21 U.S.C. § 881 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 881: Forfeitures
Forfeitures
Status: in_force

(a) Subject property

The following shall be subject to forfeiture to the United States and no property right shall exist in them:

(1) All controlled substances which have been manufactured, distributed, dispensed, or acquired in violation of this subchapter.

(2) All raw materials, products, and equipment of any kind which are used, or intended for use, in manufacturing, compounding, processing, delivering, importing, or exporting any controlled substance or listed chemical in violation of this subchapter.

(3) All property which is used, or intended for use, as a container for property described in paragraph (1), (2), or (9).

(4) All conveyances, including aircraft, vehicles, or vessels, which are used, or are intended for use, to transport, or in any manner to facilitate the transportation, sale, receipt, possession, or concealment of property described in paragraph (1), (2), or (9).

(5) All books, records, and research, including formulas, microfilm, tapes, and data which are used, or intended for use, in violation of this subchapter.

(6) All moneys, negotiable instruments, securities, or other things of value furnished or intended to be furnished by any person in exchange for a controlled substance or listed chemical in violation of this subchapter, all proceeds traceable to such an exchange, and all moneys, negotiable instruments, and securities used or intended to be used to facilitate any violation of this subchapter.

(7) All real property, including any right, title, and interest (including any leasehold interest) in the whole of any lot or tract of land and any appurtenances or improvements, which is used, or intended to be used, in any manner or part, to commit, or to facilitate the commission of, a violation of this subchapter punishable by more than one year's imprisonment.

(8) All controlled substances which have been possessed in violation of this subchapter.

(9) All listed chemicals, all drug manufacturing equipment, all tableting machines, all encapsulating machines, and all gelatin capsules, which have been imported, exported, manufactured, possessed, distributed, dispensed, acquired, or intended to be distributed, dispensed, acquired, imported, or exported, in violation of this subchapter or subchapter II.

(10) Any drug paraphernalia (as defined in section 863 of this title).

(11) Any firearm (as defined in section 921 of title 18) used or intended to be used to facilitate the transportation, sale, receipt, possession, or concealment of property described in paragraph (1) or (2) and any proceeds traceable to such property.

(b) Seizure procedures

Any property subject to forfeiture to the United States under this section may be seized by the Attorney General in the manner set forth in section 981(b) of title 18.

(c) Custody of Attorney General

Property taken or detained under this section shall not be repleviable, but shall be deemed to be in the custody of the Attorney General, subject only to the orders and decrees of the court or the official having jurisdiction thereof. Whenever property is seized under any of the provisions of this subchapter, the Attorney General may—

(1) place the property under seal;

(2) remove the property to a place designated by him; or

(3) require that the General Services Administration take custody of the property and remove it, if practicable, to an appropriate location for disposition in accordance with law.

(d) Other laws and proceedings applicable

The provisions of law relating to the seizure, summary and judicial forfeiture, and condemnation of property for violation of the customs laws; the disposition of such property or the proceeds from the sale thereof; the remission or mitigation of such forfeitures; and the compromise of claims shall apply to seizures and forfeitures incurred, or alleged to have been incurred, under any of the provisions of this subchapter, insofar as applicable and not inconsistent with the provisions hereof; except that such duties as are imposed upon the customs officer or any other person with respect to the seizure and forfeiture of property under the customs laws shall be performed with respect to seizures and forfeitures of property under this subchapter by such officers, agents, or other persons as may be authorized or designated for that purpose by the Attorney General, except to the extent that such duties arise from seizures and forfeitures effected by any customs officer.

(e) Disposition of forfeited property

(1) Whenever property is civilly or criminally forfeited under this subchapter the Attorney General may—

(A) retain the property for official use or, in the manner provided with respect to transfers under section 1616a of title 19, transfer the property to any Federal agency or to any State or local law enforcement agency which participated directly in the seizure or forfeiture of the property;

(B) except as provided in paragraph (4), sell, by public sale or any other commercially feasible means, any forfeited property which is not required to be destroyed by law and which is not harmful to the public;

(C) require that the General Services Administration take custody of the property and dispose of it in accordance with law;

(D) forward it to the Bureau of Narcotics and Dangerous Drugs for disposition (including delivery for medical or scientific use to any Federal or State agency under regulations of the Attorney General); or

(E) transfer the forfeited personal property or the proceeds of the sale of any forfeited personal or real property to any foreign country which participated directly or indirectly in the seizure or forfeiture of the property, if such a transfer—

(i) has been agreed to by the Secretary of State;

(ii) is authorized in an international agreement between the United States and the foreign country; and

(iii) is made to a country which, if applicable, has been certified under section 2291j(b) of title 22.

(2)(A) The proceeds from any sale under subparagraph (B) of paragraph (1) and any moneys forfeited under this subchapter shall be used to pay—

(i) all property expenses of the proceedings for forfeiture and sale including expenses of seizure, maintenance of custody, advertising, and court costs; and

(ii) awards of up to $100,000 to any individual who provides original information which leads to the arrest and conviction of a person who kills or kidnaps a Federal drug law enforcement agent.

Any award paid for information concerning the killing or kidnapping of a Federal drug law enforcement agent, as provided in clause (ii), shall be paid at the discretion of the Attorney General.

(B) The Attorney General shall forward to the Treasurer of the United States for deposit in accordance with section 524(c) of title 28, any amounts of such moneys and proceeds remaining after payment of the expenses provided in subparagraph (A), except that, with respect to forfeitures conducted by the Postal Service, the Postal Service shall deposit in the Postal Service Fund, under section 2003(b)(7) of title 39, such moneys and proceeds.

(3) The Attorney General shall assure that any property transferred to a State or local law enforcement agency under paragraph (1)(A)—

(A) has a value that bears a reasonable relationship to the degree of direct participation of the State or local agency in the law enforcement effort resulting in the forfeiture, taking into account the total value of all property forfeited and the total law enforcement effort with respect to the violation of law on which the forfeiture is based; and

(B) will serve to encourage further cooperation between the recipient State or local agency and Federal law enforcement agencies.

(4)(A) With respect to real property described in subparagraph (B), if the chief executive officer of the State involved submits to the Attorney General a request for purposes of such subparagraph, the authority established in such subparagraph is in lieu of the authority established in paragraph (1)(B).

(B) In the case of property described in paragraph (1)(B) that is civilly or criminally forfeited under this subchapter, if the property is real property that is appropriate for use as a public area reserved for recreational or historic purposes or for the preservation of natural conditions, the Attorney General, upon the request of the chief executive officer of the State in which the property is located, may transfer title to the property to the State, either without charge or for a nominal charge, through a legal instrument providing that—

(i) such use will be the principal use of the property; and

(ii) title to the property reverts to the United States in the event that the property is used otherwise.

(f) Forfeiture and destruction of schedule I and II substances

(1) All controlled substances in schedule I or II that are possessed, transferred, sold, or offered for sale in violation of the provisions of this subchapter; all dangerous, toxic, or hazardous raw materials or products subject to forfeiture under subsection (a)(2) of this section; and any equipment or container subject to forfeiture under subsection (a)(2) or (3) which cannot be separated safely from such raw materials or products shall be deemed contraband and seized and summarily forfeited to the United States. Similarly, all substances in schedule I or II, which are seized or come into the possession of the United States, the owners of which are unknown, shall be deemed contraband and summarily forfeited to the United States.

(2) The Attorney General may direct the destruction of all controlled substances in schedule I or II seized for violation of this subchapter; all dangerous, toxic, or hazardous raw materials or products subject to forfeiture under subsection (a)(2) of this section; and any equipment or container subject to forfeiture under subsection (a)(2) or (3) which cannot be separated safely from such raw materials or products under such circumstances as the Attorney General may deem necessary.

(g) Plants

(1) All species of plants from which controlled substances in schedules I and II may be derived which have been planted or cultivated in violation of this subchapter, or of which the owners or cultivators are unknown, or which are wild growths, may be seized and summarily forfeited to the United States.

(2) The failure, upon demand by the Attorney General or his duly authorized agent, of the person in occupancy or in control of land or premises upon which such species of plants are growing or being stored, to produce an appropriate registration, or proof that he is the holder thereof, shall constitute authority for the seizure and forfeiture.

(3) The Attorney General, or his duly authorized agent, shall have authority to enter upon any lands, or into any dwelling pursuant to a search warrant, to cut, harvest, carry off, or destroy such plants.

(h) Vesting of title in United States

All right, title, and interest in property described in subsection (a) shall vest in the United States upon commission of the act giving rise to forfeiture under this section.

(i) Stay of civil forfeiture proceedings

The provisions of section 981(g) of title 18 regarding the stay of a civil forfeiture proceeding shall apply to forfeitures under this section.

(j) Venue

In addition to the venue provided for in section 1395 of title 28 or any other provision of law, in the case of property of a defendant charged with a violation that is the basis for forfeiture of the property under this section, a proceeding for forfeiture under this section may be brought in the judicial district in which the defendant owning such property is found or in the judicial district in which the criminal prosecution is brought.

(l) 1 Agreement between Attorney General and Postal Service for performance of functions

The functions of the Attorney General under this section shall be carried out by the Postal Service pursuant to such agreement as may be entered into between the Attorney General and the Postal Service.

(Pub. L. 91–513, title II, §511, Oct. 27, 1970, 84 Stat. 1276; Pub. L. 95–633, title III, §301(a), Nov. 10, 1978, 92 Stat. 3777; Pub. L. 96–132, §14, Nov. 30, 1979, 93 Stat. 1048; Pub. L. 98–473, title II, §§306, 309, 518, Oct. 12, 1984, 98 Stat. 2050, 2051, 2075; Pub. L. 99–570, title I, §§1006(c), 1865, 1992, Oct. 27, 1986, 100 Stat. 3207–7, 3207–54, 3207–59; Pub. L. 99–646, §74, Nov. 10, 1986, 100 Stat. 3618; Pub. L. 100–690, title V, §5105, title VI, §§6059, 6074, 6075, 6077(a), (b), 6253, Nov. 18, 1988, 102 Stat. 4301, 4319, 4323–4325, 4363; Pub. L. 101–189, div. A, title XII, §1215(a), Nov. 29, 1989, 103 Stat. 1569; Pub. L. 101–647, title XX, §§2003, 2004, 2007, 2008, Nov. 29, 1990, 104 Stat. 4855, 4856; Pub. L. 102–239, §2, Dec. 17, 1991, 105 Stat. 1912; Pub. L. 103–447, title I, §102(d), Nov. 2, 1994, 108 Stat. 4693; Pub. L. 104–237, title II, §201(b), Oct. 3, 1996, 110 Stat. 3101; Pub. L. 106–185, §§2(c)(2), 5(b), 8(b), Apr. 25, 2000, 114 Stat. 210, 214, 216; Pub. L. 107–273, div. B, title IV, §4002(e)(3), Nov. 2, 2002, 116 Stat. 1810.)

Editorial Notes

References in Text

Subchapter II, referred to in subsec. (a)(9), was in the original "title III", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

Schedules I and II, referred to in subsecs. (f) and (g), are set out in section 812(c) of this title.

Amendments

2002—Subsec. (a)(10). Pub. L. 107–273 substituted "section 863 of this title" for "section 1822 of the Mail Order Drug Paraphernalia Control Act".

2000—Subsec. (a)(4). Pub. L. 106–185, §2(c)(2), struck out before period at end ", except that—

"(A) no conveyance used by any person as a common carrier in the transaction of business as a common carrier shall be forfeited under the provisions of this section unless it shall appear that the owner or other person in charge of such conveyance was a consenting party or privy to a violation of this subchapter or subchapter II of this chapter;

"(B) no conveyance shall be forfeited under the provisions of this section by reason of any act or omission established by the owner thereof to have been committed or omitted by any person other than such owner while such conveyance was unlawfully in the possession of a person other than the owner in violation of the criminal laws of the United States, or of any State; and

"(C) no conveyance shall be forfeited under this paragraph to the extent of an interest of an owner, by reason of any act or omission established by that owner to have been committed or omitted without the knowledge, consent, or willful blindness of the owner".

Subsec. (a)(6). Pub. L. 106–185, §2(c)(2), struck out before period at end ", except that no property shall be forfeited under this paragraph, to the extent of the interest of an owner, by reason of any act or omission established by that owner to have been committed or omitted without the knowledge or consent of that owner".

Subsec. (a)(7). Pub. L. 106–185, §2(c)(2), struck out before period at end ", except that no property shall be forfeited under this paragraph, to the extent of an interest of an owner, by reason of any act or omission established by that owner to have been committed or omitted without the knowledge or consent of that owner".

Subsec. (b). Pub. L. 106–185, §5(b), inserted heading and amended text of subsec. (b) generally. Prior to amendment, subsec. (b) authorized the Attorney General to seize property under this subchapter upon process issued pursuant to the Supplemental Rules for Certain Admirality and Maritime claims and to seize it without process in certain described circumstances.

Subsec. (i). Pub. L. 106–185, §8(b), inserted heading and amended text of subsec. (i) generally. Prior to amendment, text read as follows: "The filing of an indictment or information alleging a violation of this subchapter or subchapter II of this chapter, or a violation of State or local law that could have been charged under this subchapter or subchapter II of this chapter, which is also related to a civil forfeiture proceeding under this section shall, upon motion of the United States and for good cause shown, stay the civil forfeiture proceeding."

1996—Subsec. (a)(2), (6). Pub. L. 104–237, §201(b)(1), inserted "or listed chemical" after "controlled substance".

Subsec. (a)(9). Pub. L. 104–237, §201(b)(2), substituted "possessed, distributed, dispensed, acquired, or intended to be distributed, dispensed, acquired," for "possessed, distributed, or intended to be distributed," and struck out "a felony provision of" after "in violation of".

1994—Subsec. (e)(1)(E)(iii). Pub. L. 103–447 substituted "section 2291j(b) of title 22" for "section 2291(h) of title 22".

1991—Subsec. (e)(1)(B). Pub. L. 102–239, §2(1), substituted "except as provided in paragraph (4), sell" for "sell".

Subsec. (e)(4). Pub. L. 102–239, §2(2), added par. (4).

1990—Subsec. (a)(10). Pub. L. 101–647, §2007, added par. (10).

Subsec. (a)(11). Pub. L. 101–647, §2008, added par. (11).

Subsec. (e)(1)(B). Pub. L. 101–647, §2003, inserted ", by public sale or any other commercially feasible means," after "sell".

Subsec. (f). Pub. L. 101–647, §2004, inserted "; all dangerous, toxic, or hazardous raw materials or products subject to forfeiture under subsection (a)(2) of this section; and any equipment or container subject to forfeiture under subsection (a)(2) or (3) which cannot be separated safely from such raw materials or products" after "this subchapter" in pars. (1) and (2).

1989—Subsec. (e)(3)(B). Pub. L. 101–189 amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "is not so transferred to circumvent any requirement of State law that prohibits forfeiture or limits use or disposition of property forfeited to State or local agencies."

1988—Subsec. (a)(3). Pub. L. 100–690, §6059(b), inserted reference to par. (9).

Subsec. (a)(4). Pub. L. 100–690, §§6059(b), 6075, inserted in introductory provisions reference to par. (9) and added subpar. (C).

Subsec. (a)(7). Pub. L. 100–690, §5105, inserted "(including any leasehold interest)" after "interest".

Subsec. (a)(9). Pub. L. 100–690, §6059(a), added par. (9).

Subsec. (e)(1)(A). Pub. L. 100–690, §6077(b), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "retain the property for official use or transfer the custody or ownership of any forfeited property to any Federal, State, or local agency pursuant to section 1616a of title 19;".

Subsec. (e)(1)(E). Pub. L. 100–690, §6074, added subpar. (E).

Subsec. (e)(2)(B). Pub. L. 100–690, §6253(b), provided for deposit of moneys and proceeds in Postal Service Fund in cases of forfeitures conducted by Postal Service.

Subsec. (e)(3). Pub. L. 100–690, §6077(a), added par. (3).

Subsec. (l). Pub. L. 100–690, §6253(a), added subsec. (l).

1986—Subsec. (b). Pub. L. 99–570, §1865(1)–(3), and Pub. L. 99–646, §74(1)–(3), in making identical amendments in introductory provision and par. (4), struck out "or criminal" after "subject to civil" and inserted paragraph permitting the Government to request issuance of a warrant authorizing seizure of property subject to forfeiture under this section in the same manner as provided for a search warrant under the Federal Rules of Criminal Procedure.

Subsec. (e). Pub. L. 99–570, §1992, designated existing provisions as par. (1) and former pars. (1) to (4) as subpars. (A) to (D), respectively, and added par. (2) in lieu of former concluding provisions which read as follows: "The Attorney General shall ensure the equitable transfer pursuant to paragraph (1) of any forfeited property to the appropriate State or local law enforcement agency so as to reflect generally the contribution of any such agency participating directly in any of the acts which led to the seizure or forfeiture of such property. A decision by the Attorney General pursuant to paragraph (1) shall not be subject to review. The proceeds from any sale under paragraph (2) and any moneys forfeited under this subchapter shall be used to pay all proper expenses of the proceedings for forfeiture and sale including expenses of seizure, maintenance of custody, advertising, and court costs. The Attorney General shall forward to the Treasurer of the United States for deposit in accordance with section 524(c) of title 28 any amounts of such moneys and proceeds remaining after payment of such expenses."

Subsec. (f). Pub. L. 99–570, §1006(c), which directed the amendment of section 511 of the "Comprehensive Drug Abuse Prevention Act of 1978" was executed to this section which is section 511 of the Comprehensive Drug Abuse Prevention Act of 1970, as the probable intent of Congress, by designating existing provisions as par. (1), inserting "or II" in two places, and adding par. (2).

Subsec. (i). Pub. L. 99–570, §1865(b) and Pub. L. 99–646, §74(b), made identical amendments, inserting ", or a violation of State or local law that could have been charged under this subchapter or subchapter II of this chapter,".

1984—Subsec. (a)(7). Pub. L. 98–473, §306(a), added par. (7).

Subsec. (a)(8). Pub. L. 98–473, §518, added par. (8).

Subsec. (b). Pub. L. 98–473, §306(b)(1), inserted "civil or criminal" after "property subject to".

Subsec. (b)(4). Pub. L. 98–473, §306(b)(2), substituted "is subject to civil or criminal forfeiture under" for "has been used or is intended to be used in violation of".

Subsec. (c). Pub. L. 98–473, §306(c)(1), in provisions preceding par. (1), inserted "any of" after "seized under".

Subsec. (c)(3). Pub. L. 98–473, §306(c)(2), inserted ", if practicable," after "remove it".

Subsec. (d). Pub. L. 98–473, §306(d), inserted "any of" after "incurred, under".

Subsec. (e). Pub. L. 98–473, §§306(e), 309, inserted "civilly or criminally" after "Whenever property is" and in provisions preceding par. (1), inserted provisions relating to transfer of custody or ownership of forfeited property in par. (1), substituted "and dispose of it" for "and remove it for disposition" in par. (3), and, in provisions following par. (4), inserted sentence requiring the Attorney General to ensure equitable transfer of any forfeited property, and substituted "accordance with section 524(c) of title 28" for "the general fund of the United States Treasury".

Subsecs. (h) to (j). Pub. L. 98–473, §306(f), added subsecs. (h) to (j).

1979—Subsec. (d). Pub. L. 96–132 substituted "The provisions" for "All provisions" and struck out "and the award of compensation to informers in respect of such forfeitures" after "compromise of claims".

1978—Subsec. (a)(6). Pub. L. 95–633, §301(1), added par. (6).

Subsec. (e). Pub. L. 95–633, §301(a)(2), (3), struck out of cl. (2) provisions relating to use of proceeds of sale and inserted last sentence relating to the forwarding by the Attorney General of money and proceeds remaining after payment of expenses.

Statutory Notes and Related Subsidiaries

Effective Date of 2000 Amendment

Amendment by Pub. L. 106–185 applicable to any forfeiture proceeding commenced on or after the date that is 120 days after Apr. 25, 2000, see section 21 of Pub. L. 106–185, set out as a note under section 1324 of Title 8, Aliens and Nationality.

Effective Date of 1989 Amendment

Pub. L. 101–189, div. A, title XII, §1215(b), Nov. 29, 1989, 103 Stat. 1569, provided that: "The amendment made by subsection (a) [amending this section] shall take effect as of October 1, 1989."

Effective Date of 1988 Amendment

Amendment by section 6059 of Pub. L. 100–690 effective 120 days after Nov. 18, 1988, see section 6061 of Pub. L. 100–690, set out as a note under section 802 of this title.

Pub. L. 100–690, title VI, §6077(c), Nov. 18, 1988, 102 Stat. 4325, as amended by Pub. L. 101–162, title II, §208, Nov. 21, 1989, 103 Stat. 1005, provided that: "Section 551(e)(3)(B) of the Controlled Substances Act [probably means section 511(e)(3)(B) of the Controlled Substances Act, 21 U.S.C. 881(e)(3)(B)], as enacted by subsection (a), shall apply with respect to fiscal years beginning after September 30, 1991."

Constructive Seizure Procedures

Pub. L. 101–225, title II, §210, Dec. 12, 1989, 103 Stat. 1913, provided that: "Not later than 6 months after the date of enactment of this Act [Dec. 12, 1989], the Secretary of Transportation and the Secretary of the Treasury, in order to avoid the devastating economic effects on innocent owners of seizures of their vessels, shall develop a procedure for constructive seizure of vessels of the United States engaged in commercial service as defined in section 2101 of title 46, United States Code, that are suspected of being used for committing violations of law involving personal use quantities of controlled substances."

Regulations for Expedited Administrative Forfeiture Procedures

Pub. L. 100–690, title VI, §6079, Nov. 18, 1988, 102 Stat. 4325, provided that:

"(a) In General.—Not later than 90 days after the date of enactment of this Act [Nov. 18, 1988], the Attorney General and the Secretary of the Treasury shall consult, and after providing a 30-day public comment period, shall prescribe regulations for expedited administrative procedures for seizures under section 511(a)(4), (6), and (7) of the Controlled Substances Act (21 U.S.C. 881(a)(4), (6), and (7)); section 596 of the Tariff Act of 1930 (19 U.S.C. 1595a(a)); and section 2 of the Act of August 9, 1939 (53 Stat. 1291; 49 U.S.C. App. 782 [now 49 U.S.C. 80303]) for violations involving the possession of personal use quantities of a controlled substance.

"(b) Specifications.—The regulations prescribed pursuant to subsection (a) shall—

"(1) minimize the adverse impact caused by prolonged detention, and

"(2) provide for a final administrative determination of the case within 21 days of seizure, or provide a procedure by which the defendant can obtain release of the property pending a final determination of the case. Such regulations shall provide that the appropriate agency official rendering a final determination shall immediately return the property if the following conditions are established:

"(A) the owner or interested party did not know of or consent to the violation;

"(B) the owner establishes a valid, good faith interest in the seized property as owner or otherwise; and

"(C)(1) the owner establishes that the owner at no time had any knowledge or reason to believe that the property in which the owner claims an interest was being or would be used in a violation of the law; and

"(2) if the owner at any time had, or should have had, knowledge or reason to believe that the property in which the owner claims an interest was being or would be used in a violation of the law, that the owner did what reasonably could be expected to prevent the violation.

An owner shall not have the seized property returned under this subsection if the owner had not acted in a normal and customary manner to ascertain how the property would be used.

"(c) Notice.—At the time of seizure or upon issuance of a summons to appear under subsection (d), the officer making the seizure shall furnish to any person in possession of the conveyance a written notice specifying the procedures under this section. At the earliest practicable opportunity after determining ownership of the seized conveyance, the head of the department or agency that seizes the conveyance shall furnish a written notice to the owner and other interested parties (including lienholders) of the legal and factual basis of the seizure.

"(d) Summons in Lieu of Seizure of Commercial Fishing Industry Vessels.—Not later than 90 days after the enactment of this Act [Nov. 18, 1988], the Attorney General, the Secretary of the Treasury, and the Secretary of Transportation shall prescribe joint regulations, after a public comment period of at least 30 days, providing for issuance of a summons to appear in lieu of seizure of a commercial fishing industry vessel as defined in section 2101(11a), (11b), and (11c) [now 2101(12), (13), and (14)] of title 46, United States Code, for violations involving the possession of personal use quantities of a controlled substance. These regulations shall apply when the violation is committed on a commercial fishing industry vessel that is proceeding to or from a fishing area or intermediate port of call, or is actively engaged in fishing operations. The authority provided under this section shall not affect existing authority to arrest an individual for drug-related offenses or to release that individual into the custody of the vessel's master. Upon answering a summons to appear, the procedures set forth in subsections (a), (b), and (c) of this section shall apply. The jurisdiction of the district court for any forfeiture incurred shall not be affected by the use of a summons under this section.

"(e) Personal Use Quantities of a Controlled Substance.—For the purposes of this section, personal use quantities of a controlled substance shall not include sweepings or other evidence of non-personal use amounts."

Executive Documents

Transfer of Functions

Bureau of Narcotics and Dangerous Drugs, including office of Director thereof, in Department of Justice abolished by Reorg. Plan No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87 Stat. 1091, set out in the Appendix to Title 5, Government Organization and Employees. Reorg. Plan No. 2 of 1973 also created in Department of Justice a single, comprehensive agency for enforcement of drug laws to be known as Drug Enforcement Administration, empowered Attorney General to authorize performance by officers, employees, and agencies of Department of functions transferred to him, and directed Attorney General to coordinate all drug law enforcement functions to assure maximum cooperation between Drug Enforcement Administration, Federal Bureau of Investigation, and other units of Department of Justice involved in drug law enforcement.

1 So in original. No subsec. (k) has been enacted.
21 U.S.C. § 464 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 464: Exemptions
Exemptions
Status: in_force

(a) Persons exempted

The Secretary shall, by regulation and under such conditions as to sanitary standards, practices, and procedures as he may prescribe, exempt from specific provisions of this chapter—

(1) retail dealers with respect to poultry products sold directly to consumers in individual retail stores, if the only processing operation performed by such retail dealers is the cutting up of poultry products on the premises where such sales to consumers are made;

(2) for such period of time as the Secretary determines that it would be impracticable to provide inspection and the exemption will aid in the effective administration of this chapter, any person engaged in the processing of poultry or poultry products for commerce and the poultry or poultry products processed by such person: Provided, however, That no such exemption shall continue in effect on and after January 1, 1970; and

(3) persons slaughtering, processing, or otherwise handling poultry or poultry products which have been or are to be processed as required by recognized religious dietary laws, to the extent that the Secretary determines necessary to avoid conflict with such requirements while still effectuating the purposes of this chapter.

(b) Territorial exemption

The Secretary may, under such sanitary conditions as he may by regulations prescribe, exempt from the inspection requirements of this chapter the slaughter of poultry, and the processing of poultry products, by any person in any Territory not organized with a legislative body, solely for distribution within such Territory, when the Secretary determines that it is impracticable to provide such inspection within the limits of funds appropriated for administration of this chapter and that such exemption will aid in the effective administration of this chapter.

(c) Personal slaughtering; custom slaughtering; name and address of the poultry producer or processor in lieu of other labeling requirements; small enterprises; slaughterers or processors of specified number of turkeys; poultry producers raising poultry on own farms

(1) The Secretary shall, by regulation and under such conditions, including sanitary standards, practices, and procedures, as he may prescribe, exempt from specific provisions of this chapter—

(A) the slaughtering by any person of poultry of his own raising, and the processing by him and transportation in commerce of the poultry products exclusively for use by him and members of his household and his nonpaying guests and employees;

(B) the custom slaughter by any person of poultry delivered by the owner thereof for such slaughter, and the processing by such slaughterer and transportation in commerce of the poultry products exclusively for use, in the household of such owner, by him and members of his household and his nonpaying guests and employees: Provided, That such custom slaughterer does not engage in the business of buying or selling any poultry products capable of use as human food;

(C) the slaughtering and processing of poultry products in any State or Territory or the District of Columbia by any poultry producer on his own premises with respect to sound and healthy poultry raised on his premises and the distribution by any person solely within such jurisdiction of the poultry products derived from such operations, if, in lieu of other labeling requirements, such poultry products are identified with the name and address of such poultry producer, and if they are not otherwise misbranded, and are sound, clean, and fit for human food when so distributed; and

(D) the slaughtering of sound and healthy poultry or the processing of poultry products of such poultry in any State or territory or the District of Columbia by any poultry producer or other person for distribution by him solely within such jurisdiction directly to household consumers, restaurants, hotels, and boarding houses, for use in their own dining rooms, or in the preparation of meals for sales direct to consumers, if, in lieu of other labeling requirements, such poultry products are identified with the name and address of the processor, and if they are not otherwise misbranded and are sound, clean, and fit for human food when distributed by such processor.

The exemptions provided for in clauses (C) and (D) above shall not apply if the poultry producer or other person engages in the current calendar year in the business of buying or selling any poultry or poultry products other than as specified in such clauses.

(2) In addition to the specific exemptions provided herein, the Secretary shall, when he determines that the protection of consumers from adulterated or misbranded poultry products will not be impaired by such action, provide by regulation, consistent with subparagraph (3), for the exemption of the operation and products of small enterprises (including poultry producers), not exempted under subparagraph (1), which are engaged in any State or Territory or the District of Columbia in slaughtering and/or cutting up poultry for distribution as carcasses or parts thereof solely for distribution within such jurisdiction, from such provisions of this chapter as he deems appropriate, while still protecting the public from adulterated or misbranded products, under such conditions, including sanitary requirements, as he shall prescribe to effectuate the purposes of this chapter.

(3) No exemption under subparagraph (1)(C) or (D) or subparagraph (2) shall apply to any poultry producer or other person who, in the current calendar year—

(A) slaughters or processes the products of more than 20,000 poultry; or

(B) slaughters or processes the products of poultry at a facility used for slaughtering or processing of the products of poultry by any other poultry producer or person.

Notwithstanding clause (B), the Secretary may grant such exemption to any poultry producer or other person if the Secretary determines, upon application of such poultry producer or other person, that granting such exemption will not impair effectuating the purposes of this chapter.

(4) The provisions of this chapter shall not apply to poultry producers with respect to poultry of their own raising on their own farms if (i) such producers slaughter not more than 1,000 poultry during the calendar year for which this exemption is being determined; (ii) such poultry producers do not engage in buying or selling poultry products other than those produced from poultry raised on their own farms; and (iii) none of such poultry moves in commerce (as defined in section 453(a) of this title).

(d) Pizzas containing poultry products

(1) Under such terms and conditions as the Secretary shall prescribe through rules and regulations issued under this section that may be necessary to ensure food safety and protect public health such as special handling procedures, the Secretary shall exempt pizzas containing a poultry product from the inspection requirements of this chapter if—

(A) the poultry product components of the pizzas have been prepared, inspected, and passed in a cured or cooked form as ready-to-eat in compliance with the requirements of this chapter; and

(B) the pizzas are to be served in public or private nonprofit institutions.

(2) The Secretary may withdraw or modify any exemption under this subsection whenever the Secretary determines such action is necessary to ensure food safety and to protect public health. The Secretary may reinstate or further modify any exemption withdrawn or modified under this subsection.

(e) Applicability of adulteration and misbranding provisions to articles exempted from inspection

The adulteration and misbranding provisions of this chapter, other than the requirement of the inspection legend, shall apply to articles which are exempted from inspection under this section, except as otherwise specified under paragraphs (a) and (d).

(f) Suspension or termination of exemption

The Secretary may by order suspend or terminate any exemption under this section with respect to any person whenever he finds that such action will aid in effectuating the purposes of this chapter.

(Pub. L. 85–172, §15, Aug. 28, 1957, 71 Stat. 447; Pub. L. 90–492, §14, Aug. 18, 1968, 82 Stat. 803; Pub. L. 97–206, June 30, 1982, 96 Stat. 136; Pub. L. 102–237, title X, §1016(b), Dec. 13, 1991, 105 Stat. 1903.)

Editorial Notes

Amendments

1991—Subsecs. (d) to (f). Pub. L. 102–237 added subsec. (d), redesignated former subsec. (d) as (e) and substituted "(d)" for "(c)", and redesignated former subsec. (e) as (f).

1982—Par. (c)(3). Pub. L. 97–206, §1, substituted provisions that no exemption would be given to persons who during the current calendar year either slaughter or process the products of more than 20,000 poultry, or slaughter or process such poultry at a facility of another poultry producer or person, but that, in the latter case, the Secretary may grant the exemption upon application of such poultry producer or person if granting such exemption would not impair the purposes of this chapter, for provisions that an exemption would not be granted to those who slaughter or process the products of more than 5,000 turkeys or an equivalent number of poultry of all species in the current calendar year (four birds of other species being deemed equivalent of one turkey).

Par. (c)(4)(i). Pub. L. 97–206, §2, substituted "1,000 poultry during the calendar year for which this exemption is being determined" for "250 turkeys, or not more than an equivalent number of birds of all species during the calendar year for which this exemption is being determined (four birds of other species being deemed the equivalent of one turkey)".

1968—Par. (a). Pub. L. 90–492, §14(a), (b), redesignated subpars. (2) to (4) as (1) to (3), respectively, and in subpar. (2), as so redesignated, substituted "January 1, 1970" for "July 1, 1960". Former subpar. (1), which exempted poultry producers with respect to poultry of their own raising on their own farms which they sold directly to household consumers, hotels, etc., for use in their own dining rooms or in the preparation of meals for sales direct to consumers only, provided that such producers did not engage in buying or selling poultry products other than those produced from poultry raised on their own farms, was struck out.

Pars. (b) to (e). Pub. L. 90–492, §14(c), added pars. (b) to (d) and redesignated former par. (b) as (e).

Statutory Notes and Related Subsidiaries

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–492 effective upon the expiration of sixty days after Aug. 18, 1968, see section 20(b) of Pub. L. 90–492, set out as a note under section 451 of this title.

Regulations

Pub. L. 102–237, title X, §1016(c), Dec. 13, 1991, 105 Stat. 1903, provided that: "No later than August 1, 1992, the Secretary of Agriculture shall issue final rules, through prior notice and comment rulemaking procedures, to implement the exemption authorized by section 23(c) of the Federal Meat Inspection Act [21 U.S.C. 623(c)] (as added by subsection (a)) and the exemption authorized by section 15(d) of the Poultry Products Inspection Act [21 U.S.C. 464(d)] (as added by subsection (b)). Prior to the issuance of the final rules, the Secretary shall hold at least one public hearing examining the public health and food safety issues raised by the granting of each of the exemptions."

Studies Concerning Grant of Future Exemptions for Poultry and Meat Food Products

Pub. L. 102–237, title X, §1016(d), Dec. 13, 1991, 105 Stat. 1903, directed Secretary of Agriculture in consultation with National Academy of Sciences to conduct a study on meat food and poultry products inspection exemptions under Federal Meat Inspection Act and Poultry Products Inspection Act and a study on an exemption from requirements of such Acts for certain wholesale meat outlets selling to hotels and other similar institutional users not later than 24 months after Dec. 13, 1991, and on completion of each study to provide the results to Committee on Agriculture of House of Representatives and Committee on Agriculture, Nutrition, and Forestry of Senate.
21 U.S.C. § 1521 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter II: DRUG-FREE COMMUNITIES / Section 1521: Findings
Findings
Status: in_force

Congress finds the following:

(1) Substance abuse among youth has more than doubled in the 5-year period preceding 1996, with substantial increases in the use of marijuana, inhalants, cocaine, methamphetamine, LSD, and heroin.

(2) The most dramatic increases in substance abuse has occurred among 13- and 14-year-olds.

(3) Casual or periodic substance abuse by youth today will contribute to hard core or chronic substance abuse by the next generation of adults.

(4) Substance abuse is at the core of other problems, such as rising violent teenage and violent gang crime, increasing health care costs, HIV infections, teenage pregnancy, high school dropouts, and lower economic productivity.

(5) Increases in substance abuse among youth are due in large part to an erosion of understanding by youth of the high risks associated with substance abuse, and to the softening of peer norms against use.

(6)(A) Substance abuse is a preventable behavior and a treatable disease; and

(B)(i) during the 13-year period beginning with 1979, monthly use of illegal drugs among youth 12 to 17 years of age declined by over 70 percent; and

(ii) data suggests that if parents would simply talk to their children regularly about the dangers of substance abuse, use among youth could be expected to decline by as much as 30 percent.

(7) Community anti-drug coalitions throughout the United States are successfully developing and implementing comprehensive, long-term strategies to reduce substance abuse among youth on a sustained basis.

(8) Intergovernmental cooperation and coordination through national, State, and local or tribal leadership and partnerships are critical to facilitate the reduction of substance abuse among youth in communities throughout the United States.

(Pub. L. 100–690, title I, §1021, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 224.)

Statutory Notes and Related Subsidiaries

Reauthorization of the Drug-Free Communities Program and Revival of Anti-Drug Abuse Act of 1988

Pub. L. 115–271, title VIII, §8203(a)(1), (2), Oct. 24, 2018, 132 Stat. 4110, 4111, as amended by Pub. L. 116–74, §2(c)(1)(A)(i)(II), Nov. 27, 2019, 133 Stat. 1157, provided that:

"(1) In general.—Chapter 2 of subtitle A of title I of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1521 et seq.), except for subchapter II (21 U.S.C. 1541 et seq.), as in effect on September 29, 1997, and as amended by the laws described in paragraph (2), is revived and restored.

"(2) Laws described.—The laws described in this paragraph are:

"(A) Public Law 107–82 (115 Stat. 814) [amending sections 1524, 1532, 1533, and 1535 of this title and enacting provisions set out as notes below].

"(B) The Office of National Drug Control Policy Reauthorization Act of 2006 (Public Law 109–469: 120 Stat. 3502) [amending sections 1524 and 1532 of this title and provisions set out as notes under this section and section 1532 of this title], as amended by paragraph (4) [amending sections 1524 and 1532 of this title and provisions set out as a note under section 1532 of this title]."

Five-Year Extension of Drug-Free Communities Support Program

Pub. L. 107–82, §1(a), Dec. 14, 2001, 115 Stat. 814, provided that: "Congress makes the following findings:

"(1) In the next 15 years, the youth population in the United States will grow by 21 percent, adding 6,500,000 youth to the population of the United States. Even if drug use rates remain constant, there will be a huge surge in drug-related problems, such as academic failure, drug-related violence, and HIV incidence, simply due to this population increase.

"(2) According to the 1994–1996 National Household Survey, 60 percent of students age 12 to 17 who frequently cut classes and who reported delinquent behavior in the past 6 months used marijuana 52 days or more in the previous year.

"(3) The 2000 Washington Kids Count survey conducted by the University of Washington reported that students whose peers have little or no involvement with drinking and drugs have higher math and reading scores than students whose peers had low level drinking or drug use.

"(4) Substance abuse prevention works. In 1999, only 10 percent of teens saw marijuana users as popular, compared to 17 percent in 1998 and 19 percent in 1997. The rate of past-month use of any drug among 12- to 17-year-olds declined 26 percent between 1997 and 1999. Marijuana use for sixth through eighth graders is at the lowest point in 5 years, as is use of cocaine, inhalants, and hallucinogens.

"(5) Community Anti-Drug Coalitions throughout the United States are successfully developing and implementing comprehensive, long-term strategies to reduce substance abuse among youth on a sustained basis. For example:

"(A) The Boston Coalition brought college and university presidents together to create the Cooperative Agreement on Underage Drinking. This agreement represents the first coordinated effort of Boston's many institutions of higher education to address issues such as binge drinking, underage drinking, and changing the norms surrounding alcohol abuse that exist on college and university campuses.

"(B) In 2000, the Coalition for a Drug-Free Greater Cincinnati surveyed more than 47,000 local students in grades 7 through 12. The results provided evidence that the Coalition's initiatives are working. For the first time in a decade, teen drug use in Greater Cincinnati appears to be leveling off. The data collected from the survey has served as a tool to strengthen relationships between schools and communities, as well as facilitate the growth of anti-drug coalitions in communities where such coalitions had not existed.

"(C) The Miami Coalition used a three-part strategy to decrease the percentage of high school seniors who reported using marijuana at least once during the most recent 30-day period. The development of a media strategy, the creation of a network of prevention agencies, and discussions with high school students about the dangers of marijuana all contributed to a decrease in the percentage of seniors who reported using marijuana from over 22 percent in 1995 to 9 percent in 1997. The Miami Coalition was able to achieve these results while national rates of marijuana use were increasing.

"(D) The Nashville Prevention Partnership worked with elementary and middle school children in an attempt to influence them toward positive life goals and discourage them from using substances. The Partnership targeted an area in East Nashville and created after school programs, mentoring opportunities, attendance initiatives, and safe passages to and from school. Attendance and test scores increased as a result of the program.

"(E) At a youth-led town meeting sponsored by the Bering Strait Community Partnership in Nome, Alaska, youth identified a need for a safe, substance-free space. With help from a variety of community partners, the Partnership staff and youth members created the Java Hut, a substance-free coffeehouse designed for youth. The Java Hut is helping to change norms in the community by providing a fun, youth-friendly atmosphere and activities that are not centered around alcohol or marijuana.

"(F) Portland's Regional Drug Initiative (RDI) has promoted the establishment of drug-free workplaces among the city's large and small employers. Over 3,000 employers have attended an RDI training session, and of those, 92 percent have instituted drug-free workplace policies. As a result, there has been a 5.5 percent decrease in positive workplace drug tests.

"(G) San Antonio Fighting Back worked to increase the age at which youth first used illegal substances. Research suggests that the later the age of first use, the lower the risk that a young person will become a regular substance abuser. As a result, the age of first illegal drug use increased from 9.4 years in 1992 to 13.5 years in 1997.

"(H) In 1990, multiple data sources confirmed a trend of increased alcohol use by teenagers in the Troy community. Using its 'multiple strategies over multiple sectors' approach, the Troy Coalition worked with parents, physicians, students, coaches, and others to address this problem from several angles. As a result, the rate of twelfth grade students who had consumed alcohol in the past month decreased from 62.1 percent to 53.3 percent between 1991 and 1998, and the rate of eighth grade students decreased from 26.3 percent to 17.4 percent. The Troy Coalition believes that this decline represents not only a change in behavior on the part of students, but also a change in the norms of the community.

"(6) Despite these successes, drug use continues to be a serious problem facing communities across the United States. For example:

"(A) According to the Pulse Check: Trends in Drug Abuse Mid-Year 2000 report—

"(i) crack and powder cocaine remains the most serious drug problem;

"(ii) marijuana remains the most widely available illicit drug, and its potency is on the rise;

"(iii) treatment sources report an increase in admissions with marijuana as the primary drug of abuse—and adolescents outnumber other age groups entering treatment for marijuana;

"(iv) 80 percent of Pulse Check sources reported increased availability of club drugs, with ecstasy (MDMA) and ketamine the most widely cited club drugs and seven sources reporting that powder cocaine is being used as a club drug by young adults;

"(v) ecstasy abuse and trafficking is expanding, no longer confined to the 'rave' scene;

"(vi) the sale and use of club drugs has grown from nightclubs and raves to high schools, the streets, neighborhoods, open venues, and younger ages;

"(vii) ecstasy users often are unknowingly purchasing adulterated tablets or some other substance sold as MDMA; and

"(viii) along with reports of increased heroin snorting as a route of administration for initiates, there is also an increase in injecting initiates and the negative health consequences associated with injection (for example, increases in HIV/AIDS and Hepatitis C) suggesting that there is a generational forgetting of the dangers of injection of the drug.

"(B) The 2000 Parent's Resource Institute for Drug Education study reported that 23.6 percent of children in the sixth through twelfth grades used illicit drugs in the past year. The same study found that monthly usage among this group was 15.3 percent.

"(C) According to the 2000 Monitoring the Future study, the use of ecstasy among eighth graders increased from 1.7 percent in 1999 to 3.1 percent in 2000, among tenth graders from 4.4 percent to 5.4 percent, and from 5.6 percent to 8.2 percent among twelfth graders.

"(D) A 1999 Mellman Group study found that—

"(i) 56 percent of the population in the United States believed that drug use was increasing in 1999;

"(ii) 92 percent of the population viewed illegal drug use as a serious problem in the United States; and

"(iii) 73 percent of the population viewed illegal drug use as a serious problem in their communities.

"(7) According to the 2001 report of the National Center on Addiction and Substance Abuse at Columbia University entitled 'Shoveling Up: The Impact of Substance Abuse on State Budgets', using the most conservative assumption, in 1998 States spent $77,900,000,000 to shovel up the wreckage of substance abuse, only $3,000,000,000 to prevent and treat the problem and $433,000,000 for alcohol and tobacco regulation and compliance. This $77,900,000,000 burden was distributed as follows:

"(A) $30,700,000,000 in the justice system (77 percent of justice spending).

"(B) $16,500,000,000 in education costs (10 percent of education spending).

"(C) $15,200,000,000 in health costs (25 percent of health spending).

"(D) $7,700,000,000 in child and family assistance (32 percent of child and family assistance spending).

"(E) $5,900,000,000 in mental health and developmental disabilities (31 percent of mental health spending).

"(F) $1,500,000,000 in public safety (26 percent of public safety spending) and $400,000,000 for the state workforce.

"(8) Intergovernmental cooperation and coordination through national, State, and local or tribal leadership and partnerships are critical to facilitate the reduction of substance abuse among youth in communities across the United States.

"(9) Substance abuse is perceived as a much greater problem nationally than at the community level. According to a 2001 study sponsored by The Pew Charitable Trusts, between 1994 and 2000—

"(A) there was a 43 percent increase in the percentage of Americans who felt progress was being made in the war on drugs at the community level;

"(B) only 9 percent of Americans say drug abuse is a 'crisis' in their neighborhood, compared to 27 percent who say this about the nation; and

"(C) the percentage of those who felt we lost ground in the war on drugs on a community level fell by more than a quarter, from 51 percent in 1994 to 37 percent in 2000."

Authorization for National Community Antidrug Coalition Institute

Pub. L. 107–82, §4, Dec. 14, 2001, 115 Stat. 821, as amended by Pub. L. 109–469, title VIII, §805, Dec. 29, 2006, 120 Stat. 3535; Pub. L. 115–271, title VIII, §8204, Oct. 24, 2018, 132 Stat. 4112; Pub. L. 116–74, §2(e), Nov. 27, 2019, 133 Stat. 1159, provided that:

"(a) In General.—Beginning in fiscal year 2020, the Director shall make a competitive grant to provide for the continuation of the National Community Anti-drug [sic] Coalition Institute.

"(b) Eligible Organizations.—An organization eligible for the grant under subsection (a) is any national nonprofit organization that represents, provides technical assistance and training to, and has special expertise and broad, national-level experience in community antidrug coalitions under this subchapter [sic, probably means chapter 2 of the National Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.)].

"(c) Use of Grant Amount.—The organization that receives the grant under subsection (a) shall continue a National Community Anti-Drug [sic] Coalition Institute to—

"(1) provide education, training, and technical assistance for coalition leaders and community teams, with emphasis on the development of coalitions serving economically disadvantaged areas;

"(2) develop and disseminate evaluation tools, mechanisms, and measures to better assess and document coalition performance measures and outcomes; and

"(3) bridge the gap between research and practice by translating knowledge from research into practical information.

"(d) Administration of Grant.—

"(1) Duration.—With respect to a grant made under subsection (a) in fiscal year 2020, the term of the grant shall be 4 years.

"(2) Disbursement.—To the extent amounts are provided in appropriation Acts for such grant, the Director shall disburse the amount of the grant made under subsection (a) on an annual basis."

Prohibition Against Duplication of Effort

Pub. L. 107–82, §5, Dec. 14, 2001, 115 Stat. 821, provided that: "The Director of the Office of National Drug Control Policy shall ensure that the same or similar activities are not carried out, through the use of funds for administrative costs provided under subchapter II [probably means chapter 2] of the National Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.) or funds provided under section 4 of this Act [set out as a note above], by more than one recipient of such funds."
21 U.S.C. § 360eee (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360eee: Definitions
Definitions
Status: in_force

In this part:

(1) Affiliate

The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has the power to control, both of the business entities.

(2) Authorized

The term "authorized" means—

(A) in the case of a manufacturer or repackager, having a valid registration in accordance with section 360 of this title;

(B) in the case of a wholesale distributor, having a valid license under State law or section 360eee–2 of this title, in accordance with section 360eee–1(a)(6) of this title, and complying with the licensure reporting requirements under section 353(e) of this title;

(C) in the case of a third-party logistics provider, having a valid license under State law or section 360eee–3(a)(1) of this title, in accordance with section 360eee–1(a)(7) of this title, and complying with the licensure reporting requirements under section 360eee–3(b) of this title; and

(D) in the case of a dispenser, having a valid license under State law.

(3) Dispenser

The term "dispenser"—

(A) means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor; and

(B) does not include a person who dispenses only products to be used in animals in accordance with section 360b(a)(5) of this title.

(4) Disposition

The term "disposition", with respect to a product within the possession or control of an entity, means the removal of such product from the pharmaceutical distribution supply chain, which may include disposal or return of the product for disposal or other appropriate handling and other actions, such as retaining a sample of the product for further additional physical examination or laboratory analysis of the product by a manufacturer or regulatory or law enforcement agency.

(5) Distribute or distribution

The term "distribute" or "distribution" means the sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription executed in accordance with section 353(b)(1) of this title or the dispensing of a product approved under section 360b(b) of this title.

(6) Exclusive distributor

The term "exclusive distributor" means the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer's product to a subsequent repackager, wholesale distributor, or dispenser.

(7) Homogeneous case

The term "homogeneous case" means a sealed case containing only product that has a single National Drug Code number belonging to a single lot.

(8) Illegitimate product

The term "illegitimate product" means a product for which credible evidence shows that the product—

(A) is counterfeit, diverted, or stolen;

(B) is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(C) is the subject of a fraudulent transaction; or

(D) appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

(9) Licensed

The term "licensed" means—

(A) in the case of a wholesale distributor, having a valid license in accordance with section 353(e) of this title or section 360eee–1(a)(6) of this title, as applicable;

(B) in the case of a third-party logistics provider, having a valid license in accordance with section 360eee–3(a) of this title or section 360eee–1(a)(7) of this title, as applicable; and

(C) in the case of a dispenser, having a valid license under State law.

(10) Manufacturer

The term "manufacturer" means, with respect to a product—

(A) a person that holds an application approved under section 355 of this title or a license issued under section 262 of title 42 for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product;

(B) a co-licensed partner of the person described in subparagraph (A) that obtains the product directly from a person described in this subparagraph or subparagraph (A) or (C); or

(C) an affiliate of a person described in subparagraph (A) or (B) that receives the product directly from a person described in this subparagraph or subparagraph (A) or (B).

(11) Package

(A) In general

The term "package" means the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product.

(B) Individual saleable unit

For purposes of this paragraph, an "individual saleable unit" is the smallest container of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser.

(12) Prescription drug

The term "prescription drug" means a drug for human use subject to section 353(b)(1) of this title.

(13) Product

The term "product" means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 360eee–1 of this title, does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42, imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 360ddd of this title), homeopathic drugs marketed in accordance with applicable guidance under this chapter, or a drug compounded in compliance with section 353a or 353b of this title.

(14) Product identifier

The term "product identifier" means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.

(15) Quarantine

The term "quarantine" means the storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.

(16) Repackager

The term "repackager" means a person who owns or operates an establishment that repacks and relabels a product or package for—

(A) further sale; or

(B) distribution without a further transaction.

(17) Return

The term "return" means providing product to the authorized immediate trading partner from which such product was purchased or received, or to a returns processor or reverse logistics provider for handling of such product.

(18) Returns processor or reverse logistics provider

The term "returns processor" or "reverse logistics provider" means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser, manufacturer, or seller or disposed of for no further distribution.

(19) Specific patient need

The term "specific patient need" refers to the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need.

(20) Standardized numerical identifier

The term "standardized numerical identifier" means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters.

(21) Suspect product

The term "suspect product" means a product for which there is reason to believe that such product—

(A) is potentially counterfeit, diverted, or stolen;

(B) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(C) is potentially the subject of a fraudulent transaction; or

(D) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

(22) Third-party logistics provider

The term "third-party logistics provider" means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.

(23) Trading partner

The term "trading partner" means—

(A) a manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or

(B) a third-party logistics provider from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product.

(24) Transaction

(A) In general

The term "transaction" means the transfer of product between persons in which a change of ownership occurs.

(B) Exemptions

The term "transaction" does not include—

(i) intracompany distribution of any product between members of an affiliate or within a manufacturer;

(ii) the distribution of a product among hospitals or other health care entities that are under common control;

(iii) the distribution of a product for emergency medical reasons including a public health emergency declaration pursuant to section 247d of title 42, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

(iv) the dispensing of a product pursuant to a prescription executed in accordance with section 353(b)(1) of this title;

(v) the distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance with section 353(d) of this title;

(vi) the distribution of blood or blood components intended for transfusion;

(vii) the distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use;

(viii) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in section 501(c)(3) of title 26 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

(ix) the distribution of a product pursuant to the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors, except that any records required to be maintained for the product shall be transferred to the new owner of the pharmacy or pharmacies or wholesale distributor or wholesale distributors;

(x) the dispensing of a product approved under section 360b(c) of this title;

(xi) products transferred to or from any facility that is licensed by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42;

(xii) a combination product that is not subject to approval under section 355 of this title or licensure under section 262 of title 42, and that is—

(I) a product comprised of a device and 1 or more other regulated components (such as a drug/device, biologic/device, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

(II) 2 or more separate products packaged together in a single package or as a unit and comprised of a drug and device or device and biological product; or

(III) 2 or more finished medical devices plus one or more drug or biological products that are packaged together in what is referred to as a "medical convenience kit" as described in clause (xiii);

(xiii) the distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to in this clause as a "medical convenience kit") if—

(I) the medical convenience kit is assembled in an establishment that is registered with the Food and Drug Administration as a device manufacturer in accordance with section 360(b)(2) of this title;

(II) the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [21 U.S.C. 801 et seq.];

(III) in the case of a medical convenience kit that includes a product, the person that manufacturers the kit—

(aa) purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and

(bb) does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and

(IV) in the case of a medical convenience kit that includes a product, the product is—

(aa) an intravenous solution intended for the replenishment of fluids and electrolytes;

(bb) a product intended to maintain the equilibrium of water and minerals in the body;

(cc) a product intended for irrigation or reconstitution;

(dd) an anesthetic;

(ee) an anticoagulant;

(ff) a vasopressor; or

(gg) a sympathomimetic;

(xiv) the distribution of an intravenous product that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);

(xv) the distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;

(xvi) the distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;

(xvii) the distribution of a medical gas (as defined in section 360ddd of this title); or

(xviii) the distribution or sale of any licensed product under section 262 of title 42 that meets the definition of a device under section 321(h) of this title.

(25) Transaction history

The term "transaction history" means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

(26) Transaction information

The term "transaction information" means—

(A) the proprietary or established name or names of the product;

(B) the strength and dosage form of the product;

(C) the National Drug Code number of the product;

(D) the container size;

(E) the number of containers;

(F) the lot number of the product;

(G) the date of the transaction;

(H) the date of the shipment, if more than 24 hours after the date of the transaction;

(I) the business name and address of the person from whom ownership is being transferred; and

(J) the business name and address of the person to whom ownership is being transferred.

(27) Transaction statement

The "transaction statement" is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—

(A) is authorized as required under the Drug Supply Chain Security Act;

(B) received the product from a person that is authorized as required under the Drug Supply Chain Security Act;

(C) received transaction information and a transaction statement from the prior owner of the product, as required under section 360eee–1 of this title;

(D) did not knowingly ship a suspect or illegitimate product;

(E) had systems and processes in place to comply with verification requirements under section 360eee–1 of this title;

(F) did not knowingly provide false transaction information; and

(G) did not knowingly alter the transaction history.

(28) Verification or verify

The term "verification" or "verify" means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager, as applicable in accordance with section 360eee–1 of this title.

(29) Wholesale distributor

The term "wholesale distributor" means a person (other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or repackager) engaged in wholesale distribution (as defined in section 353(e)(4) of this title).

(June 25, 1938, ch. 675, §581, as added Pub. L. 113–54, title II, §202, Nov. 27, 2013, 127 Stat. 599.)

Editorial Notes

References in Text

The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in par. (24)(B)(xiii)(II), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified principally to chapter 13 (§801 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Drug Supply Chain Security Act, referred to in par. (27)(A), (B), is Pub. L. 113–54, title II, Nov. 27, 2013, 127 Stat. 599. For complete classification of this Act to the Code, see Short Title note set out under section 301 of this title and Tables.
21 U.S.C. § 360j (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360j: General provisions respecting control of devices intended for human use
General provisions respecting control of devices intended for human use
Status: in_force

(a) General rule

Any requirement authorized by or under section 351, 352, 360, or 360i of this title applicable to a device intended for human use shall apply to such device until the applicability of the requirement to the device has been changed by action taken under section 360c, 360d, or 360e of this title or under subsection (g) of this section, and any requirement established by or under section 351, 352, 360, or 360i of this title which is inconsistent with a requirement imposed on such device under section 360d or 360e of this title or under subsection (g) of this section shall not apply to such device.

(b) Custom devices

(1) In general

The requirements of sections 360d and 360e of this title shall not apply to a device that—

(A) is created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing);

(B) in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under section 360d of this title or requirement under section 360e of this title;

(C) is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;

(D) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;

(E)(i) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated); or

(ii) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated);

(F) is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals described in clause (i) or (ii) of subparagraph (E); and

(G) may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices.

(2) Limitations

Paragraph (1) shall apply to a device only if—

(A) such device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical;

(B) production of such device under paragraph (1) is limited to no more than 5 units per year of a particular device type, provided that such replication otherwise complies with this section; and

(C) the manufacturer of such device notifies the Secretary on an annual basis, in a manner prescribed by the Secretary, of the manufacture of such device.

(3) Guidance

Not later than 2 years after July 9, 2012, the Secretary shall issue final guidance on replication of multiple devices described in paragraph (2)(B).

(c) Trade secrets

Any information reported to or otherwise obtained by the Secretary or his representative under section 360c, 360d, 360e, 360f, 360h, 360i, or 374 of this title or under subsection (f) or (g) of this section which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section shall be considered confidential and shall not be disclosed and may not be used by the Secretary as the basis for the reclassification of a device from class III to class II or class I or as the basis for the establishment or amendment of a performance standard under section 360d of this title for a device reclassified from class III to class II, except (1) in accordance with subsection (h), and (2) that such information may be disclosed to other officers or employees concerned with carrying out this chapter or when relevant in any proceeding under this chapter (other than section 360c or 360d of this title).

(d) Notices and findings

Each notice of proposed rulemaking under section 360c, 360d, 360e, 360f, 360h, or 360i of this title, or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth—

(1) the manner in which interested persons may examine data and other information on which the notice or findings is based, and

(2) the period within which interested persons may present their comments on the notice or findings (including the need therefor) orally or in writing, which period shall be at least sixty days but may not exceed ninety days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefor.

(e) Restricted devices

(1) The Secretary may by regulation require that a device be restricted to sale, distribution, or use—

(A) only upon the written or oral authorization of a practitioner licensed by law to administer or use such device, or

(B) upon such other conditions as the Secretary may prescribe in such regulation,

if, because of its potentiality for harmful effect or the collateral measures necessary to its use, the Secretary determines that there cannot otherwise be reasonable assurance of its safety and effectiveness. No condition prescribed under subparagraph (B) may restrict the use of a device to persons with specific training or experience in its use or to persons for use in certain facilities unless the Secretary determines that such a restriction is required for the safe and effective use of the device. No such condition may exclude a person from using a device solely because the person does not have the training or experience to make him eligible for certification by a certifying board recognized by the American Board of Medical Specialties or has not been certified by such a Board. A device subject to a regulation under this subsection is a restricted device.

(2) The label of a restricted device shall bear such appropriate statements of the restrictions required by a regulation under paragraph (1) as the Secretary may in such regulation prescribe.

(f) Good manufacturing practice requirements

(1)(A) The Secretary may, in accordance with subparagraph (B), prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device), packing, storage, and installation of a device conform to current good manufacturing practice, as prescribed in such regulations, to assure that the device will be safe and effective and otherwise in compliance with this chapter.

(B) Before the Secretary may promulgate any regulation under subparagraph (A) he shall—

(i) afford the advisory committee established under paragraph (3) an opportunity to submit recommendations to him with respect to the regulation proposed to be promulgated;

(ii) afford opportunity for an oral hearing; and

(iii) ensure that such regulation conforms, to the extent practicable, with internationally recognized standards defining quality systems, or parts of the standards, for medical devices.

The Secretary shall provide the advisory committee a reasonable time to make its recommendation with respect to proposed regulations under subparagraph (A).

(2)(A) Any person subject to any requirement prescribed by regulations under paragraph (1) may petition the Secretary for an exemption or variance from such requirement. Such a petition shall be submitted to the Secretary in such form and manner as he shall prescribe and shall—

(i) in the case of a petition for an exemption from a requirement, set forth the basis for the petitioner's determination that compliance with the requirement is not required to assure that the device will be safe and effective and otherwise in compliance with this chapter,

(ii) in the case of a petition for a variance from a requirement, set forth the methods proposed to be used in, and the facilities and controls proposed to be used for, the manufacture, packing, storage, and installation of the device in lieu of the methods, facilities, and controls prescribed by the requirement, and

(iii) contain such other information as the Secretary shall prescribe.

(B) The Secretary may refer to the advisory committee established under paragraph (3) any petition submitted under subparagraph (A). The advisory committee shall report its recommendations to the Secretary with respect to a petition referred to it within sixty days of the date of the petition's referral. Within sixty days after—

(i) the date the petition was submitted to the Secretary under subparagraph (A), or

(ii) if the petition was referred to an advisory committee, the expiration of the sixty-day period beginning on the date the petition was referred to the advisory committee,

whichever occurs later, the Secretary shall by order either deny the petition or approve it.

(C) The Secretary may approve—

(i) a petition for an exemption for a device from a requirement if he determines that compliance with such requirement is not required to assure that the device will be safe and effective and otherwise in compliance with this chapter, and

(ii) a petition for a variance for a device from a requirement if he determines that the methods to be used in, and the facilities and controls to be used for, the manufacture, packing, storage, and installation of the device in lieu of the methods, controls, and facilities prescribed by the requirement are sufficient to assure that the device will be safe and effective and otherwise in compliance with this chapter.

An order of the Secretary approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of the device to be granted the variance under the petition as may be necessary to assure that the device will be safe and effective and otherwise in compliance with this chapter.

(D) After the issuance of an order under subparagraph (B) respecting a petition, the petitioner shall have an opportunity for an informal hearing on such order.

(3) The Secretary shall establish an advisory committee for the purpose of advising and making recommendations to him with respect to regulations proposed to be promulgated under paragraph (1)(A) and the approval or disapproval of petitions submitted under paragraph (2). The advisory committee shall be composed of nine members as follows:

(A) Three of the members shall be appointed from persons who are officers or employees of any State or local government or of the Federal Government.

(B) Two of the members shall be appointed from persons who are representative of interests of the device manufacturing industry; two of the members shall be appointed from persons who are representative of the interests of physicians and other health professionals; and two of the members shall be representative of the interests of the general public.

Members of the advisory committee who are not officers or employees of the United States, while attending conferences or meetings of the committee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent of the rate in effect for grade GS–18 of the General Schedule, for each day (including traveltime) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently. The Secretary shall designate one of the members of the advisory committee to serve as its chairman. The Secretary shall furnish the advisory committee with clerical and other assistance. Section 1013 of title 5 shall not apply with respect to the duration of the advisory committee established under this paragraph.

(g) Exemption for devices for investigational use

(1) It is the purpose of this subsection to encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.

(2)(A) The Secretary shall, within the one hundred and twenty-day period beginning on May 28, 1976, by regulation prescribe procedures and conditions under which devices intended for human use may upon application be granted an exemption from the requirements of section 352, 360, 360d, 360e, 360f, 360i, or 379e of this title or subsection (e) or (f) of this section or from any combination of such requirements to permit the investigational use of such devices by experts qualified by scientific training and experience to investigate the safety and effectiveness of such devices.

(B) The conditions prescribed pursuant to subparagraph (A) shall include the following:

(i) A requirement that an application be submitted to the Secretary before an exemption may be granted and that the application be submitted in such form and manner as the Secretary shall specify.

(ii) A requirement that the person applying for an exemption for a device assure the establishment and maintenance of such records, and the making of such reports to the Secretary of safety or effectiveness data obtained as a result of the investigational use of the device during the exemption, as the Secretary determines will enable him to assure compliance with such conditions, review the progress of the investigation, and evaluate the safety and effectiveness of the device.

(iii) Such other requirements as the Secretary may determine to be necessary for the protection of the public health and safety.

(C) Procedures and conditions prescribed pursuant to subparagraph (A) for an exemption may appropriately vary depending on (i) the scope and duration of clinical testing to be conducted under such exemption, (ii) the number of human subjects that are to be involved in such testing, (iii) the need to permit changes to be made in the device subject to the exemption during testing conducted in accordance with a clinical testing plan required under paragraph (3)(A), and (iv) whether the clinical testing of such device is for the purpose of developing data to obtain approval for the commercial distribution of such device.

(3) Procedures and conditions prescribed pursuant to paragraph (2)(A) shall require, as a condition to the exemption of any device to be the subject of testing involving human subjects, that the person applying for the exemption—

(A) submit a plan for any proposed clinical testing of the device and a report of prior investigations of the device (including, where appropriate, tests on animals) adequate to justify the proposed clinical testing—

(i) to the institutional review committee established in accordance with regulations of the Secretary to supervise clinical testing of devices in the facilities where the proposed clinical testing is to be conducted, or

(ii) to the Secretary, if—

(I) no such committee exists, or

(II) the Secretary finds that the process of review by such committee is inadequate (whether or not the plan for such testing has been approved by such committee),

for review for adequacy to justify the commencement of such testing; and, unless the plan and report are submitted to the Secretary, submit to the Secretary a summary of the plan and a report of prior investigations of the device (including, where appropriate, tests on animals);

(B) promptly notify the Secretary (under such circumstances and in such manner as the Secretary prescribes) of approval by an institutional review committee of any clinical testing plan submitted to it in accordance with subparagraph (A);

(C) in the case of a device to be distributed to investigators for testing, obtain signed agreements from each of such investigators that any testing of the device involving human subjects will be under such investigator's supervision and in accordance with subparagraph (D) and submit such agreements to the Secretary; and

(D) assure that informed consent will be obtained from each human subject (or his representative) of proposed clinical testing involving such device, except where, subject to such conditions as the Secretary may prescribe—

(i) the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject; or

(ii) the investigator conducting or supervising the proposed clinical testing of the device determines in writing that there exists a life threatening situation involving the human subject of such testing which necessitates the use of such device and it is not feasible to obtain informed consent from the subject and there is not sufficient time to obtain such consent from his representative.

The determination required by subparagraph (D)(ii) shall be concurred in by a licensed physician who is not involved in the testing of the human subject with respect to which such determination is made unless immediate use of the device is required to save the life of the human subject of such testing and there is not sufficient time to obtain such concurrence.

(4)(A) An application, submitted in accordance with the procedures prescribed by regulations under paragraph (2), for an exemption for a device (other than an exemption from section 360f of this title) shall be deemed approved on the thirtieth day after the submission of the application to the Secretary unless on or before such day the Secretary by order disapproves the application and notifies the applicant of the disapproval of the application.

(B) The Secretary may disapprove an application only if he finds that the investigation with respect to which the application is submitted does not conform to procedures and conditions prescribed under regulations under paragraph (2). Such a notification shall contain the order of disapproval and a complete statement of the reasons for the Secretary's disapproval of the application and afford the applicant opportunity for an informal hearing on the disapproval order.

(C) Consistent with paragraph (1), the Secretary shall not disapprove an application under this subsection because the Secretary determines that—

(i) the investigation may not support a substantial equivalence or de novo classification determination or approval of the device;

(ii) the investigation may not meet a requirement, including a data requirement, relating to the approval or clearance of a device; or

(iii) an additional or different investigation may be necessary to support clearance or approval of the device.

(5) The Secretary may by order withdraw an exemption granted under this subsection for a device if the Secretary determines that the conditions applicable to the device under this subsection for such exemption are not met. Such an order may be issued only after opportunity for an informal hearing, except that such an order may be issued before the provision of an opportunity for an informal hearing if the Secretary determines that the continuation of testing under the exemption with respect to which the order is to be issued will result in an unreasonable risk to the public health.

(6)(A) Not later than 1 year after November 21, 1997, the Secretary shall by regulation establish, with respect to a device for which an exemption under this subsection is in effect, procedures and conditions that, without requiring an additional approval of an application for an exemption or the approval of a supplement to such an application, permit—

(i) developmental changes in the device (including manufacturing changes) that do not constitute a significant change in design or in basic principles of operation and that are made in response to information gathered during the course of an investigation; and

(ii) changes or modifications to clinical protocols that do not affect—

(I) the validity of data or information resulting from the completion of an approved protocol, or the relationship of likely patient risk to benefit relied upon to approve a protocol;

(II) the scientific soundness of an investigational plan submitted under paragraph (3)(A); or

(III) the rights, safety, or welfare of the human subjects involved in the investigation.

(B) Regulations under subparagraph (A) shall provide that a change or modification described in such subparagraph may be made if—

(i) the sponsor of the investigation determines, on the basis of credible information (as defined by the Secretary) that the applicable conditions under subparagraph (A) are met; and

(ii) the sponsor submits to the Secretary, not later than 5 days after making the change or modification, a notice of the change or modification.

(7)(A) In the case of a person intending to investigate the safety or effectiveness of a class III device or any implantable device, the Secretary shall ensure that the person has an opportunity, prior to submitting an application to the Secretary or to an institutional review committee, to submit to the Secretary, for review, an investigational plan (including a clinical protocol). If the applicant submits a written request for a meeting with the Secretary regarding such review, the Secretary shall, not later than 30 days after receiving the request, meet with the applicant for the purpose of reaching agreement regarding the investigational plan (including a clinical protocol). The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, a proposed plan (including a clinical protocol) for determining whether there is a reasonable assurance of effectiveness, and, if available, information regarding the expected performance from the device.

(B) Any agreement regarding the parameters of an investigational plan (including a clinical protocol) that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Any such agreement shall not be changed, except—

(i) with the written agreement of the sponsor or applicant; or

(ii) pursuant to a decision, made in accordance with subparagraph (C) by the director of the office in which the device involved is reviewed, that a substantial scientific issue essential to determining the safety or effectiveness of the device involved has been identified.

(C) A decision under subparagraph (B)(ii) by the director shall be in writing, and may be made only after the Secretary has provided to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant are present and at which the director documents the scientific issue involved.

(8)(A) At any time, the Secretary may prohibit the sponsor of an investigation from conducting the investigation (referred to in this paragraph as a "clinical hold") if the Secretary makes a determination described in subparagraph (B). The Secretary shall specify the basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical hold, and confirm such determination in writing.

(B) For purposes of subparagraph (A), a determination described in this subparagraph with respect to a clinical hold is a determination that—

(i) the device involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the device, the design of the clinical investigation, the condition for which the device is to be investigated, and the health status of the subjects involved; or

(ii) the clinical hold should be issued for such other reasons as the Secretary may by regulation establish.

(C) Any written request to the Secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold.

(9)(A)(i) 1 The sponsor of a device for which submission of an application for an investigational device exemption is required shall submit to the Secretary in such application a diversity action plan for clinical studies of the device, in the form and manner specified in guidance issued by the Secretary.

(ii) The sponsor of a device for which submission of an application for an investigational device exemption is not required, except for a device being studied as described in section 812.2(c) of title 21, Code of Federal Regulations (or successor regulations), shall develop a diversity action plan for any clinical study with respect to the device. Such diversity action plan shall be submitted to the Secretary in any premarket notification under section 360(k) of this title, request for classification under section 360c(f)(2) of this title, or application for premarket approval under section 360e of this title for such device.

(B) A diversity action plan under clause (i) or (ii) of subparagraph (A) shall include—

(i) the sponsor's goals for enrollment in the clinical study;

(ii) the sponsor's rationale for such goals; and

(iii) an explanation of how the sponsor intends to meet such goals.

(C)(i) On the initiative of the Secretary or at the request of a sponsor, the Secretary may waive any requirement in subparagraph (A) or (B) if the Secretary determines that a waiver is necessary based on what is known or can be determined about the prevalence or incidence of the disease or condition for which the device is under investigation (including in terms of the patient population that may use the device), if conducting a clinical investigation in accordance with a diversity action plan would otherwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency.

(ii) The Secretary shall issue a written response granting or denying a request from a sponsor for a waiver within 60 days of receiving such request.

(D) No diversity action plan shall be required for a submission described in section 360bbb of this title.

(h) Release of information respecting safety and effectiveness

(1) The Secretary shall promulgate regulations under which a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the Secretary and which was the basis for—

(A) an order under section 360e(d)(1)(A) of this title approving an application for premarket approval for the device or denying approval of such an application or an order under section 360e(e) of this title withdrawing approval of such an application for the device,

(B) an order under section 360e(f)(6)(A) of this title revoking an approved protocol for the device, an order under section 360e(f)(6)(B) of this title declaring a protocol for the device completed or not completed, or an order under section 360e(f)(7) of this title revoking the approval of the device, or

(C) an order approving an application under subsection (g) for an exemption for the device from section 360f of this title or an order disapproving, or withdrawing approval of, an application for an exemption under such subsection for the device,

shall be made available to the public upon issuance of the order. Summaries of information made available pursuant to this paragraph respecting a device shall include information respecting any adverse effects on health of the device.

(2) The Secretary shall promulgate regulations under which each advisory committee established under section 360e(g)(2)(B) of this title shall make available to the public a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the advisory committee and which was the basis for its recommendation to the Secretary made pursuant to section 360e(g)(2)(A) of this title. A summary of information upon which such a recommendation is based shall be made available pursuant to this paragraph only after the issuance of the order with respect to which the recommendation was made and each summary shall include information respecting any adverse effect on health of the device subject to such order.

(3) Except as provided in paragraph (4), any information respecting a device which is made available pursuant to paragraph (1) or (2) of this subsection (A) may not be used to establish the safety or effectiveness of another device for purposes of this chapter by any person other than the person who submitted the information so made available, and (B) shall be made available subject to subsection (c) of this section.

(4)(A) Subject to subparagraph (C), any information contained in an application for premarket approval filed with the Secretary pursuant to section 360e(c) of this title (including information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of a device, but excluding descriptions of methods of manufacture and product composition and other trade secrets) shall be available, 6 years after the application has been approved by the Secretary, for use by the Secretary in—

(i) approving another device;

(ii) determining whether a product development protocol has been completed, under section 360e of this title for another device;

(iii) establishing a performance standard or special control under this chapter; or

(iv) classifying or reclassifying another device under section 360c of this title and subsection (l)(2).

(B) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by paragraph (1)(A) shall be available for use by the Secretary as the evidentiary basis for the agency actions described in subparagraph (A).

(C) No information contained in an application for premarket approval filed with the Secretary pursuant to section 360e(c) of this title may be used to approve or clear any application submitted under section 360e or 360(k) of this title or to classify a product under section 360c(f)(2) of this title for a combination product containing as a constituent part an approved drug (as defined in section 353(g)(5)(B) of this title) unless—

(i) the application includes the certification or statement referenced in section 353(g)(5)(A) of this title;

(ii) the applicant provides notice as described in section 353(g)(5)(A) of this title; and

(iii) the Secretary's approval of such application is subject to the provisions in section 353(g)(5)(C) of this title.

(i) Proceedings of advisory panels and committees

Each panel under section 360c of this title and each advisory committee established under section 360d(b)(5)(B) or 360e(g) of this title or under subsection (f) of this section shall make and maintain a transcript of any proceeding of the panel or committee. Each such panel and committee shall delete from any transcript made pursuant to this subsection information which under subsection (c) of this section is to be considered confidential.

(j) Traceability

Except as provided in section 360i(e) of this title, no regulation under this chapter may impose on a type or class of device requirements for the traceability of such type or class of device unless such requirements are necessary to assure the protection of the public health.

(k) Research and development

The Secretary may enter into contracts for research, testing, and demonstrations respecting devices and may obtain devices for research, testing, and demonstration purposes without regard to section 3324(a) and (b) of title 31 and section 6101 of title 41.

(l) Transitional provisions for devices considered as new drugs

(1) Any device intended for human use—

(A) for which on May 28, 1976 (hereinafter in this subsection referred to as the "enactment date") an approval of an application submitted under section 355(b) of this title was in effect;

(B) for which such an application was filed on or before the enactment date and with respect to which application no order of approval or refusing to approve had been issued on such date under subsection (c) or (d) of such section;

(C) for which on the enactment date an exemption under subsection (i) of such section was in effect;

(D) which is within a type of device described in subparagraph (A), (B), or (C) and is substantially equivalent to another device within that type;

(E) which the Secretary in a notice published in the Federal Register before the enactment date has declared to be a new drug subject to section 355 of this title; or

(F) with respect to which on the enactment date an action is pending in a United States court under section 332, 333, or 334 of this title for an alleged violation of a provision of section 331 of this title which enforces a requirement of section 355 of this title or for an alleged violation of section 355(a) of this title,

is classified in class III unless the Secretary in response to a petition submitted under paragraph (2) has classified such device in class I or II.

(2) The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer or importer of a device classified under paragraph (1) may petition the Secretary (in such form and manner as he shall prescribe) for the issuance of an order classifying the device in class I or class II. Within thirty days of the filing of such a petition, the Secretary shall notify the petitioner of any deficiencies in the petition which prevent the Secretary from making a decision on the petition. Except as provided in paragraph (3)(D)(ii), within one hundred and eighty days after the filing of a petition under this paragraph, the Secretary shall, after consultation with the appropriate panel under section 360c of this title, by order either deny the petition or order the classification, in accordance with the criteria prescribed by section 360c(a)(1)(A) of this title or 360c(a)(1)(B) of this title, of the device in class I or class II.

(3)(A) In the case of a device which is described in paragraph (1)(A) and which is in class III—

(i) such device shall on the enactment date be considered a device with an approved application under section 360e of this title, and

(ii) the requirements applicable to such device before the enactment date under section 355 of this title shall continue to apply to such device until changed by the Secretary as authorized by this chapter.

(B) In the case of a device which is described in paragraph (1)(B) and which is in class III, an application for such device shall be considered as having been filed under section 360e of this title on the enactment date. The period in which the Secretary shall act on such application in accordance with section 360e(d)(1) of this title shall be one hundred and eighty days from the enactment date (or such greater period as the Secretary and the applicant may agree upon after the Secretary has made the finding required by section 360e(d)(1)(B)(i) of this title) less the number of days in the period beginning on the date an application for such device was filed under section 355 of this title and ending on the enactment date. After the expiration of such period such device is required, unless exempt under subsection (g), to have in effect an approved application under section 360e of this title.

(C) A device which is described in paragraph (1)(C) and which is in class III shall be considered a new drug until the expiration of the ninety-day period beginning on the date of the promulgation of regulations under subsection (g) of this section. After the expiration of such period such device is required, unless exempt under subsection (g), to have in effect an approved application under section 360e of this title.

(D)(i) Except as provided in clauses (ii) and (iii), a device which is described in subparagraph (D), (E), or (F) of paragraph (1) and which is in class III is required, unless exempt under subsection (g) of this section, to have on and after sixty days after the enactment date in effect an approved application under section 360e of this title.

(ii) If—

(I) a petition is filed under paragraph (2) for a device described in subparagraph (D), (E), or (F) of paragraph (1), or

(II) an application for premarket approval is filed under section 360e of this title for such a device,

within the sixty-day period beginning on the enactment date (or within such greater period as the Secretary, after making the finding required under section 360e(d)(1)(B) of this title, and the petitioner or applicant may agree upon), the Secretary shall act on such petition or application in accordance with paragraph (2) or section 360e of this title except that the period within which the Secretary must act on the petition or application shall be within the one hundred and twenty-day period beginning on the date the petition or application is filed. If such a petition or application is filed within such sixty-day (or greater) period, clause (i) of this subparagraph shall not apply to such device before the expiration of such one hundred and twenty-day period, or if such petition is denied or such application is denied approval, before the date of such denial, whichever occurs first.

(iii) In the case of a device which is described in subparagraph (E) of paragraph (1), which the Secretary in a notice published in the Federal Register after March 31, 1976, declared to be a new drug subject to section 355 of this title, and which is in class III—

(I) the device shall, after eighteen months after the enactment date, have in effect an approved application under section 360e of this title unless exempt under subsection (g) of this section, and

(II) the Secretary may, during the period beginning one hundred and eighty days after the enactment date and ending eighteen months after such date, restrict the use of the device to investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of such device, and to investigational use in accordance with the requirements applicable under regulations under subsection (g) of this section to investigational use of devices granted an exemption under such subsection.

If the requirements under subsection (g) of this section are made applicable to the investigational use of such a device, they shall be made applicable in such a manner that the device shall be made reasonably available to physicians meeting appropriate qualifications prescribed by the Secretary.

(4) Repealed. Pub. L. 105–115, title I, §125(b)(2)(E), Nov. 21, 1997, 111 Stat. 2325.

(5)(A) Before December 1, 1991, the Secretary shall by order require manufacturers of devices described in paragraph (1), which are subject to revision of classification under subparagraph (B), to submit to the Secretary a summary of and citation to any information known or otherwise available to the manufacturers respecting the devices, including adverse safety or effectiveness information which has not been submitted under section 360i of this title. The Secretary may require a manufacturer to submit the adverse safety or effectiveness data for which a summary and citation were submitted, if such data are available to the manufacturer.

(B) Except as provided in subparagraph (C), after the issuance of an order under subparagraph (A) but before December 1, 1992, the Secretary shall publish a regulation in the Federal Register for each device which is classified in class III under paragraph (1) revising the classification of the device so that the device is classified into class I or class II, unless the regulation requires the device to remain in class III. In determining whether to revise the classification of a device or to require a device to remain in class III, the Secretary shall apply the criteria set forth in section 360c(a) of this title. Before the publication of a regulation requiring a device to remain in class III or revising its classification, the Secretary shall publish a proposed regulation respecting the classification of a device under this subparagraph and provide an opportunity for the submission of comments on any such regulation. No regulation under this subparagraph requiring a device to remain in class III or revising its classification may take effect before the expiration of 90 days from the date of the publication in the Federal Register of the proposed regulation.

(C) The Secretary may by notice published in the Federal Register extend the period prescribed by subparagraph (B) for a device for an additional period not to exceed 1 year.

(m) Humanitarian device exemption

(1) To the extent consistent with the protection of the public health and safety and with ethical standards, it is the purpose of this subsection to encourage the discovery and use of devices intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect not more than 8,000 individuals in the United States.

(2) The Secretary may grant a request for an exemption from the effectiveness requirements of sections 360d and 360e of this title for a device for which the Secretary finds that—

(A) the device is designed to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States,

(B) the device would not be available to a person with a disease or condition referred to in subparagraph (A) unless the Secretary grants such an exemption and there is no comparable device, other than under this exemption, available to treat or diagnose such disease or condition, and

(C) the device will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.

The request shall be in the form of an application submitted to the Secretary and such application shall include the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application). Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.

(3) Except as provided in paragraph (6), no person granted an exemption under paragraph (2) with respect to a device may sell the device for an amount that exceeds the costs of research and development, fabrication, and distribution of the device.

(4) Devices granted an exemption under paragraph (2) may only be used—

(A) in facilities in which clinical testing of devices is supervised by an institutional review committee established in accordance with the regulations of the Secretary; and

(B) if, before the use of a device, an institutional review committee or an appropriate local committee approves the use in the treatment or diagnosis of a disease or condition referred to in paragraph (2)(A), unless a physician determines in an emergency situation that approval from an institutional review committee or an appropriate local committee can not be obtained in time to prevent serious harm or death to a patient.

In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee or an appropriate local committee, the physician shall, after the use of the device, notify the chairperson of the institutional review committee or an appropriate local committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.

(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued compliance with the requirements of this subsection if the Secretary believes such demonstration to be necessary to protect the public health, if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met, or if the Secretary has reason to believe that the criteria for the exemption are no longer met. If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing.

(6)(A) Except as provided in subparagraph (D), the prohibition in paragraph (3) shall not apply with respect to a person granted an exemption under paragraph (2) if each of the following conditions apply:

(i) The device with respect to which the exemption is granted—

(I) is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or

(II) is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients or that occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe.

(ii) During any calendar year, the number of such devices distributed during that year under each exemption granted under this subsection does not exceed the annual distribution number for such device. In this paragraph, the term "annual distribution number" means the number of such devices reasonably needed to treat, diagnose, or cure a population of 8,000 individuals in the United States. The Secretary shall determine the annual distribution number when the Secretary grants such exemption.

(iii) Such person immediately notifies the Secretary if the number of such devices distributed during any calendar year exceeds the annual distribution number referred to in clause (ii).

(iv) The request for such exemption is submitted on or before October 1, 2027.

(B) The Secretary may inspect the records relating to the number of devices distributed during any calendar year of a person granted an exemption under paragraph (2) for which the prohibition in paragraph (3) does not apply.

(C) A person may petition the Secretary to modify the annual distribution number determined by the Secretary under subparagraph (A)(ii) with respect to a device if additional information arises, and the Secretary may modify such annual distribution number.

(D) If a person notifies the Secretary, or the Secretary determines through an inspection under subparagraph (B), that the number of devices distributed during any calendar year exceeds the annual distribution number, as required under subparagraph (A)(iii), and modified under subparagraph (C), if applicable, then the prohibition in paragraph (3) shall apply with respect to such person for such device for any sales of such device after such notification.

(E)(i) In this subsection, the term "pediatric patients" means patients who are 21 years of age or younger at the time of the diagnosis or treatment.

(ii) In this subsection, the term "pediatric subpopulation" means 1 of the following populations:

(I) Neonates.

(II) Infants.

(III) Children.

(IV) Adolescents.

(7) The Secretary shall refer any report of an adverse event regarding a device described in paragraph (6)(A)(i)(I) for which the prohibition under paragraph (3) does not apply pursuant to paragraph (6)(A) that the Secretary receives to the Office of Pediatric Therapeutics, established under section 393a of this title. In considering the report, the Director of the Office of Pediatric Therapeutics, in consultation with experts in the Center for Devices and Radiological Health, shall provide for periodic review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such committee regarding whether the Secretary should take action under this chapter in response to the report.

(8) The Secretary, acting through the Office of Pediatric Therapeutics and the Center for Devices and Radiological Health, shall provide for an annual review by the Pediatric Advisory Committee of all devices described in paragraph (6)(A)(i)(I) to ensure that the exemption under paragraph (2) remains appropriate for the pediatric populations for which it is granted.

(n) Regulation of contact lenses as devices

(1) All contact lenses shall be deemed to be devices under section 321(h) of this title.

(2) Paragraph (1) shall not be construed as bearing on or being relevant to the question of whether any product other than a contact lens is a device as defined by section 321(h) of this title or a drug as defined by section 321(g) of this title.

(o) Regulation of medical and certain decisions support software

(1) The term device,2 as defined in section 321(h) of this title, shall not include a software function that is intended—

(A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management, and laboratory workflow;

(B) for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;

(C) to serve as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as—

(i) such records were created, stored, transferred, or reviewed by health care professionals, or by individuals working under supervision of such professionals;

(ii) such records are part of health information technology that is certified under section 300jj–11(c)(5) of title 42; and

(iii) such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;

(D) for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings; or

(E) unless the function is intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system, for the purpose of—

(i) displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);

(ii) supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and

(iii) enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.

(2) In the case of a product with multiple functions that contains—

(A) at least one software function that meets the criteria under paragraph (1) or that otherwise does not meet the definition of device under section 321(h) of this title; and

(B) at least one function that does not meet the criteria under paragraph (1) and that otherwise meets the definition of a device under section 321(h) of this title,

the Secretary shall not regulate the software function of such product described in subparagraph (A) as a device. Notwithstanding the preceding sentence, when assessing the safety and effectiveness of the device function or functions of such product described in subparagraph (B), the Secretary may assess the impact that the software function or functions described in subparagraph (A) have on such device function or functions.

(3)(A) Notwithstanding paragraph (1), a software function described in subparagraph (C), (D), or (E) of paragraph (1) shall not be excluded from the definition of device under section 321(h) of this title if—

(i) the Secretary makes a finding that use of such software function would be reasonably likely to have serious adverse health consequences; and

(ii) the software function has been identified in a final order issued by the Secretary under subparagraph (B).

(B) Subparagraph (A) shall apply only if the Secretary—

(i) publishes a notification and proposed order in the Federal Register;

(ii) includes in such notification the Secretary's finding, including the rationale and identification of the evidence on which such finding was based, as described in subparagraph (A)(i); and

(iii) provides for a period of not less than 30 calendar days for public comment before issuing a final order or withdrawing such proposed order.

(C) In making a finding under subparagraph (A)(i) with respect to a software function, the Secretary shall consider—

(i) the likelihood and severity of patient harm if the software function were to not perform as intended;

(ii) the extent to which the software function is intended to support the clinical judgment of a health care professional;

(iii) whether there is a reasonable opportunity for a health care professional to review the basis of the information or treatment recommendation provided by the software function; and

(iv) the intended user and user environment, such as whether a health care professional will use a software function of a type described in subparagraph (E) of paragraph (1).

(4) Nothing in this subsection shall be construed as limiting the authority of the Secretary to—

(A) exercise enforcement discretion as to any device subject to regulation under this chapter;

(B) regulate software used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans; or

(C) regulate software as a device under this chapter if such software meets the criteria under section 360c(a)(1)(C) of this title.

(p) Diagnostic imaging devices intended for use with contrast agents

(1) In general

The Secretary may, subject to the succeeding provisions of this subsection, approve an application (or a supplement to such an application) submitted under section 360e of this title with respect to an applicable medical imaging device, or, in the case of an applicable medical imaging device for which a notification is submitted under section 360(k) of this title, may make a substantial equivalence determination with respect to an applicable medical imaging device, or may grant a request submitted under section 360c(f)(2) of this title for an applicable medical imaging device, if such application, notification, or request involves the use of a contrast agent that is not—

(A) in a concentration, rate of administration, or route of administration that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in concentration, rate of administration, or route of administration exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device;

(B) in a region, organ, or system of the body that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in region, organ, or system of the body exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device;

(C) in a patient population that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines such differences in patient population exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device; or

(D) in an imaging modality that is different from those described in the approved labeling of the contrast agent.

(2) Premarket review

The agency center charged with premarket review of devices shall have primary jurisdiction with respect to the review of an application, notification, or request described in paragraph (1). In conducting such review, such agency center may—

(A) consult with the agency center charged with the premarket review of drugs or biological products; and

(B) review information and data provided to the Secretary by the sponsor of a contrast agent in an application submitted under section 355 of this title or section 262 of title 42, so long as the sponsor of such contrast agent has provided to the sponsor of the applicable medical imaging device that is the subject of such review a right of reference and the application is submitted in accordance with this subsection.

(3) Applicable requirements

An application submitted under section 360e of this title, a notification submitted under section 360(k) of this title, or a request submitted under section 360c(f)(2) of this title, as described in paragraph (1), with respect to an applicable medical imaging device shall be subject to the requirements of such respective section. Such application, notification, or request shall only be subject to the requirements of this chapter applicable to devices.

(4) Definitions

For purposes of this subsection—

(A) the term "applicable medical imaging device" means a device intended to be used in conjunction with a contrast agent (or class of contrast agents) for an imaging use that is not described in the approved labeling of such contrast agent (or the approved labeling of any contrast agent in the same class as such contrast agent); and

(B) the term "contrast agent" means a drug that is approved under section 355 of this title or licensed under section 262 of title 42, is intended for use in conjunction with an applicable medical imaging device, and—

(i) is a diagnostic radiopharmaceutical, as defined in section 3 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or

(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.

(q) Regulation of over-the-counter hearing aids

(1) Definition

(A) In general

In this subsection, the term "over-the-counter hearing aid" means a device that—

(i) uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations) (or any successor regulation);

(ii) is intended to be used by adults age 18 and older to compensate for perceived mild to moderate hearing impairment;

(iii) through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user's hearing needs;

(iv) may—

(I) use wireless technology; or

(II) include tests for self-assessment of hearing loss; and

(v) is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

(B) Exception

Such term does not include a personal sound amplification product intended to amplify sound for nonhearing impaired consumers in situations including hunting and bird-watching.

(2) Regulation

An over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section 709(b) of the FDA Reauthorization Act of 2017 and shall be exempt from sections 801.420 and 801.421 of title 21, Code of Federal Regulations (or any successor regulations).

(June 25, 1938, ch. 675, §520, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 565; amended Pub. L. 101–629, §§3(b)(2), 4(b)(2), 5(c)(2), 6(b)(2), 11, 14(a), 18(e), (f), Nov. 28, 1990, 104 Stat. 4514, 4516, 4518, 4519, 4522, 4524, 4529; Pub. L. 102–571, title I, §107(10), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 105–115, title I, §125(b)(2)(E), title II, §§201(a), 203, 216(a)(1), title IV, §410(a), Nov. 21, 1997, 111 Stat. 2325, 2332, 2334, 2349, 2372; Pub. L. 109–96, §1, Nov. 9, 2005, 119 Stat. 2119; Pub. L. 110–85, title III, §303(a), title VIII, §801(b)(3)(E), Sept. 27, 2007, 121 Stat. 860, 921; Pub. L. 112–144, title V, §507(c), title VI, §§601, 606, 613(a), 617, July 9, 2012, 126 Stat. 1045, 1051, 1054, 1060, 1062; Pub. L. 114–255, div. A, title III, §§3024(a), 3038(b), 3052(a), 3056, 3060(a), Dec. 13, 2016, 130 Stat. 1099, 1110, 1124, 1128, 1130; Pub. L. 115–52, title V, §502(b), title VII, §§706(a), 709(a), Aug. 18, 2017, 131 Stat. 1037, 1058, 1065; Pub. L. 117–180, div. F, title V, §5002, Sept. 30, 2022, 136 Stat. 2167; Pub. L. 117–229, div. C, title III, §303, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–286, §4(a)(156), Dec. 27, 2022, 136 Stat. 4323; Pub. L. 117–328, div. FF, title III, §§3103, 3601(b), Dec. 29, 2022, 136 Stat. 5807, 5861.)

Delayed Applicability of Amendment

For provisions related to delayed applicability of subsection (g)(9) of this section as added by section 3601(b) of Pub. L. 117–328, see Effective Date of 2022 Amendment note set out under section 355 of this title.

Editorial Notes

References in Text

July 9, 2012, referred to in subsec. (b)(3), was in the original "the date of enactment of this section", which was translated as meaning the date of enactment of Pub. L. 112–144, which amended subsec. (b) generally, to reflect the probable intent of Congress.

Section 709(b) of the FDA Reauthorization Act of 2017, referred to in subsec. (q)(2), is section 709(b) of Pub. L. 115–52, which is set out as a note below.

Codification

In subsec. (k), "section 3324(a) and (b) of title 31 and section 6101 of title 41" substituted for "sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5)" on authority of Pub. L. 97–258, §4(b), Sept. 13, 1982, 96 Stat. 1067, which Act enacted Title 31, Money and Finance, and Pub. L. 111–350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

Amendments

2022—Subsec. (f)(3). Pub. L. 117–286 substituted "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act" in concluding provisions.

Subsec. (g)(9). Pub. L. 117–328, §3601(b), added par. (9).

Subsec. (m)(6)(A)(iv). Pub. L. 117–328, §3103, substituted "October 1, 2027" for "December 24, 2022".

Pub. L. 117–229 substituted "December 24, 2022" for "December 17, 2022".

Pub. L. 117–180 substituted "December 17" for "October 1".

2017—Subsec. (m)(4). Pub. L. 115–52, §502(b)(1)(B), inserted "or an appropriate local committee" after "review committee" in two places in concluding provisions.

Subsec. (m)(4)(B). Pub. L. 115–52, §502(b)(1)(A), inserted "or an appropriate local committee" after "review committee" in two places.

Subsec. (m)(6)(A)(iv). Pub. L. 115–52, §502(b)(2), substituted "2022" for "2017".

Subsec. (p). Pub. L. 115–52, §706(a), added subsec. (p).

Subsec. (q). Pub. L. 115–52, §709(a), added subsec. (q). Amendment was executed to this section as amended by section 706(a) of Pub. L. 115–52, notwithstanding directory language referring to section as amended by section 708 of Pub. L. 115–52, which did not amend this section.

2016—Subsec. (g)(3). Pub. L. 114–255, §3024(a)(2), substituted "subparagraph (D)(ii)" for "subparagraph (D)" in concluding provisions.

Subsec. (g)(3)(A)(i). Pub. L. 114–255, §3056(1)(A), struck out "local" before "institutional review committee" and "which has been" before "established in accordance with".

Subsec. (g)(3)(B). Pub. L. 114–255, §3056(1)(B), substituted "an institutional" for "a local institutional".

Subsec. (g)(3)(D). Pub. L. 114–255, §3024(a)(1), substituted "except where, subject to such conditions as the Secretary may prescribe—" for "except where subject to such conditions as the Secretary may prescribe,", added cl. (i), and inserted cl. (ii) designation before "the investigator".

Subsec. (h)(4)(A). Pub. L. 114–255, §3038(b)(1), substituted "Subject to subparagraph (C), any information" for "Any information" in introductory provisions.

Subsec. (h)(4)(C). Pub. L. 114–255, §3038(b)(2), added subpar. (C).

Subsec. (m)(1). Pub. L. 114–255, §3052(a)(1), substituted "not more than 8,000" for "fewer than 4,000".

Subsec. (m)(2)(A). Pub. L. 114–255, §3052(a)(2), substituted "not more than 8,000" for "fewer than 4,000".

Subsec. (m)(4). Pub. L. 114–255, §3056(2)(C), struck out "local" after "chairperson of the" in concluding provisions.

Subsec. (m)(4)(A). Pub. L. 114–255, §3056(2)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: "in facilities that have established, in accordance with regulations of the Secretary, a local institutional review committee to supervise clinical testing of devices in the facilities, and".

Subsec. (m)(4)(B). Pub. L. 114–255, §3056(2)(B), substituted "an institutional" for "a local institutional".

Subsec. (m)(6)(A)(ii). Pub. L. 114–255, §3052(a)(3), substituted "8,000" for "4,000".

Subsec. (o). Pub. L. 114–255, §3060(a), added subsec. (o).

2012—Subsec. (b). Pub. L. 112–144, §617, amended subsec. (b) generally. Prior to amendment, subsec. (b) related to custom devices.

Subsec. (g)(2)(B)(ii). Pub. L. 112–144, §601(1), inserted "safety or effectiveness" before "data obtained".

Subsec. (g)(4)(C). Pub. L. 112–144, §601(2), added subpar. (C).

Subsec. (g)(8). Pub. L. 112–144, §606, added par. (8).

Subsec. (m)(6)(A)(i). Pub. L. 112–144, §613(a)(1)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows:

"(i)(I) The device with respect to which the exemption is granted is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs.

"(II) The device was not previously approved under this subsection for the pediatric patients or the pediatric subpopulation described in subclause (I) prior to September 27, 2007."

Subsec. (m)(6)(A)(ii). Pub. L. 112–144, §613(a)(1)(A)(ii), added cl. (ii) and struck out former cl. (ii) which read as follows: "During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number shall be based on the number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure, and of that number, the number of individuals likely to use the device, and the number of devices reasonably necessary to treat such individuals. In no case shall the annual distribution number exceed the number identified in paragraph (2)(A)."

Subsec. (m)(6)(A)(iv). Pub. L. 112–144, §507(c), substituted "2017" for "2012".

Subsec. (m)(6)(C). Pub. L. 112–144, §613(a)(1)(B), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: "A person may petition the Secretary to modify the annual distribution number specified by the Secretary under subparagraph (A)(ii) with respect to a device if additional information on the number of individuals affected by the disease or condition arises, and the Secretary may modify such number but in no case shall the annual distribution number exceed the number identified in paragraph (2)(A)."

Subsec. (m)(7). Pub. L. 112–144, §613(a)(2), substituted "regarding a device described in paragraph (6)(A)(i)(I)" for "regarding a device".

Subsec. (m)(8). Pub. L. 112–144, §613(a)(3), substituted "of all devices described in paragraph (6)(A)(i)(I)" for "of all devices described in paragraph (6)".

2007—Subsec. (m)(2). Pub. L. 110–85, §801(b)(3)(E), inserted before period at end of first sentence of concluding provisions "and such application shall include the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application)".

Subsec. (m)(3). Pub. L. 110–85, §303(a)(1), substituted "Except as provided in paragraph (6), no" for "No".

Subsec. (m)(5). Pub. L. 110–85, §303(a)(2), inserted ", if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met," after "public health" and inserted at end "If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing."

Subsec. (m)(6) to (8). Pub. L. 110–85, §303(a)(3), added pars. (6) to (8) and struck out former par. (6) which read as follows: "The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing."

2005—Subsec. (n). Pub. L. 109–96 added subsec. (n).

1997—Subsec. (f)(1)(B)(iii). Pub. L. 105–115, §410(a), added cl. (iii).

Subsec. (g)(6), (7). Pub. L. 105–115, §201(a), added pars. (6) and (7).

Subsec. (h)(4). Pub. L. 105–115, §216(a)(1), amended par. (4) generally. Prior to amendment, par. (4) related to premarket approval of devices.

Subsec. (l). Pub. L. 105–115, §125(b)(2)(E), struck out "or antibiotic drugs" after "new drugs" in heading.

Subsec. (l)(4). Pub. L. 105–115, §125(b)(2)(E), struck out par. (4) which read as follows: "Any device intended for human use which on the enactment date was subject to the requirements of section 357 of this title shall be subject to such requirements as follows:

"(A) In the case of such a device which is classified into class I, such requirements shall apply to such device until the effective date of the regulation classifying the device into such class.

"(B) In the case of such a device which is classified into class II, such requirements shall apply to such device until the effective date of a performance standard applicable to the device under section 360d of this title.

"(C) In the case of such a device which is classified into class III, such requirements shall apply to such device until the date on which the device is required to have in effect an approved application under section 360e of this title."

Subsec. (m)(2). Pub. L. 105–115, §203(1), inserted at end "The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application."

Subsec. (m)(4). Pub. L. 105–115, §203(2)(B), inserted at end "In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use."

Subsec. (m)(4)(B). Pub. L. 105–115, §203(2)(A), inserted before period at end ", unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient".

Subsec. (m)(5). Pub. L. 105–115, §203(3), amended par. (5) generally. Prior to amendment, par. (5) read as follows: "An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take effect. The Secretary may extend such an exemption for a period of 18 months if the Secretary is able to make the findings set forth in paragraph (2) and if the applicant supplies information demonstrating compliance with paragraph (3). An exemption may be extended more than once and may be extended after the expiration of such 5-year period."

Subsec. (m)(6). Pub. L. 105–115, §203(4), amended par. (6) generally. Prior to amendment, par. (6) read as follows: "Within one year of November 28, 1990, the Secretary shall issue regulations to implement this subsection."

1992—Subsec. (g)(2)(A). Pub. L. 102–571 substituted "379e" for "376".

1990—Subsec. (c). Pub. L. 101–629, §11(1), substituted "from class III to class II or class I" for "under section 360c of this title from class III to class II" and inserted "(1) in accordance with subsection (h), and (2)" after "except".

Subsec. (f)(1)(A). Pub. L. 101–629, §18(e), inserted "pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device)," after "manufacture,".

Subsec. (h)(3). Pub. L. 101–629, §11(2)(A), substituted "Except as provided in paragraph (4), any" for "Any".

Subsec. (h)(4). Pub. L. 101–629, §11(2)(B), added par. (4).

Subsec. (i). Pub. L. 101–629, §6(b)(2), substituted "section 360d(b)(5)(B)" for "section 360d(g)(5)(B)".

Subsec. (j). Pub. L. 101–629, §3(b)(2), substituted "Except as provided in section 360i(e) of this title, no" for "No".

Subsec. (l)(2). Pub. L. 101–629, §18(f), struck out "and after affording the petitioner an opportunity for an informal hearing" after "under this paragraph".

Pub. L. 101–629, §5(c)(2), substituted "The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer" for "The manufacturer".

Subsec. (l)(5). Pub. L. 101–629, §4(b)(2), added par. (5).

Subsec. (m). Pub. L. 101–629, §14(a), added subsec. (m).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Subsec. (g)(9) of this section, as added by section 3601(b) of Pub. L. 117–328, applicable only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under section 3602 of Pub. L. 117–328, see section 3602(c) of Pub. L. 117–328, set out as a note under section 355 of this title.

Effective Date of 1997 Amendment

Amendment by sections 201(a), 203, 216(a)(1), and 410(a) of 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 this title.

Effective Date of 1990 Amendment

Pub. L. 101–629, §14(b), Nov. 28, 1990, 104 Stat. 4525, provided that: "Subsection (m) of section 520 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360j(m)], as added by the amendment made by subsection (a), shall take effect on the effective date of the regulations issued by the Secretary under paragraph (6) of such subsection."

Regulations and Guidance Concerning Over-the-Counter Hearing Aids

Pub. L. 115–52, title VII, §709(b), (c), Aug. 18, 2017, 131 Stat. 1066, 1067, provided that:

"(b) Regulations To Establish Category.—

"(1) In general.—The Secretary of Health and Human Services (referred to in this section [amending this section and enacting this note] as the 'Secretary'), not later than 3 years after the date of enactment of this Act [Aug. 18, 2017], shall promulgate proposed regulations to establish a category of over-the-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by subsection (a), and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.

"(2) Requirements.—In promulgating the regulations under paragraph (1), the Secretary shall—

"(A) include requirements that provide reasonable assurances of the safety and effectiveness of over-the-counter hearing aids;

"(B) include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids;

"(C) include requirements for appropriate labeling of over-the-counter hearing aids, including requirements that such labeling include a conspicuous statement that the device is only intended for adults age 18 and older, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of medically treatable causes of hearing loss, and advisements to consult promptly with a licensed health care practitioner; and

"(D) describe the requirements under which the sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

"(3) Premarket notification.—The Secretary shall make findings under section 510(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j[(q)]), as amended by subsection (a)) require a report under section 510(k) [21 U.S.C. 360(k)] to provide reasonable assurance of safety and effectiveness.

"(4) Effect on state law.—No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j[(q)]), as amended by subsection (a)) through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids.

"(5) No effect on private remedies.—Nothing in this section shall be construed to modify or otherwise affect the ability of any person to exercise a private right of action under any State or Federal product liability, tort, warranty, contract, or consumer protection law.

"(c) New Guidance Issued.—Not later than the date on which final regulations are issued under subsection (b), the Secretary shall update and finalize the draft guidance of the Department of Health and Human Services entitled 'Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products', issued on November 7, 2013. Such updated and finalized guidance shall clarify which products, on the basis of claims or other marketing, advertising, or labeling material, meet the definition of a device in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet the definition of a personal sound amplification product, as set forth in such guidance."

Guidance Document on Probable Benefit

Pub. L. 114–255, div. A, title III, §3052(b), Dec. 13, 2016, 130 Stat. 1125, provided that: "Not later than 18 months after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance that defines the criteria for establishing 'probable benefit' as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C))."

Reports

Pub. L. 114–255, div. A, title III, §3060(b), Dec. 13, 2016, 130 Stat. 1132, provided that: "The Secretary of Health and Human Services (referred to in this subsection as the 'Secretary'), after consultation with agencies and offices of the Department of Health and Human Services involved in health information technology, shall publish a report, not later than 2 years after the date of enactment of this Act [Dec. 13, 2016] and every 2 years thereafter, that—

"(1) includes input from outside experts, such as representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small businesses, purchasers, employers, and other stakeholders with relevant expertise, as determined by the Secretary;

"(2) examines information available to the Secretary on any risks and benefits to health associated with software functions described in section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j[(o)(1)]) (as amended by subsection (a)); and

"(3) summarizes findings regarding the impact of such software functions on patient safety, including best practices to promote safety, education, and competency related to such functions."

Applicability to Existing Devices

Pub. L. 112–144, title VI, §613(b), July 9, 2012, 126 Stat. 1061, provided that: "A sponsor of a device for which an exemption was approved under paragraph (2) of section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the date of enactment of this Act [July 9, 2012] may seek a determination under subclause (I) or (II) of section 520(m)(6)(A)(i) (as amended by subsection (a)). If the Secretary of Health and Human Services determines that such subclause (I) or (II) applies with respect to a device, clauses (ii), (iii), and (iv) of subparagraph (A) and subparagraphs (B), (C), (D), and (E) of paragraph (6) of such section 520(m) shall apply to such device, and the Secretary shall determine the annual distribution number for purposes of clause (ii) of such subparagraph (A) when making the determination under this subsection."

Guidance

Pub. L. 110–85, title III, §303(c), Sept. 27, 2007, 121 Stat. 862, provided that: "Not later than 180 days after the date of the enactment of this Act [Sept. 27, 2007], the Commissioner of Food and Drugs shall issue guidance for institutional review committees on how to evaluate requests for approval for devices for which a humanitarian device exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted."

Pub. L. 107–250, title II, §213, Oct. 26, 2002, 116 Stat. 1614, provided that: "Not later than 270 days after the date of the enactment of this Act [Oct. 26, 2002], the Secretary of Health and Human Services shall issue guidance on the following:

"(1) The type of information necessary to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in pediatric populations.

"(2) Protections for pediatric subjects in clinical investigations of the safety or effectiveness of such devices."

Report on Humanitarian Device Exemptions

Pub. L. 101–629, §14(c), Nov. 28, 1990, 104 Stat. 4525, directed Secretary of Health and Human Services, within 4 years after issuance of regulations under 21 U.S.C. 360j(m)(6), to report to Congress on types of devices exempted, an evaluation of effects of such section, and a recommendation on extension of the section.

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

1 See Delayed Applicability of Amendment note below.

2 So in original. Probably should be "The term 'device',".

3 So in original. Probably should be "sections".
21 U.S.C. § 1903 (2024) — Title 21: FOOD AND DRUGS / Chapter 24: INTERNATIONAL NARCOTICS TRAFFICKING / Section 1903: Public identification of significant foreign narcotics traffickers and required reports
Public identification of significant foreign narcotics traffickers and required reports
Status: in_force

(a) Provision of information to the President

The Secretary of the Treasury, the Attorney General, the Secretary of Defense, the Secretary of State, and the Director of Central Intelligence shall consult among themselves and provide the appropriate and necessary information to enable the President to submit the report under subsection (b). This information shall also be provided to the Director of the Office of National Drug Control Policy.

(b) Public identification and sanctioning of significant foreign narcotics traffickers

Not later than June 1, 2000, and not later than June 1 of each year thereafter, the President shall submit a report to the Permanent Select Committee on Intelligence, and the Committees on the Judiciary, International Relations, Armed Services, and Ways and Means of the House of Representatives; and to the Select Committee on Intelligence, and the Committees on the Judiciary, Foreign Relations, Armed Services, and Finance of the Senate—

(1) identifying publicly the foreign persons that the President determines are appropriate for sanctions pursuant to this chapter; and

(2) detailing publicly the President's intent to impose sanctions upon these significant foreign narcotics traffickers pursuant to this chapter.

The report required in this subsection shall not include information on persons upon which United States sanctions imposed under this chapter, or otherwise on account of narcotics trafficking, are already in effect.

(c) Unclassified report required

The report required by subsection (b) shall be submitted in unclassified form and made available to the public.

(d) Classified report

(1) Not later than July 1, 2000, and not later than July 1 of each year thereafter, the President shall provide the Permanent Select Committee on Intelligence of the House of Representatives and the Select Committee on Intelligence of the Senate with a report in classified form describing in detail the status of the sanctions imposed under this chapter, including the personnel and resources directed towards the imposition of such sanctions during the preceding fiscal year, and providing background information with respect to newly-identified significant foreign narcotics traffickers and their activities.

(2) Such classified report shall describe actions the President intends to undertake or has undertaken with respect to such significant foreign narcotics traffickers.

(3) The report required under this subsection is in addition to the President's obligations to keep the intelligence committees of Congress fully and currently informed pursuant to the provisions of the National Security Act of 1947.

(e) Exclusion of certain information

(1) Intelligence

Notwithstanding any other provision of this section, the reports described in subsections (b) and (d) shall not disclose the identity of any person, if the Director of Central Intelligence determines that such disclosure could compromise an intelligence operation, activity, source, or method of the United States.

(2) Law enforcement

Notwithstanding any other provision of this section, the reports described in subsections (b) and (d) shall not disclose the name of any person if the Attorney General, in coordination as appropriate with the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, and the Secretary of the Treasury, determines that such disclosure could reasonably be expected to—

(A) compromise the identity of a confidential source, including a State, local, or foreign agency or authority or any private institution that furnished information on a confidential basis;

(B) jeopardize the integrity or success of an ongoing criminal investigation or prosecution;

(C) endanger the life or physical safety of any person; or

(D) cause substantial harm to physical property.

(f) Notification required

(1) Whenever either the Director of Central Intelligence or the Attorney General makes a determination under subsection (e), the Director of Central Intelligence or the Attorney General shall notify the Permanent Select Committee on Intelligence of the House of Representatives and the Select Committee on Intelligence of the Senate, and explain the reasons for such determination.

(2) The notification required under this subsection shall be submitted to the Permanent Select Committee on Intelligence of the House of Representatives and the Select Committee on Intelligence of the Senate not later than July 1, 2000, and on an annual basis thereafter.

(g) Determinations not to apply sanctions

(1) The President may waive the application to a significant foreign narcotics trafficker of any sanction authorized by this chapter if the President determines that the application of sanctions under this chapter would significantly harm the national security of the United States.

(2) When the President determines not to apply sanctions that are authorized by this chapter to any significant foreign narcotics trafficker, the President shall notify the Permanent Select Committee on Intelligence, and the Committees on the Judiciary, International Relations, Armed Services, and Ways and Means of the House of Representatives, and the Select Committee on Intelligence, and the Committees on the Judiciary, Foreign Relations, Armed Services, and Finance of the Senate not later than 21 days after making such determination.

(h) Changes in determinations to impose sanctions

(1) Additional determinations

(A) If at any time after the report required under subsection (b) the President finds that a foreign person is a significant foreign narcotics trafficker and such foreign person has not been publicly identified in a report required under subsection (b), the President shall submit an additional public report containing the information described in subsection (b) with respect to such foreign person to the Permanent Select Committee on Intelligence, and the Committees on the Judiciary, International Relations, Armed Services, and Ways and Means of the House of Representatives, and the Select Committee on Intelligence, and the Committees on the Judiciary, Foreign Relations, Armed Services, and Finance of the Senate.

(B) The President may apply sanctions authorized under this chapter to the significant foreign narcotics trafficker identified in the report submitted under subparagraph (A) as if the trafficker were originally included in the report submitted pursuant to subsection (b) of this section.

(C) The President shall notify the Secretary of the Treasury of any determination made under this paragraph.

(2) Revocation of determination

(A) Whenever the President finds that a foreign person that has been publicly identified as a significant foreign narcotics trafficker in the report required under subsection (b) or this subsection no longer engages in those activities for which sanctions under this chapter may be applied, the President shall issue public notice of such a finding.

(B) Not later than the date of the public notice issued pursuant to subparagraph (A), the President shall notify, in writing and in classified or unclassified form, the Permanent Select Committee on Intelligence, and the Committees on the Judiciary, International Relations, Armed Services, and Ways and Means of the House of Representatives, and the Select Committee on Intelligence, and the Committees on the Judiciary, Foreign Relations, Armed Services, and Finance of the Senate of actions taken under this paragraph and a description of the basis for such actions.

(i) Protection of classified information in Federal court challenges relating to designations

In any judicial review of a determination made under this section, if the determination was based on classified information (as defined in section 1(a) of the Classified Information Procedures Act) such information may be submitted to the reviewing court ex parte and in camera. This subsection does not confer or imply any right to judicial review.

(Pub. L. 106–120, title VIII, §804, Dec. 3, 1999, 113 Stat. 1626; Pub. L. 114–198, title VIII, §801, July 22, 2016, 130 Stat. 755.)

Editorial Notes

References in Text

The National Security Act of 1947, referred to in subsec. (d)(3), is act July 26, 1947, ch. 343, 61 Stat. 495, which was formerly classified principally to chapter 15 (§401 et seq.) of Title 50, War and National Defense, prior to editorial reclassification in Title 50, and is now classified principally to chapter 44 (§3001 et seq.) of Title 50. For complete classification of this Act to the Code, see Tables.

Section 1(a) of the Classified Information Procedures Act, referred to in subsec. (i), is section 1(a) of Pub. L. 96–456, Oct. 15, 1980, 94 Stat. 2025, which is set out in the Appendix to Title 18, Crimes and Criminal Procedure.

Amendments

2016—Subsec. (i). Pub. L. 114–198 added subsec. (i).

Statutory Notes and Related Subsidiaries

Change of Name

Committee on International Relations of House of Representatives changed to Committee on Foreign Affairs of House of Representatives by House Resolution No. 6, One Hundred Tenth Congress, Jan. 5, 2007.

Reference to the Director of Central Intelligence or the Director of the Central Intelligence Agency in the Director's capacity as the head of the intelligence community deemed to be a reference to the Director of National Intelligence. Reference to the Director of Central Intelligence or the Director of the Central Intelligence Agency in the Director's capacity as the head of the Central Intelligence Agency deemed to be a reference to the Director of the Central Intelligence Agency. See section 1081(a), (b) of Pub. L. 108–458, set out as a note under section 3001 of Title 50, War and National Defense.

Executive Documents

Delegation of Functions

For delegation of Congressional reporting functions of President under subsec. (d) of this section, see section 1 of Ex. Ord. No. 13313, July 31, 2003, 68 F.R. 46075, set out as a note under section 301 of Title 3, The President.

Delegation of Functions Under Section 804(h)(2)(A) of the Foreign Narcotics Kingpin Designation Act

Memorandum of President of the United States, May 31, 2013, 78 F.R. 33943, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, I hereby delegate the functions conferred upon the President by section 804(h)(2)(A) of the Foreign Narcotics Kingpin Designation Act (21 U.S.C. 1903(h)(2)(A)), to the Secretary of the Treasury.

You are authorized and directed to publish this memorandum in the Federal Register.

Barack Obama.      

Delegation of Functions Under the Foreign Narcotics Kingpin Designation Act

Memorandum of President of the United States, May 15, 2015, 80 F.R. 29201, provided:

Memorandum for the Secretary of the Treasury

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, I hereby delegate the functions conferred upon the President by sections 804(b), (c), (g), and (h) of the Foreign Narcotics Kingpin Designation Act (21 U.S.C. 1903(b), (c), (g), and (h)), to the Secretary of the Treasury.

You are authorized and directed to publish this memorandum in the Federal Register.

Barack Obama.