42 U.S. Code § 262 - Regulation of biological products

A person that submits an application for a license under this paragraph shall submit to the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c].

if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).

A person that submits an application for a license under this paragraph is subject to sections 505(o), 505(p), and 505–1 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(o), (p), 355–1].

The qualified indication for a drug, submitted under this subsection, if such supplemental application complies with the requirements of subparagraph (B) of section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c)(5)].

In this subparagraph, the terms “qualified indication” and “qualified data summary” have the meanings given such terms in section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.

No person shall falsely label or mark any package or container of any (c) Inspection of establishment for propagation and preparation

Any officer, agent, or employee of the Department of Health and Human Services , authorized by the biological product.

Upon a determination that a batch, lot, or other quantity of a product licensed under this section presents an imminent or substantial hazard to the public health, the section 554 of title 5.

Any violation of paragraph (1) shall subject the violator to a civil penalty of up to $100,000 per day of violation. The amount of a civil penalty under this paragraph shall, effective December 1 of each year beginning 1 year after the effective date of this paragraph, be increased by the percent change in the Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base quarter of the preceding year, adjusted to the nearest ⅒ of 1 percent. For purposes of this paragraph, the term “base quarter”, as used with respect to a year, means the calendar quarter ending on September 30 of such year and the price index for a base quarter is the arithmetical mean of such index for the 3 months comprising such quarter.

No person shall interfere with any officer, agent, or employee of the regulations made by authority thereof.

Any person who shall violate, or aid or abet in violating, any of the provisions of this section shall be punished upon conviction by a fine not exceeding $500 or by imprisonment not exceeding one year, or by both such fine and imprisonment, in the discretion of the court.

Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].

shall be subject to no restriction on the export of the product under this chapter or the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] if the product is manufactured, processed, packaged, and held in conformity with current good manufacturing practice requirements or meets international manufacturing standards as certified by an international standards organization recognized by theFederal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)).

Any person may submit an application for licensure of a (2) Content

(i) Required information An application submitted under this subsection shall include information demonstrating that—

an assessment of toxicity (which may rely on, or consist of, a study or studies described in item (aa) or (cc)); and

a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the (II)

the condition or conditions of use prescribed, recommended, or suggested in the labeling proposed for the reference product;

may include any additional information in support of the application, including publicly-available information with respect to the (III)

may include information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the (B) Interchangeability

An application (or a supplement to an application) submitted under this subsection may include information demonstrating that the (3) Evaluation by Secretary Upon review of an application (or a supplement to an application) submitted under this subsection, the (A) the (i)

the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).

(4) Safety standards for determining interchangeability Upon review of an application submitted under this subsection or any supplement to such application, the (A) the (i)

An application submitted under this subsection shall be reviewed by the division within the Food and Drug Administration that is responsible for the review and approval of the application under which the (C) Risk evaluation and mitigation strategies

1 year after the first commercial marketing of the first interchangeable biosimilar biological product to be approved as interchangeable for that reference product;

a final court decision on all patents in suit in an action instituted under subsection (l)(6) against the applicant that submitted the application for the first approved interchangeable biosimilar biological product; or

the dismissal with or without prejudice of an action instituted under subsection (l)(6) against the applicant that submitted the application for the first approved interchangeable biosimilar (C)

42 months after approval of the first interchangeable biosimilar biological product if the applicant that submitted such application has been sued under subsection (l)(6) and such litigation is still ongoing within such 42-month period; or

18 months after approval of the first interchangeable biosimilar biological product if the applicant that submitted such application has not been sued under subsection (l)(6).

For purposes of this paragraph, the term “final court decision” means a final decision of a court from which no appeal (other than a petition to the United States Supreme Court for a writ of certiorari) has been or can be taken, and the term “first interchangeable biosimilar biological product” means any interchangeable biosimilar (7) Exclusivity for reference product

Approval of an application under this subsection may not be made effective by the (B) Filing period

An approved application that is deemed to be a license for a Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a) for purposes of subparagraphs (A) and (B).

The exclusivity periods described in section 527, section 505A(b)(1)(A)(ii), and section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360cc and 355a(b)(1)(A)(ii), (c)(1)(A)(ii)] shall continue to apply to aBiologics Price Competition and Innovation Act of 2009.

The issuance (or non-issuance) of guidance under subparagraph (A) shall not preclude the review of, or action on, an application submitted under this subsection.

Clause (i) shall not be construed to require the (9) Public listing

Every 30 days after the publication of the first list under clause (i), the Biologics Price Competition and Innovation Act of 2009.

Not later than 30 days after a list of patents under subsection (l)(3)(A), or a supplement to such list under subsection (l)(7), has been provided by the Secretary, and the (iv) Listing of exclusivities

Unless otherwise agreed to by a person that submits an application under subsection (k) (referred to in this subsection as the “subsection (k) applicant”) and the sponsor of the application for the (B) In general

When a subsection (k) applicant submits an application under subsection (k), such applicant shall provide to the persons described in clause (ii), subject to the terms of this paragraph, confidential access to the information required to be produced pursuant to paragraph (2) and any other information that the subsection (k) applicant determines, in its sole discretion, to be appropriate (referred to in this subsection as the “confidential information”).

One or more attorneys designated by the (II) In-house counsel

One attorney that represents the (iii) Patent owner access

A representative of the owner of a patent exclusively licensed to a (C) Limitation on disclosure

No person that receives confidential information pursuant to subparagraph (B) shall disclose any confidential information to any other person or entity, including the (D) Use of confidential information

Confidential information shall be used for the sole and exclusive purpose of determining, with respect to each patent assigned to or exclusively licensed by the (E) Ownership of confidential information

The confidential information disclosed under this paragraph is, and shall remain, the property of the subsection (k) applicant. By providing the confidential information pursuant to this paragraph, the subsection (k) applicant does not provide the (F) Effect of infringement action

as an admission by the subsection (k) applicant regarding the validity, enforceability, or infringement of any patent; or

as an agreement or admission by the subsection (k) applicant with respect to the competency, relevance, or materiality of any confidential information.

The disclosure of any confidential information in violation of this paragraph shall be deemed to cause the subsection (k) applicant to suffer irreparable harm for which there is no adequate legal remedy and the court shall consider immediate injunctive relief to be an appropriate and necessary remedy for any violation or threatened violation of this paragraph.

(A) List by reference product sponsor Not later than 60 days after the receipt of the application and information under paragraph (2), the (i)

a detailed statement that describes, on a claim by claim basis, the factual and legal basis of the opinion of the subsection (k) applicant that such patent is invalid, unenforceable, or will not be infringed by the commercial marketing of the (II)

a statement that the subsection (k) applicant does not intend to begin commercial marketing of the (iii)

Not later than 60 days after receipt of the list and statement under subparagraph (B), the (4) Patent resolution negotiations

After receipt by the subsection (k) applicant of the statement under paragraph (3)(C), the (B) Failure to reach agreement

If, within 15 days of beginning negotiations under subparagraph (A), the subsection (k) applicant and the (5) Patent resolution if no agreement

The subsection (k) applicant shall notify the (B) Exchange of patent lists

the list of patents that the subsection (k) applicant believes should be the subject of an action for patent infringement under paragraph (6); and

the list of patents, in accordance with clause (ii), that the (ii) Number of patents listed by reference product sponsor

Subject to subclause (II), the number of patents listed by the (II) Exception

If a subsection (k) applicant does not list any patent under clause (i)(I), the (6) Immediate patent infringement action

If the subsection (k) applicant and the (B) Action if no agreement on patent list

If the provisions of paragraph (5) apply to the parties as described in paragraph (4)(B), not later than 30 days after the exchange of lists under paragraph (5)(B), the (C) Notification and publication of complaint

Not later than 30 days after a complaint is served to a subsection (k) applicant in an action for patent infringement described under this paragraph, the subsection (k) applicant shall provide the (ii) Publication by Secretary

If a subsection (k) applicant provides the application and information required under paragraph (2)(A), neither the section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent that is described in clauses (i) and (ii) of paragraph (8)(B).

If a subsection (k) applicant fails to complete an action required of the subsection (k) applicant under paragraph (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), paragraph (7), or paragraph (8)(A), the section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent included in the list described in paragraph (3)(A), including as provided under paragraph (7).

If a subsection (k) applicant fails to provide the application and information required under paragraph (2)(A), the section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent that claims the biological product.

The provisions of subsections (a), (d), (e), (f), (h), (i), (j), (k), (l), (n), and (p) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a(a), (d), (e), (f), (h), (i), (j), (k), (l), (n), (p)] shall apply with respect to the extension of a period under paragraphs (2) and (3) to the same extent and in the same manner as such provisions apply with respect to the extension of a period under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a(b), (c)].

(2) Market exclusivity for new biological products If, prior to approval of an application that is submitted under subsection (a), the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a(d)(4)]—

if the section 526 [1] [21 U.S.C. 360bb] for a rare disease or condition, the period for such[1] [21 U.S.C. 360cc(a)] is deemed to be 7 years and 6 months rather than 7 years.

(3) Market exclusivity for already-marketed biological products If the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a(d)(4)]—

if the section 526 1 [21 U.S.C. 360bb] for a rare disease or condition, the period for such21 U.S.C. 360cc(a)] is deemed to be 7 years and 6 months rather than 7 years.

The 21 U.S.C. 355a(d)(4)] is made later than 9 months prior to the expiration of such period.

In the case of an application under subsection (a) with respect to a Controlled Substances Act [21 U.S.C. 801 et seq.], approval of such application shall not take effect until the interim final rule controlling theControlled Substances Act [21 U.S.C. 811(j)].

(2) Date of approval For purposes of this section, with respect to an application described in paragraph (1), references to the date of approval of such application, or licensure of the product subject to such application, shall mean the later of—

The effective date of this paragraph, referred to in subsec. (d)(2), is the effective date of section 315 of Pub. L. 99–660 which added subsec. (d)(2). See Effective Date of 1986 Amendment note set out below.

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (g), (h), (j), and (k)(5)(C), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009, referred to in subsec. (k)(7)(D), (9)(A)(i)(I), (ii), is section 7002(e)(4) of Pub. L. 111–148, which is set out in a note under this section.

Sections 526, 527(a), and 505A(d)(4), referred to in subsec. (m)(2)(B), (3)(B), (4), probably mean sections 526, 527(a), and 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, which are classified to sections 360bb, 360cc(a), and 355a(d)(4), respectively, of Title 21, Food and Drugs.

The Controlled Substances Act, referred to in subsec. (n)(1), is title II of Pub. L. 91–513, Oct. 27, 1970 , 84 Stat. 1242, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Short Title note set out under section 801 of Title 21 and Tables.

2022—Subsec. (k)(2)(A)(i)(I)(bb). Pub. L. 117–328, § 3209(b), amended item (bb) generally. Prior to amendment, item (bb) read as follows: “animal studies (including the assessment of toxicity); and”.

Subsec. (k)(6). Pub. L. 117–328, § 3206(2), substituted “taken, and the term Pub. L. 117–328, § 3206(1), substituted “ThePub. L. 116–260, § 322, added subcl. (III).

2019—Subsec. (i)(1). Pub. L. 116–94, § 605, struck out “(except any chemically synthesized polypeptide)” after “protein”.

2017—Subsec. (m)(2) to (4). Pub. L. 115–52 substituted “section 505A(d)(4)” for “section 505A(d)(3)”.

2016—Subsec. (a)(2)(E). Pub. L. 114–255 added subpar. (E).

2015—Subsec. (n). Pub. L. 114–89 added subsec. (n).

2012—Subsec. (m)(1). Pub. L. 112–144 substituted “(f), (h), (i), (j), (k), (l), (n), and (p)” for “(f), (i), (j), (k), (l), (p), and (q)”.

2010—Subsec. (a)(1)(A). Pub. L. 111–148, § 7002(a)(1), inserted “under this subsection or subsection (k)” after “biologics license”.

Subsec. (i). Pub. L. 111–148, § 7002(b), substituted “In this section:” for “In this section,”, designated remainder of existing provisions as par. (1), substituted “The term” for “the term”, inserted “protein (except any chemically synthesized polypeptide),” after “allergenic product,”, and added pars. (2) to (4).

Subsec. (j). Pub. L. 110–85, § 901(c)(2), inserted “, including the requirements under sections 505(o), 505(p), and 505–1 of such Act,” after “and Cosmetic Act”.

2003—Subsec. (a)(2)(B), (C). Pub. L. 108–155 added subpar. (B) and redesignated former subpar. (B) as (C).

1997—Subsec. (a). Pub. L. 105–115, § 123(a)(1), amended subsec. (a) generally. Prior to amendment, subsec. (a) related to intrastate and interstate traffic inPub. L. 105–115, § 123(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) read as follows: “No person shall falsely label or mark any package or container of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid; nor alter any label or mark on any package or container of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid so as to falsify such label or mark.”

Subsec. (c). Pub. L. 105–115, § 123(c), substituted Pub. L. 105–115, § 123(a)(2), designated par. (2) as subsec. (d), redesignated subpars. (A) and (B) of par. (2) as pars. (1) and (2), respectively, in par. (2), substituted “Any violation of paragraph (1)” for “Any violation of subparagraph (A)” and substituted “this paragraph” for “this subparagraph” wherever appearing, and struck out former par. (1) which read as follows: “Licenses for the maintenance of establishments for the propagation or manufacture and preparation of products described in subsection (a) of this section may be issued only upon a showing that the establishment and the products for which a license is desired meet standards, designed to insure the continued safety, purity, and potency of such products, prescribed inPub. L. 105–115, § 123(d), added subsec. (i).

1996—Subsec. (h). Pub. L. 104–134, § 2104, amended subsec. (h) generally, revising and restating former provisions, which also related to exportation of partially processedPub. L. 104–134, § 2102(d)(2), substituted “in a country listed under section 802(b)(1)” for “in a country listed under section 802(b)(A)” and “to a country listed under section 802(b)(1)” for “to a country listed under section 802(b)(4)”.

1992—Subsec. (c). Pub. L. 102–300, which directed substitution of “Health and HumanPub. L. 99–660, § 315, designated existing provisions as par. (1) and added par. (2).

1970—Subsecs. (a) to (c). Pub. L. 91–515 inserted “vaccine, blood, blood component or derivative, allergenic product,” after “antitoxin” wherever appearing.

Amendment by Pub. L. 110–85 effective 180 days after Sept. 27, 2007 , see section 909 of Pub. L. 110–85, set out as a note under section 331 of Title 21, Food and Drugs.

Amendment by Pub. L. 108–155 effective Dec. 3, 2003 , except as otherwise provided, see section 4 of Pub. L. 108–155, set out as an Effective Date note under section 355c of Title 21, Food and Drugs.

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997 , except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of Title 21, Food and Drugs.

“Paragraph (1) of section 351(h) of the Public Health Service Act [former 42 U.S.C. 262(h)(1)] as added by subsection (a) shall take effect upon the expiration of 90 days after the date of the enactment of this Act [ Nov. 14, 1986 ].”

Amendment by section 315 of Pub. L. 99–660 effective Dec. 22, 1987 , see section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title.

Except as provided in paragraph (2), an application for a Public Health Service Act (42 U.S.C. 262) (as amended by this Act).

has been submitted to the Pub. L. 111–148, see Short Title of 2010 Amendment note under section 201 of this title] as the “(ii)

With respect to an application for a Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is filed not later than March 23, 2019 , and is not approved as of March 23, 2020 , thesection 505 after March 23, 2020 .

“(ii) Effect on listed drugs.— Only for purposes of carrying out clause (i), with respect to any applicable listed drug with respect to such application, the following shall apply:

“(I) Any drug that is a Public Health Service Act (42 U.S.C. 262) pursuant to subparagraph (A) and that is referenced in an application described in clause (i), shall continue to be identified as a listed drug on the list published pursuant to section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and the information for such drug on such list shall not be revised after March 20, 2020 , until—

such drug is removed from such list in accordance with subclause (III) or subparagraph (C) of such section 505(j)(7); or

Any drug that is a Public Health Service Act (42 U.S.C. 262) pursuant to subparagraph (A) and that is referenced in an application described in clause (i) shall be subject only to requirements applicable to “(III)

Upon approval under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act of an application described in clause (i), theFederal Food, Drug, and Cosmetic Act any listed drug that is aPublic Health Service Act pursuant to subparagraph (A) and that is referenced in such approved application, unless such listed drug is referenced in one or more additional applications described in clause (i).

Upon approval of an application described in clause (i), such approved application shall be deemed to be a license for the Public Health Service Act.

An application described in clause (i) shall contain a patent certification or statement described in, as applicable, section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act or clauses (vii) and (viii) of section 505(j)(2)(A) of such Act and, with respect to any listed drug referenced in such application, comply with related requirements concerning any timely filed patent information listed pursuant to section 505(j)(7) of such Act.

“(bb) Date of approval.— The earliest possible date on which any pending application described in clause (i) may be approved shall be determined based on—

the last expiration date of any applicable period of exclusivity that would prevent such approval and that is described in section 505(c)(3)(E), 505(j)(5)(B)(iv), 505(j)(5)(F), 505A [21 U.S.C. 355a], 505E [21 U.S.C. 355f], or 527 [21 U.S.C. 360cc] of the Federal Food, Drug, and Cosmetic Act; and

if the application was submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act and references any listed drug, the last applicable date determined under subparagraph (A), (B), or (C) of section 505(c)(3) of such Act, or, if the application was submitted under section 505(j) of such Act, the last applicable date determined under clause (i), (ii), or (iii) of section 505(j)(5)(B) of such Act.

Nothing in this subparagraph shall be construed to affect section 351(k)(7)(D) of the Public Health Service Act.

The March 23, 2020 , pursuant to clause (i), and continue to identify any applicable listed drug pursuant to clause (ii) on the list published pursuant to section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, even if such review or listing may reveal the existence of such application and the identity of any listed drug for which the investigations described in section 505(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act are relied upon by the applicant for approval of the pending application. Nothing in this subparagraph shall be construed as authorizing thesection 552(b)(4) of title 5, United States Code.

Beginning on October 1, 2022 , this subparagraph shall have no force or effect and any applications described in clause (i) that have not been approved shall be deemed withdrawn.

For purposes of this subsection, the term ‘Public Health Service Act (42 U.S.C. 262) (as amended by this Act).”

During the period beginning on the date of enactment of this Act [ Mar. 23, 2010 ] and ending on October 1, 2010 , thePublic Health Service Act [42 U.S.C. 262(k)] (as added by this Act) during such period.

“(i) In general.— On the date that is 2 years after first receiving a user fee applicable to an application for a Public Health Service Act [42 U.S.C. 262(k)] (as added by this Act), and on a biennial basis thereafter until October 1, 2013 , thesection 351(k). Such an audit shall compare—

the costs of reviewing such applications under such section 351(k) to the amount of the user fee applicable to such applications; and

the ratio of the costs of reviewing applications for 42 U.S.C. 262(a)] (as amended by this Act) to the amount of the user fee applicable to such applications under such section 351(a).

If the audit performed under clause (i) indicates that the ratios compared under subclause (II) of such clause differ by more than 5 percent, then the section 351(k) [42 U.S.C. 262(k)] to more appropriately account for the costs of reviewing such applications.

The section 3511 of title 31, United State Code, to ensure the validity of any potential variability.”

“If a Public Health Service Act (42 U.S.C. 262) (as amended by this Act) has been designated under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare disease or condition, a “(1)

the 7-year period described in section 527(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc(a)); and

Notwithstanding any other provision of this subtitle (or an amendment made by this subtitle), the savings to the Federal Government generated as a result of the enactment of this subtitle shall be used for deficit reduction.”

such biological agents can be used as weapons by individuals or organizations for the purpose of domestic or international terrorism or for other criminal purposes;

the transfer and possession of potentially hazardous biological agents should be regulated to protect public health and safety; and

efforts to protect the public from exposure to such agents should ensure that individuals and groups with legitimate objectives continue to have access to such agents for clinical and research purposes.

[Amended sections 175, 177, and 178 of Title 18, Crimes and Criminal Procedure.]