (or for which a registration has been suspended under such section), such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until the foreign facility is so registered. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.
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(i) If an article of food is being imported or offered for import into the United States and a notice under paragraph (1) is not provided in advance in accordance with the requirements under paragraph (1), such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such notice is submitted to the Secretary, and the Secretary examines the notice and determines that the notice is in accordance with the requirements under paragraph (1). Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.
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(o) If an article that is a device is being imported or offered for import into the United States, and the importer, owner, or consignee of such article does not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 360(i) of this title of each establishment that with respect to such article is required under such section to register with the Secretary, the article may be refused admission. If the article is refused admission for failure to submit such a statement, the article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such a statement is submitted to the Secretary. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.
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(1) The Secretary may require, as a condition of granting admission to an article of food imported or offered for import into the United States, that an entity described in paragraph (3) provide a certification, or such other assurances as the Secretary determines appropriate, that the article of food complies with applicable requirements of this chapter. Such certification or assurances may be provided in the form of shipment-specific certificates, a listing of certified facilities that manufacture, process, pack, or hold such food, or in such other form as the Secretary may specify.
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(4) The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence.
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(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for—(I) the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity, and strength; and
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(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for the manufacture, processing, and packing of drugs in the country are adequate to preserve their identity, quality, purity, and strength.
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(e) This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility:(1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).The exemption under paragraph (3) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter2 21, Code of Federal Regulations (or any successor regulations).
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(B) consistent with section 384d of this title, establish a process for the issuance of a facility certification to accompany food offered for importation by importers who have voluntarily agreed to participate in such program; and
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(d) Eligibility shall be limited to an importer offering food for importation from a facility that has a certification described in subsection (a). In reviewing the applications and making determinations on such applications, the Secretary shall consider the risk of the food to be imported based on factors, such as the following:(1) The known safety risks of the food to be imported.(2) The compliance history of foreign suppliers used by the importer, as appropriate.(3) The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards for a designated food.(4) The compliance of the importer with the requirements of section 384a of this title.(5) The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.(6) The potential risk for intentional adulteration of the food.(7) Any other factor that the Secretary determines appropriate.
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(5) The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.
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(1) may enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered under section 350d of this title; and
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(2) shall direct resources to inspections of foreign facilities, suppliers, and food types, especially such facilities, suppliers, and food types that present a high risk (as identified by the Secretary), to help ensure the safety and security of the food supply of the United States.
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(6) The term “eligible entity” means a foreign entity, including a foreign facility registered under section 350d of this title, in the food import supply chain that chooses to be audited by an accredited third-party auditor or the audit agent of such accredited third-party auditor.
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(ii) whether a facility is eligible to receive a facility certification under section 384b(a) of this title for purposes of participating in the program under section 384b of this title.
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(A) An accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii), the Secretary) may not accredit a third-party auditor unless such third-party auditor agrees to issue a written and, as appropriate, electronic food certification, described in section 381(q) of this title, or facility certification under section 384b(a) of this title, as appropriate, to accompany each food shipment for import into the United States from an eligible entity, subject to requirements set forth by the Secretary. Such written or electronic certification may be included with other documentation regarding such food shipment. The Secretary shall consider certifications under section 381(q) of this title and participation in the voluntary qualified importer program described in section 384b of this title when targeting inspection resources under section 350j of this title.
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(ii) determine whether a facility is eligible to be a facility from which food may be offered for import under the voluntary qualified importer program under section 384b of this title.
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(i) An accredited third-party auditor shall issue a food certification under section 381(q) of this title or a facility certification described under subparagraph (B) only after conducting a regulatory audit and such other activities that may be necessary to establish compliance with the requirements of such sections.
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(i) if food certified under section 381(q) of this title or from a facility certified under paragraph (2)(B) by such third-party auditor is linked to an outbreak of foodborne illness that has a reasonable probability of causing serious adverse health consequences or death in humans or animals;
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(a) The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and in response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities), that will provide improvements to such facilities, technologies, and inspection capacity. Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection.
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(1) In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include—(A) facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate—(i) improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies;(ii) improvements in equipment and information technology enhancement to identify unapproved, counterfeit, or other unlawful controlled substances for destruction;(iii) the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods;(iv) upgrades to the security of import facilities; and(v) innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and(B) innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate.
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(A) facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate—(i) improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies;(ii) improvements in equipment and information technology enhancement to identify unapproved, counterfeit, or other unlawful controlled substances for destruction;(iii) the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods;(iv) upgrades to the security of import facilities; and(v) innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and
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(i) improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies;
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(iv) upgrades to the security of import facilities; and
Citations to §364(3)(C)
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(e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 379e of this title. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 361(a) of this title).
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(1) The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person.
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(1) 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 adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.
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(3) Such regulations shall, to the extent deemed necessary by the Secretary to assure the safety of the use or uses for which a particular color additive is listed, prescribe the conditions under which such additive may be safely employed for such use or uses (including, but not limited to, specifications, hereafter in this section referred to as tolerance limitations, as to the maximum quantity or quantities which may be used or permitted to remain in or on the article or articles in or on which it is used; specifications as to the manner in which such additive may be added to or used in or on such article or articles; and directions or other labeling or packaging requirements for such additive).
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(5) The term “prescription drug establishment” means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form. For purposes of this paragraph, the term “manufactured” does not include packaging.
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(ii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing.
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(B) For purposes of subparagraph (A)(ii), the term “manufactured” does not include packaging.
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(iii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies, testing, or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.
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(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter, the Poison Prevention 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.).
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(a) 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 otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this chapter, the Poison Prevention 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.).
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(b) Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement for labeling or packaging that—(1) protects an important public interest that would otherwise be unprotected;(2) would not cause a cosmetic to be in violation of any applicable requirement or prohibition under Federal law; and(3) would not unduly burden interstate commerce.
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(c) For purposes of subsection (a), a reference to a State requirement that relates to the packaging or labeling of a cosmetic means any specific requirement relating to the same aspect of such cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under this chapter for packaging or labeling, including any State requirement relating to public information or any other form of public communication.
Citations to §364(4)
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(a) The responsible person shall submit to the Secretary any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person.
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(1) The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person.
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(2) The responsible person shall submit to the Secretary any new and material medical information, related to a serious adverse event report submitted to the Secretary in accordance with paragraph (1), that is received by the responsible person within 1 year of the initial report to the Secretary, no later than 15 business days after such information is received by such responsible person.
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(3) The Secretary shall develop systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related to, a serious adverse event.
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(d) The responsible person shall receive reports of adverse events through the domestic address, domestic telephone number, or electronic contact information included on the label in accordance with section 364e(a) of this title.
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(1) The responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or distributed by such person received by such person, for a period of 6 years, except that a responsible person that is considered a small business for the purposes of section 364h of this title, who does not engage in the manufacturing or processing of the cosmetic products described in subsection 364h(b) of this title, shall maintain such records for a period of 3 years.
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(A) The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 374 of this title.
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(f) If the Secretary has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event required to be reported under this section, the Secretary may request in writing a list of such ingredients or categories of ingredients in the specific fragrances or flavors in the cosmetic product, from the responsible person. The responsible person shall ensure that the requested information is submitted to the Secretary within 30 days of such request. In response to a request under section 552 of title 5, information submitted to the Secretary under this subsection shall be withheld under section 552(b)(3) of title 5.
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(3) If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person. Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such facility.
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(E) the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.
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(1) For each cosmetic product, the responsible person shall submit to the Secretary a cosmetic product listing, or ensure that such submission is made, at such time and in such manner as the Secretary may prescribe.
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(2) The responsible person of a cosmetic product that is marketed on December 29, 2022, shall submit to the Secretary a cosmetic product listing not later than 1 year after December 29, 2022, or for a cosmetic product that is first marketed after December 29, 2022, within 120 days of marketing such product in interstate commerce. Thereafter, any updates to such listing shall be made annually, consistent with paragraphs (4) and (5).
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(3) The Secretary shall provide for an abbreviated process for the renewal of any cosmetic product listing under this subsection with respect to which there has been no change since the responsible person submitted the previous listing.
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(ii) the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
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(5) A responsible person that is required to submit a cosmetic product listing shall submit any updates to such cosmetic product listing annually.
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(6) A responsible person may submit product listing information as part of a facility registration or separately.
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(A) notice to the facility registrant of the cosmetic product or other responsible person, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Secretary that the facility registration should be suspended; and
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(B) an opportunity, within 5 business days of the notice provided under subparagraph (A), for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration.
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(a) A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.
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(b) Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 361(a) of this title. A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product.
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(a) Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.
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(b) The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after December 29, 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.
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(a) If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such cosmetic product, and to any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. This subsection shall not be construed to extend to recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).
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(a) If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under section 361 of this title or misbranded under section 362 of this title and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by the Secretary (if so prescribed), the Secretary may, by order, require, as the Secretary determines necessary, such person to immediately cease distribution of such article.
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(b) The Secretary shall provide the responsible person who is subject to an order under subsection (a) with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify the order.
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(a) Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.
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(b) The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.(2) Cosmetic products that are injected.(3) Cosmetic products that are intended for internal use.(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
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(1) The manufacturer, packer, or distributor whose name (pursuant to section 352(b)(1) of this title) appears on the label of a nonprescription drug 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 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.
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(1) 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.
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(2) The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.
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(1) 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.
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(A) The responsible person shall permit an authorized person to have access to records required to be maintained under this section, during an inspection pursuant to section 374 of this title.
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(1) 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 adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.
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(1) 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 343(y) of this title.
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(2) The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.
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(1) 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.
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(A) The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 374 of this title.
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(a) The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or section 387e(h) of this title and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of section 360j(f) of this title, or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of section 355 of this title or the importer (as defined in section 384a of this title) is in violation of such section 384a of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section 331(ll) of this title, or is a controlled substance subject to an order under section 360bbb–8d of this title, or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under subsection (f) of such section) have not been complied with regarding such article or1 (5) such article is being imported or offered for import in violation of section 331(cc) of this title, then any such article described in any of clauses (1) through (5) shall be refused admission, except as provided in subsection (b) of this section. If it appears from the examination of such samples or otherwise that the article is a counterfeit drug or counterfeit device, such article shall be refused admission. With respect to an article of food, if importation of such food is subject to, but not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be refused admission. If such article is subject to a requirement under section 364a, 379aa, or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in section 364, 379aa, or 379aa–1 of this title) has not complied with a requirement of such section 364a, 379aa, or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such section 364a, 379aa, or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug, device, or tobacco product refused admission under this section, if such drug, device, or tobacco product is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 1498(a)(1) of title 19) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug, device, or tobacco product under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug, device, or tobacco product. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug, device, or tobacco product, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug, device, or tobacco product after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c). Such process may be combined with the notice and opportunity to appear before the Secretary and introduce testimony, as described in the first sentence of this subsection, as long as appropriate notice is provided to the owner or consignee. Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act [21 U.S.C. 951 et seq.].
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(b) Pending decision as to the admission of an article being imported or offered for import, the Secretary of the Treasury may authorize delivery of such article to the owner or consignee upon the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury. If it appears to the Secretary of Health and Human Services that (1) an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be brought into compliance with this chapter or rendered other than a food, drug, device, or cosmetic, or (2) with respect to an article described in subsection (a) relating to the requirements of section 364a, 379aa, or 379aa–1 of this title, the responsible person (as defined in section 364, 379aa, or 379aa–1 of this title) can take action that would assure that the responsible person is in compliance with section 364a, 379aa, or 379aa–1 of this title, as the case may be, final determination as to admission of such article may be deferred and, upon filing of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection, the Secretary may, in accordance with regulations, authorize the applicant, or, with respect to clause (2), the responsible person, to perform such relabeling or other action specified in such authorization (including destruction or export of rejected articles or portions thereof, as may be specified in the Secretary’s authorization). All such relabeling or other action pursuant to such authorization shall in accordance with regulations be under the supervision of an officer or employee of the Department of Health and Human Services designated by the Secretary, or an officer or employee of the Department of the Treasury designated by the Secretary of the Treasury.
Citations to §364(5)
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(a) The responsible person shall submit to the Secretary any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person.
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(1) The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person.
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(2) The responsible person shall submit to the Secretary any new and material medical information, related to a serious adverse event report submitted to the Secretary in accordance with paragraph (1), that is received by the responsible person within 1 year of the initial report to the Secretary, no later than 15 business days after such information is received by such responsible person.
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(3) The Secretary shall develop systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related to, a serious adverse event.
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(f) If the Secretary has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event required to be reported under this section, the Secretary may request in writing a list of such ingredients or categories of ingredients in the specific fragrances or flavors in the cosmetic product, from the responsible person. The responsible person shall ensure that the requested information is submitted to the Secretary within 30 days of such request. In response to a request under section 552 of title 5, information submitted to the Secretary under this subsection shall be withheld under section 552(b)(3) of title 5.
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(g) A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (b)(2), or an adverse event report, or any new information, voluntarily submitted to the Secretary shall be considered 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 released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and(2) a record about an individual under section 552a of title 5 (commonly referred to as the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would constitute 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 information is redacted.
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(3) The term “serious adverse event” is an adverse 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 subparagraph (A).
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(4) The term “serious adverse event report” means a report that is required to be submitted to the Secretary under subsection (b).
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(1) The manufacturer, packer, or distributor whose name (pursuant to section 352(b)(1) of this title) appears on the label of a nonprescription drug 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 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.
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(1) 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.
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(2) The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.
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(3) The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.
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(d) Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for nonprescription drugs, and may be accompanied by additional information.
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(f) A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered 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 released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and(2) a record about an individual under section 552a of title 5 (commonly referred to as the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would constitute 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 information is redacted.
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(2) The term “serious adverse event” is an adverse 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 subparagraph (A).
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(3) The term “serious adverse event report” means a report that is required to be submitted to the Secretary under subsection (b).
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(1) 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 adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.
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(1) 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 343(y) of this title.
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(2) The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.
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(3) The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.
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(d) Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for dietary supplements, and may be accompanied by additional information.
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(f) A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered 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 released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and(2) a record about an individual under section 552a of title 5 (commonly referred to as the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would constitute 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 information is redacted.