21 U.S.C. § 472 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 472: Interstate shipment of poultry inspected by Federal and State agencies for certain small establishments
Interstate shipment of poultry inspected by Federal and State agencies for certain small establishments
Status: in_force

(a) Definitions

(1) Appropriate State agency

The term "appropriate State agency" means a State agency described in section 454(a)(1) of this title.

(2) Designated personnel

The term "designated personnel" means inspection personnel of a State agency that have undergone all necessary inspection training and certification to assist the Secretary in the administration and enforcement of this chapter, including rules and regulations issued under this chapter.

(3) Eligible establishment

The term "eligible establishment" means an establishment that is in compliance with—

(A) the State inspection program of the State in which the establishment is located; and

(B) this chapter, including rules and regulations issued under this chapter.

(4) Poultry item

The term "poultry item" means—

(A) a portion of poultry; and

(B) a poultry product.

(5) Selected establishment

The term "selected establishment" means an eligible establishment that is selected by the Secretary, in coordination with the appropriate State agency of the State in which the eligible establishment is located, under subsection (b) to ship poultry items in interstate commerce.

(b) Authority of Secretary to allow shipments

(1) In general

Subject to paragraph (2), the Secretary, in coordination with the appropriate State agency of the State in which an establishment is located, may select the establishment to ship poultry items in interstate commerce, and place on each poultry item shipped in interstate commerce a Federal mark, stamp, tag, or label of inspection, if—

(A) the poultry item qualifies for the Federal mark, stamp, tag, or label of inspection under the requirements of this chapter;

(B) the establishment is an eligible establishment; and

(C) inspection services for the establishment are provided by designated personnel.

(2) Prohibited establishments

In carrying out paragraph (1), the Secretary, in coordination with an appropriate State agency, shall not select an establishment that—

(A) on average, employs more than 25 employees (including supervisory and nonsupervisory employees), as defined by the Secretary;

(B) as of the date of the enactment of this section, ships in interstate commerce carcasses, portions of carcasses, or poultry items that are inspected by the Secretary in accordance with this chapter;

(C)(i) is a Federal establishment;

(ii) was a Federal establishment as of the date of the enactment of this section, and was reorganized on a later date under the same name or a different name or person by the person, firm, or corporation that controlled the establishment as of the date of the enactment of this section; or

(iii) was a State establishment as of the date of the enactment of this section that—

(I) as of the date of the enactment of this section, employed more than 25 employees; and

(II) was reorganized on a later date by the person, firm, or corporation that controlled the establishment as of the date of the enactment of this section;

(D) is in violation of this chapter;

(E) is located in a State that does not have a State inspection program; or

(F) is the subject of a transition carried out in accordance with a procedure developed by the Secretary under paragraph (3)(A).

(3) Establishments that employ more than 25 employees

(A) Development of procedure

The Secretary may develop a procedure to transition to a Federal establishment any establishment under this section that, on average, consistently employs more than 25 employees.

(B) Eligibility of certain establishments

(i) In general

A State establishment that employs more than 25 employees but less than 35 employees as of the date of the enactment of this section may be selected as a selected establishment under this subsection.

(ii) Procedures

A State establishment shall be subject to the procedures established under subparagraph (A) beginning on the date that is 3 years after the effective date described in subsection (i).

(c) Reimbursement of State costs

The Secretary shall reimburse a State for costs related to the inspection of selected establishments in the State in accordance with Federal requirements in an amount of not less than 60 percent of eligible State costs.

(d) Coordination between Federal and State agencies

(1) In general

The Secretary shall designate an employee of the Federal Government as State coordinator for each appropriate State agency—

(A) to provide oversight and enforcement of this section; and

(B) to oversee the training and inspection activities of designated personnel of the State agency.

(2) Supervision

A State coordinator shall be under the direct supervision of the Secretary.

(3) Duties of State coordinator

(A) In general

A State coordinator shall visit selected establishments with a frequency that is appropriate to ensure that selected establishments are operating in a manner that is consistent with this chapter (including regulations and policies under this chapter).

(B) Quarterly reports

A State coordinator shall, on a quarterly basis, submit to the Secretary a report that describes the status of each selected establishment that is under the jurisdiction of the State coordinator with respect to the level of compliance of each selected establishment with the requirements of this chapter.

(C) Immediate notification requirement

If a State coordinator determines that any selected establishment that is under the jurisdiction of the State coordinator is in violation of any requirement of this chapter, the State coordinator shall—

(i) immediately notify the Secretary of the violation; and

(ii) deselect the selected establishment or suspend inspection at the selected establishment.

(4) Performance evaluations

Performance evaluations of State coordinators designated under this subsection shall be conducted by the Secretary as part of the Federal agency management control system.

(e) Audits

(1) Periodic audits conducted by Inspector General of the Department of Agriculture

Not later than 2 years after the effective date described in subsection (i), and not less often than every 3 years thereafter, the Inspector General of the Department of Agriculture shall conduct an audit of each activity taken by the Secretary under this section for the period covered by the audit to determine compliance with this section.

(2) Audit conducted by Comptroller General of the United States

Not earlier than 3 years, nor later than 5 years, after the date of the enactment of this section, the Comptroller General of the United States shall conduct an audit of the implementation of this section to determine—

(A) the effectiveness of the implementation of this section; and

(B) the number of selected establishments selected by the Secretary to ship poultry items under this section.

(f) Transition grants

The Secretary may provide grants to appropriate State agencies to assist the appropriate State agencies in helping establishments covered by this chapter to transition to selected establishments.

(g) Violations

Any selected establishment that the Secretary determines to be in violation of any requirement of this chapter shall be transitioned to a Federal establishment in accordance with a procedure developed by the Secretary under subsection (b)(3)(A).

(h) Effect

Nothing in this section limits the jurisdiction of the Secretary with respect to the regulation of poultry and poultry products under this chapter.

(i) Effective date

(1) In general

This section takes effect on the date on which the Secretary, after providing a period of public comment (including through the conduct of public meetings or hearings), promulgates final regulations to carry out this section.

(2) Requirement

Not later than 18 months after the date of the enactment of this section, the Secretary shall promulgate final regulations in accordance with paragraph (1).

(Pub. L. 85–172, §31, as added Pub. L. 110–234, title XI, §11015(b), May 22, 2008, 122 Stat. 1365, and Pub. L. 110–246, §4(a), title XI, §11015(b), June 18, 2008, 122 Stat. 1664, 2127.)

Editorial Notes

References in Text

The date of the enactment of this section, referred to in subsecs. (b)(2)(B), (C)(ii), (iii), (3)(B)(i), (e)(2), and (i)(2), is the date of enactment of Pub. L. 110–246, which was approved June 18, 2008.

Final regulations to carry out this section, referred to in subsec. (i)(1), were published in the Federal Register on May 2, 2011, eff. July 1, 2011; see 76 F.R. 24756.

Codification

Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246.

Statutory Notes and Related Subsidiaries

Effective Date

Enactment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.
21 U.S.C. § 71 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter I: EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Section 71: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section 71, act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, which related to inspection of meat and meat food products, examination of cattle before slaughtering, separate slaughtering of diseased animals and examination of carcasses, was transferred to section 603 of this title.

Section 72, act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, which related to post mortem examination of carcasses, marking and labeling, destruction of condemned carcasses, and reinspection, was transferred to section 604 of this title.

Section 73, act Mar. 4, 1907, ch. 2907, 34 Stat. 1261, which related to examination of carcasses brought into slaughtering or packing establishments and of meat food products issued from and returned thereto, was transferred to section 605 of this title.

Section 74, act Mar. 4, 1907, ch. 2907, 34 Stat. 1261, which related to examination and inspection of meat food products, marks of inspection, destruction of condemned products, and products for export, was transferred to section 606 of this title and was subsequently repealed by Pub. L. 110–234, title XI, §11016(b)(1)(B), May 22, 2008, 122 Stat. 1369, and Pub. L. 110–246, §4(a), title XI, §11016(b)(1)(B), June 18, 2008, 122 Stat. 1664, 2131.

Section 75, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which related to labeling of receptacles and coverings of meat and meat food products inspected and passed, supervision by inspectors, prohibition of sales under false names, was transferred to section 607 of this title.

Section 76, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which related to sanitary inspection and regulation of slaughtering and packing establishments, and rejection of meat or meat food products unfit for food, was transferred to section 608 of this title.

Section 77, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which related to examination of cattle and food products thereof slaughtered and prepared during night time, was transferred to section 609 of this title.

Section 78, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which related to prohibition of transportation of carcasses, meat, or meat food products not properly inspected and marked, was transferred to section 610 of this title.

Section 79, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to forgery, alteration, and unauthorized use of marks, labels, and certificates, was transferred to section 611 of this title.

Section 80, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to inspection of animals for export, was transferred to section 612 of this title and was subsequently repealed by Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508.

Section 81, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to certificates of condition of animals for export, was transferred to section 613 of this title and was subsequently repealed by Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508.

Section 82, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to clearance to vessels carrying cattle for export with proper certificate of inspection, was transferred to section 614 of this title and was subsequently repealed by Pub. L. 107–171, title X, §10418(a)(19), May 13, 2002, 116 Stat. 508.

Section 83, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to inspection of carcasses, the meat of which is intended for export, was transferred to section 615 of this title.

Section 84, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to certificates of condition of carcasses, the meat of which is intended for export, was transferred to section 616 of this title.

Section 85, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to clearance to vessels carrying meat for export with proper certificate of inspection, was transferred to section 617 of this title.

Section 86, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which related to official certificates of inspection and delivery of copies thereof to different parties, was transferred to section 618 of this title.

Section 87, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which related to prohibition of transportation or sale of meat or meat food products without complying with provisions of inspection law, was transferred to section 619 of this title.

Section 88, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which related to offenses and penalties, was transferred to section 620 of this title.

Section 89, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which related to appointment of inspectors, their duties, and rule making authority of the Secretary of Agriculture, was transferred to section 621 of this title.

Section 90, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which related to penalties for bribery, was transferred to section 622 of this title.

Section 91, acts Mar. 4, 1907, ch. 2907, 34 Stat. 1265; June 29, 1938, ch. 810, 52 Stat. 1235, which related to definitions, exceptions to inspection requirements in case of farmers and retailers, and penalties for sale of meat and meat food products unfit for food, was transferred to section 623 of this title.

Section 92, act Mar. 4, 1907, ch. 2907, 34 Stat. 1265, which was a proviso following the first sentence of section 91 of this title, was restored to that section and has been transferred to section 623 of this title.
21 U.S.C. § 198a (2024) — Title 21: FOOD AND DRUGS / Chapter 6: NARCOTIC DRUGS / Section 198a: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section 198a, act Aug. 11, 1955, ch. 800, §1, 69 Stat. 684, as amended, which related to the authority of Secretary of the Treasury to issue subpenas, administer oaths and compel attendance of witnesses for purpose of any investigation, was transferred to section 967 of this title.

Section 198b, act Aug. 11, 1955, ch. 800, §2, 69 Stat. 685, which related to service of subpenas and proof of service, was transferred to section 968 of this title.

Section 198c, act Aug. 11, 1955, ch. 800, §3, 69 Stat. 685, which related to contempt proceedings, was transferred to section 969 of this title.
21 U.S.C. § 1036 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1036: Pasteurization and labeling of egg products at official plants
Pasteurization and labeling of egg products at official plants
Status: in_force

(a) Contents of label

Egg products inspected at any official plant under the authority of this chapter and found to be not adulterated shall be pasteurized before they leave the official plant, except as otherwise permitted by regulations of the Secretary, and shall at the time they leave the official plant, bear in distinctly legible form on their shipping containers or immediate containers, or both, when required by regulations of the Secretary, the official inspection legend and official plant number, of the plant where the products were processed, and such other information as the Secretary may require by regulations to describe the products adequately and to assure that they will not have false or misleading labeling.

(b) False or misleading or use of nonapproved labeling or containers; determination by Secretary; procedures applicable; appeal

No labeling or container shall be used for egg products at official plants if it is false or misleading or has not been approved as required by the regulations of the Secretary. If the Secretary has reason to believe that any labeling or the size or form of any container in use or proposed for use with respect to egg products at any official plant is false or misleading in any particular, he may direct that such use be withheld unless the labeling or container is modified in such manner as he may prescribe so that it will not be false or misleading. If the person using or proposing to use the labeling or container does not accept the determination of the Secretary, such person may request a hearing, but the use of the labeling or container shall, if the Secretary so directs, be withheld pending hearing and final determination by the Secretary. Any such determination by the Secretary shall be conclusive unless, within thirty days after receipt of notice of such final determination, the person adversely affected thereby appeals to the United States court of appeals for the circuit in which such person has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit. The provisions of section 194 of title 7,1 shall be applicable to appeals taken under this section.

(Pub. L. 91–597, §7, Dec. 29, 1970, 84 Stat. 1625.)

Editorial Notes

References in Text

This chapter, referred to in subsec. (a), was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

1 So in original. The comma probably should not appear.
21 U.S.C. § 884 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 884: Immunity and privilege
Immunity and privilege
Status: in_force

(a) Refusal to testify

Whenever a witness refuses, on the basis of his privilege against self-incrimination, to testify or provide other information in a proceeding before a court or grand jury of the United States, involving a violation of this subchapter, and the person presiding over the proceeding communicates to the witness an order issued under this section, the witness may not refuse to comply with the order on the basis of his privilege against self-incrimination. But no testimony or other information compelled under the order issued under subsection (b) of this section or any information obtained by the exploitation of such testimony or other information, may be used against the witness in any criminal case, including any criminal case brought in a court of a State, except a prosecution for perjury, giving a false statement, or otherwise failing to comply with the order.

(b) Order of United States district court

In the case of any individual who has been or may be called to testify or provide other information at any proceeding before a court or grand jury of the United States, the United States district court for the judicial district in which the proceeding is or may be held shall issue, upon the request of the United States attorney for such district, an order requiring such individual to give any testimony or provide any other information which he refuses to give or provide on the basis of his privilege against self-incrimination.

(c) Request by United States attorney

A United States attorney may, with the approval of the Attorney General or the Deputy Attorney General, the Associate Attorney General, or any Assistant Attorney General designated by the Attorney General, request an order under subsection (b) when in his judgment—

(1) the testimony or other information from such individual may be necessary to the public interest; and

(2) such individual has refused or is likely to refuse to testify or provide other information on the basis of his privilege against self-incrimination.

(Pub. L. 91–513, title II, §514, Oct. 27, 1970, 84 Stat. 1278; Pub. L. 100–690, title VII, §7020(f), Nov. 18, 1988, 102 Stat. 4396.)

Editorial Notes

Amendments

1988—Subsec. (c). Pub. L. 100–690 inserted reference to Associate Attorney General.
21 U.S.C. § 1044 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1044: Exemption of certain activities
Exemption of certain activities
Status: in_force

(a) Regulation for exemptions

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

(1) the sale, transportation, possession, or use of eggs which contain no more restricted eggs than are allowed by the tolerance in the official standards of United States consumer grades for shell eggs;

(2) the processing of egg products at any plant where the facilities and operating procedures meet such sanitary standards as may be prescribed by the Secretary, and where the eggs received or used in the manufacture of egg products contain no more restricted eggs than are allowed by the official standards of United States consumer grades for shell eggs, and the egg products processed at such plant;

(3) the sale of eggs by any poultry producer from his own flocks directly to a household consumer exclusively for use by such consumer and members of his household and his nonpaying guests and employees, and the transportation, possession, and use of such eggs in accordance with this paragraph;

(4) the processing of egg products by any poultry producer from eggs of his own flocks' production for sale of such products directly to a household consumer exclusively for use by such consumer and members of his household and his nonpaying guests and employees, and the egg products so processed when handled in accordance with this paragraph;

(5) the sale of eggs by shell egg packers on his own premises directly to household consumers for use by such consumer and members of his household and his nonpaying guests and employees, and the transportation, possession, and use of such eggs in accordance with this paragraph;

(6) for such period of time (not to exceed two years) during the initiation of operations under this chapter as the Secretary determines that it is impracticable to provide inspection, the processing of egg products at any class of plants and the egg products processed at such plants; and

(7) the sale of eggs by any egg producer with an annual egg production from a flock of three thousand or less hens.

(b) Plants located in noncontiguous areas of United States

The Secretary shall, by regulation and under such procedures as he may prescribe, exempt any plant located within noncontiguous areas of the United States from specific provisions of this chapter, where, despite good faith efforts by the owner of such plant, such owner has not been able to bring his plant into full compliance with this chapter: Provided, That in order to provide at least minimum standards for the protection of the public health, whenever processing operations are being conducted at any such plant, continuous inspection shall be maintained to assure that it is operated in a sanitary manner. No exemption under this subsection shall be granted for a period extending beyond December 31, 1971.

(c) Suspension or termination of exemptions

The Secretary may immediately suspend or terminate any exemption under paragraph (a)(2) or (6) 1 of this section at any time with respect to any person, if the conditions of exemption prescribed by this section or the regulations of the Secretary are not being met. The Secretary may modify or revoke any regulation granting exemption under this chapter whenever he deems such action appropriate to effectuate the purposes of this chapter.

(Pub. L. 91–597, §15, Dec. 29, 1970, 84 Stat. 1629; Pub. L. 92–67, Aug. 6, 1971, 85 Stat. 173.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1971—Subsecs. (b), (c). Pub. L. 92–67 added subsec. (b) and redesignated former subsec. (b) as (c).

Statutory Notes and Related Subsidiaries

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.

1 So in original. Probably should be "subsection (a)(2) or (6)".
21 U.S.C. § 829 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 829: Prescriptions
Prescriptions
Status: in_force

(a) Schedule II substances

Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may be dispensed without the written prescription of a practitioner, except that in emergency situations, as prescribed by the Secretary by regulation after consultation with the Attorney General, such drug may be dispensed upon oral prescription in accordance with section 503(b) of that Act [21 U.S.C. 353(b)]. Prescriptions shall be retained in conformity with the requirements of section 827 of this title. No prescription for a controlled substance in schedule II may be refilled.

(b) Schedule III and IV substances

Except when dispensed directly by a practitioner, other than a pharmacist, to an ultimate user, no controlled substance in schedule III or IV, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act [21 U.S.C. 353(b)]. Such prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.

(c) Schedule V substances

No controlled substance in schedule V which is a drug may be distributed or dispensed other than for a medical purpose.

(d) Non-prescription drugs with abuse potential

Whenever it appears to the Attorney General that a drug not considered to be a prescription drug under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] should be so considered because of its abuse potential, he shall so advise the Secretary and furnish to him all available data relevant thereto.

(e) Controlled substances dispensed by means of the Internet

(1) No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.

(2) As used in this subsection:

(A) The term "valid prescription" means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—

(i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or

(ii) a covering practitioner.

(B)(i) The term "in-person medical evaluation" means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.

(ii) Nothing in clause (i) shall be construed to imply that 1 in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.

(C) The term "covering practitioner" means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who—

(i) has conducted at least 1 in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and

(ii) is temporarily unavailable to conduct the evaluation of the patient.

(3) Nothing in this subsection shall apply to—

(A) the delivery, distribution, or dispensing of a controlled substance by a practitioner engaged in the practice of telemedicine; or

(B) the dispensing or selling of a controlled substance pursuant to practices as determined by the Attorney General by regulation, which shall be consistent with effective controls against diversion.

(f) Partial fills of schedule II controlled substances

(1) Partial fills

A prescription for a controlled substance in schedule II may be partially filled if—

(A) it is not prohibited by State law;

(B) the prescription is written and filled in accordance with this subchapter, regulations prescribed by the Attorney General, and State law;

(C) the partial fill is requested by the patient or the practitioner that wrote the prescription; and

(D) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.

(2) Remaining portions

(A) In general

Except as provided in subparagraph (B), remaining portions of a partially filled prescription for a controlled substance in schedule II—

(i) may be filled; and

(ii) shall be filled not later than 30 days after the date on which the prescription is written.

(B) Emergency situations

In emergency situations, as described in subsection (a), the remaining portions of a partially filled prescription for a controlled substance in schedule II—

(i) may be filled; and

(ii) shall be filled not later than 72 hours after the prescription is issued.

(3) Currently lawful partial fills

Notwithstanding paragraph (1) or (2), in any circumstance in which, as of the day before July 22, 2016, a prescription for a controlled substance in schedule II may be lawfully partially filled, the Attorney General may allow such a prescription to be partially filled.

(Pub. L. 91–513, title II, §309, Oct. 27, 1970, 84 Stat. 1260; Pub. L. 110–425, §2, Oct. 15, 2008, 122 Stat. 4820; Pub. L. 114–198, title VII, §702(a), July 22, 2016, 130 Stat. 740.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a), (b), (d), and (e)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Schedules II, III, IV, and V, referred to in subsecs. (a) to (c), are set out in section 812(c) of this title.

Amendments

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

2008—Subsec. (e). Pub. L. 110–425 added subsec. (e).

Statutory Notes and Related Subsidiaries

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–425 effective 180 days after Oct. 15, 2008, except as otherwise provided, see section 3(j) of Pub. L. 110–425, set out as a note under section 802 of this title.

Effective Date

Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as a note under section 801 of this title.

Construction of 2016 Amendment

Pub. L. 114–198, title VII, §702(b), July 22, 2016, 130 Stat. 741, provided that: "Nothing in this section [amending this section] shall be construed to affect the authority of the Attorney General to allow a prescription for a controlled substance in schedule III, IV, or V of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) to be partially filled."

Dispensation of Narcotic Drugs for the Purpose of Relieving Acute Withdrawal Symptoms From Opioid Use Disorder

Pub. L. 116–215, div. B, title III, §1302, Dec. 11, 2020, 134 Stat. 1046, provided that: "Not later than 180 days after the date of enactment of this Act [Dec. 11, 2020], the Attorney General shall revise section 1306.07(b) of title 21, Code of Federal Regulations, so that practitioners, in accordance with applicable State, Federal, or local laws relating to controlled substances, are allowed to dispense not more than a three-day supply of narcotic drugs to one person or for one person's use at one time for the purpose of initiating maintenance treatment or detoxification treatment (or both)."

Programs and Materials for Training on Certain Circumstances Under Which a Pharmacist May Decline To Fill a Prescription

Pub. L. 115–271, title III, §3212, Oct. 24, 2018, 132 Stat. 3947, as amended by Pub. L. 117–328, div. FF, title I, §1271(a), Dec. 29, 2022, 136 Stat. 5685, provided that:

"(a) In General.—The Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate not later than 1 year after the date of enactment of the Restoring Hope for Mental Health and Well-Being Act of 2022 [Dec. 29, 2022], and update periodically thereafter, as appropriate, materials for pharmacists, health care providers, and patients on—

"(1) circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act (21 U.S.C. 829) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and

"(2) other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances.

"(b) Materials Included.—In developing materials under subsection (a), the Secretary of Health and Human Services shall include information for—

"(1) pharmacists on how to verify the identity of the patient;

"(2) pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and

"(3) other health care practitioners and the public on a pharmacist's ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1)).

"(c) Stakeholder Input.—In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients, including individuals with chronic pain.

"(d) Materials for Training on Verification of Identity.—Not later than 1 year after the date of enactment of this subsection [Dec. 29, 2022], the Secretary of Health and Human Services, after seeking stakeholder input in accordance with subsection (c), shall—

"(1) update the materials developed under subsection (a) to include information for pharmacists on how to verify the identity of the patient; and

"(2) disseminate, as appropriate, the updated materials."

Effect of Scheduling on Prescriptions

Pub. L. 101–647, title XIX, §1902(c), Nov. 29, 1990, 104 Stat. 4852, provided that any prescription for anabolic steroids subject to refill on or after Nov. 29, 1990, could be refilled without restriction under subsec. (a) of this section.
21 U.S.C. § 354 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 354: Veterinary feed directive drugs
Veterinary feed directive drugs
Status: in_force

(a) Lawful veterinary feed directive requirement

(1) A drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 360b(b) of this title, a conditionally-approved application filed pursuant to section 360ccc of this title, or an index listing pursuant to section 360ccc–1 of this title to use under the professional supervision of a licensed veterinarian is a veterinary feed directive drug. Any animal feed bearing or containing a veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian's professional practice. When labeled, distributed, held, and used in accordance with this section, a veterinary feed directive drug and any animal feed bearing or containing a veterinary feed directive drug shall be exempt from section 352(f) of this title.

(2) A veterinary feed directive is lawful if it—

(A) contains such information as the Secretary may by general regulation or by order require; and

(B) is in compliance with the conditions and indications for use of the drug set forth in the notice published pursuant to section 360b(i) of this title, or the index listing pursuant to section 360ccc–1(e) of this title.

(3)(A) Any persons involved in the distribution or use of animal feed bearing or containing a veterinary feed directive drug and the licensed veterinarian issuing the veterinary feed directive shall maintain a copy of the veterinary feed directive applicable to each such feed, except in the case of a person distributing such feed to another person for further distribution. Such person distributing the feed shall maintain a written acknowledgment from the person to whom the feed is shipped stating that that person shall not ship or move such feed to an animal production facility without a veterinary feed directive or ship such feed to another person for further distribution unless that person has provided the same written acknowledgment to its immediate supplier.

(B) Every person required under subparagraph (A) to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.

(C) Any person who distributes animal feed bearing or containing a veterinary feed directive drug shall upon first engaging in such distribution notify the Secretary of that person's name and place of business. The failure to provide such notification shall be deemed to be an act which results in the drug being misbranded.

(b) Labeling and advertising

A veterinary feed directive drug and any feed bearing or containing a veterinary feed directive drug shall be deemed to be misbranded if their labeling fails to bear such cautionary statement and such other information as the Secretary may by general regulation or by order prescribe, or their advertising fails to conform to the conditions and indications for use published pursuant to section 360b(i) of this title, or the index listing pursuant to section 360ccc–1(e) of this title or fails to contain the general cautionary statement prescribed by the Secretary.

(c) Nonprescription status

Neither a drug subject to this section, nor animal feed bearing or containing such a drug, shall be deemed to be a prescription article under any Federal or State law.

(June 25, 1938, ch. 675, §504, as added Pub. L. 104–250, §5(b), Oct. 9, 1996, 110 Stat. 3155; amended Pub. L. 108–282, title I, §102(b)(5)(G), (H), Aug. 2, 2004, 118 Stat. 903.)

Editorial Notes

Prior Provisions

A prior section 354, act June 25, 1938, ch. 675, §504, 52 Stat. 1052, which directed Secretary to promulgate regulations for listing of coal-tar colors, was repealed effective July 12, 1960, subject to provisions of section 203 of Pub. L. 86–618, by Pub. L. 86–618, title I, §103(a)(2), title II, §202, July 12, 1960, 74 Stat. 398, 404.

Amendments

2004—Subsec. (a)(1). Pub. L. 108–282, §102(b)(5)(G), substituted "360b(b) of this title, a conditionally-approved application filed pursuant to section 360ccc of this title, or an index listing pursuant to section 360ccc–1 of this title" for "360b(b) of this title".

Subsecs. (a)(2)(B), (b). Pub. L. 108–282, §102(b)(5)(H), substituted "360b(i) of this title, or the index listing pursuant to section 360ccc–1(e) of this title" for "360b(i) of this title".
21 U.S.C. § 205 (2024) — Title 21: FOOD AND DRUGS / Chapter 7: PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA / Section 205: Display of license in pharmacy
Display of license in pharmacy
Status: in_force

Every license to practice pharmacy shall be conspicuously displayed by the person to whom the same has been issued in the pharmacy, drug store, or place of business, if any, of which the said person is the owner or part owner or manager.

(Mar. 3, 1915, ch. 74, §5, 38 Stat. 819.)
21 U.S.C. § 695 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter V: MISCELLANEOUS PROVISIONS / Section 695: Payment of cost of meat-inspection service; exception
Payment of cost of meat-inspection service; exception
Status: in_force

The cost of inspection rendered on and after July 1, 1948, under the requirements of laws relating to Federal inspection of meat and meat food products shall be borne by the United States except the cost of overtime and holiday pay paid pursuant to section 2219a of title 7.

(June 5, 1948, ch. 423, 62 Stat. 344; Pub. L. 107–171, title X, §10703(c)(2), May 13, 2002, 116 Stat. 517.)

Editorial Notes

References in Text

Section 2219a of title 7, referred to in text, was in the original "section 10703 of the Farm Security and Rural Investment Act of 2002", meaning section 10703 of Pub. L. 107–171, which enacted section 2219a of Title 7, Agriculture, amended this section, section 468 of this title, and section 5549 of Title 5, Government Organization and Employees, and repealed section 394 of Title 7.

Codification

Section was formerly classified to section 98 of this title.

Section was not enacted as part of the Federal Meat Inspection Act which is classified to subchapters I to IV–A of this chapter.

Amendments

2002—Pub. L. 107–171 substituted "overtime and holiday pay paid pursuant to section 2219a of title 7." for "overtime pursuant to section 394 of title 7."
21 U.S.C. § 2104 (2024) — Title 21: FOOD AND DRUGS / Chapter 26: FOOD SAFETY / Section 2104: State and Federal cooperation
State and Federal cooperation
Status: in_force

(a) In general

The Secretary shall work with the States in undertaking activities and programs that assist in improving the safety of food, including fresh and processed produce, so that State food safety programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage States to—

(1) establish, continue, or strengthen State food safety programs, especially with respect to the regulation of retail commercial food establishments; and

(2) establish procedures and requirements for ensuring that processed produce under the jurisdiction of State food safety programs is not unsafe for human consumption.

(b) Assistance

The Secretary may provide to a State, for planning, developing, and implementing such a food safety program—

(1) advisory assistance;

(2) technical assistance, training, and laboratory assistance (including necessary materials and equipment); and

(3) financial and other assistance.

(c) Service agreements

The Secretary may, under an agreement entered into with a Federal, State, or local agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under this subsection may provide for training of State employees.

(Pub. L. 110–85, title X, §1004, Sept. 27, 2007, 121 Stat. 964.)
21 U.S.C. § 872a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 872a: Public-private education program
Public-private education program
Status: in_force

(a) Advisory panel

The Attorney General shall establish an advisory panel consisting of an appropriate number of representatives from Federal, State, tribal, and local law enforcement and regulatory agencies with experience in investigating and prosecuting illegal transactions of precursor chemicals. The Attorney General shall convene the panel as often as necessary to develop and coordinate educational programs for wholesale and retail distributors of precursor chemicals and supplies.

(b) Continuation of current efforts

The Attorney General shall continue to—

(1) maintain an active program of seminars and training to educate wholesale and retail distributors of precursor chemicals and supplies regarding the identification of suspicious transactions and their responsibility to report such transactions; and

(2) provide assistance to State, tribal, and local law enforcement and regulatory agencies to facilitate the establishment and maintenance of educational programs for distributors of precursor chemicals and supplies.

(Pub. L. 104–237, title V, §503, Oct. 3, 1996, 110 Stat. 3112; Pub. L. 111–211, title II, §232(b), July 29, 2010, 124 Stat. 2278.)

Editorial Notes

Codification

Section was enacted as part of the Comprehensive Methamphetamine Control Act of 1996, and not as part of the Controlled Substances Act which comprises this subchapter.

Amendments

2010—Subsec. (a). Pub. L. 111–211, §232(b)(1), inserted "tribal," after "State,".

Subsec. (b)(2). Pub. L. 111–211, §232(b)(2), inserted ", tribal," after "State".
21 U.S.C. § 2301 (2024) — Title 21: FOOD AND DRUGS / Chapter 28: SANCTIONS WITH RESPECT TO FOREIGN TRAFFICKERS OF ILLICIT SYNTHETIC OPIOIDS / Section 2301: Sense of Congress
Sense of Congress
Status: in_force

It is the sense of Congress that—

(1) the United States should apply economic and other financial sanctions to foreign traffickers of illicit opioids to protect the national security, foreign policy, and economy of the United States and the health of the people of the United States;

(2) it is imperative that the People's Republic of China follow through on full implementation of the new regulations, adopted May 1, 2019, to treat all fentanyl analogues as controlled substances under the laws of the People's Republic of China, including by devoting sufficient resources for implementation and strict enforcement of the new regulations; and

(3) the effective enforcement of the new regulations should result in diminished trafficking of illicit fentanyl originating from the People's Republic of China into the United States.

(Pub. L. 116–92, div. F, title LXXII, §7202, Dec. 20, 2019, 133 Stat. 2262.)

Statutory Notes and Related Subsidiaries

Short Title

Pub. L. 116–92, div. F, title LXXII, §7201, Dec. 20, 2019, 133 Stat. 2262, provided that: "This title [enacting this chapter and amending section 2291h of Title 22, Foreign Relations and Intercourse] may be cited as the 'Fentanyl Sanctions Act'."
21 U.S.C. § 146 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter IV: IMPORTATION OF MILK AND CREAM / Section 146: Authorization of appropriations
Authorization of appropriations
Status: in_force

There is authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, the sum of $50,000 per annum, to enable the Secretary of Health and Human Services to carry out the provisions of this subchapter.

(Feb. 15, 1927, ch. 155, §6, 44 Stat. 1103; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695.)

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see Transfer of Functions notes set out under section 321 of this title.
21 U.S.C. § 844a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 844a: Civil penalty for possession of small amounts of certain controlled substances
Civil penalty for possession of small amounts of certain controlled substances
Status: in_force

(a) In general

Any individual who knowingly possesses a controlled substance that is listed in section 841(b)(1)(A) of this title in violation of section 844 of this title in an amount that, as specified by regulation of the Attorney General, is a personal use amount shall be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each such violation.

(b) Income and net assets

The income and net assets of an individual shall not be relevant to the determination whether to assess a civil penalty under this section or to prosecute the individual criminally. However, in determining the amount of a penalty under this section, the income and net assets of an individual shall be considered.

(c) Prior conviction

A civil penalty may not be assessed under this section if the individual previously was convicted of a Federal or State offense relating to a controlled substance.

(d) Limitation on number of assessments

A civil penalty may not be assessed on an individual under this section on more than two separate occasions.

(e) Assessment

A civil penalty under this section may be assessed by the Attorney General only by an order made on the record after opportunity for a hearing in accordance with section 554 of title 5. The Attorney General shall provide written notice to the individual who is the subject of the proposed order informing the individual of the opportunity to receive such a hearing with respect to the proposed order. The hearing may be held only if the individual makes a request for the hearing before the expiration of the 30-day period beginning on the date such notice is issued.

(f) Compromise

The Attorney General may compromise, modify, or remit, with or without conditions, any civil penalty imposed under this section.

(g) Judicial review

If the Attorney General issues an order pursuant to subsection (e) after a hearing described in such subsection, the individual who is the subject of the order may, before the expiration of the 30-day period beginning on the date the order is issued, bring a civil action in the appropriate district court of the United States. In such action, the law and the facts of the violation and the assessment of the civil penalty shall be determined de novo, and shall include the right of a trial by jury, the right to counsel, and the right to confront witnesses. The facts of the violation shall be proved beyond a reasonable doubt.

(h) Civil action

If an individual does not request a hearing pursuant to subsection (e) and the Attorney General issues an order pursuant to such subsection, or if an individual does not under subsection (g) seek judicial review of such an order, the Attorney General may commence a civil action in any appropriate district court of the United States for the purpose of recovering the amount assessed and an amount representing interest at a rate computed in accordance with section 1961 of title 28. Such interest shall accrue from the expiration of the 30-day period described in subsection (g). In such an action, the decision of the Attorney General to issue the order, and the amount of the penalty assessed by the Attorney General, shall not be subject to review.

(i) Limitation

The Attorney General may not under this subsection 1 commence proceeding against an individual after the expiration of the 5-year period beginning on the date on which the individual allegedly violated subsection (a).

(j) Expungement procedures

The Attorney General shall dismiss the proceedings under this section against an individual upon application of such individual at any time after the expiration of 3 years if—

(1) the individual has not previously been assessed a civil penalty under this section;

(2) the individual has paid the assessment;

(3) the individual has complied with any conditions imposed by the Attorney General;

(4) the individual has not been convicted of a Federal or State offense relating to a controlled substance; and

(5) the individual agrees to submit to a drug test, and such test shows the individual to be drug free.

A nonpublic record of a disposition under this subsection shall be retained by the Department of Justice solely for the purpose of determining in any subsequent proceeding whether the person qualified for a civil penalty or expungement under this section. If a record is expunged under this subsection, an individual concerning whom such an expungement has been made shall not be held thereafter under any provision of law to be guilty of perjury, false swearing, or making a false statement by reason of his failure to recite or acknowledge a proceeding under this section or the results thereof in response to an inquiry made of him for any purpose.

(Pub. L. 91–513, title II, §405, formerly Pub. L. 100–690, title VI, §6486, Nov. 18, 1988, 102 Stat. 4384, renumbered §405 of Pub. L. 91–513, and amended Pub. L. 101–647, title X, §1002(g)(1), (2), Nov. 29, 1990, 104 Stat. 4828.)

Editorial Notes

Prior Provisions

A prior section 405 of Pub. L. 91–513 was renumbered section 418 and is classified to section 859 of this title.

Amendments

1990—Subsec. (a). Pub. L. 101–647, §1002(g)(2)(A), made technical amendments to references to sections 841(b)(1)(A) and 844 of this title to correct references to corresponding provisions of original act.

Subsecs. (c), (j)(4). Pub. L. 101–647, §1002(g)(2)(B), (C), struck out "as defined in section 802 of this title" after "controlled substance".

1 So in original. Probably should be "section".
21 U.S.C. § 360aa (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360aa: Recommendations for investigations of drugs for rare diseases or conditions
Recommendations for investigations of drugs for rare diseases or conditions
Status: in_force

(a) Request by sponsor; response by Secretary

The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before—

(1) it may be approved for such disease or condition under section 355 of this title, or

(2) if the drug is a biological product, it may be licensed for such disease or condition under section 262 of title 42.

If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under section 355 of this title or licensing of such drug for such disease or condition under section 262 of title 42.

(b) Regulations

The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).

(June 25, 1938, ch. 675, §525, as added Pub. L. 97–414, §2(a), Jan. 4, 1983, 96 Stat. 2049; amended Pub. L. 99–91, §3(a)(1), Aug. 15, 1985, 99 Stat. 387; Pub. L. 105–115, title I, §125(b)(2)(F), (G), Nov. 21, 1997, 111 Stat. 2325, 2326.)

Editorial Notes

Amendments

1997—Subsec. (a). Pub. L. 105–115, §125(b)(2)(G), struck out ", certification of such drug for such disease or condition under section 357 of this title," before "or licensing of such drug" in closing provisions.

Subsec. (a)(1) to (3). Pub. L. 105–115, §125(b)(2)(F), inserted "or" at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2), which read as follows: "if the drug is an antibiotic, it may be certified for such disease or condition under section 357 of this title, or".

1985—Subsec. (a). Pub. L. 99–91 struck out "or" at end of par. (1), inserted par. (2), redesignated former par. (2) as (3) and struck out "before" after "product,", and in last sentence inserted provisions relating to certification of such drug for disease or condition under section 357 of this title and substituted "licensing of such drug for such disease or condition under section 262 of title 42" for "licensing under section 262 of title 42 for such disease or condition".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Pub. L. 99–91, §8, Aug. 15, 1985, 99 Stat. 392, provided that:

"(a) General Rule.—Except as provided in subsection (b), this Act and the amendments made by this Act [amending this section, sections 360bb, 360cc, and 360ee of this title, and sections 295g–1 and 6022 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under section 301 of this title and section 236 of Title 42] shall take effect October 1, 1985.

"(b) Exception.—The amendments made by sections 2, 3, and 6(a) [amending this section and sections 360bb and 360cc of this title] shall take effect on the date of the enactment of this Act [Aug. 15, 1985]. The amendment made by section 6(b) [amending section 6022 of Title 42] shall take effect October 19, 1984. The amendments made by section 7 [amending section 295g–1 of Title 42] shall take effect October 1, 1984 and shall cease to be in effect after September 30, 1985."

Rare Disease Endpoint Advancement Pilot Program

Pub. L. 117–328, div. FF, title III, §3208, Dec. 29, 2022, 136 Stat. 5821, provided that:

"(a) In General.—The Secretary [of Health and Human Services] shall establish a pilot program under which the Secretary establishes procedures to provide increased interaction with sponsors of rare disease drug development programs for purposes of advancing the development of efficacy endpoints, including surrogate and intermediate endpoints, for drugs intended to treat rare diseases, including through—

"(1) determining eligibility of participants for such program; and

"(2) developing and implementing a process for applying to, and participating in, such a program.

"(b) Public Workshops.—The Secretary shall conduct up to 3 public workshops, which shall be completed not later than September 30, 2026, to discuss topics relevant to the development of endpoints for rare diseases, which may include discussions about—

"(1) novel endpoints developed through the pilot program established under this section; and

"(2) as appropriate, the use of real world evidence and real world data to support the validation of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases.

"(c) Reports.—

"(1) Interim report.—Not later than September 30, 2026, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the completed and ongoing activities in the pilot program established under this section and public workshops described in subsection (b).

"(2) Final report.—Not later than September 30, 2027, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing the outcomes of the pilot program established under this section.

"(d) Guidance.—Not later than September 30, 2027, the Secretary shall issue guidance describing best practices and strategies for development of efficacy endpoints, including surrogate and intermediate endpoints, for rare diseases.

"(e) Sunset.—The Secretary may not accept any new application or request to participate in the program established by this section on or after October 1, 2027."

ALS and Other Rare Neurodegenerative Disease Action Plan

Pub. L. 117–79, §4, Dec. 23, 2021, 135 Stat. 1536, provided that:

"(a) In General.—Not later than 6 months after the date of enactment of this Act [Dec. 23, 2021], the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration an action plan describing actions the Food and Drug Administration intends to take during the 5-year period following publication of the plan with respect to program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives to—

"(1) foster the development of safe and effective drugs that improve or extend, or both, the lives of people living with amyotrophic lateral sclerosis and other rare neurodegenerative diseases; and

"(2) facilitate access to investigational drugs for amyotrophic lateral sclerosis and other rare neurodegenerative diseases.

"(b) Contents.—The initial action plan published under subsection (a) shall—

"(1) identify appropriate representation from within the Food and Drug Administration to be responsible for implementation of such action plan;

"(2) include elements to facilitate—

"(A) interactions and collaboration between the Food and Drug Administration, including the review centers thereof, and stakeholders including patients, sponsors, and the external biomedical research community;

"(B) consideration of cross-cutting clinical and regulatory policy issues, including consistency of regulatory advice and decisionmaking;

"(C) identification of key regulatory science and policy issues critical to advancing development of safe and effective drugs; and

"(D) enhancement of collaboration and engagement of the relevant centers and offices of the Food and Drug Administration with other operating divisions within the Department of Health and Human Services, the Partnership, and the broader neurodegenerative disease community; and

"(3) be subject to revision, as determined appropriate by the Secretary of Health and Human Services."

Review Groups on Rare Diseases and Neglected Diseases of the Developing World; Report; Guidance; Standards

Pub. L. 111–80, title VII, §740, Oct. 21, 2009, 123 Stat. 2127, provided that:

"(a) The Commissioner of Food and Drugs shall establish within the Food and Drug Administration a review group which shall recommend to the Commissioner of Food and Drugs appropriate preclinical, trial design, and regulatory paradigms and optimal solutions for the prevention, diagnosis, and treatment of rare diseases: Provided, That the Commissioner of Food and Drugs shall appoint individuals employed by the Food and Drug Administration to serve on the review group: Provided further, That members of the review group shall have specific expertise relating to the development of articles for use in the prevention, diagnosis, or treatment of rare diseases, including specific expertise in developing or carrying out clinical trials.

"(b) The Commissioner of Food and Drugs shall establish within the Food and Drug Administration a review group which shall recommend to the Commissioner of Food and Drugs appropriate preclinical, trial design, and regulatory paradigms and optimal solutions for the prevention, diagnosis, and treatment of neglected diseases of the developing world: Provided, That the Commissioner of Food and Drugs shall appoint individuals employed by the Food and Drug Administration to serve on the review group: Provided further, That members of the review group shall have specific expertise relating to the development of articles for use in the prevention, diagnosis, or treatment of neglected diseases of the developing world, including specific expertise in developing or carrying out clinical trials: Provided further, That for the purposes of this section the term 'neglected disease of the developing world' means a tropical disease, as defined in section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(3)).

"(c) The Commissioner of Food and Drugs shall—

"(1) submit, not later than 1 year after the date of the establishment of review groups under subsections (a) and (b), a report to Congress that describes both the findings and recommendations made by the review groups under subsections (a) and (b);

"(2) issue, not later than 180 days after submission of the report to Congress under paragraph (1), guidance based on such recommendations for articles for use in the prevention, diagnosis, and treatment of rare diseases and for such uses in neglected diseases of the developing world; and

"(3) develop, not later than 180 days after submission of the report to Congress under paragraph (1), internal review standards based on such recommendations for articles for use in the prevention, diagnosis, and treatment of rare diseases and for such uses in neglected diseases of the developing world."

Study

Pub. L. 100–290, §3(d), Apr. 18, 1988, 102 Stat. 91, directed Secretary of Health and Human Services to conduct a study to determine whether the application of subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360aa et seq. (relating to drugs for rare diseases and conditions), and 26 U.S.C. 28 (relating to tax credit) to medical devices or medical foods for rare diseases or conditions or to both was needed to encourage development of such devices and foods and report results of the study to Congress not later than one year after Apr. 18, 1988.

Congressional Findings

Pub. L. 97–414, §1(b), Jan. 4, 1983, 96 Stat. 2049, provided that: "The Congress finds that—

"(1) there are many diseases and conditions, such as Huntington's disease, myoclonus, ALS (Lou Gehrig's disease), Tourette syndrome, and muscular dystrophy which affect such small numbers of individuals residing in the United States that the diseases and conditions are considered rare in the United States;

"(2) adequate drugs for many of such diseases and conditions have not been developed;

"(3) drugs for these diseases and conditions are commonly referred to as 'orphan drugs';

"(4) because so few individuals are affected by any one rare disease or condition, a pharmaceutical company which develops an orphan drug may reasonably expect the drug to generate relatively small sales in comparison to the cost of developing the drug and consequently to incur a financial loss;

"(5) there is reason to believe that some promising orphan drugs will not be developed unless changes are made in the applicable Federal laws to reduce the costs of developing such drugs and to provide financial incentives to develop such drugs; and

"(6) it is in the public interest to provide such changes and incentives for the development of orphan drugs."
21 U.S.C. § 2313a (2024) — Title 21: FOOD AND DRUGS / Chapter 28: SANCTIONS WITH RESPECT TO FOREIGN TRAFFICKERS OF ILLICIT SYNTHETIC OPIOIDS / Subchapter I: SANCTIONS WITH RESPECT TO FOREIGN OPIOID TRAFFICKERS / Section 2313a: Designation of transactions of sanctioned persons as of primary money laundering concern
Designation of transactions of sanctioned persons as of primary money laundering concern
Status: in_force

(a) In general

If the Secretary of the Treasury determines that reasonable grounds exist for concluding that 1 or more financial institutions operating outside of the United States, 1 or more classes of transactions within, or involving, a jurisdiction outside of the United States, or 1 or more types of accounts within, or involving, a jurisdiction outside of the United States, is of primary money laundering concern in connection with illicit opioid trafficking, the Secretary of the Treasury may, by order, regulation, or otherwise as permitted by law—

(1) require domestic financial institutions and domestic financial agencies to take 1 or more of the special measures provided for in section 9714(a)(1) of the National Defense Authorization Act for Fiscal Year 2021 (Public Law 116–283; 31 U.S.C. 5318A note); or

(2) prohibit, or impose conditions upon, certain transmittals of funds (to be defined by the Secretary) by any domestic financial institution or domestic financial agency, if such transmittal of funds involves any such institution, class of transaction, or type of accounts.

(b) Classified information

In any judicial review of a finding of the existence of a primary money laundering concern, or of the requirement for 1 or more special measures with respect to a primary money laundering concern made under this section, if the designation or imposition, or both, were based on classified information (as defined in section 1(a) of the Classified Information Procedures Act (18 U.S.C. App.)), such information may be submitted by the Secretary to the reviewing court ex parte and in camera. This subsection does not confer or imply any right to judicial review of any finding made or any requirement imposed under this section.

(c) Availability of information

The exemptions from, and prohibitions on, search and disclosure referred to in section 9714(c) of the National Defense Authorization Act for Fiscal Year 2021 (Public Law 116–283; 31 U.S.C. 5318A note) shall apply to any report or record of report filed pursuant to a requirement imposed under subsection (a). For purposes of section 552 of title 5, this subsection shall be considered a statute described in subsection (b)(3)(B) of such section.

(d) Penalties

The penalties referred to in section 9714(d) of the National Defense Authorization Act for Fiscal Year 2021 (Public Law 116–283; 31 U.S.C. 5318A note) shall apply to violations of any order, regulation, special measure, or other requirement imposed under subsection (a), in the same manner and to the same extent as described in such section 9714(d).

(e) Injunctions

The Secretary of the Treasury may bring a civil action to enjoin a violation of any order, regulation, special measure, or other requirement imposed under subsection (a) in the same manner and to the same extent as described in section 9714(e) of the National Defense Authorization Act for Fiscal Year 2021 (Public Law 116–283; 31 U.S.C. 5318A note).

(Pub. L. 116–92, div. F, title LXXII, §7213A, as added Pub. L. 118–50, div. E, title II, §3201(a), Apr. 24, 2024, 138 Stat. 940.)

Editorial Notes

References in Text

Section 1(a) of the Classified Information Procedures Act, referred to in subsec. (b), 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.
21 U.S.C. § 360fff (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360fff: Definitions
Definitions
Status: in_force

In this part—

(1) the term "Advisory Committee" means the Nonprescription Drug Advisory Committee of the Food and Drug Administration or any successor to such Committee;

(2) the term "final sunscreen order" means an order published by the Secretary in the Federal Register containing information stating that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—

(A) is GRASE and is not misbranded if marketed in accordance with such order; or

(B) is not GRASE and is misbranded;

(3) the term "GRASE" means generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of a drug as described in section 321(p) of this title;

(4) the term "GRASE determination" means, with respect to a nonprescription active ingredient or a combination of nonprescription active ingredients, a determination of whether such ingredient or combination of ingredients is GRASE;

(5) the term "nonprescription" means not subject to section 353(b)(1) of this title;

(6) the term "pending request" means each request with respect to a nonprescription sunscreen active ingredient submitted under section 330.14 of title 21, Code of Federal Regulations (as in effect on November 26, 2014) for consideration for inclusion in the over-the-counter drug monograph system—

(A) that was determined to be eligible for such review by publication of a notice of eligibility in the Federal Register prior to November 26, 2014; and

(B) for which safety and effectiveness data have been submitted to the Secretary prior to November 26, 2014;

(7) the term "proposed sunscreen order" means an order containing a tentative determination published by the Secretary in the Federal Register containing information proposing that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—

(A) is GRASE and is not misbranded if marketed in accordance with such order;

(B) is not GRASE and is misbranded; or

(C) is not GRASE and is misbranded because the data are insufficient to classify such ingredient or combination of ingredients as GRASE and not misbranded and additional information is necessary to allow the Secretary to determine otherwise;

(8) the term "sponsor" means the person that submitted—

(A) a request under section 360fff–1 of this title;

(B) a pending request; or

(C) any other application subject to this part;

(9) the term "sunscreen" means a drug containing one or more sunscreen active ingredients; and

(10) the term "sunscreen active ingredient" means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering ultraviolet radiation.

(June 25, 1938, ch. 675, §586, as added Pub. L. 113–195, §2(a), Nov. 26, 2014, 128 Stat. 2035.)

Statutory Notes and Related Subsidiaries

Construction

Pub. L. 113–195, §2(b), Nov. 26, 2014, 128 Stat. 2045, provided that: "Nothing in the amendment made by this section [enacting this section and sections 360fff–1 to [former] 360fff–5 of this title] shall be construed to—

"(1) limit the right of a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360fff(8)], as added by subsection (a)) to request that the Secretary of Health and Human Services convene an advisory committee; or

"(2) limit the authority of the Secretary of Health and Human Services to meet with a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a))."
21 U.S.C. § 387c (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387c: Misbranded tobacco products
Misbranded tobacco products
Status: in_force

(a) In general

A tobacco product shall be deemed to be misbranded—

(1) if its labeling is false or misleading in any particular;

(2) if in package form unless it bears a label containing—

(A) the name and place of business of the tobacco product manufacturer, packer, or distributor;

(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;

(C) an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and

(D) the statement required under section 387t(a) of this title,

except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary;

(3) if any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(4) if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation;

(5) if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regulations;

(6) if it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 387e(b), 387e(c), 387e(d), or 387e(h) of this title, if it was not included in a list required by section 387e(i) of this title, if a notice or other information respecting it was not provided as required by such section or section 387e(j) of this title, or if it does not bear such symbols from the uniform system for identification of tobacco products prescribed under section 387e(e) of this title as the Secretary by regulation requires;

(7) if, in the case of any tobacco product distributed or offered for sale in any State—

(A) its advertising is false or misleading in any particular; or

(B) it is sold or distributed in violation of section 387f(d)(5) of this title or of regulations prescribed under section 387f(d) of this title;

(8) unless, in the case of any tobacco product distributed or offered for sale in any State, the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product—

(A) a true statement of the tobacco product's established name as described in paragraph (4), printed prominently; and

(B) a brief statement of—

(i) the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindications; and

(ii) in the case of specific tobacco products made subject to a finding by the Secretary after notice and opportunity for comment that such action is appropriate to protect the public health, a full description of the components of such tobacco product or the formula showing quantitatively each ingredient of such tobacco product to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing;

(9) if it is a tobacco product subject to a tobacco product standard established under section 387g of this title, unless it bears such labeling as may be prescribed in such tobacco product standard; or

(10) if there was a failure or refusal—

(A) to comply with any requirement prescribed under section 387d or 387h of this title; or

(B) to furnish any material or information required under section 387i of this title.

(b) Prior approval of label statements

The Secretary may, by regulation, require prior approval of statements made on the label of a tobacco product to ensure that such statements do not violate the misbranding provisions of subsection (a) and that such statements comply with other provisions of the Family Smoking Prevention and Tobacco Control Act (including the amendments made by such Act). No regulation issued under this subsection may require prior approval by the Secretary of the content of any advertisement, except for modified risk tobacco products as provided in section 387k of this title. No advertisement of a tobacco product published after June 22, 2009, shall, with respect to the language of label statements as prescribed under section 1333 of title 15 and section 4402 of title 15 or the regulations issued under such sections, be subject to the provisions of sections 52 through 55 of title 15.

(June 25, 1938, ch. 675, §903, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22, 2009, 123 Stat. 1788; amended Pub. L. 116–94, div. N, title I, §603(d)(3), Dec. 20, 2019, 133 Stat. 3124.)

Editorial Notes

References in Text

The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (b), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

Prior Provisions

A prior section 903 of act June 25, 1938, was renumbered section 1003 and is classified to section 393 of this title.

Another prior section 903 of act June 25, 1938, was renumbered section 1004 and is classified to section 394 of this title.

Amendments

2019—Subsec. (a)(7)(B). Pub. L. 116–94 inserted "section 387f(d)(5) of this title or of" after "violation of".

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 111–31, div. A, title I, §103(q)(5), (6), June 22, 2009, 123 Stat. 1840, provided that:

"(5) Package label requirements.—The package label requirements of paragraphs (3) and (4) of section 903(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387c(a)] (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act [June 22, 2009]. The package label requirements of paragraph (2) of such section 903(a) for cigarettes shall take effect on the date that is 15 months after the issuance of the regulations required by section 4(d) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333[(d)]), as amended by section 201 of this division. The package label requirements of paragraph (2) of such section 903(a) for tobacco products other than cigarettes shall take effect on the date that is 12 months after the date of enactment of this Act. The effective date shall be with respect to the date of manufacture, provided that, in any case, beginning 30 days after such effective date, a manufacturer shall not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with section 903(a)(2), (3), and (4) and section 920(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387t(a)].

"(6) Advertising requirements.—The advertising requirements of section 903(a)(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 387c(a)(8)] (as amended by this division) shall take effect on the date that is 12 months after the date of enactment of this Act [June 22, 2009]."
21 U.S.C. § 642 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter II: MEAT PROCESSORS AND RELATED INDUSTRIES / Section 642: Recordkeeping requirements
Recordkeeping requirements
Status: in_force

(a) Classes of persons bound; scope of disclosure; access to places of business; examination of records, facilities, and inventories; copies; samples

The following classes of persons, firms, and corporations shall keep such records as will fully and correctly disclose all transactions involved in their businesses; and all persons, firms, and corporations subject to such requirements shall, at all reasonable times upon notice by a duly authorized representative of the Secretary, afford such representative access to their places of business and opportunity to examine the facilities, inventory, and records thereof, to copy all such records, and to take reasonable samples of their inventory upon payment of the fair market value therefor—

(1) Any persons, firms, or corporations that engage, for commerce, in the business of slaughtering any cattle, sheep, swine, goats, horses, mules, or other equines, or preparing, freezing, packaging, or labeling any carcasses, or parts or products of carcasses, of any such animals, for use as human food or animal food;

(2) Any persons, firms, or corporations that engage in the business of buying or selling (as meat brokers, wholesalers or otherwise), or transporting in commerce, or storing in or for commerce, or importing, any carcasses, or parts or products of carcasses, of any such animals;

(3) Any persons, firms, or corporations that engage in business, in or for commerce, as renderers, or engage in the business of buying, selling, or transporting, in commerce, or importing, any dead, dying, disabled, or diseased cattle, sheep, swine, goats, horses, mules, or other equines, or parts of the carcasses of any such animals that died otherwise than by slaughter.

(b) Period of maintenance

Any record required to be maintained by this section shall be maintained for such period of time as the Secretary may by regulations prescribe.

(Mar. 4, 1907, ch. 2907, title II, §202, as added Pub. L. 90–201, §14, Dec. 15, 1967, 81 Stat. 593.)
21 U.S.C. § 826a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 826a: Attorney General report on drug shortages
Attorney General report on drug shortages
Status: in_force

Not later than 6 months after July 9, 2012, and annually thereafter, the Attorney General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on the Judiciary of the Senate a report on drug shortages that—

(1) identifies the number of requests received under section 826(h) of this title (as added by section 1005 of this Act), the average review time for such requests, the number of requests granted and denied under such section, and, for each of the requests denied under such section, the basis for such denial;

(2) describes the coordination between the Drug Enforcement Administration and Food and Drug Administration on efforts to prevent or alleviate drug shortages; and

(3) identifies drugs containing a controlled substance subject to section 826 of this title when such a drug is determined by the Secretary to be in shortage.

(Pub. L. 112–144, title X, §1006, July 9, 2012, 126 Stat. 1105.)

Editorial Notes

References in Text

Section 1005 of this Act, referred to in par. (1), means section 1005 of Pub. L. 112–144, which amended section 826 of this title.

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Controlled Substances Act which comprises this subchapter.

Statutory Notes and Related Subsidiaries

Definition of "Secretary"

The term "Secretary" as meaning the Secretary of Health and Human Services, see section 1001(b) of Pub. L. 112–144, set out as an Effect of Notification note under section 356c of this title.
21 U.S.C. § 360ll (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360ll: Notification of defects in and repair or replacement of electronic products
Notification of defects in and repair or replacement of electronic products
Status: in_force

(a) Notification; exemption

(1) Every manufacturer of electronic products who discovers that an electronic product produced, assembled, or imported by him has a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation, or that an electronic product produced, assembled, or imported by him on or after the effective date of an applicable standard prescribed pursuant to section 360kk of this title fails to comply with such standard, shall immediately notify the Secretary of such defect or failure to comply if such product has left the place of manufacture and shall (except as authorized by paragraph (2)) with reasonable promptness furnish notification of such defect or failure to the persons (where known to the manufacturer) specified in subsection (b) of this section.

(2) If, in the opinion of such manufacturer, the defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any person, he may, at the time of giving notice to the Secretary of such defect or failure to comply, apply to the Secretary for an exemption from the requirement of notice to the persons specified in subsection (b). If such application states reasonable grounds for such exemption, the Secretary shall afford such manufacturer an opportunity to present his views and evidence in support of the application, the burden of proof being on the manufacturer. If, after such presentation, the Secretary is satisfied that such defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any person, he shall exempt such manufacturer from the requirement of notice to the persons specified in subsection (b) of this section and from the requirements of repair or replacement imposed by subsection (f) of this section.

(b) Method of notification

The notification (other than to the Secretary) required by paragraph (1) of subsection (a) of this section shall be accomplished—

(1) by certified mail to the first purchaser of such product for purposes other than resale, and to any subsequent transferee of such product; and

(2) by certified mail or other more expeditious means to the dealers or distributors of such manufacturer to whom such product was delivered.

(c) Requisite elements of notification

The notifications required by paragraph (1) of subsection (a) of this section shall contain a clear description of such defect or failure to comply with an applicable standard, an evaluation of the hazard reasonably related to such defect or failure to comply, and a statement of the measures to be taken to repair such defect. In the case of a notification to a person referred to in subsection (b) of this section, the notification shall also advise the person of his rights under subsection (f) of this section.

(d) Copies to Secretary of communications by manufacturers to dealers or distributors regarding defects

Every manufacturer of electronic products shall furnish to the Secretary a true or representative copy of all notices, bulletins, and other communications to the dealers or distributors of such manufacturer or to purchasers (or subsequent transferees) of electronic products of such manufacturer regarding any such defect in such product or any such failure to comply with a standard applicable to such product. The Secretary shall disclose to the public so much of the information contained in such notice or other information obtained under section 360nn of this title as he deems will assist in carrying out the purposes of this part, but he shall not disclose any information which contains or relates to a trade secret or other matter referred to in section 1905 of title 18 unless he determines that it is necessary to carry out the purposes of this part.

(e) Notice from Secretary to manufacturer of defects or failure to comply with standards

If through testing, inspection, investigation, or research carried out pursuant to this part, or examination of reports submitted pursuant to section 360nn of this title, or otherwise, the Secretary determines that any electronic product—

(1) does not comply with an applicable standard prescribed pursuant to section 360kk of this title; or

(2) contains a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation;

he shall immediately notify the manufacturer of such product of such defect or failure to comply. The notice shall contain the findings of the Secretary and shall include all information upon which the findings are based. The Secretary shall afford such manufacturer an opportunity to present his views and evidence in support thereof, to establish that there is no failure of compliance or that the alleged defect does not exist or does not relate to safety of use of the product by reason of the emission of such radiation hazard. If after such presentation by the manufacturer the Secretary determines that such product does not comply with an applicable standard prescribed pursuant to section 360kk of this title, or that it contains a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation, the Secretary shall direct the manufacturer to furnish the notification specified in subsection (c) of this section to the persons specified in paragraphs (1) and (2) of subsection (b) of this section (where known to the manufacturer), unless the manufacturer has applied for an exemption from the requirement of such notification on the ground specified in paragraph (2) of subsection (a) and the Secretary is satisfied that such noncompliance or defect is not such as to create a significant risk of injury, including genetic injury, to any person.

(f) Correction of defects

If any electronic product is found under subsection (a) or (e) to fail to comply with an applicable standard prescribed under this part or to have a defect which relates to the safety of use of such product, and the notification specified in subsection (c) is required to be furnished on account of such failure or defect, the manufacturer of such product shall (1) without charge, bring such product into conformity with such standard or remedy such defect and provide reimbursement for any expenses for transportation of such product incurred in connection with having such product brought into conformity or having such defect remedied, (2) replace such product with a like or equivalent product which complies with each applicable standard prescribed under this part and which has no defect relating to the safety of its use, or (3) make a refund of the cost of such product. The manufacturer shall take the action required by this subsection in such manner, and with respect to such persons, as the Secretary by regulations shall prescribe.

(g) Effective date

This section shall not apply to any electronic product that was manufactured before October 18, 1968.

(June 25, 1938, ch. 675, §535, formerly act July 1, 1944, ch. 373, title III, §535, formerly §359, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1180; renumbered §535 and amended Pub. L. 101–629, §19(a)(1)(B), (2)(C), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was classified to section 263g of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which renumbered section 263g of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a)(1). Pub. L. 101–629, §19(a)(2)(C)(i), substituted "section 360kk" for "section 263f".

Subsec. (d). Pub. L. 101–629, §19(a)(1)(B), (2)(C)(ii), substituted "section 360nn" for "section 263i" and "this part" for "this subpart" in two places.

Subsec. (e). Pub. L. 101–629, §19(a)(1)(B), (2)(C), substituted "this part" for "this subpart" and "section 360nn" for "section 263i" in introductory provisions and "section 360kk" for "section 263f" in par. (1) and concluding provisions.

Subsec. (f). Pub. L. 101–629, §19(a)(1)(B), substituted "this part" for "this subpart" in two places.

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.
21 U.S.C. § 96 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter I: EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Section 96: Repealed. Pub. L. 90-201, §18, Dec. 15, 1967, 81 Stat. 600
Repealed. Pub. L. 90-201, §18, Dec. 15, 1967, 81 Stat. 600
Status: repealed

Section, act July 24, 1919, ch. 26, 41 Stat. 241, provided for marking horse meat transported in interstate commerce. See section 619 of this title.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Repeal effective Dec. 15, 1967, see section 20 of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 356i (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 356i: Prompt reports of marketing status
Prompt reports of marketing status
Status: in_force

(a) Notification of withdrawal

The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall notify the Secretary in writing 180 days prior to withdrawing the approved drug from sale, or if 180 days is not practicable as soon as practicable but not later than the date of withdrawal. The holder shall include with such notice the—

(1) National Drug Code;

(2) identity of the drug by established name (or, in the case of a biological product, the proper name) and by proprietary name, if any;

(3) new drug application number, abbreviated application number, or biologics license application number;

(4) strength of the drug;

(5) date on which the drug is expected to no longer be available for sale; and

(6) reason for withdrawal of the drug.

(b) Notification of drug not available for sale

The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall notify the Secretary in writing within 180 calendar days of the date of approval of the drug if the drug will not be available for sale within 180 calendar days of such date of approval. The holder shall include with such notice the—

(1) identity of the drug by established name (or, in the case of a biological product, the proper name) and by proprietary name, if any;

(2) new drug application number, abbreviated application number, or biologics license application number;

(3) strength of the drug;

(4) date on which the drug will be available for sale, if known; and

(5) reason for not marketing the drug after approval.

(c) Additional one-time report

Within 180 days of December 29, 2022, all holders of applications approved under subsection (a) or (k) of section 262 of title 42 shall review the information in the list published under section 262(k)(9)(A) of title 42 and shall submit a written notice to the Secretary—

(1) stating that all of the application holder's biological products in the list published under such section 262(k)(9)(A) of title 42 that are not listed as discontinued are available for sale; or

(2) including the information required pursuant to subsection (a) or (b), as applicable, for each of the application holder's biological products that are in the list published under such section 262(k)(9)(A) of title 42 and not listed as discontinued, but have been discontinued from sale or never have been available for sale.

(d) Failure to meet requirements

If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may—

(1) move the application holder's drugs from the active section of the list published under section 355(j)(7)(A) of this title to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with section 355(j)(7)(C) of this title drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness; and

(2) identify the application holder's biological products as discontinued in the list published under section 262(k)(9)(A) of title 42, except that the Secretary shall remove from the list in accordance with section 262(k)(9)(B) of such title biological products for which the license has been revoked or suspended for reasons of safety, purity, or potency.

(e) Updates

The Secretary shall update the list published under section 355(j)(7)(A) of this title based on the information provided under subsections (a), (b), and (c) by moving drugs that are not available for sale from the active section to the discontinued section of the list, except that drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness shall be removed from the list in accordance with section 355(j)(7)(C) of this title. The Secretary shall update the list published under section 262(k)(9)(A) of title 42 based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that biological products for which the license has been revoked or suspended for safety, purity, or potency reasons shall be removed from the list in accordance with section 262(k)(9)(B) of title 42. The Secretary shall make monthly updates to the lists referred to in the preceding sentences based on the information provided pursuant to subsections (a) and (b), and shall update such lists based on the information provided under subsection (c) as soon as practicable.

(f) Limitation on use of notices

Any notice submitted under this section shall not be made public by the Secretary and shall be used solely for the purpose of the updates described in subsection (e).

(June 25, 1938, ch. 675, §506I, as added Pub. L. 115–52, title VIII, §804, Aug. 18, 2017, 131 Stat. 1071; amended Pub. L. 117–328, div. FF, title III, §3201, Dec. 29, 2022, 136 Stat. 5808.)

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–328, §3201(a)(1)(A), substituted "The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42" for "The holder of an application approved under subsection (c) or (j) of section 355 of this title" in introductory provisions.

Subsec. (a)(2). Pub. L. 117–328, §3201(a)(1)(B), substituted "established name (or, in the case of a biological product, the proper name)" for "established name".

Subsec. (a)(3). Pub. L. 117–328, §3201(a)(1)(C), substituted ", abbreviated application number, or biologics license application number" for "or abbreviated application number".

Subsec. (b). Pub. L. 117–328, §3201(a)(2)(A), substituted "The holder of an application approved under subsection (c) or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42" for "The holder of an application approved under subsection (c) or (j)" in introductory provisions.

Subsec. (b)(1). Pub. L. 117–328, §3201(a)(2)(B), substituted "established name (or, in the case of a biological product, the proper name)" for "established name".

Subsec. (b)(2). Pub. L. 117–328, §3201(a)(2)(C), substituted ", abbreviated application number, or biologics license application number" for "or abbreviated application number".

Subsec. (c). Pub. L. 117–328, §3201(b), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to an additional one-time report to be done within 180 days of Aug. 18, 2017.

Subsec. (d). Pub. L. 117–328, §3201(c)(1), added subsec. (d) and struck out former subsec. (d). Prior to amendment, text read as follows: "If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may move the application holder's drugs from the active section of the list published under subsection 355(j)(7)(A) of this title to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with subsection 355(j)(7)(C) of this title drugs the Secretary determines have been withdrawn from sale for reasons of safety of effectiveness."

Subsec. (e). Pub. L. 117–328, §3201(d), substituted "section 355(j)(7)(A) of this title" for "subsection 355(j)(7)(A) of this title" and "section 355(j)(7)(C) of this title" for "subsection 355(j)(7)(C) of this title".

Pub. L. 117–328, §3201(c)(2), inserted "The Secretary shall update the list published under section 262(k)(9)(A) of title 42 based on information provided under subsections (a), (b), and (c) by identifying as discontinued biological products that are not available for sale, except that biological products for which the license has been revoked or suspended for safety, purity, or potency reasons shall be removed from the list in accordance with section 262(k)(9)(B) of title 42." before "The Secretary shall make monthly updates" and substituted "monthly updates to the lists referred to in the preceding sentences" for "monthly updates to the list" and "and shall update such lists based on" for "and shall update the list based on".
21 U.S.C. § 1601 (2024) — Title 21: FOOD AND DRUGS / Chapter 21: BIOMATERIALS ACCESS ASSURANCE / Section 1601: Findings
Findings
Status: in_force

The Congress finds that—

(1) each year millions of citizens of the United States depend on the availability of lifesaving or life-enhancing medical devices, many of which are permanently implantable within the human body;

(2) a continued supply of raw materials and component parts is necessary for the invention, development, improvement, and maintenance of the supply of the devices;

(3) most of the medical devices are made with raw materials and component parts that—

(A) move in interstate commerce;

(B) are not designed or manufactured specifically for use in medical devices; and

(C) come in contact with internal human tissue;

(4) the raw materials and component parts also are used in a variety of nonmedical products;

(5) because small quantities of the raw materials and component parts are used for medical devices, sales of raw materials and component parts for medical devices constitute an extremely small portion of the overall market for the raw materials and component parts;

(6) under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) manufacturers of medical devices are required to demonstrate that the medical devices are safe and effective, including demonstrating that the products are properly designed and have adequate warnings or instructions;

(7) notwithstanding the fact that raw materials and component parts suppliers do not design, produce, or test a final medical device, the suppliers have been the subject of actions alleging inadequate—

(A) design and testing of medical devices manufactured with materials or parts supplied by the suppliers; or

(B) warnings related to the use of such medical devices;

(8) even though suppliers of raw materials and component parts have very rarely been held liable in such actions, such suppliers have ceased supplying certain raw materials and component parts for use in medical devices for a number of reasons, including concerns about the costs of such litigation;

(9) unless alternate sources of supply can be found, the unavailability of raw materials and component parts for medical devices will lead to unavailability of lifesaving and life-enhancing medical devices;

(10) because other suppliers of the raw materials and component parts in foreign nations are refusing to sell raw materials or component parts for use in manufacturing certain medical devices in the United States, the prospects for development of new sources of supply for the full range of threatened raw materials and component parts for medical devices are remote;

(11) it is unlikely that the small market for such raw materials and component parts in the United States could support the large investment needed to develop new suppliers of such raw materials and component parts;

(12) attempts to develop such new suppliers would raise the cost of medical devices;

(13) courts that have considered the duties of the suppliers of the raw materials and component parts have generally found that the suppliers do not have a duty—

(A) to evaluate the safety and efficacy of the use of a raw material or component part in a medical device; or

(B) to warn consumers concerning the safety and effectiveness of a medical device;

(14) because medical devices and the raw materials and component parts used in their manufacture move in interstate commerce, a shortage of such raw materials and component parts affects interstate commerce;

(15) in order to safeguard the availability of a wide variety of lifesaving and life-enhancing medical devices, immediate action is needed—

(A) to clarify the permissible bases of liability for suppliers of raw materials and component parts for medical devices; and

(B) to provide expeditious procedures to dispose of unwarranted suits against the suppliers in such manner as to minimize litigation costs;

(16) the several States and their courts are the primary architects and regulators of our tort system; Congress, however, must, in certain circumstances involving the national interest, address tort issues, and a threatened shortage of raw materials and component parts for lifesaving medical devices is one such circumstance; and

(17) the protections set forth in this chapter are needed to assure the continued supply of materials for lifesaving medical devices, although such protections do not protect negligent suppliers.

(Pub. L. 105–230, §2, Aug. 13, 1998, 112 Stat. 1519.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in par. (6), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 105–230, §8, Aug. 13, 1998, 112 Stat. 1529, provided that: "This Act [enacting this chapter] shall apply to all civil actions covered under this Act that are commenced on or after the date of enactment of this Act [Aug. 13, 1998], including any such action with respect to which the harm asserted in the action or the conduct that caused the harm occurred before the date of enactment of this Act."

Short Title

Pub. L. 105–230, §1, Aug. 13, 1998, 112 Stat. 1519, provided that: "This Act [enacting this chapter] may be cited as the 'Biomaterials Access Assurance Act of 1998'."
21 U.S.C. § 376 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 376: Examination of sea food on request of packer; marking food with results; fees; penalties
Examination of sea food on request of packer; marking food with results; fees; penalties
Status: in_force

The Secretary, upon application of any packer of any sea food for shipment or sale within the jurisdiction of this chapter, may, at his discretion, designate inspectors to examine and inspect such food and the production, packing, and labeling thereof. If on such examination and inspection compliance is found with the provisions of this chapter and regulations promulgated thereunder, the applicant shall be authorized or required to mark the food as provided by regulation to show such compliance. Services under this section shall be rendered only upon payment by the applicant of fees fixed by regulation in such amounts as may be necessary to provide, equip, and maintain an adequate and efficient inspection service. Receipts from such fees shall be covered into the Treasury and shall be available to the Secretary for expenditures incurred in carrying out the purposes of this section, including expenditures for salaries of additional inspectors when necessary to supplement the number of inspectors for whose salaries Congress has appropriated. The Secretary is authorized to promulgate regulations governing the sanitary and other conditions under which the service herein provided shall be granted and maintained, and for otherwise carrying out the purposes of this section. Any person who forges, counterfeits, simulates, or falsely represents, or without proper authority uses any mark, stamp, tag, label, or other identification devices authorized or required by the provisions of this section or regulations thereunder, shall be guilty of a misdemeanor, and shall on conviction thereof be subject to imprisonment for not more than one year or a fine of not less than $1,000 nor more than $5,000, or both such imprisonment and fine.

(June 25, 1938, ch. 675, §706, formerly §702A, formerly June 30, 1906, ch. 3915, §10A, as added June 22, 1934, ch. 712, 48 Stat. 1204; amended Aug. 27, 1935, ch. 739, 49 Stat. 871; June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059, renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784; renumbered §702A of act June 25, 1938, July 12, 1943, ch. 221, title II, 57 Stat. 500; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; renumbered §706, Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498; Pub. L. 103–80, §3(dd)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was formerly classified to section 372a of this title prior to renumbering by Pub. L. 102–571.

Section, which formerly was not a part of the Federal Food, Drug, and Cosmetic Act, originally was classified to section 14a of this title. Section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title, provided that the section should remain in force and effect and be applicable to the provisions of this chapter. Act July 12, 1943, renumbered this section as 702A of the Federal Food, Drug, and Cosmetic Act.

Prior Provisions

A prior section 376, act June 25, 1938, ch. 675, §706, 52 Stat. 1058, as amended, which related to listing and certification of color additives for foods, drugs, devices, and cosmetics, was renumbered section 721 of act June 25, 1938, by Pub. L. 102–571, title I, §106(4), Oct. 29, 1992, 106 Stat. 4498, and transferred to section 379e of this title.

Amendments

1993—Pub. L. 103–80 struck out "of Agriculture" after "Secretary" in two places.

1992—Pub. L. 102–300, which directed the amendment of the section by striking out "of Health, Education, and Welfare" wherever appearing, could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.

Statutory Notes and Related Subsidiaries

Transfer of Functions

Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
21 U.S.C. § 161 (2024) — Title 21: FOOD AND DRUGS / Chapter 5A: BUREAU OF NARCOTICS / Section 161: Omitted
Omitted
Status: omitted

Editorial Notes

Codification

Section 161, acts June 14, 1930, ch. 488, §1, 46 Stat. 585; Oct. 15, 1949, ch. 695, §6(a), 63 Stat. 881, established a Bureau of Narcotics in the Department of the Treasury and provided for appointment of a Commissioner of Narcotics for the Bureau with duty of making an annual report to Congress.

Section 162, acts June 14, 1930, ch. 488, §2, 46 Stat. 585; June 26, 1930, ch. 623, §1, 46 Stat. 819; Oct. 27, 1970, Pub. L. 91–513, title III, §1101(a)(4), 84 Stat. 1291, provided for appointment and compensation of a deputy commissioner and other personnel for the Bureau of Narcotics, required the deputy to be an acting Commissioner during absence or disability of the Commissioner or a vacancy in the office, and authorized designation of a member of the Treasury Department as an acting Commissioner in event there is no Commissioner or deputy commissioner.

Section 163, act Mar. 3, 1927, ch. 348, §4(a), 44 Stat. 1382, provided for transfer of control of narcotic drugs to the Secretary of the Treasury from the Commissioner of Internal Revenue and his assistants, agents, and inspectors.

Section 164, acts June 14, 1930, ch. 488, §3, 46 Stat. 586; June 26, 1930, ch. 623, §2, 46 Stat. 819; Ex. Ord. No. 6639, Mar. 10, 1934, abolished the Federal Narcotics Control Board and transferred powers of such Board to the Commissioner of Narcotics, authorized the Secretary of the Treasury to confer or impose his duties under section 163 of this title upon the Commissioner or other personnel of the Bureau of Narcotics, continued in effect orders, rules, and regulations in existence on July 1, 1930, until modified, superseded, or repealed by the Commissioner, with approval of the Secretary of the Treasury, and provided for determination before such Bureau of Narcotics of proceedings, investigations, and other matters pending on July 1, 1930 before Bureau of Prohibition or Federal Narcotics Control Board respecting narcotic drug law administration or enforcement. Bureau of Prohibition personnel, records, property, and unexpended balances of appropriations were previously transferred to Bureau of Narcotics as were powers of the Attorney General respecting the Bureau of Prohibition to the Commissioner of Internal Revenue.

Section 165, act June 14, 1930, ch. 488, §5, 46 Stat. 587, provided for review of decisions of Commissioner of Narcotics by the Secretary of the Treasury.

Executive Documents

Transfer of Functions

Functions of the Secretary of the Treasury administered through or respecting the Bureau of Narcotics and all functions of the Bureau, the Commissioner of Narcotics, and the officers, employees and agencies of the Bureau were transferred to the Attorney General and the Bureau and the office of Commissioner of Narcotics were abolished by Reorg. Plan No. 1 of 1968, eff. Apr. 8, 1968, 33 F.R. 5611, 82 Stat. 1367, set out in the Appendix to Title 5, Government Organization and Employees. All positions, personnel, property, records, and unexpended balances of appropriations, allocations, and other funds of the Bureau and the Treasury Department, in connection with functions transferred under this reorganization plan, were transferred to the Justice Department.

The Bureau of Narcotics and Dangerous Drugs, including the office of Director thereof, in the Department of Justice was 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 the Department of Justice a single, comprehensive agency for the enforcement of drug laws to be known as the Drug Enforcement Administration, empowered the Attorney General to authorize the performance by officers, employees, and agencies of the Department of functions transferred to him, and directed the Attorney General to coordinate all drug law enforcement functions to assure maximum cooperation between the Drug Enforcement Administration, the Federal Bureau of Investigation, and the other units of the Department of Justice involved in drug law enforcement.
21 U.S.C. § 358 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 358: Authority to designate official names
Authority to designate official names
Status: in_force

(a) Necessity or desirability; use in official compendiums; infringement of trademarks

The Secretary may designate an official name for any drug or device if he determines that such action is necessary or desirable in the interest of usefulness and simplicity. Any official name designated under this section for any drug or device shall be the only official name of that drug or device used in any official compendium published after such name has been prescribed or for any other purpose of this chapter. In no event, however, shall the Secretary establish an official name so as to infringe a valid trademark.

(b) Review of names in official compendiums

Within a reasonable time after October 10, 1962, and at such other times as he may deem necessary, the Secretary shall cause a review to be made of the official names by which drugs are identified in the official United States Pharmacopoeia, the official Homoeopathic Pharmacopoeia of the United States, and the official National Formulary, and all supplements thereto, and at such times as he may deem necessary shall cause a review to be made of the official names by which devices are identified in any official compendium (and all supplements thereto) to determine whether revision of any of those names is necessary or desirable in the interest of usefulness and simplicity.

(c) Determinations of complexity, usefulness, multiplicity, or lack of name; designation by Secretary

Whenever he determines after any such review that (1) any such official name is unduly complex or is not useful for any other reason, (2) two or more official names have been applied to a single drug or device, or to two or more drugs which are identical in chemical structure and pharmacological action and which are substantially identical in strength, quality, and purity, or to two or more devices which are substantially equivalent in design and purpose or (3) no official name has been applied to a medically useful drug or device, he shall transmit in writing to the compiler of each official compendium in which that drug or drugs or device are identified and recognized his request for the recommendation of a single official name for such drug or drugs or device which will have usefulness and simplicity. Whenever such a single official name has not been recommended within one hundred and eighty days after such request, or the Secretary determines that any name so recommended is not useful for any reason, he shall designate a single official name for such drug or drugs or device. Whenever he determines that the name so recommended is useful, he shall designate that name as the official name of such drug or drugs or device. Such designation shall be made as a regulation upon public notice and in accordance with the procedure set forth in section 553 of title 5.

(d) Revised official names; compilation, publication, and public distribution of listings

After each such review, and at such other times as the Secretary may determine to be necessary or desirable, the Secretary shall cause to be compiled, published, and publicly distributed a list which shall list all revised official names of drugs or devices designated under this section and shall contain such descriptive and explanatory matter as the Secretary may determine to be required for the effective use of those names.

(e) Request by compiler of official compendium for designation of name

Upon a request in writing by any compiler of an official compendium that the Secretary exercise the authority granted to him under subsection (a), he shall upon public notice and in accordance with the procedure set forth in section 553 of title 5 designate the official name of the drug or device for which the request is made.

(June 25, 1938, ch. 675, §508, as added Pub. L. 87–781, title I, §111(a), Oct. 10, 1962, 76 Stat. 789; amended Pub. L. 94–295, §5(b), May 28, 1976, 90 Stat. 581; Pub. L. 103–80, §3(q), Aug. 13, 1993, 107 Stat. 777.)

Editorial Notes

Amendments

1993—Subsecs. (c), (e). Pub. L. 103–80 substituted reference to section 553 of title 5 for "section 4 of the Administrative Procedure Act (5 U.S.C. 1003)".

1976—Subsec. (a). Pub. L. 94–295 substituted "drug or device" for "drug" wherever appearing.

Subsec. (b). Pub. L. 94–295 substituted "National Formulary, and all supplements thereto, and at such times as he may deem necessary shall cause a review to be made of the official names by which devices are identified in any official compendium (and all supplements thereto)" for "National Formulary, and all supplements thereto,".

Subsec. (c)(2). Pub. L. 94–295 inserted "or device" after "single drug", and "or to two or more devices which are substantially equivalent in design and purpose" after "purity,".

Subsec. (c)(3). Pub. L. 94–295 inserted "or device" after "useful drug" and after "drug or drugs" wherever appearing.

Subsec. (d). Pub. L. 94–295 inserted "or devices" after "drugs".

Subsec. (e). Pub. L. 94–295 substituted "drug or device" for "drug".

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 87–781, title I, §111(b), Oct. 10, 1962, 76 Stat. 790, provided that: "This section [enacting this section] shall take effect on the date of its enactment [Oct. 10, 1962]."
21 U.S.C. § 1201 (2024) — Title 21: FOOD AND DRUGS / Chapter 17: NATIONAL DRUG ENFORCEMENT POLICY / Section 1201: Repealed. Pub. L. 100-690, title I, §1007(a)(3), Nov. 18, 1988, 102 Stat. 4187
Repealed. Pub. L. 100-690, title I, §1007(a)(3), Nov. 18, 1988, 102 Stat. 4187
Status: repealed

Section 1201, Pub. L. 98–473, title II, §1302, Oct. 12, 1984, 98 Stat. 2168, set forth Congressional findings and declaration of purpose relating to illegal flow of narcotics into United States.

Section 1202, Pub. L. 98–473, title II, §1303, Oct. 12, 1984, 98 Stat. 2168, established National Drug Enforcement Policy Board.

Section 1203, Pub. L. 98–473, title II, §1304, Oct. 12, 1984, 98 Stat. 2169, delineated responsibilities and functions of National Drug Enforcement Policy Board.

Section 1204, Pub. L. 98–473, title II, §1305, Oct. 12, 1984, 98 Stat. 2170, related to reports to Congress.

Statutory Notes and Related Subsidiaries

Effective Date of Repeal

Pub. L. 100–690, title I, §1007(a)(3), Nov. 18, 1988, 102 Stat. 4187, provided that the repeal of this chapter is effective on 30th day after first Director of National Drug Control Policy is confirmed by the Senate.

Short Title

Pub. L. 98–473, title II, §1301, Oct. 12, 1984, 98 Stat. 2168, which provided that chapter XIII (§§1301 to 1307) of title II of Pub. L. 98–473 was to be cited as the National Narcotics Act of 1984, was repealed by Pub. L. 100–690, title I, §1007(a)(3), Nov. 18, 1988, 102 Stat. 4187.

Executive Documents

Executive Order No. 12590

Ex. Ord. No. 12590, Mar. 26, 1987, 52 F.R. 10021, as amended by Ex. Ord. No. 13284, §11, Jan. 23, 2003, 68 F.R. 4076, provided for the establishment of a National Drug Policy Board, designated its membership and functions, and authorized coordinating groups.
21 U.S.C. § 157 (2024) — Title 21: FOOD AND DRUGS / Chapter 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS / Section 157: Inspection
Inspection
Status: in_force

Any officer, agent, or employee of the Department of Agriculture duly authorized by the Secretary of Agriculture for the purpose may, at any hour during the daytime or nighttime, enter and inspect any establishment where any virus, serum, toxin, or analogous product for use in the treatment of domestic animals is prepared for sale, barter, exchange, or shipment as aforesaid.

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 833; Pub. L. 99–198, title XVII, §1768(d), Dec. 23, 1985, 99 Stat. 1655.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Another section 1768 of Pub. L. 99–198, cited as a credit to this section, amended section 136y of Title 7, Agriculture.

Amendments

1985—Pub. L. 99–198 struck out "licensed under this chapter" after "enter and inspect any establishment".

Statutory Notes and Related Subsidiaries

Effective Date of 1985 Amendment

Amendment by Pub. L. 99–198 effective Dec. 23, 1985, except as otherwise provided, see section 1768(f) of Pub. L. 99–198, set out as a note under section 151 of this title.

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.
21 U.S.C. § 350 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 350: Vitamins and minerals
Vitamins and minerals
Status: in_force

(a) Authority and limitations of Secretary; applicability

(1) Except as provided in paragraph (2)—

(A) the Secretary may not establish, under section 321(n), 341, or 343 of this title, maximum limits on the potency of any synthetic or natural vitamin or mineral within a food to which this section applies;

(B) the Secretary may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the Secretary determines is nutritionally rational or useful;

(C) the Secretary may not limit, under section 321(n), 341, or 343 of this title, the combination or number of any synthetic or natural—

(i) vitamin,

(ii) mineral, or

(iii) other ingredient of food,

within a food to which this section applies.

(2) Paragraph (1) shall not apply in the case of a vitamin, mineral, other ingredient of food, or food, which is represented for use by individuals in the treatment or management of specific diseases or disorders, by children, or by pregnant or lactating women. For purposes of this subparagraph,1 the term "children" means individuals who are under the age of twelve years.

(b) Labeling and advertising requirements for foods

(1) A food to which this section applies shall not be deemed under section 343 of this title to be misbranded solely because its label bears, in accordance with section 343(i)(2) of this title, all the ingredients in the food or its advertising contains references to ingredients in the food which are not vitamins or minerals.

(2) The labeling for any food to which this section applies may not list its ingredients which are not dietary supplement ingredients described in section 321(ff) of this title (i) except as a part of a list of all the ingredients of such food, and (ii) unless such ingredients are listed in accordance with applicable regulations under section 343 of this title. To the extent that compliance with clause (i) of this subparagraph is impracticable or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.

(c) Definitions

(1) For purposes of this section, the term "food to which this section applies" means a food for humans which is a food for special dietary use—

(A) which is or contains any natural or synthetic vitamin or mineral, and

(B) which—

(i) is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or

(ii) if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.

(2) For purposes of paragraph (1)(B)(i), a food shall be considered as intended for ingestion in liquid form only if it is formulated in a fluid carrier and it is intended for ingestion in daily quantities measured in drops or similar small units of measure.

(3) For purposes of paragraph (1) and of section 343(j) of this title insofar as that section is applicable to food to which this section applies, the term "special dietary use" as applied to food used by man means a particular use for which a food purports or is represented to be used, including but not limited to the following:

(A) Supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition, including but not limited to the condition of disease, convalescence, pregnancy, lactation, infancy, allergic hypersensitivity to food, underweight, overweight, or the need to control the intake of sodium.

(B) Supplying a vitamin, mineral, or other ingredient for use by man to supplement his diet by increasing the total dietary intake.

(C) Supplying a special dietary need by reason of being a food for use as the sole item of the diet.

(June 25, 1938, ch. 675, §411, as added Pub. L. 94–278, title V, §501(a), Apr. 22, 1976, 90 Stat. 410; amended Pub. L. 103–417, §§3(c), 7(d), Oct. 25, 1994, 108 Stat. 4328, 4331.)

Editorial Notes

Amendments

1994—Subsec. (b)(2). Pub. L. 103–417, §7(d), redesignated subpar. (A) as par. (2), substituted "dietary supplement ingredients described in section 321(ff) of this title" for "vitamins or minerals", and struck out former subpar. (B), which read as follows: "Notwithstanding the provisions of subparagraph (A), the labeling and advertising for any food to which this section applies may not give prominence to or emphasize ingredients which are not—

"(i) vitamins,

"(ii) minerals, or

"(iii) represented as a source of vitamins or minerals."

Subsec. (c)(1)(B)(i). Pub. L. 103–417, §3(c)(1), inserted "powder, softgel, gelcap," after "capsule,".

Subsec. (c)(1)(B)(ii). Pub. L. 103–417, §3(c)(2), struck out "does not simulate and" after "in such a form,".

Statutory Notes and Related Subsidiaries

Effective Date of 1994 Amendment

For provision that dietary supplements may be labeled after Oct. 25, 1994, in accordance with amendments made by section 7(d) of Pub. L. 103–417, and shall be so labeled after Dec. 31, 1996, see section 7(e) of Pub. L. 103–417, set out as a note under section 343 of this title.

Amendment of Inconsistent Regulations by Secretary

Pub. L. 94–278, title V, §501(b), Apr. 22, 1976, 90 Stat. 411, as amended by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, provided that: "The Secretary of Health and Human Services shall amend any regulation promulgated under the Federal Food, Drug, and Cosmetic Act [this chapter] which is inconsistent with section 411 of such Act [section 350 of this title] (as added by subsection (a)) and such amendments shall be promulgated in accordance with section 553 of title 5, United States Code."

1 So in original. Probably should be "paragraph".
21 U.S.C. § 864a (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 864a: Grants to reduce production of methamphetamines from anhydrous ammonia
Grants to reduce production of methamphetamines from anhydrous ammonia
Status: in_force

(a) Definitions

In this section:

(1) Eligible entity

The term "eligible entity" means—

(A) a producer of agricultural commodities;

(B) a cooperative association, a majority of the members of which produce or process agricultural commodities; or

(C) a person in the trade or business of—

(i) selling an agricultural product (including an agricultural chemical) at retail, predominantly to farmers and ranchers; or

(ii) aerial and ground application of an agricultural chemical.

(2) Nurse tank

The term "nurse tank" shall be considered to be a cargo tank (within the meaning of section 173.315(m) of title 49, Code of Federal Regulations, as in effect as of the date of the enactment of this Act).

(b) Grant authority

The Secretary may make a grant to an eligible entity to enable the eligible entity to obtain and add to an anhydrous ammonia fertilizer nurse tank a physical lock or a substance to reduce the amount of methamphetamine that can be produced from any anhydrous ammonia removed from the nurse tank.

(c) Grant amount

The amount of a grant made under this section to an eligible entity shall be the product obtained by multiplying—

(1) an amount not less than $40 and not more than $60, as determined by the Secretary; and

(2) the number of fertilizer nurse tanks of the eligible entity.

(d) Authorization of appropriations

There is authorized to be appropriated to the Secretary to make grants under this section $15,000,000 for the period of fiscal years 2008 through 2012.

(Pub. L. 110–234, title XIV, §14203, May 22, 2008, 122 Stat. 1458; Pub. L. 110–246, §4(a), title XIV, §14203, June 18, 2008, 122 Stat. 1664, 2220.)

Editorial Notes

References in Text

The date of the enactment of this Act, referred to in subsec. (a)(2), is the date of enactment of Pub. L. 110–246, which was approved June 18, 2008.

Codification

Pub. L. 110–234 and Pub. L. 110–246 enacted identical sections. Pub. L. 110–234 was repealed by section 4(a) of Pub. L. 110–246.

Section was enacted as part of the Food, Conservation, and Energy Act of 2008, and not as part of the Controlled Substances Act which comprises this subchapter.

Statutory Notes and Related Subsidiaries

Effective Date

Enactment of this section and repeal of Pub. L. 110–234 by Pub. L. 110–246 effective May 22, 2008, the date of enactment of Pub. L. 110–234, see section 4 of Pub. L. 110–246, set out as a note under section 8701 of Title 7, Agriculture.

Definition of "Secretary"

"Secretary" as meaning the Secretary of Agriculture, see section 8701 of Title 7, Agriculture.
21 U.S.C. § 335b (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter III: PROHIBITED ACTS AND PENALTIES / Section 335b: Civil penalties
Civil penalties
Status: in_force

(a) In general

Any person that the Secretary finds—

(1) knowingly made or caused to be made, to any officer, employee, or agent of the Department of Health and Human Services, a false statement or misrepresentation of a material fact in connection with an abbreviated drug application,

(2) bribed or attempted to bribe or paid or attempted to pay an illegal gratuity to any officer, employee, or agent of the Department of Health and Human Services in connection with an abbreviated drug application,

(3) destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document or other material evidence which was the property of or in the possession of the Department of Health and Human Services for the purpose of interfering with that Department's discharge of its responsibilities in connection with an abbreviated drug application,

(4) knowingly failed to disclose, to an officer or employee of the Department of Health and Human Services, a material fact which such person had an obligation to disclose relating to any drug subject to an abbreviated drug application,

(5) knowingly obstructed an investigation of the Department of Health and Human Services into any drug subject to an abbreviated drug application,

(6) is a person that has an approved or pending drug product application and has knowingly—

(A) employed or retained as a consultant or contractor, or

(B) otherwise used in any capacity the services of,

a person who was debarred under section 335a of this title, or

(7) is an individual debarred under section 335a of this title and, during the period of debarment, provided services in any capacity to a person that had an approved or pending drug product application,

shall be liable to the United States for a civil penalty for each such violation in an amount not to exceed $250,000 in the case of an individual and $1,000,000 in the case of any other person.

(b) Procedure

(1) In general

(A) Action by the Secretary

A civil penalty under subsection (a) shall be assessed by the Secretary on a person by an order made on the record after an opportunity for an agency hearing on disputed issues of material fact and the amount of the penalty. In the course of any investigation or hearing under this subparagraph, the Secretary may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation.

(B) Action by the Attorney General

In lieu of a proceeding under subparagraph (A), the Attorney General may, upon request of the Secretary, institute a civil action to recover a civil money penalty in the amount and for any of the acts set forth in subsection (a). Such an action may be instituted separately from or in connection with any other claim, civil or criminal, initiated by the Attorney General under this chapter.

(2) Amount

In determining the amount of a civil penalty under paragraph (1), the Secretary or the court shall take into account the nature, circumstances, extent, and gravity of the act subject to penalty, the person's ability to pay, the effect on the person's ability to continue to do business, any history of prior, similar acts, and such other matters as justice may require.

(3) Limitation on actions

No action may be initiated under this section—

(A) with respect to any act described in subsection (a) that occurred before May 13, 1992, or

(B) more than 6 years after the date when facts material to the act are known or reasonably should have been known by the Secretary but in no event more than 10 years after the date the act took place.

(c) Judicial review

Any person that is the subject of an adverse decision under subsection (b)(1)(A) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the person resides, by filing in such court (within 60 days following the date the person is notified of the Secretary's decision) a petition requesting that the decision be modified or set aside.

(d) Recovery of penalties

The Attorney General may recover any civil penalty (plus interest at the currently prevailing rates from the date the penalty became final) assessed under subsection (b)(1)(A) in an action brought in the name of the United States. The amount of such penalty may be deducted, when the penalty has become final, from any sums then or later owing by the United States to the person against whom the penalty has been assessed. In an action brought under this subsection, the validity, amount, and appropriateness of the penalty shall not be subject to judicial review.

(e) Informants

The Secretary may award to any individual (other than an officer or employee of the Federal Government or a person who materially participated in any conduct described in subsection (a)) who provides information leading to the imposition of a civil penalty under this section an amount not to exceed—

(1) $250,000, or

(2) one-half of the penalty so imposed and collected,

whichever is less. The decision of the Secretary on such award shall not be reviewable.

(June 25, 1938, ch. 675, §307, as added Pub. L. 102–282, §3, May 13, 1992, 106 Stat. 159; amended Pub. L. 103–80, §3(g), Aug. 13, 1993, 107 Stat. 776.)

Editorial Notes

Prior Provisions

A prior section 307 of act June 25, 1938, was renumbered section 310 and is classified to section 337 of this title.

Amendments

1993—Subsec. (b)(3)(A). Pub. L. 103–80 made technical amendment to reference to May 13, 1992, to reflect correction of corresponding provision of original act.

Statutory Notes and Related Subsidiaries

Construction

This section not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title.
21 U.S.C. § 860 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 860: Distribution or manufacturing in or near schools and colleges
Distribution or manufacturing in or near schools and colleges
Status: in_force

(a) Penalty

Any person who violates section 841(a)(1) of this title or section 856 of this title by distributing, possessing with intent to distribute, or manufacturing a controlled substance in or on, or within one thousand feet of, the real property comprising a public or private elementary, vocational, or secondary school or a public or private college, junior college, or university, or a playground, or housing facility owned by a public housing authority, or within 100 feet of a public or private youth center, public swimming pool, or video arcade facility, is (except as provided in subsection (b)) subject to (1) twice the maximum punishment authorized by section 841(b) of this title; and (2) at least twice any term of supervised release authorized by section 841(b) of this title for a first offense. A fine up to twice that authorized by section 841(b) of this title may be imposed in addition to any term of imprisonment authorized by this subsection. Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a person shall be sentenced under this subsection to a term of imprisonment of not less than one year. The mandatory minimum sentencing provisions of this paragraph shall not apply to offenses involving 5 grams or less of marihuana.

(b) Second offenders

Any person who violates section 841(a)(1) of this title or section 856 of this title by distributing, possessing with intent to distribute, or manufacturing a controlled substance in or on, or within one thousand feet of, the real property comprising a public or private elementary, vocational, or secondary school or a public or private college, junior college, or university, or a playground, or housing facility owned by a public housing authority, or within 100 feet of a public or private youth center, public swimming pool, or video arcade facility, after a prior conviction under subsection (a) has become final is punishable (1) by the greater of (A) a term of imprisonment of not less than three years and not more than life imprisonment or (B) three times the maximum punishment authorized by section 841(b) of this title for a first offense, and (2) at least three times any term of supervised release authorized by section 841(b) of this title for a first offense. A fine up to three times that authorized by section 841(b) of this title may be imposed in addition to any term of imprisonment authorized by this subsection. Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a person shall be sentenced under this subsection to a term of imprisonment of not less than three years. Penalties for third and subsequent convictions shall be governed by section 841(b)(1)(A) of this title.

(c) Employing children to distribute drugs near schools or playgrounds

Notwithstanding any other law, any person at least 21 years of age who knowingly and intentionally—

(1) employs, hires, uses, persuades, induces, entices, or coerces a person under 18 years of age to violate this section; or

(2) employs, hires, uses, persuades, induces, entices, or coerces a person under 18 years of age to assist in avoiding detection or apprehension for any offense under this section by any Federal, State, or local law enforcement official,

is punishable by a term of imprisonment, a fine, or both, up to triple those authorized by section 841 of this title.

(d) Suspension of sentence; probation; parole

In the case of any mandatory minimum sentence imposed under this section, imposition or execution of such sentence shall not be suspended and probation shall not be granted. An individual convicted under this section shall not be eligible for parole until the individual has served the mandatory minimum term of imprisonment as provided by this section.

(e) Definitions

For the purposes of this section—

(1) The term "playground" means any outdoor facility (including any parking lot appurtenant thereto) intended for recreation, open to the public, and with any portion thereof containing three or more separate apparatus intended for the recreation of children including, but not limited to, sliding boards, swingsets, and teeterboards.

(2) The term "youth center" means any recreational facility and/or gymnasium (including any parking lot appurtenant thereto), intended primarily for use by persons under 18 years of age, which regularly provides athletic, civic, or cultural activities.

(3) The term "video arcade facility" means any facility, legally accessible to persons under 18 years of age, intended primarily for the use of pinball and video machines for amusement containing a minimum of ten pinball and/or video machines.

(4) The term "swimming pool" includes any parking lot appurtenant thereto.

(Pub. L. 91–513, title II, §419, formerly §405A, as added Pub. L. 98–473, title II, §503(a), Oct. 12, 1984, 98 Stat. 2069; amended Pub. L. 99–570, title I, §§1004(a), 1104, 1105(c), 1841(b), 1866(b), (c), Oct. 27, 1986, 100 Stat. 3207–6, 3207–11, 3207–52, 3207–55; Pub. L. 99–646, §28, Nov. 10, 1986, 100 Stat. 3598; Pub. L. 100–690, title VI, §§6452(b)(1), 6457, 6458, Nov. 18, 1988, 102 Stat. 4371, 4373; renumbered §419 and amended Pub. L. 101–647, title X, §§1002(b), 1003(b), title XII, §1214, title XV, §1502, title XXXV, §3599L, Nov. 29, 1990, 104 Stat. 4827, 4829, 4833, 4836, 4932; Pub. L. 103–322, title XIV, §140006, title XXXII, §320107, title XXXIII, §330009(a), Sept. 13, 1994, 108 Stat. 2032, 2111, 2143.)

Editorial Notes

Codification

Section was classified to section 845a of this title prior to renumbering by Pub. L. 101–647.

Amendments

1994—Subsec. (a). Pub. L. 103–322, §320107, substituted "playground, or housing facility owned by a public housing authority, or within" for "playground, or within".

Subsec. (b). Pub. L. 103–322, §§320107, 330009(a), substituted "playground, or housing facility owned by a public housing authority, or within" for "playground, or within" and inserted a period at end of penultimate sentence.

Subsecs. (c) to (e). Pub. L. 103–322, §140006, added subsec. (c) and redesignated former subsecs. (c) and (d) as (d) and (e), respectively.

1990—Subsec. (a). Pub. L. 101–647, §1502(1), inserted "or a playground," after "university," and struck out "playground," after "within 100 feet of a".

Pub. L. 101–647, §1214(1)(C), substituted "a person shall be sentenced under this subsection to a term of imprisonment of not less than one year" for "a term of imprisonment under this subsection shall be not less than one year".

Pub. L. 101–647, §1214(1)(B), inserted "A fine up to twice that authorized by section 841(b) of this title may be imposed in addition to any term of imprisonment authorized by this subsection."

Pub. L. 101–647, §1214(1)(A), which directed the amendment of par. (1) by striking out ", or a fine, or both," could not be executed because those words did not appear. See note below.

Pub. L. 101–647, §1003(b)(1), which directed the substitution of "subject to (1) twice the maximum punishment authorized by section 841(b) of this title" for "punishable (1) by a term of imprisonment, or a fine, or both, up to twice that authorized by section 841(b) of this title", was executed by making the substitution for "punishable (1) by a term of imprisonment, or fine, or both, up to twice that authorized by section 841(b) of this title" to reflect the probable intent of Congress.

Subsec. (b). Pub. L. 101–647, §3599L, substituted "has become final" for "have become final".

Pub. L. 101–647, §1502(2), inserted "or a playground," after "university," and struck out "playground," after "within 100 feet of a".

Pub. L. 101–647, §1214(2)(B), inserted after first sentence "A fine up to three times that authorized by section 841(b) of this title may be imposed in addition to any term of imprisonment authorized by this subsection. Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a person shall be sentenced under this subsection to a term of imprisonment of not less than three years".

Subsec. (b)(1)(B). Pub. L. 101–647, §1214(2)(A), which directed the amendment of subpar. (B) by striking ", or a fine up to three times that" through "or both", could not be executed because the language did not appear after execution of the intervening amendment by Pub. L. 101–647, §1003(b)(2). See below.

Pub. L. 101–647, §1003(b)(2), substituted "three times the maximum punishment authorized by section 841(b) of this title for a first offense" for "a term of imprisonment of up to three times that authorized by section 841(b) of this title for a first offense, or a fine up to three times that authorized by section 841(b) of this title for a first offense, or both".

Subsec. (c). Pub. L. 101–647, §1214(3), inserted "mandatory minimum" after "In the case of any", struck out "subsection (b)" after "imposed under", struck out "of" before "this section" in a reference to "of this section" which was editorially added before ", imposition or", and substituted "An individual convicted under this section shall not be eligible for parole until the individual has served the mandatory minimum term of imprisonment as provided by this section" for "An individual convicted under subsection (b) of this section shall not be eligible for parole under chapter 311 of title 18 until the individual has served the minimum sentence required by such subsection".

1988—Subsec. (a). Pub. L. 100–690, §§6457, 6458(a), inserted ", possessing with intent to distribute," after "distributing" and ", or within 100 feet of a playground, public or private youth center, public swimming pool, or video arcade facility," after "university".

Subsec. (b). Pub. L. 100–690, §§6452(b)(1), 6457, 6458(a), inserted ", possessing with intent to distribute," after "distributing", and ", or within 100 feet of a playground, public or private youth center, public swimming pool, or video arcade facility," after "university", substituted "a prior conviction" for "a prior conviction or convictions", and inserted at end "Penalties for third and subsequent convictions shall be governed by section 841(b)(1)(A) of this title."

Subsec. (d). Pub. L. 100–690, §6458(b), added subsec. (d).

1986—Subsec. (a). Pub. L. 99–570, §§1104(a), (b), 1105(c), 1841(b)(1), inserted "or section 856 of this title" and "or manufacturing", substituted "a public or private elementary, vocational, or secondary school or a public or private college, junior college, or university" for "a public or private elementary or secondary school", struck out "involving the same controlled substance and schedule" after "for a first offense", and inserted "Except to the extent a greater minimum sentence is otherwise provided by section 841(b) of this title, a term of imprisonment under this subsection shall be not less than one year. The mandatory minimum sentencing provisions of this paragraph shall not apply to offenses involving 5 grams or less of marihuana."

Pub. L. 99–570, §1004(a), substituted "term of supervised release" for "special parole term".

Subsec. (b). Pub. L. 99–646 which directed that "parole" be inserted after "(2) at least three times any special" could not be executed in view of prior amendment by Pub. L. 99–570, §1104(c) below.

Pub. L. 99–570, §1866(b), which directed that "term of supervised release" be substituted for "special term" could not be executed in view of prior amendment by Pub. L. 99–570, §1104(c) below.

Pub. L. 99–570, §§1104(a), 1841(b)(2), inserted reference to section 856 of this title, inserted "or manufacturing" after "distributing" and substituted "a public or private elementary, vocational, or secondary school or a public or private college, junior college, or university" for "a public or private elementary or secondary school".

Pub. L. 99–570, §1104(c), amended cls. (1) and (2) generally. Prior to amendment, cls. (1) and (2) read as follows: "(1) by a term of imprisonment of not less than three years and not more than life imprisonment and (2) at least three times any special term authorized by section 841(b) of this title for a second or subsequent offense involving the same controlled substance and schedule."

Subsec. (c). Pub. L. 99–570, §1866(c), substituted reference to chapter 311 of title 18 for reference to section 4202 of that title.

Statutory Notes and Related Subsidiaries

Effective Date of 1986 Amendment

Amendment by section 1004(a) of Pub. L. 99–570 effective on date of taking effect of section 3583 of Title 18, Crimes and Criminal Procedure (Nov. 1, 1987), see section 1004(b) of Pub. L. 99–570 set out as a note under section 841 of this title.
21 U.S.C. § 357 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 357: Qualification of drug development tools
Qualification of drug development tools
Status: in_force

(a) Process for qualification

(1) In general

The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which—

(A)(i) a requestor initiates such process by submitting a letter of intent to the Secretary; and

(ii) the Secretary accepts or declines to accept such letter of intent;

(B)(i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and

(ii) the Secretary accepts or declines to accept the qualification plan; and

(C)(i) if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package;

(ii) the Secretary determines whether to accept such qualification package for review; and

(iii) if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section.

(2) Acceptance and review of submissions

(A) In general

Subparagraphs (B), (C), and (D) shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as "qualification submissions").

(B) Acceptance factors; nonacceptance

The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use.

(C) Prioritization of qualification review

The Secretary may prioritize the review of a full qualification package submitted under paragraph (1) with respect to a drug development tool, based on factors determined appropriate by the Secretary, including—

(i) as applicable, the severity, rarity, or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition; and

(ii) the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority.

(D) Engagement of external experts

The Secretary may, for purposes of the review of qualification submissions, through the use of cooperative agreements, grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph (1) or the review of any full qualification package under paragraph (3).

(3) Review of full qualification package

The Secretary shall—

(A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and

(B) determine whether the drug development tool at issue is qualified for its proposed context of use.

(4) Qualification

The Secretary shall determine whether a drug development tool is qualified for a proposed context of use based on the scientific merit of a full qualification package reviewed under paragraph (3).

(b) Effect of qualification

(1) In general

A drug development tool determined to be qualified under subsection (a)(4) for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph (2).

(2) Use of a drug development tool

Subject to paragraph (3), a drug development tool qualified under this section may be used for—

(A) supporting or obtaining approval or licensure (as applicable) of a drug or biological product (including in accordance with section 356(c) of this title) under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262]; or

(B) supporting the investigational use of a drug or biological product under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)].

(3) Rescission or modification

(A) In general

The Secretary may rescind or modify a determination under this section to qualify a drug development tool if the Secretary determines that the drug development tool is not appropriate for the proposed context of use specified by the requestor. Such a determination may be based on new information that calls into question the basis for such qualification.

(B) Meeting for review

If the Secretary rescinds or modifies under subparagraph (A) a determination to qualify a drug development tool, the requestor involved shall, on request, be granted a meeting with the Secretary to discuss the basis of the Secretary's decision to rescind or modify the determination before the effective date of the rescission or modification.

(c) Transparency

(1) In general

Subject to paragraph (3), the Secretary shall make publicly available, and update on at least a biannual basis, on the Internet website of the Food and Drug Administration the following:

(A) Information with respect to each qualification submission under the qualification process under subsection (a), including—

(i) the stage of the review process applicable to the submission;

(ii) the date of the most recent change in stage status;

(iii) whether external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package; and

(iv) submissions from requestors under the qualification process under subsection (a), including any data and evidence contained in such submissions, and any updates to such submissions.

(B) The Secretary's formal written determinations in response to such qualification submissions.

(C) Any rescissions or modifications under subsection (b)(3) of a determination to qualify a drug development tool.

(D) Summary reviews that document conclusions and recommendations for determinations to qualify drug development tools under subsection (a).

(E) A comprehensive list of—

(i) all drug development tools qualified under subsection (a); and

(ii) all surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product (including in accordance with section 356(c) of this title) under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262].

(2) Relation to Trade Secrets Act

Information made publicly available by the Secretary under paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18.

(3) Applicability

(A) In general

Nothing in this section shall be construed as authorizing or directing the Secretary to disclose—

(i) any information contained in an application submitted under section 355 of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] that is confidential commercial or trade secret information subject to section 552(b)(4) of title 5 or section 1905 of title 18; or

(ii) in the case of a drug development tool that may be used to support the development of a qualified countermeasure, security countermeasure, or qualified pandemic or epidemic product, as defined in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [42 U.S.C. 247d–6a, 247d–6b, 247d–6d], any information that the Secretary determines has a significant potential to affect national security.

(B) Public acknowledgment

In the case that the Secretary, pursuant to subparagraph (A)(ii), does not make information publicly available, the Secretary shall provide on the internet website of the Food and Drug Administration an acknowledgment of the information that has not been disclosed, pursuant to subparagraph (A)(ii).

(d) Rule of construction

Nothing in this section shall be construed—

(1) to alter the standards of evidence under subsection (c) or (d) of section 355 of this title, including the substantial evidence standard in such subsection (d), or under section 351 of the Public Health Service Act [42 U.S.C. 262] (as applicable); or

(2) to limit the authority of the Secretary to approve or license products under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], as applicable (as in effect before December 13, 2016).

(e) Definitions

In this section:

(1) Biomarker

The term "biomarker"—

(A) means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and

(B) includes a surrogate endpoint.

(2) Biomedical research consortia

The term "biomedical research consortia" means collaborative groups that may take the form of public-private partnerships and may include government agencies, institutions of higher education (as defined in section 1001(a) of title 20), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals.

(3) Clinical outcome assessment

The term "clinical outcome assessment" means—

(A) a measurement of a patient's symptoms, overall mental state, or the effects of a disease or condition on how the patient functions; and

(B) includes a patient-reported outcome.

(4) Context of use

The term "context of use" means, with respect to a drug development tool, the circumstances under which the drug development tool is to be used in drug development and regulatory review.

(5) Drug development tool

The term "drug development tool" includes—

(A) a biomarker;

(B) a clinical outcome assessment; and

(C) any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.

(6) Patient-reported outcome

The term "patient-reported outcome" means a measurement based on a report from a patient regarding the status of the patient's health condition without amendment or interpretation of the patient's report by a clinician or any other person.

(7) Qualification

The terms "qualification" and "qualified" mean a determination by the Secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this chapter.

(8) Requestor

The term "requestor" means an entity or entities, including a drug sponsor or a biomedical research consortia, seeking to qualify a drug development tool for a proposed context of use under this section.

(9) Surrogate endpoint

The term "surrogate endpoint" means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and—

(A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or

(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 356(c) of this title.

(June 25, 1938, ch. 675, §507, as added Pub. L. 114–255, div. A, title III, §3011(a), Dec. 13, 2016, 130 Stat. 1086; amended Pub. L. 116–22, title VII, §705(e), June 24, 2019, 133 Stat. 964.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (d)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Prior Provisions

A prior section 357, act June 25, 1938, ch. 675, §507, as added July 6, 1945, ch. 281, §3, 59 Stat. 463; amended Mar. 10, 1947, ch. 16, §3, 61 Stat. 12; July 13, 1949, ch. 305, §2, 63 Stat. 409; Aug. 5, 1953, ch. 334, §2, 67 Stat. 389; Pub. L. 87–781, title I, §§105(a), (b), (d)–(f), 106(a), (b), Oct. 10, 1962, 76 Stat. 785, 786, 787; Pub. L. 90–399, §105(b), July 13, 1968, 82 Stat. 352; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(p), Aug. 13, 1993, 107 Stat. 777, related to certification of drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, prior to repeal by Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

Amendments

2019—Subsec. (c)(3). Pub. L. 116–22 designated existing provisions as subpar. (A), inserted heading and "or directing" after "authorizing" in text, substituted "disclose—" for "disclose", designated remainder of existing provisions as cl. (i) of subpar. (A), substituted ";or" for period at end, and added cl. (ii) of subpar. (A) and subpar. (B).

Statutory Notes and Related Subsidiaries

Guidance

Pub. L. 114–255, div. A, title III, §3011(b), Dec. 13, 2016, 130 Stat. 1089, provided that:

"(1) In general.—The Secretary of Health and Human Services (referred to in this section [this note] as the 'Secretary') shall, in consultation with biomedical research consortia (as defined in subsection (e) of section 507 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 357] (as added by subsection (a)) and other interested parties through a collaborative public process, issue guidance to implement such section 507 that—

"(A) provides a conceptual framework describing appropriate standards and scientific approaches to support the development of biomarkers delineated under the taxonomy established under paragraph (3);

"(B) with respect to the qualification process under such section 507—

"(i) describes the requirements that entities seeking to qualify a drug development tool under such section shall observe when engaging in such process;

"(ii) outlines reasonable timeframes for the Secretary's review of letters, qualification plans, or full qualification packages submitted under such process; and

"(iii) establishes a process by which such entities or the Secretary may consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the Secretary in the review of qualification plans and full qualification submissions under such section; and

"(C) includes such other information as the Secretary determines appropriate.

"(2) Timing.—Not later than 3 years after the date of the enactment of this Act [Dec. 13, 2016], the Secretary shall issue draft guidance under paragraph (1) on the implementation of section 507 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 357] (as added by subsection (a)). The Secretary shall issue final guidance on the implementation of such section not later than 6 months after the date on which the comment period for the draft guidance closes.

"(3) Taxonomy.—

"(A) In general.—For purposes of informing guidance under this subsection, the Secretary shall, in consultation with biomedical research consortia and other interested parties through a collaborative public process, establish a taxonomy for the classification of biomarkers (and related scientific concepts) for use in drug development.

"(B) Public availability.—Not later than 2 years after the date of the enactment of this Act, the Secretary shall make such taxonomy publicly available in draft form for public comment. The Secretary shall finalize the taxonomy not later than 1 year after the close of the public comment period."
21 U.S.C. § 879 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 879: Search warrants
Search warrants
Status: in_force

A search warrant relating to offenses involving controlled substances may be served at any time of the day or night if the judge or United States magistrate judge issuing the warrant is satisfied that there is probable cause to believe that grounds exist for the warrant and for its service at such time.

(Pub. L. 91–513, title II, §509, Oct. 27, 1970, 84 Stat. 1274; Pub. L. 93–481, §3, Oct. 26, 1974, 88 Stat. 1455; Pub. L. 101–650, title III, §321, Dec. 1, 1990, 104 Stat. 5117.)

Editorial Notes

Amendments

1974—Pub. L. 93–481 struck out designation "(a)" before "A search warrant", and struck out subsec. (b) which permitted officers authorized to execute search warrants to break open and enter premises under certain circumstances and which required that such officers identify themselves and give reasons and authority for their entry after such entry.

Statutory Notes and Related Subsidiaries

Change of Name

"United States magistrate judge" substituted in text for "United States magistrate" pursuant to section 321 of Pub. L. 101–650, set out as a note under section 631 of Title 28, Judiciary and Judicial Procedure.
21 U.S.C. § 337 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter III: PROHIBITED ACTS AND PENALTIES / Section 337: Proceedings in name of United States; provision as to subpoenas
Proceedings in name of United States; provision as to subpoenas
Status: in_force

(a) Except as provided in subsection (b), all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States. Subpoenas for witnesses who are required to attend a court of the United States, in any district, may run into any other district in any proceeding under this section.

(b)(1) A State may bring in its own name and within its jurisdiction proceedings for the civil enforcement, or to restrain violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f), 343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if the food that is the subject of the proceedings is located in the State.

(2) No proceeding may be commenced by a State under paragraph (1)—

(A) before 30 days after the State has given notice to the Secretary that the State intends to bring such proceeding,

(B) before 90 days after the State has given notice to the Secretary of such intent if the Secretary has, within such 30 days, commenced an informal or formal enforcement action pertaining to the food which would be the subject of such proceeding, or

(C) if the Secretary is diligently prosecuting a proceeding in court pertaining to such food, has settled such proceeding, or has settled the informal or formal enforcement action pertaining to such food.

In any court proceeding described in subparagraph (C), a State may intervene as a matter of right.

(June 25, 1938, ch. 675, §310, formerly §307, 52 Stat. 1046; Sept. 3, 1954, ch. 1263, §37, 68 Stat. 1239; Pub. L. 101–535, §4, Nov. 8, 1990, 104 Stat. 2362; renumbered §310, Pub. L. 102–282, §2, May 13, 1992, 106 Stat. 150.)

Editorial Notes

Amendments

1990—Pub. L. 101–535 substituted "(a) Except as provided in subsection (b), all" for "All" and "any proceeding under this section" for "any such proceeding" and added subsec. (b).

1954—Act Sept. 3, 1954, struck out reference to section 654 of title 28.

Statutory Notes and Related Subsidiaries

Effective Date of 1990 Amendment

Amendment by Pub. L. 101–535 effective 24 months after Nov. 8, 1990, except that such amendment effective Dec. 31, 1993, with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances, see section 10(a)(1)(C) of Pub. L. 101–535, set out as a note under section 343 of this title.

Construction of Amendments by Pub. L. 101–535

Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.
21 U.S.C. § 466 (2024) — Title 21: FOOD AND DRUGS / Chapter 10: POULTRY AND POULTRY PRODUCTS INSPECTION / Section 466: Imports
Imports
Status: in_force

(a) Compliance with standards and regulations; status after importation

No slaughtered poultry, or parts or products thereof, of any kind shall be imported into the United States unless they are healthful, wholesome, fit for human food, not adulterated, and contain no dye, chemical, preservative, or ingredient which renders them unhealthful, unwholesome, adulterated, or unfit for human food and unless they also comply with the rules and regulations made by the Secretary of Agriculture to assure that imported poultry or poultry products comply with the standards provided for in this chapter. All imported, slaughtered poultry, or parts or products thereof, shall after entry into the United States in compliance with such rules and regulations be deemed and treated as domestic slaughtered poultry, or parts or products thereof, within the meaning and subject to the provisions of this chapter and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and Acts amendatory of, supplemental to, or in substitution for such chapter and Act.

(b) Rules and regulations; destruction and exportation of refused imports

The Secretary of Agriculture is authorized to make rules and regulations to carry out the purposes of this section and in such rules and regulations the Secretary of Agriculture may prescribe the terms and conditions for the destruction of all slaughtered poultry, or parts or products thereof, offered for entry and refused admission into the United States unless such slaughtered poultry, or parts or products thereof, be exported by the consignee within the time fixed therefor in such rules and regulations.

(c) Storage, cartage and labor charges for imports refused admission

All charges for storage, cartage, and labor with respect to any product which is refused admission pursuant to this section shall be paid by the owner or consignee, and in default of such payment shall constitute a lien against any other products imported thereafter by or for such owner or consignee.

(d) Domestic standards and processing facilities applicable; enforcement

(1) Notwithstanding any other provision of law, all poultry, or parts or products of poultry, capable of use as human food offered for importation into the United States shall—

(A) be subject to inspection, sanitary, quality, species verification, and residue standards that achieve a level of sanitary protection equivalent to that achieved under United States standards; and

(B) have been processed in facilities and under conditions that achieve a level of sanitary protection equivalent to that achieved under United States standards.

(2)(A) The Secretary may treat as equivalent to a United States standard a standard of an exporting country described in paragraph (1) if the exporting country provides the Secretary with scientific evidence or other information, in accordance with risk assessment methodologies determined appropriate by the Secretary, to demonstrate that the standard of the exporting country achieves the level of sanitary protection achieved under the United States standard. For the purposes of this subsection, the term "sanitary protection" means protection to safeguard public health.

(B) The Secretary may—

(i) determine, on a scientific basis, that the standard of the exporting country does not achieve the level of protection that the Secretary considers appropriate; and

(ii) provide the basis for the determination in writing to the exporting country on request.

(3) Any such imported poultry article that does not meet such standards shall not be permitted entry into the United States.

(4) The Secretary shall enforce this subsection through—

(A) random inspections for such species verification and for residues; and

(B) random sampling and testing of internal organs and fat of carcasses for residues at the point of slaughter by the exporting country, in accordance with methods approved by the Secretary.

(Pub. L. 85–172, §17, Aug. 28, 1957, 71 Stat. 448; Pub. L. 99–198, title XVII, §1701(a), Dec. 23, 1985, 99 Stat. 1633; Pub. L. 103–182, title III, §361(e), Dec. 8, 1993, 107 Stat. 2123; Pub. L. 103–465, title IV, §431(k), Dec. 8, 1994, 108 Stat. 4969.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Amendments

1994—Subsec. (d)(1). Pub. L. 103–465, §431(k)(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Notwithstanding any other provision of law, except as provided in paragraph (2), all poultry, or parts or products thereof, capable of use as human food offered for importation into the United States shall—

"(A) be subject to the same inspection, sanitary, quality, species verification, and residue standards applied to products produced in the United States; and

"(B) have been processed in facilities and under conditions that are the same as those under which similar products are processed in the United States."

Subsec. (d)(2)(A). Pub. L. 103–465, §431(k)(2)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "Notwithstanding any other provision of law, all poultry, or parts or products of poultry, capable of use as human food offered for importation into the United States from Canada and Mexico shall—

"(i) comply with paragraph (1); or

"(ii)(I) be subject to inspection, sanitary, quality, species verification, and residue standards that are equivalent to United States standards; and

"(II) have been processed in facilities and under conditions that meet standards that are equivalent to United States standards."

Subsec. (d)(2)(B), (C). Pub. L. 103–465, §431(k)(2)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: "The Secretary may treat as equivalent to a United States standard a standard of Canada or Mexico described in subparagraph (A)(ii) if the exporting country provides the Secretary with scientific evidence or other information, in accordance with risk assessment methodologies agreed to by the Secretary and the exporting country, to demonstrate that the standard of the exporting country achieves the level of protection that the Secretary considers appropriate."

1993—Subsec. (d). Pub. L. 103–182, in par. (1), inserted "except as provided in paragraph (2)," before "all poultry" in introductory provisions, added par. (2), and redesignated former pars. (2) and (3) as (3) and (4), respectively.

1985—Par. (d). Pub. L. 99–198 added par. (d).

Statutory Notes and Related Subsidiaries

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–465 effective, except as otherwise provided, on the date of entry into force of the World Trade Organization Agreement with respect to the United States (Jan. 1, 1995), see section 451 of Pub. L. 103–465, set out as an Effective Date note under section 3601 of Title 19, Customs Duties.

Effective Date of 1985 Amendment

Pub. L. 99–198, title XVII, §1701(b), Dec. 23, 1985, 99 Stat. 1633, provided that: "The amendment made by this section [amending this section] shall become effective 6 months after the date of enactment of this Act [Dec. 23, 1985]."
21 U.S.C. § 2251 (2024) — Title 21: FOOD AND DRUGS / Chapter 27: FOOD SAFETY MODERNIZATION / Subchapter IV: MISCELLANEOUS PROVISIONS / Section 2251: Jurisdiction; authorities
Jurisdiction; authorities
Status: in_force

Nothing in this Act, or an amendment made by this Act, shall be construed to—

(1) alter the jurisdiction between the Secretary of Agriculture and the Secretary of Health and Human Services, under applicable statutes, regulations, or agreements regarding voluntary inspection of non-amenable species under the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.);

(2) alter the jurisdiction between the Alcohol and Tobacco Tax and Trade Bureau and the Secretary of Health and Human Services, under applicable statutes and regulations;

(3) limit the authority of the Secretary of Health and Human Services under—

(A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as in effect on the day before January 4, 2011; or

(B) the Public Health Service Act [42 U.S.C. 201 et seq.] as in effect on the day before January 4, 2011;

(4) alter or limit the authority of the Secretary of Agriculture under the laws administered by such Secretary, including—

(A) the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);

(B) the Poultry Products Inspection Act (21 U.S.C. 451 et seq.);

(C) the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);

(D) the United States Grain Standards Act (7 U.S.C. 71 et seq.);

(E) the Packers and Stockyards Act, 1921 (7 U.S.C. 181 et seq.);

(F) the United States Warehouse Act (7 U.S.C. 241 et seq.);

(G) the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.); and

(H) the Agricultural Adjustment Act (7 U.S.C. 601 et seq.), reenacted with the amendments made by the Agricultural Marketing Agreement Act of 1937; or

(5) alter, impede, or affect the authority of the Secretary of Homeland Security under the Homeland Security Act of 2002 (6 U.S.C. 101 et seq.) or any other statute, including any authority related to securing the borders of the United States, managing ports of entry, or agricultural import and entry inspection activities.

(Pub. L. 111–353, title IV, §403, Jan. 4, 2011, 124 Stat. 3972.)

Editorial Notes

References in Text

This Act, referred to in text, is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

The Agricultural Marketing Act of 1946, referred to in pars. (1) and (4)(G), is title II of act Aug. 14, 1946, ch. 966, 60 Stat. 1087, which is classified generally to chapter 38 (§1621 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 1621 of Title 7 and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in par. (3)(A), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

The Public Health Service Act, referred to in par. (3)(B), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

The Federal Meat Inspection Act, referred to in par. (4)(A), is titles I to V of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and Pub. L. 110–246, title XI, §11015(a), June 18, 2008, 122 Stat. 2124, which are classified generally to subchapters I to IV–A (§601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables.

The Poultry Products Inspection Act, referred to in par. (4)(B), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to chapter 10 (§451 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 451 of this title and Tables.

The Egg Products Inspection Act, referred to in par. (4)(C), is Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to chapter 15 (§1031 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

The United States Grain Standards Act, referred to in par. (4)(D), is part B of act Aug. 11, 1916, ch. 313, 39 Stat. 482, which is classified generally to chapter 3 (§71 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see section 71 of Title 7 and Tables.

The Packers and Stockyards Act, 1921, referred to in par. (4)(E), is act Aug. 15, 1921, ch. 64, 42 Stat. 159, which is classified generally to chapter 9 (§181 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see section 181 of Title 7 and Tables.

The United States Warehouse Act, referred to in par. (4)(F), is part C of act Aug. 11, 1916, ch. 313, 39 Stat. 486, which is classified generally to chapter 10 (§241 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 241 of Title 7 and Tables.

The Agricultural Adjustment Act (7 U.S.C. 601 et seq.), reenacted with the amendments made by the Agricultural Marketing Agreement Act of 1937, referred to in par. (4)(H), is title I of act May 12, 1933, ch. 25, 48 Stat. 31, which is classified generally to chapter 26 (§601 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 601 of Title 7 and Tables.

The Homeland Security Act of 2002, referred to in par. (5), is Pub. L. 107–296, Nov. 25, 2002, 116 Stat. 2135, which is classified principally to chapter 1 (§101 et seq.) of Title 6, Domestic Security. For complete classification of this Act to the Code, see Short Title note set out under section 101 of Title 6 and Tables.
21 U.S.C. § 356h (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 356h: Competitive generic therapies
Competitive generic therapies
Status: in_force

(a) In general

The Secretary may, at the request of an applicant of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of an abbreviated new drug application under section 355(j) of this title for such drug.

(b) Designation process

(1) Request

The applicant may request the Secretary to designate the drug as a competitive generic therapy.

(2) Timing

A request under paragraph (1) may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under section 355(j) of this title.

(3) Criteria

A drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition.

(4) Designation

Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may—

(A) determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and

(B) if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy.

(c) Actions

In expediting the development and review of an application under subsection (a), the Secretary may, as requested by the applicant, take actions including the following:

(1) Hold meetings with the applicant and the review team throughout the development of the drug prior to submission of the application for such drug under section 355(j) of this title.

(2) Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable.

(3) Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to drug-device combination products and other complex products.

(4) Assign a cross-disciplinary project lead—

(A) to facilitate an efficient review of the development program and application, including manufacturing inspections; and

(B) to serve as a scientific liaison between the review team and the applicant.

(d) Reporting requirement

Not later than one year after the date of the approval of an application under section 355(j) of this title with respect to a drug for which the development and review is expedited under this section, the sponsor of such drug shall report to the Secretary on whether the drug has been marketed in interstate commerce since the date of such approval.

(e) Definitions

In this section:

(1) The term "generic drug" means a drug that is approved pursuant to section 355(j) of this title.

(2) The term "inadequate generic competition" means, with respect to a drug, there is not more than one approved drugs 1 on the list of drugs described in section 355(j)(7)(A) of this title (not including drugs on the discontinued section of such list) that is—

(A) the reference listed drug; or

(B) a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.

(3) The term "reference listed drug" means the listed drug (as such term is used in section 355(j) of this title) for the drug involved.

(June 25, 1938, ch. 675, §506H, as added Pub. L. 115–52, title VIII, §803(a), Aug. 18, 2017, 131 Stat. 1070.)

Statutory Notes and Related Subsidiaries

Guidance; Amended Regulations

Pub. L. 115–52, title VIII, §803(b), Aug. 18, 2017, 131 Stat. 1071, provided that:

"(1) In general.—

"(A) Issuance.—The Secretary of Health and Human Services shall—

"(i) not later than 18 months after the date of enactment of this Act [Aug. 18, 2017], issue draft guidance on section 506H of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356h], as added by subsection (a); and

"(ii) not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such section 506H.

"(B) Contents.—The guidance issued under this paragraph shall—

"(i) specify the process and criteria by which the Secretary makes a designation under section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);

"(ii) specify the actions the Secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and

"(iii) include good review management practices for competitive generic therapies.

"(2) Amended regulations.—The Secretary of Health and Human Services shall issue or revise any regulations as may be necessary to carry out this section not later than 2 years after the date of enactment of this Act [Aug. 18, 2017]."

1 So in original. Probably should be "drug".