Summaries of 2003 and 2004 Congressional acts authorizing HHS Secretary to declare emergencies justifying 'emergency use' authorization for introducing EUA products into interstate commerce
Sept. 12, 2025 Update:
St. Benedict Memo - Congressional lawmaking acts related to biological product non-regulation, purported control of “biological select agents and toxins” [BSATs] and other elements of deceit-based federal communicable disease control, vaccination, biodefense and pandemic preparedness programs
Original post:
I’ve been working on the next installment. Below are sections summarizing provisions through which Congress established a program authorizing introduction into interstate commerce and “emergency use” of drugs, devices and biological products.
2003 - 21 USC 360bbb-3 [FDCA 564] - Food and Drugs; Authorization for medical products for use in emergencies
In 1997 (PL 105-115), Congress authorized the "expanded access to unapproved therapies" program, codified at 21 USC 360bbb to 360bbb-2.
In 2003 (PL 108-136, NDAA) Congress added a new provision: "authorization for medical products for use in emergencies," codified at 21 USC 360bbb-3.
Congress authorized the HHS Secretary to "authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an ‘emergency use’)...notwithstanding" other legal provisions governing interstate commerce in drugs, devices and biological products including FDCA 505, [21 USC 355, New Drugs], FDCA 510(k) [21 USC 360(k), Report preceding introduction of devices into interstate commerce], FDCA 515 [21 USC 360e, Premarket approval of devices] and PHSA 351 [42 USC 262, Regulation of biological products]. 21 USC 360bbb-3(a)(1)
Congress provided that, through an "emergency use" authorization, the HHS Secretary may authorize use of two categories of products:
use of a product that "is not approved, licensed, or cleared for commercial distribution" under the laws listed (to be known as an "unapproved product" use) or
use of a product that "is approved, licensed, or cleared under such a provision, but which use is not...an approved, licensed, or cleared use" (to be known as an "unapproved use of an approved product"). 21 USC 360bbb-3(a)(2)
Congress provided that an "emergency use" would be in addition to any other, authorized use. 21 USC 360bbb-3(a)(3)
Congress defined the term ‘biological product’ by reference the definition at 42 USC 262(i) [PHSA 351(i)] as of 1997 (PL 105-115):
The term “biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.
Congress defined the term 'product' to mean "a drug, device, or biological product," and defined the terms ‘emergency use,’ ‘unapproved product’ and ‘unapproved use of an approved product’ by reference to the first paragraph. 21 USC 360bbb-3(a)(4)
Congress authorized the HHS Secretary to "declare an emergency justifying the [emergency use] authorization...for a product on the basis of a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents." 21 USC 360bbb-3(b)(1)
Congress provided for termination of an emergency use authorization declaration to occur upon the earlier of two possible events: "a determination" by the HHS Secretary in consultation with the Secretary of Defense "that the circumstances [military emergency] have ceased to exist; or "the expiration of the one-year period beginning on the date on which the [HHS Secretary's emergency justifying use authorization] declaration is made." 21 USC 360bbb-3(b)(2)(A)
Congress authorized the HHS Secretary to renew a declaration at his discretion. 21 USC 360bbb-3(b)(2)(B)
Congress provided for the HHS Secretary to consult with product manufacturers for disposing of products whose distribution and use in interstate commerce would become unauthorized if the authorization terminated. 21 USC 360bbb-3(b)(2)(C)
Congress directed the HHS Secretary to give advance notice that a declaration was to be terminated, so that users and manufacturers could make arrangements for product returns, disposition of labeling and other informational records, and other disposition. 21 USC 360bbb-3(b)(3)
Congress directed the HHS Secretary to publish "each declaration, determination, advance notice of termination, and renewal" in the Federal Register. 21 USC 360bbb-3(b)(4)
Congress provided "criteria" for issuance of emergency use authorization declarations. Congress directed the HHS Secretary to issue an EUA declaration only if, after consulting with the NIH Director and CDC director "to the extent feasible and appropriate given the circumstances of the emergency involved" he or concludes:
that an agent specified in a declaration...can cause a serious or life-threatening disease or condition;
that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing…such disease or condition; or a serious or life-threatening disease or condition caused by a product authorized under [the EUA] section, approved or cleared under the [Food Drug and Cosmetic Act, for drugs and devices], or licensed under [PHSA 351/42 USC 262, for biological products] for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product;
that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; and
that such other criteria as the Secretary may by regulation prescribe are satisfied." 21 USC 360bbb-3(c)
Congress, under "scope of authorization" provisions, directed the HHS Secretary to state in his "emergency use" authorization declarations, "each disease or condition that the product may be used to diagnose, prevent, or treat;...the Secretary’s conclusions...that the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product; and the Secretary’s conclusions...concerning the safety and potential effectiveness of the product in diagnosing, preventing, or treating such diseases or conditions, including an assessment of the available scientific evidence." 21 USC 360bbb-3(d)
Congress, under "conditions of authorization" provisions, directed the HHS Secretary to "establish such conditions....as the Secretary finds necessary or appropriate to protect the public health," for emergency use of unapproved products, "to the extent practicable given the circumstances of the emergency," for "a person who carries out any activity for which the authorization is issued." 21 USC 360bbb-3(e)(1)(A)
Congress directed the HHS Secretary to establish "appropriate conditions" for health care professionals administering unapproved products, ensuring that they are informed that the Secretary has authorized the emergency use of the product; of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and of the alternatives to the product that are available, and of their benefits and risks. 21 USC 360bbb-3(e)(1)(A)(i)
Congress directed the HHS Secretary to establish "appropriate conditions" for "individuals to whom [unapproved products are] administered," ensuring that they are informed that the Secretary has authorized the emergency use of the product; of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and "of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks." 21 USC 360bbb-3(e)(1)(A)(ii)
Congress directed the HHS Secretary to establish "appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the product." 21 USC 360bbbb-3(e)(1)(A)(iii)
Congress directed the HHS Secretary to establish "appropriate conditions" for manufacturers of unapproved product, concerning recordkeeping and reporting, including records access by the Secretary. 21 USC 360bbb-3(e)(1)(A)(iv)
Congress authorized the HHS Secretary to establish "such conditions...as [he] finds necessary or appropriate to protect the public health," for persons who carry out other activities, such as which entities may distribute the [EUA] product...including limitation to distribution by government entities and...how distribution is to be performed…who may administer the product...and...the categories of individuals to whom, and the circumstances under which, the product may be administered...; conditions with respect to the collection and analysis of information...concerning the safety and effectiveness of the [EUA] product; and (for persons other than manufacturers), conditions concerning record-keeping and reporting, including records access by the Secretary. 21 USC 360bbb-3(e)(1)(B)
Congress directed and authorized much the same conditions for "unapproved use of an approved product" emergency use authorizations, "to the extent practicable given the circumstances of the emergency." 21 USC 360bbb-3(e)(2)(A)
Congress withheld authority for distributors or anyone else to "alter or obscure the labeling provided by the manufacturer" in the event the "emergency use authorizes a change in the labeling of the product, but the manufacturer of the product chooses not to make such change." 21 USC 360bbb-3(e)(2)(B)(i)
Congress authorized persons who are not manufacturers, in such circumstances (manufacturer refusal to change labeling) and who "choose to act under this clause" to "provide appropriate information with respect to such product in addition to the manufacturer's labeling, as long as he does not "alter or obscure" the manufacturer's labeling.
Congress noted that "such additional information shall not be considered labeling for purposes of [FDCA] section 502." 21 USC 360bbb-3(e)(2)(B)(ii)
[FDCA 502 [21 USC 352] prohibits "misbranding" of drugs and devices and deems a drug or device to be misbranded "if its labeling is false or misleading in any particular."]
Congress prohibited the HHS Secretary from establishing, with respect to the distribution and administration of an EUA product for unapproved uses, conditions more restrictive than those for distribution and administration of the product for its approved uses. 21 USC 360bbb-3(e)(2)(C).
Congress authorized the HHS Secretary to waive or limit, "to the extent appropriate given the circumstances of the emergency," requirements regarding current good manufacturing practice [cGMP] otherwise applicable to the manufacture, processing, packing, or holding of products, including requirements under FDCA Section 501 [21 USC 351]. 21 USC 360bbb-3(e)(3)
[FDCA Section 501 prohibits interstate commerce in "adulterated drugs and devices," and deems a drug or device to be adulterated (among other findings) "if it consists in whole or in part of any filthy, putrid, or decomposed substance; if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess." 21 USC 351(a)]
Congress authorized the HHS Secretary to "establish conditions on advertisements and other promotional descriptive printed matter that relate to the emergency use of an EUA product including, with respect to drugs and biological products, requirements applicable to required contents of advertising for prescription drugs pursuant to FDCA 502(n) [21 USC 352(n), or, with respect to devices, requirements under FDCA 502(r) [21 USC 352(r)].
[FDCA Section 502(n) provides that a prescription drug shall be deemed to be misbranded... "unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of (1) the established name as defined in section 502(e)57, printed prominently and in type at least half as large as that used for any trade or brand name thereof, (2) the formula showing quantitatively each ingredient of such drug to the extent required for labels under section 502(e)57, and (3) such other information in brief summary relating to side effects, contraindications, and effectiveness..."
FDCA Section 502(r) provides that a device shall be deemed to be misbranded "...unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that device (1) a true statement of the device’s established name as defined in section 502(e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, and (2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications and, in the case of specific devices made subject to a finding by the Secretary after notice and opportunity for comment that such action is necessary to protect the public health, a full description of the components of such device or the formula showing quantitatively each ingredient of such device..."]
Congress provided for the "duration" of an emergency use authorization to be effective "until the earlier of the termination of the [HHS Secretary's emergency] declaration...or a revocation" and provided that, "notwithstanding" the termination of a declaration under subsection (b) or a revocation under subsection (g), an authorization "shall continue to be effective to provide for continued use of an unapproved product with respect to a patient to whom it was administered during the [emergency declaration's period in effect], to the extent found necessary by such patient’s attending physician." 21 USC 360bbb-3(f)
Congress directed the HHS Secretary periodically review the circumstances and the appropriateness of an authorization, and authorized the HHS Secretary to revoke an authorization "if the criteria...are no longer met or other circumstances make such revocation appropriate to protect the public health or safety." 21 USC 360bbb-3(g)
Congress directed the HHS Secretary to publish, in the Federal Register, notice of each authorization, and each termination or revocation of an authorization, and "an explanation of the reasons therefor (which may include a summary of data or information that has been submitted in an application [for approval] even if such summary may indirectly reveal the existence of such application." 21 USC 360bbb-3(h)(1)
Congress affirmed the applicability of 18 USC 1905, prohibiting public disclosure by US government officers and employees of confidential information, and affirmed the applicability of an exemption provision of the Freedom of Information Act allowing federal officers to withhold "trade secrets and commercial or financial information obtained from a person and privileged or confidential" from public disclosure under 5 USC 552(b)(4). 21 USC 360bbb-3(h)(2)
Congress provided that "actions under the authority of this section by the [HHS] Secretary or by the Secretary of Defense are committed to agency discretion" and therefore beyond the reach of judicial review under the Administrative Procedure Act at 5 USC 701 as generally applied by federal courts. 21 USC 360bbb-3(i)
Congress provided, as "rules of construction," that nothing in the "emergency use" authorization law "impairs the authority of the President as Commander in Chief of the Armed Forces" under the US Constitution;...impairs the authority of the Secretary of Defense with respect to the Department of Defense, including the armed forces, under other provisions of Federal law, or ...impairs the authority of the United States to use or manage quantities of a product that are owned or controlled by the United States (including quantities in [the Strategic National Stockpile])." 21 USC 360bbb-3(j)
Congress provided a categorical exclusion, for "emergency use" of products, from laws governing conduct of clinical investigations, by providing: "If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of" FDCA 505(i), FDCA 520(g), any other FDCA provision or PHSA 351. 21 USC 360bbb-3(k)
Congress provided for persons asked to carry out activities under the "emergency use" authorization law to have the "option to carry out authorized activities," but withheld from the HHS Secretary "any authority to require any person to carry out any activity that becomes lawful pursuant to an [emergency use] authorization." Congress provided that "no person is required to inform the Secretary that the person will not be carrying out such activity," with one exception. Congress required "a manufacturer of a sole-source unapproved product authorized for emergency use" to report to the HHS Secretary "if such manufacturer does not intend to carry out any activity under the authorization." 21 USC 360bbb-3(l)
Congress provided that the "option to carry out authorized activities" would only have legal effect on a person who carries out an activity for which an authorization under this section is issued, and provided that "nothing in this subsection may be construed as restricting the Secretary from imposing conditions on persons who carry out any activity pursuant to an [emergency use] authorization." 21 USC 360bbb-3(l)
2004 - 21 USC 360bbb-3 [FDCA 564] - Food and Drugs; Authorization for medical products for use in emergencies
In 2004 (PL 108-276), Congress amended provisions for "authorization for medical products for use in emergencies" which Congress had enacted in 2003 (PL 108-136) and had been codified at 21 USC 360bbb-3.
When first enacted in 2003, the law authorized the HHS Secretary to declare an emergency justifying the authorization of emergency use of products "on the basis of a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents." This predicate was codified at 21 USC 360bbb-3(b)(1) in 2003 and renumbered to 21 USC 360bbb-3(b)(1)(B) as of 2004.
In 2004, Congress provided two additional predicates authorizing the [HHS] Secretary to "declare an emergency justifying the authorization" for emergency use of products.
In 2004, Congress authorized the HHS Secretary to declare an emergency on the basis of "a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents" 21 USC 360bbb-3(b)(1)(A) as of 2004.
In 2004, Congress authorized the HHS Secretary to declare an emergency on the basis of his own determination: "a determination by the [HHS] Secretary of a public health emergency under [PHSA] section 319 [42 USC 247d] that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents." 21 USC 360bbb-3(b)(1)(C) as of 2004.
In 2004, Congress amended the "termination of declaration" provision, such that the HHS Secretary's declaration (of an emergency justifying authorization for emergency use of products) terminates upon the earlier of a determination by the HHS Secretary, in consultation as appropriate with the Secretary of Homeland Security or the Secretary of Defense, that the circumstances (military emergency, domestic emergency, public health emergency, or significant potential for such emergencies) have "ceased to exist" or the expiration of the one-year period from the date on which the HHS declaration was made. 21 USC 360bbb-3(b)(2)(A) as of 2004
Congress maintained the HHS Secretary's authority to renew any such declaration in his sole discretion. 21 USC 360bbb-3(b)(2)(B)
In 2004, Congress amended the "actions committed to agency discretion" provision, to cover the actions of the HHS Secretary, Secretary of Defense (covered by the 2003 version) and cover the actions of the Secretary of Homeland Security. 21 USC 360bbb-3(i) as of 2004
In 2013 (PL 113-5) Congress added to 360bbb-3, another predicate authorizing the HHS Secretary to issue emergency use authorization declarations upon "the identification of a material threat pursuant to [PHSA] section 319F–2 [42 U.S.C. 247d–6b]...sufficient to affect national security or the health and security of United States citizens living abroad.” 21 USC 360bbb-3(b)(1)(D) as of 2013.
Related:
Feb. 9, 2023 - On the significance of 21 USC 360bbb-3(k): "use" of EUA products "shall not constitute clinical investigation."
Dec. 1, 2023 - On 'mandates,' and the irrelevance of informed consent principles in the EUA countermeasures use context.
June 9, 2025 - On whether US-HHS Secretary Alex Azar needed UN-WHO declaration of "public health emergency of international concern" to issue determination that "public health emergency exists" in January 2020. [includes discussion of 21 USC 360bbb-3(b)(1)]
