21 U.S.C. § 360e (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360e: Premarket approval
Premarket approval
Status: in_force

(a) General requirement

A class III device—

(1) which is subject to an order issued under subsection (b) (or a regulation promulgated under such subsection prior to July 9, 2012); or

(2) which is a class III device because of section 360c(f) of this title,

is required to have, unless exempt under section 360j(g) of this title, an approval under this section of an application for premarket approval or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval.

(b) Order to require premarket approval

(1) In the case of a class III device which—

(A) was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976; or

(B) is (i) of a type so introduced or delivered, and (ii) is substantially equivalent to another device within that type,

the Secretary shall by administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 360c(b) of this title, and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, require that such device have an approval under this section of an application for premarket approval. Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner.

(2) A proposed order required under paragraph (1) shall contain—

(A) the proposed order;

(B) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved application for premarket approval and the benefit to the public from use of the device;

(C) opportunity for the submission of comments on the proposed order and the proposed findings; and

(D) opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.

(3) After the expiration of the period for comment on a proposed order and proposed findings published under paragraph (2), consideration of comments submitted on such proposed order and findings, and a meeting of a device classification panel described in section 360c(b) of this title, the Secretary shall (A) issue an administrative order under paragraph (1) and publish in the Federal Register findings on the matters referred to in paragraph (2)(B), or (B) publish a notice terminating the proceeding for the issuance of the administrative order together with the reasons for such termination. If a notice of termination is published, the Secretary shall (unless such notice is issued because the device is a banned device under section 360f of this title) initiate a proceeding under section 360c(e) of this title to reclassify the device subject to the proceeding terminated by such notice.

(c) Application for premarket approval

(1) Any person may file with the Secretary an application for premarket approval for a class III device. Such an application for a device shall contain—

(A) full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective;

(B) a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device;

(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device;

(D) an identifying reference to any performance standard under section 360d of this title which would be applicable to any aspect of such device if it were a class II device, and either adequate information to show that such aspect of such device fully meets such performance standard or adequate information to justify any deviation from such standard;

(E) such samples of such device and of components thereof as the Secretary may reasonably require, except that where the submission of such samples is impracticable or unduly burdensome, the requirement of this subparagraph may be met by the submission of complete information concerning the location of one or more such devices readily available for examination and testing;

(F) specimens of the labeling proposed to be used for such device;

(G) the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application); and

(H) such other information relevant to the subject matter of the application as the Secretary, with the concurrence of the appropriate panel under section 360c of this title, may require.

(2)(A) Any person may file with the Secretary a report seeking premarket approval for a class III device referred to in subsection (a) that is a reprocessed single-use device. Such a report shall contain the following:

(i) The device name, including both the trade or proprietary name and the common or usual name.

(ii) The establishment registration number of the owner or operator submitting the report.

(iii) Actions taken to comply with performance standards under section 360d of this title.

(iv) Proposed labels, labeling, and advertising sufficient to describe the device, its intended use, and directions for use.

(v) Full reports of all information, published or known to or which should be reasonably known to the applicant, concerning investigations which have been made to show whether or not the device is safe or effective.

(vi) A description of the device's components, ingredients, and properties.

(vii) A full description of the methods used in, and the facilities and controls used for, the reprocessing and packing of the device.

(viii) Such samples of the device that the Secretary may reasonably require.

(ix) A financial certification or disclosure statement or both, as required by part 54 of title 21, Code of Federal Regulations.

(x) A statement that the applicant believes to the best of the applicant's knowledge that all data and information submitted to the Secretary are truthful and accurate and that no material fact has been omitted in the report.

(xi) Any additional data and information, including information of the type required in paragraph (1) for an application under such paragraph, that the Secretary determines is necessary to determine whether there is reasonable assurance of safety and effectiveness for the reprocessed device.

(xii) Validation data described in section 360(o)(1)(A) of this title that demonstrates that the reasonable assurance of the safety or effectiveness of the device will remain after the maximum number of times the device is reprocessed as intended by the person submitting such report.

(B) In the case of a class III device referred to in subsection (a) that is a reprocessed single-use device:

(i) Subparagraph (A) of this paragraph applies in lieu of paragraph (1).

(ii) Subject to clause (i), the provisions of this section apply to a report under subparagraph (A) to the same extent and in the same manner as such provisions apply to an application under paragraph (1).

(iii) Each reference in other sections of this chapter to an application under this section, other than such a reference in section 379i or 379j of this title, shall be considered to be a reference to a report under subparagraph (A).

(iv) Each reference in other sections of this chapter to a device for which an application under this section has been approved, or has been denied, suspended, or withdrawn, other than such a reference in section 379i or 379j of this title, shall be considered to be a reference to a device for which a report under subparagraph (A) has been approved, or has been denied, suspended, or withdrawn, respectively.

(3) Upon receipt of an application meeting the requirements set forth in paragraph (1), the Secretary—

(A) may on the Secretary's own initiative, or

(B) shall, upon the request of an applicant unless the Secretary finds that the information in the application which would be reviewed by a panel substantially duplicates information which has previously been reviewed by a panel appointed under section 360c of this title,

refer such application to the appropriate panel under section 360c of this title for study and for submission (within such period as he may establish) of a report and recommendation respecting approval of the application, together with all underlying data and the reasons or basis for the recommendation. Where appropriate, the Secretary shall ensure that such panel includes, or consults with, one or more pediatric experts.

(4)(A) Prior to the submission of an application under this subsection, the Secretary shall accept and review any portion of the application that the applicant and the Secretary agree is complete, ready, and appropriate for review, except that such requirement does not apply, and the Secretary has discretion whether to accept and review such portion, during any period in which, under section 379j(g) of this title, the Secretary does not have the authority to collect fees under section 379j(a) of this title.

(B) Each portion of a submission reviewed under subparagraph (A) and found acceptable by the Secretary shall not be further reviewed after receipt of an application that satisfies the requirements of paragraph (1), unless a significant issue of safety or effectiveness provides the Secretary reason to review such accepted portion.

(C) Whenever the Secretary determines that a portion of a submission under subparagraph (A) is unacceptable, the Secretary shall, in writing, provide to the applicant a description of any deficiencies in such portion and identify the information that is required to correct these deficiencies, unless the applicant is no longer pursuing the application.

(5)(A) In requesting additional information with respect to an application under this section, the Secretary shall consider the least burdensome appropriate means necessary to demonstrate a reasonable assurance of device safety and effectiveness.

(B) For purposes of subparagraph (A), the term "necessary" means the minimum required information that would support a determination by the Secretary that an application provides a reasonable assurance of the safety and effectiveness of the device.

(C) For purposes of this paragraph, the Secretary shall consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness.

(D) Nothing in this paragraph alters the standards for premarket approval of a device.

(d) Action on application for premarket approval

(1)(A) As promptly as possible, but in no event later than one hundred and eighty days after the receipt of an application under subsection (c) (except as provided in section 360j(l)(3)(D)(ii) of this title or unless, in accordance with subparagraph (B)(i), an additional period as agreed upon by the Secretary and the applicant), the Secretary, after considering the report and recommendation submitted under paragraph (2) of such subsection, shall—

(i) issue an order approving the application if he finds that none of the grounds for denying approval specified in paragraph (2) of this subsection applies; or

(ii) deny approval of the application if he finds (and sets forth the basis for such finding as part of or accompanying such denial) that one or more grounds for denial specified in paragraph (2) of this subsection apply.

In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling.

(B)(i) The Secretary may not enter into an agreement to extend the period in which to take action with respect to an application submitted for a device subject to a regulation promulgated under subsection (b) unless he finds that the continued availability of the device is necessary for the public health.

(ii) An order approving an application for a device may require as a condition to such approval that the sale and distribution of the device be restricted but only to the extent that the sale and distribution of a device may be restricted under a regulation under section 360j(e) of this title.

(iii) The Secretary shall accept and review statistically valid and reliable data and any other information from investigations conducted under the authority of regulations required by section 360j(g) of this title to make a determination of whether there is a reasonable assurance of safety and effectiveness of a device subject to a pending application under this section if—

(I) the data or information is derived from investigations of an earlier version of the device, the device has been modified during or after the investigations (but prior to submission of an application under subsection (c)) and such a modification of the device does not constitute a significant change in the design or in the basic principles of operation of the device that would invalidate the data or information; or

(II) the data or information relates to a device approved under this section, is available for use under this chapter, and is relevant to the design and intended use of the device for which the application is pending.

(2) The Secretary shall deny approval of an application for a device if, upon the basis of the information submitted to the Secretary as part of the application and any other information before him with respect to such device, the Secretary finds that—

(A) there is a lack of a showing of reasonable assurance that such device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof;

(B) there is a lack of a showing of reasonable assurance that the device is effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof;

(C) the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or installation of such device do not conform to the requirements of section 360j(f) of this title;

(D) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or

(E) such device is not shown to conform in all respects to a performance standard in effect under section 360d of this title compliance with which is a condition to approval of the application and there is a lack of adequate information to justify the deviation from such standard.

Any denial of an application shall, insofar as the Secretary determines to be practicable, be accompanied by a statement informing the applicant of the measures required to place such application in approvable form (which measures may include further research by the applicant in accordance with one or more protocols prescribed by the Secretary).

(3)(A)(i) The Secretary shall, upon the written request of an applicant, meet with the applicant, not later than 100 days after the receipt of an application that has been filed as complete under subsection (c), to discuss the review status of the application.

(ii) The Secretary shall, in writing and prior to the meeting, provide to the applicant a description of any deficiencies in the application that, at that point, have been identified by the Secretary based on an interim review of the entire application and identify the information that is required to correct those deficiencies.

(iii) The Secretary shall notify the applicant promptly of—

(I) any additional deficiency identified in the application, or

(II) any additional information required to achieve completion of the review and final action on the application,

that was not described as a deficiency in the written description provided by the Secretary under clause (ii).

(B) The Secretary and the applicant may, by mutual consent, establish a different schedule for a meeting required under this paragraph.

(4) An applicant whose application has been denied approval may, by petition filed on or before the thirtieth day after the date upon which he receives notice of such denial, obtain review thereof in accordance with either paragraph (1) or (2) of subsection (g), and any interested person may obtain review, in accordance with paragraph (1) or (2) of subsection (g), of an order of the Secretary approving an application.

(5)(A)(i) Unless the change is consistent with a predetermined change control plan approved under section 360e–4 of this title, a supplemental application shall be required for any change to a device subject to an approved application under this subsection that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing and the holder of the approved application submits a written notice to the Secretary that describes in detail the change, summarizes the data or information supporting the change, and informs the Secretary that the change has been made under the requirements of section 360j(f) of this title.

(ii) The holder of an approved application who submits a notice under clause (i) with respect to a manufacturing change of a device may distribute the device 30 days after the date on which the Secretary receives the notice, unless the Secretary within such 30-day period notifies the holder that the notice is not adequate and describes such further information or action that is required for acceptance of such change. If the Secretary notifies the holder that a supplemental application is required, the Secretary shall review the supplement within 135 days after the receipt of the supplement. The time used by the Secretary to review the notice of the manufacturing change shall be deducted from the 135-day review period if the notice meets appropriate content requirements for premarket approval supplements.

(B)(i) Subject to clause (ii), in reviewing a supplement to an approved application, for an incremental change to the design of a device that affects safety or effectiveness, the Secretary shall approve such supplement if—

(I) nonclinical data demonstrate that the design modification creates the intended additional capacity, function, or performance of the device; and

(II) clinical data from the approved application and any supplement to the approved application provide a reasonable assurance of safety and effectiveness for the changed device.

(ii) The Secretary may require, when necessary, additional clinical data to evaluate the design modification of the device to provide a reasonable assurance of safety and effectiveness.

(e) Withdrawal and temporary suspension of approval of application

(1) The Secretary shall, upon obtaining, where appropriate, advice on scientific matters from a panel or panels under section 360c of this title, and after due notice and opportunity for informal hearing to the holder of an approved application for a device, issue an order withdrawing approval of the application if the Secretary finds—

(A) that such device is unsafe or ineffective under the conditions of use prescribed, recommended, or suggested in the labeling thereof;

(B) on the basis of new information before him with respect to such device, evaluated together with the evidence available to him when the application was approved, that there is a lack of a showing of reasonable assurance that the device is safe or effective under the conditions of use prescribed, recommended, or suggested in the labeling thereof;

(C) that the application contained or was accompanied by an untrue statement of a material fact;

(D) that the applicant (i) has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 360i(a) of this title, (ii) has refused to permit access to, or copying or verification of, such records as required by section 374 of this title, or (iii) has not complied with the requirements of section 360 of this title;

(E) on the basis of new information before him with respect to such device, evaluated together with the evidence before him when the application was approved, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such device do not conform with the requirements of section 360j(f) of this title and were not brought into conformity with such requirements within a reasonable time after receipt of written notice from the Secretary of nonconformity;

(F) on the basis of new information before him, evaluated together with the evidence before him when the application was approved, that the labeling of such device, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact; or

(G) on the basis of new information before him, evaluated together with the evidence before him when the application was approved, that such device is not shown to conform in all respects to a performance standard which is in effect under section 360d of this title compliance with which was a condition to approval of the application and that there is a lack of adequate information to justify the deviation from such standard.

(2) The holder of an application subject to an order issued under paragraph (1) withdrawing approval of the application may, by petition filed on or before the thirtieth day after the date upon which he receives notice of such withdrawal, obtain review thereof in accordance with either paragraph (1) or (2) of subsection (g).

(3) If, after providing an opportunity for an informal hearing, the Secretary determines there is reasonable probability that the continuation of distribution of a device under an approved application would cause serious, adverse health consequences or death, the Secretary shall by order temporarily suspend the approval of the application approved under this section. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw such application.

(f) Product development protocol

(1) In the case of a class III device which is required to have an approval of an application submitted under subsection (c), such device shall be considered as having such an approval if a notice of completion of testing conducted in accordance with a product development protocol approved under paragraph (4) has been declared completed under paragraph (6).

(2) Any person may submit to the Secretary a proposed product development protocol with respect to a device. Such a protocol shall be accompanied by data supporting it. If, within thirty days of the receipt of such a protocol, the Secretary determines that it appears to be appropriate to apply the requirements of this subsection to the device with respect to which the protocol is submitted, the Secretary—

(A) may, at the initiative of the Secretary, refer the proposed protocol to the appropriate panel under section 360c of this title for its recommendation respecting approval of the protocol; or

(B) shall so refer such protocol upon the request of the submitter, unless the Secretary finds that the proposed protocol and accompanying data which would be reviewed by such panel substantially duplicate a product development protocol and accompanying data which have previously been reviewed by such a panel.

(3) A proposed product development protocol for a device may be approved only if—

(A) the Secretary determines that it is appropriate to apply the requirements of this subsection to the device in lieu of the requirement of approval of an application submitted under subsection (c); and

(B) the Secretary determines that the proposed protocol provides—

(i) a description of the device and the changes which may be made in the device,

(ii) a description of the preclinical trials (if any) of the device and a specification of (I) the results from such trials to be required before the commencement of clinical trials of the device, and (II) any permissible variations in preclinical trials and the results therefrom,

(iii) a description of the clinical trials (if any) of the device and a specification of (I) the results from such trials to be required before the filing of a notice of completion of the requirements of the protocol, and (II) any permissible variations in such trials and the results therefrom,

(iv) a description of the methods to be used in, and the facilities and controls to be used for, the manufacture, processing, and, when relevant, packing and installation of the device,

(v) an identifying reference to any performance standard under section 360d of this title to be applicable to any aspect of such device,

(vi) if appropriate, specimens of the labeling proposed to be used for such device,

(vii) such other information relevant to the subject matter of the protocol as the Secretary, with the concurrence of the appropriate panel or panels under section 360c of this title, may require, and

(viii) a requirement for submission of progress reports and, when completed, records of the trials conducted under the protocol which records are adequate to show compliance with the protocol.

(4) The Secretary shall approve or disapprove a proposed product development protocol submitted under paragraph (2) within one hundred and twenty days of its receipt unless an additional period is agreed upon by the Secretary and the person who submitted the protocol. Approval of a protocol or denial of approval of a protocol is final agency action subject to judicial review under chapter 7 of title 5.

(5) At any time after a product development protocol for a device has been approved pursuant to paragraph (4), the person for whom the protocol was approved may submit a notice of completion—

(A) stating (i) his determination that the requirements of the protocol have been fulfilled and that, to the best of his knowledge, there is no reason bearing on safety or effectiveness why the notice of completion should not become effective, and (ii) the data and other information upon which such determination was made, and

(B) setting forth the results of the trials required by the protocol and all the information required by subsection (c)(1).

(6)(A) The Secretary may, after providing the person who has an approved protocol an opportunity for an informal hearing and at any time prior to receipt of notice of completion of such protocol, issue a final order to revoke such protocol if he finds that—

(i) such person has failed substantially to comply with the requirements of the protocol,

(ii) the results of the trials obtained under the protocol differ so substantially from the results required by the protocol that further trials cannot be justified, or

(iii) the results of the trials conducted under the protocol or available new information do not demonstrate that the device tested under the protocol does not present an unreasonable risk to health and safety.

(B) After the receipt of a notice of completion of an approved protocol the Secretary shall, within the ninety-day period beginning on the date such notice is received, by order either declare the protocol completed or declare it not completed. An order declaring a protocol not completed may take effect only after the Secretary has provided the person who has the protocol opportunity for an informal hearing on the order. Such an order may be issued only if the Secretary finds—

(i) such person has failed substantially to comply with the requirements of the protocol,

(ii) the results of the trials obtained under the protocol differ substantially from the results required by the protocol, or

(iii) there is a lack of a showing of reasonable assurance of the safety and effectiveness of the device under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.

(C) A final order issued under subparagraph (A) or (B) shall be in writing and shall contain the reasons to support the conclusions thereof.

(7) At any time after a notice of completion has become effective, the Secretary may issue an order (after due notice and opportunity for an informal hearing to the person for whom the notice is effective) revoking the approval of a device provided by a notice of completion which has become effective as provided in subparagraph (B) if he finds that any of the grounds listed in subparagraphs (A) through (G) of subsection (e)(1) of this section apply. Each reference in such subparagraphs to an application shall be considered for purposes of this paragraph as a reference to a protocol and the notice of completion of such protocol, and each reference to the time when an application was approved shall be considered for purposes of this paragraph as a reference to the time when a notice of completion took effect.

(8) A person who has an approved protocol subject to an order issued under paragraph (6)(A) revoking such protocol, a person who has an approved protocol with respect to which an order under paragraph (6)(B) was issued declaring that the protocol had not been completed, or a person subject to an order issued under paragraph (7) revoking the approval of a device may, by petition filed on or before the thirtieth day after the date upon which he receives notice of such order, obtain review thereof in accordance with either paragraph (1) or (2) of subsection (g).

(g) Review

(1) Upon petition for review of—

(A) an order under subsection (d) approving or denying approval of an application or an order under subsection (e) withdrawing approval of an application, or

(B) an order under subsection (f)(6)(A) revoking an approved protocol, under subsection (f)(6)(B) declaring that an approved protocol has not been completed, or under subsection (f)(7) revoking the approval of a device,

the Secretary shall, unless he finds the petition to be without good cause or unless a petition for review of such order has been submitted under paragraph (2), hold a hearing, in accordance with section 554 of title 5, on the order. The panel or panels which considered the application, protocol, or device subject to such order shall designate a member to appear and testify at any such hearing upon request of the Secretary, the petitioner, or the officer conducting the hearing, but this requirement does not preclude any other member of the panel or panels from appearing and testifying at any such hearing. Upon completion of such hearing and after considering the record established in such hearing, the Secretary shall issue an order either affirming the order subject to the hearing or reversing such order and, as appropriate, approving or denying approval of the application, reinstating the application's approval, approving the protocol, or placing in effect a notice of completion.

(2)(A) Upon petition for review of—

(i) an order under subsection (d) approving or denying approval of an application or an order under subsection (e) withdrawing approval of an application, or

(ii) an order under subsection (f)(6)(A) revoking an approved protocol, under subsection (f)(6)(B) declaring that an approved protocol has not been completed, or under subsection (f)(7) revoking the approval of a device,

the Secretary shall refer the application or protocol subject to the order and the basis for the order to an advisory committee of experts established pursuant to subparagraph (B) for a report and recommendation with respect to the order. The advisory committee shall, after independent study of the data and information furnished to it by the Secretary and other data and information before it, submit to the Secretary a report and recommendation, together with all underlying data and information and a statement of the reasons or basis for the recommendation. A copy of such report shall be promptly supplied by the Secretary to any person who petitioned for such referral to the advisory committee.

(B) The Secretary shall establish advisory committees (which may not be panels under section 360c of this title) to receive referrals under subparagraph (A). The Secretary shall appoint as members of any such advisory committee persons qualified in the subject matter to be referred to the committee and of appropriately diversified professional backgrounds, except that the Secretary may not appoint to such a committee any individual who is in the regular full-time employ of the United States and engaged in the administration of this chapter. Members of an advisory committee (other than officers or employees of the United States), while attending conferences or meetings of their committee or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent for grade GS–18 of the General Schedule for each day (including traveltime) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently. The Secretary shall designate the chairman of an advisory committee from its members. The Secretary shall furnish each advisory committee with clerical and other assistance, and shall by regulation prescribe the procedures to be followed by each such committee in acting on referrals made under subparagraph (A).

(C) The Secretary shall make public the report and recommendation made by an advisory committee with respect to an application and shall by order, stating the reasons therefor, either affirm the order referred to the advisory committee or reverse such order and, if appropriate, approve or deny approval of the application, reinstate the application's approval, approve the protocol, or place in effect a notice of completion.

(h) Service of orders

Orders of the Secretary under this section shall be served (1) in person by any officer or employee of the department designated by the Secretary, or (2) by mailing the order by registered mail or certified mail addressed to the applicant at his last known address in the records of the Secretary.

(i) Revision

(1) Before December 1, 1995, the Secretary shall by order require manufacturers of devices, which were introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and which are subject to revision of classification under paragraph (2), to submit to the Secretary a summary of and citation to any information known or otherwise available to the manufacturer respecting such devices, including adverse safety or effectiveness information which has not been submitted under section 360i of this title. The Secretary may require the manufacturer to submit the adverse safety or effectiveness data for which a summary and citation were submitted, if such data are available to the manufacturer.

(2) After the issuance of an order under paragraph (1) but before the date that is 2 years after July 9, 2012, the Secretary shall issue an administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 360c(b) of this title, and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, for each device—

(A) which the Secretary has classified as a class III device, and

(B) for which no administrative order has been issued under subsection (b) (or no regulation has been promulgated under such subsection prior to July 9, 2012),

revising the classification of the device so that the device is classified into class I or class II, unless the administrative order issued under this paragraph requires the device to remain in class III. In determining whether to revise the classification of a device or to require a device to remain in class III, the Secretary shall apply the criteria set forth in section 360c(a) of this title.

(3) The Secretary shall, as promptly as is reasonably achievable, but not later than 12 months after the effective date of the order requiring a device to remain in class III, establish a schedule for the issuance of an administrative order under subsection (b) for each device which is subject to the order requiring the device to remain in class III.

(June 25, 1938, ch. 675, §515, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 552; amended Pub. L. 101–629, §§4(b)(1), 9(a), 18(c), Nov. 28, 1990, 104 Stat. 4515, 4521, 4528; Pub. L. 103–80, §3(t), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105–115, title II, §§201(b), 202, 205(c), 209(b), 216(b), Nov. 21, 1997, 111 Stat. 2334, 2338, 2341, 2349; Pub. L. 107–250, title II, §§209, 210, title III, §302(c), Oct. 26, 2002, 116 Stat. 1613, 1614, 1618; Pub. L. 108–214, §2(d)(1), Apr. 1, 2004, 118 Stat. 576; Pub. L. 110–85, title VIII, §801(b)(3)(D), Sept. 27, 2007, 121 Stat. 921; Pub. L. 112–144, title II, §203(g), title VI, §608(b)(1), July 9, 2012, 126 Stat. 1006, 1056; Pub. L. 114–255, div. A, title III, §§3051(c)(1), 3058(b), 3101(a)(2)(J), Dec. 13, 2016, 130 Stat. 1124, 1129, 1154; Pub. L. 115–52, title II, §203(f)(2)(A), Aug. 18, 2017, 131 Stat. 1015; Pub. L. 117–328, div. FF, title III, §3308(b)(2), Dec. 29, 2022, 136 Stat. 5836.)

Editorial Notes

Amendments

2022—Subsec. (d)(5)(A)(i). Pub. L. 117–328 substituted "Unless the change is consistent with a predetermined change control plan approved under section 360e–4 of this title, a supplemental" for "A supplemental".

2017—Subsec. (c)(4)(A). Pub. L. 115–52 substituted "section 379j(g)" for "section 379j(h)".

2016—Subsec. (a)(1). Pub. L. 114–255, §3101(a)(2)(J), substituted "subject to an order" for "subject to a an order".

Subsec. (c)(5). Pub. L. 114–255, §3058(b), added par. (5).

Subsec. (d)(5), (6). Pub. L. 114–255, §3051(c)(1), redesignated par. (6) as (5) and struck out former par. (5) which read as follows: "In order to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, the Secretary shall provide review priority for devices—

"(A) representing breakthrough technologies,

"(B) for which no approved alternatives exist,

"(C) which offer significant advantages over existing approved alternatives, or

"(D) the availability of which is in the best interest of the patients."

2012—Subsec. (a)(1). Pub. L. 112–144, §608(b)(1)(A), substituted "an order issued under subsection (b) (or a regulation promulgated under such subsection prior to July 9, 2012)" for "regulation promulgated under subsection (b)".

Subsec. (b). Pub. L. 112–144, §608(b)(1)(B)(i)(I), which directed substitution of "Order" for "Regulation" in the heading of par. (1) of subsec. (b), was executed by making the substitution in the heading of subsec. (b), to reflect the probable intent of Congress.

Subsec. (b)(1). Pub. L. 112–144, §608(b)(1)(B)(i)(II), in concluding provisions, substituted "by administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 360c(b) of this title, and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5" for "by regulation, promulgated in accordance with this subsection" and inserted at end "Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner."

Subsec. (b)(2). Pub. L. 112–144, §608(b)(1)(B)(ii), struck out subpar. (A) designation after "(2)" and substituted "A proposed order required under paragraph (1) shall contain—" for "A proceeding for the promulgation of a regulation under paragraph (1) respecting a device shall be initiated by the publication in the Federal Register of a notice of proposed rulemaking. Such notice shall contain—" in introductory provisions, redesignated cls. (i) to (iv) as subpars. (A) to (D), respectively, substituted "order" for "regulation" in subpars. (A) and (C), and struck out former subpar. (B) which read as follows: "If, within fifteen days after publication of a notice under subparagraph (A), the Secretary receives a request for a change in the classification of a device, he shall, within sixty days of the publication of such notice and after consultation with the appropriate panel under section 360c of this title, by order published in the Federal Register, either deny the request for change in classification or give notice of his intent to initiate such a change under section 360c(e) of this title."

Subsec. (b)(3). Pub. L. 112–144, §608(b)(1)(B)(iii)(I), (II), (IV), (V), substituted "proposed order" for "proposed regulation" in two places, "paragraph (2)," for "paragraph (2) and after", "(A) issue an administrative order under paragraph (1)" for "(A) promulgate such regulation", "paragraph (2)(B)" for "paragraph (2)(A)(ii)", and "issuance of the administrative order" for "promulgation of the regulation".

Pub. L. 112–144, §608(b)(1)(B)(iii)(III), which directed insertion of "and a meeting of a device classification panel described in section 360c(b) of this title," after "such proposed regulation and findings," was inserted after "such proposed order and findings," to reflect the probable intent of Congress and amendment by Pub. L. 112–144, §608(b)(1)(B)(iii)(I). See above.

Subsec. (b)(4). Pub. L. 112–144, §608(b)(1)(B)(iv), struck out par. (4) which read as follows: "The Secretary, upon his own initiative or upon petition of an interested person, may by regulation amend or revoke any regulation promulgated under this subsection. A regulation to amend or revoke a regulation under this subsection shall be promulgated in accordance with the requirements prescribed by this subsection for the promulgation of the regulation to be amended or revoked."

Subsec. (c)(4)(A). Pub. L. 112–144, §203(g), substituted "379j(h)" for "379j(g)".

Subsec. (i)(2). Pub. L. 112–144, §608(b)(1)(C)(i)(III), (IV), in concluding provisions, substituted "administrative order issued under this paragraph requires" for "regulation requires" and struck out at end "Before the publication of a regulation requiring a device to remain in class III or revising its classification, the Secretary shall publish a proposed regulation respecting the classification of a device under this paragraph and provide reasonable opportunity for the submission of comments on any such regulation. No regulation requiring a device to remain in class III or revising its classification may take effect before the expiration of 90 days from the date of its publication in the Federal Register as a proposed regulation."

Pub. L. 112–144, §608(b)(1)(C)(i)(I), in introductory provisions, substituted "the date that is 2 years after July 9, 2012" for "December 1, 1995" and "issue an administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 360c(b) of this title, and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5," for "publish a regulation in the Federal Register".

Subsec. (i)(2)(B). Pub. L. 112–144, §608(b)(1)(C)(i)(II), substituted "administrative order has been issued under subsection (b) (or no regulation has been promulgated under such subsection prior to July 9, 2012)" for "final regulation has been promulgated under subsection (b) of this section".

Subsec. (i)(3). Pub. L. 112–144, §608(b)(1)(C)(ii), substituted "order requiring" for "regulation requiring" in two places and "issuance of an administrative order under subsection (b)" for "promulgation of a subsection (b) of this section regulation".

2007—Subsec. (c)(1)(G), (H). Pub. L. 110–85 added subpar. (G) and redesignated former subpar. (G) as (H).

2004—Subsec. (c)(3). Pub. L. 108–214, §2(d)(1)(B), amended directory language of Pub. L. 107–250, §210. See 2002 Amendment note below.

Pub. L. 108–214, §2(d)(1)(A)(i), redesignated par. (3) relating to acceptance and review of any portion of the application prior to submission as (4).

Subsec. (c)(4). Pub. L. 108–214, §2(d)(1)(A), redesignated par. (3) relating to acceptance and review of any portion of the application prior to submission as (4) and substituted "unless a significant issue of safety" for "unless an issue of safety" in subpar. (B).

2002—Subsec. (a). Pub. L. 107–250, §302(c)(1), inserted "or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval" before period in concluding provisions.

Subsec. (c)(2). Pub. L. 107–250, §302(c)(2)(B), added par. (2). Former par. (2) redesignated (3).

Subsec. (c)(3). Pub. L. 107–250, §302(c)(2)(A), redesignated par. (2) relating to Secretary's referral of application to appropriate panel as (3).

Pub. L. 107–250, §210, as amended by Pub. L. 108–214, §2(d)(1)(B), inserted "Where appropriate, the Secretary shall ensure that such panel includes, or consults with, one or more pediatric experts." at the end of the concluding provisions of par. (3) as redesignated by Pub. L. 107–250, §302(c)(2)(A).

Pub. L. 107–250, §209, added par. (3) relating to acceptance and review of any portion of the application prior to submission.

1997—Subsec. (d)(1)(A). Pub. L. 105–115, §205(c)(1), inserted at end "In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling."

Subsec. (d)(1)(B)(iii). Pub. L. 105–115, §201(b), added cl. (iii).

Subsec. (d)(3), (4). Pub. L. 105–115, §202(1), 209(b), added par. (3) and redesignated former par. (3) as (4).

Subsec. (d)(5). Pub. L. 105–115, §202(2), added par. (5).

Subsec. (d)(6). Pub. L. 105–115, §205(c)(2), added par. (6).

Subsec. (f)(2). Pub. L. 105–115, §216(b), substituted "the Secretary—" and subpars. (A) and (B) for "he shall refer the proposed protocol to the appropriate panel under section 360c of this title for its recommendation respecting approval of the protocol."

1993—Subsec. (c)(2)(A). Pub. L. 103–80 struck out "refer such application" after "own initiative".

1990—Subsec. (c)(2). Pub. L. 101–629, §18(c), substituted "the Secretary—" for "the Secretary shall" and added subpars. (A) and (B).

Subsec. (e). Pub. L. 101–629, §9(a)(2), inserted "and temporary suspension" after "Withdrawal" in heading.

Subsec. (e)(3). Pub. L. 101–629, §9(a)(1), added par. (3).

Subsec. (i). Pub. L. 101–629, §4(b)(1), added subsec. (i).

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 3 of part C of subchapter VII of this chapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 2012 Amendment

Amendment by section 203(g) of Pub. L. 112–144 effective Oct. 1, 2012, with additional provision for assessment of certain fees, see section 206 of Pub. L. 112–144, set out as a note under section 379i of this title.

Effective Date of 1997 Amendment

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

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.

Report on Certain Devices

Pub. L. 107–250, title II, §205, Oct. 26, 2002, 116 Stat. 1612, directed the Secretary of Health and Human Services, not later than one year after Oct. 26, 2002, to report to the appropriate committees of Congress on the timeliness and effectiveness of device premarket reviews by centers other than the Center for Devices and Radiological Health, including information on the times required to log in and review original submissions and supplements, times required to review manufacturers' replies to submissions, times to approve or clear such devices, and recommendations on improvement of performance and reassignment of responsibility for regulating such devices.

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

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.
21 U.S.C. § 801 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 801: Congressional findings and declarations: controlled substances
Congressional findings and declarations: controlled substances
Status: in_force

The Congress makes the following findings and declarations:

(1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.

(2) The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people.

(3) A major portion of the traffic in controlled substances flows through interstate and foreign commerce. Incidents of the traffic which are not an integral part of the interstate or foreign flow, such as manufacture, local distribution, and possession, nonetheless have a substantial and direct effect upon interstate commerce because—

(A) after manufacture, many controlled substances are transported in interstate commerce,

(B) controlled substances distributed locally usually have been transported in interstate commerce immediately before their distribution, and

(C) controlled substances possessed commonly flow through interstate commerce immediately prior to such possession.

(4) Local distribution and possession of controlled substances contribute to swelling the interstate traffic in such substances.

(5) Controlled substances manufactured and distributed intrastate cannot be differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate.

(6) Federal control of the intrastate incidents of the traffic in controlled substances is essential to the effective control of the interstate incidents of such traffic.

(7) The United States is a party to the Single Convention on Narcotic Drugs, 1961, and other international conventions designed to establish effective control over international and domestic traffic in controlled substances.

(Pub. L. 91–513, title II, §101, Oct. 27, 1970, 84 Stat. 1242.)

Editorial Notes

References in Text

This subchapter, referred to in par. (1), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out below and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 91–513, title II, §704, Oct. 27, 1970, 84 Stat. 1284, provided that:

"(a) Except as otherwise provided in this section, this title [see Short Title note below] shall become effective on the first day of the seventh calendar month that begins after the day immediately preceding the date of enactment [Oct. 27, 1970].

"(b) Parts A, B, E, and F of this title [Parts A, B, E, and F of this subchapter], section 702 [set out as a note under section 321 of this title], this section, and sections 705 through 709 [sections 901 to 904 of this title and note set out below], shall become effective upon enactment [Oct. 27, 1970].

"(c) Sections 305 (relating to labels and labeling) [section 825 of this title], and 306 (relating to manufacturing quotas) [section 826 of this title] shall become effective on the date specified in subsection (a) of this section, except that the Attorney General may by order published in the Federal Register postpone the effective date of either or both of these sections for such period as he may determine to be necessary for the efficient administration of this title [see Short Title note below]."

Short Title of 2022 Amendment

Pub. L. 117–215, §1(a), Dec. 2, 2022, 136 Stat. 2257, provided that: "This Act [amending sections 802, 822, 823, 824, 827, 829a, 831, 841, 843, 882, and 958 of this title and sections 290bb–36d, 290dd–3, 1395l, 1395m, 1395cc–6, and 1396b of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under this section, section 823 of this title, and sections 241 and 284 of Title 42] may be cited as the 'Medical Marijuana and Cannabidiol Research Expansion Act'."

Short Title of 2021 Amendment

Pub. L. 117–53, §1, Nov. 10, 2021, 135 Stat. 411, provided that: "This Act [amending section 822 of this title] may be cited as the 'Ensuring Compliance Against Drug Diversion Act of 2021'."

Pub. L. 117–36, §1, Aug. 6, 2021, 135 Stat. 328, provided that: "This Act [amending section 824 of this title] may be cited as the 'Debarment Enforcement of Bad Actor Registrants Act of 2021' or the 'DEBAR Act of 2021'."

Short Title of 2018 Amendment

Pub. L. 115–271, title III, §3211, Oct. 24, 2018, 132 Stat. 3947, provided that: "This chapter [chapter 2 (§§3211, 3212) of subtitle B of title III of Pub. L. 115–271, enacting provisions set out as a note under section 829 of this title] may be cited as the 'Empowering Pharmacists in the Fight Against Opioid Abuse Act'."

Pub. L. 115–271, title III, §3221, Oct. 24, 2018, 132 Stat. 3947, provided that: "This chapter [chapter 3 (§§3221–3223) of subtitle B of title III of Pub. L. 115–271, amending section 822 of this title and enacting provisions set out as notes under section 822 of this title] may be cited as the 'Safe Disposal of Unused Medication Act'."

Pub. L. 115–271, title III, §3231, Oct. 24, 2018, 132 Stat. 3949, provided that: "This chapter [chapter 4 (§§3231, 3232) of subtitle B of title III of Pub. L. 115–271, amending section 831 of this title] may be cited as the 'Special Registration for Telemedicine Clarification Act of 2018'."

Pub. L. 115–271, title III, §3271, Oct. 24, 2018, 132 Stat. 3952, provided that: "This chapter [chapter 7 (§§3271–3274) of subtitle B of title III of Pub. L. 115–271, amending sections 827, 842, and 873 of this title and enacting provisions set out as a note under section 827 of this title] may be cited as the 'Using Data To Prevent Opioid Diversion Act of 2018'."

Pub. L. 115–271, title III, §3281, Oct. 24, 2018, 132 Stat. 3954, provided that: "This chapter [chapter 8 (§§3281, 3282) of subtitle B of title III of Pub. L. 115–271, amending section 826 of this title and enacting provisions set out as a note under section 826 of this title] may be cited as the 'Opioid Quota Reform Act'."

Pub. L. 115–271, title III, §3291, Oct. 24, 2018, 132 Stat. 3956, provided that: "This chapter [chapter 9 (§§3291, 3292) of subtitle B of title III of Pub. L. 115–271, enacting section 832 of this title and amending section 802 of this title] may be cited as the 'Preventing Drug Diversion Act of 2018'."

Short Title of 2017 Amendment

Pub. L. 115–83, §1, Nov. 17, 2017, 131 Stat. 1267, provided that: "This Act [amending section 823 of this title] may be cited as the 'Protecting Patient Access to Emergency Medications Act of 2017'."

Short Title of 2016 Amendment

Pub. L. 114–145, §1, Apr. 19, 2016, 130 Stat. 354, provided that: "This Act [amending sections 823 and 824 of this title] may be cited as the 'Ensuring Patient Access and Effective Drug Enforcement Act of 2016'."

Short Title of 2014 Amendment

Pub. L. 113–260, §1, Dec. 18, 2014, 128 Stat. 2929, provided that: "This Act [amending sections 802, 811, 825, 842, and 960 of this title and enacting provisions set out as a note under section 825 of this title] may be cited as the 'Designer Anabolic Steroid Control Act of 2014'."

Pub. L. 113–143, §1, Aug. 1, 2014, 128 Stat. 1750, provided that: "This Act [amending section 822 of this title] may be cited as the 'Veterinary Medicine Mobility Act of 2014'."

Short Title of 2012 Amendment

Pub. L. 112–144, title XI, §1151, July 9, 2012, 126 Stat. 1130, provided that: "This subtitle [subtitle D (§§1151–1153) of title XI of Pub. L. 112–144, amending sections 811 and 812 of this title] may be cited as the 'Synthetic Drug Abuse Prevention Act of 2012'."

Short Title of 2010 Amendment

Pub. L. 111–273, §1, Oct. 12, 2010, 124 Stat. 2858, provided that: "This Act [amending sections 822 and 828 of this title and enacting provisions set out as a note under section 822 of this title and listed in a table relating to sentencing guidelines set out as a note under section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Secure and Responsible Drug Disposal Act of 2010'."

Pub. L. 111–268, §1, Oct. 12, 2010, 124 Stat. 2847, provided that: "This Act [amending sections 830 and 842 of this title and enacting provisions set out as notes under section 830 of this title] may be cited as the 'Combat Methamphetamine Enhancement Act of 2010'."

Pub. L. 111–220, §1, Aug. 3, 2010, 124 Stat. 2372, provided that: "This Act [amending sections 841, 844, and 960 of this title and enacting provisions listed in a table relating to sentencing guidelines set out under section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Fair Sentencing Act of 2010'."

Short Title of 2008 Amendment

Pub. L. 110–425, §1, Oct. 15, 2008, 122 Stat. 4820, provided that: "This Act [enacting section 831 of this title, amending sections 802, 823, 827, 829, 841, 843, 882, and 960 of this title, and enacting provisions set out as notes under section 802 of this title and listed in a table relating to sentencing guidelines set out as a note under section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Ryan Haight Online Pharmacy Consumer Protection Act of 2008'."

Pub. L. 110–415, §1, Oct. 14, 2008, 122 Stat. 4349, provided that: "This Act [amending section 830 of this title] may be cited as the 'Methamphetamine Production Prevention Act of 2008'."

Short Title of 2006 Amendment

Pub. L. 109–177, title VII, §701, Mar. 9, 2006, 120 Stat. 256, provided that: "This title [see Tables for classification] may be cited as the 'Combat Methamphetamine Epidemic Act of 2005'."

Short Title of 2005 Amendment

Pub. L. 109–57, §1(a), Aug. 2, 2005, 119 Stat. 592, provided that: "This Act [amending section 953 of this title] may be cited as the 'Controlled Substances Export Reform Act of 2005'."

Short Title of 2004 Amendment

Pub. L. 108–358, §1, Oct. 22, 2004, 118 Stat. 1661, provided that: "This Act [enacting section 290bb–25f of Title 42, The Public Health and Welfare, amending sections 802 and 811 of this title, enacting provisions set out as notes under section 802 of this title and section 290aa–4 of Title 42 and listed in a table relating to sentencing guidelines set out as a note under section 994 of Title 28, Judiciary and Judicial Procedure, and amending provisions set out as a note under section 802 of this title] may be cited as the 'Anabolic Steroid Control Act of 2004'."

Short Title of 2003 Amendment

Pub. L. 108–21, title VI, §608(a), Apr. 30, 2003, 117 Stat. 691, provided that: "This section [amending sections 843 and 856 of this title and enacting provisions listed in a table relating to sentencing guidelines set out as a note under section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Illicit Drug Anti-Proliferation Act of 2003'."

Short Title of 2000 Amendments

Pub. L. 106–310, div. B, title XXXV, §3501, Oct. 17, 2000, 114 Stat. 1222, provided that: "This title [amending sections 823 and 824 of this title] may be cited as the 'Drug Addiction Treatment Act of 2000'."

Pub. L. 106–310, div. B, title XXXVI, §3601, Oct. 17, 2000, 114 Stat. 1227, provided that: "This title [enacting section 864 of this title and sections 290aa–5b and 290bb–9 of Title 42, The Public Health and Welfare, amending sections 802, 830, 853, 856, and 863 of this title, sections 3663 and 3663A of Title 18, Crimes and Criminal Procedure, section 524 of Title 28, Judiciary and Judicial Procedure, and sections 285o–2 and 3751 of Title 42, and enacting provisions set out as notes under this section and sections 802, 872, 873, 886, and 1706 of this title, sections 524 and 994 of Title 28, and sections 201, 290aa–4, 290aa–5b and 3751 of Title 42] may be cited as the 'Methamphetamine Anti-Proliferation Act of 2000'."

Pub. L. 106–172, §1, Feb. 18, 2000, 114 Stat. 7, provided that: "This Act [amending sections 802, 827, 841 and 960 of this title and enacting provisions set out as notes under this section and section 812 of this title] may be cited as the 'Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000'."

Short Title of 1998 Amendment

Pub. L. 105–277, div. C, title VIII, §801(a), Oct. 21, 1998, 112 Stat. 2681–693, provided that: "This title [enacting section 1713 of this title and section 2291–5 of Title 22, Foreign Relations and Intercourse, amending section 956 of this title, and enacting provisions set out as notes under sections 801 and 956 of this title and section 2291 of Title 22] may be cited as the 'Western Hemisphere Drug Elimination Act'."

Pub. L. 105–277, div. C, title VIII, subtitle G (§§871, 872), §871, Oct. 21, 1998, 112 Stat. 2681–707, and Pub. L. 105–357, §1, Nov. 10, 1998, 112 Stat. 3271, provided that such subtitle and such Act, which amended section 956 of this title and enacted provisions set out as notes under section 956 of this title "may be cited as the 'Controlled Substances Trafficking Prohibition Act'."

Pub. L. 105–277, div. E, §1, Oct. 21, 1998, 112 Stat. 2681–759, provided that: "This division [amending sections 841 and 960 of this title and section 13705 of Title 42, The Public Health and Welfare] may be cited as the 'Methamphetamine Trafficking Penalty Enhancement Act of 1998'."

Short Title of 1996 Amendments

Pub. L. 104–305, §1, Oct. 13, 1996, 110 Stat. 3807, provided that: "This Act [amending sections 841, 844, 959, and 960 of this title and enacting provisions set out as notes under section 872 of this title and section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Drug-Induced Rape Prevention and Punishment Act of 1996'."

Pub. L. 104–237, §1(a), Oct. 3, 1996, 110 Stat. 3099, provided that: "This Act [enacting section 872a of this title, amending sections 802, 814, 830, 841 to 844, 853, 881, 959, and 960 of this title and section 1607 of Title 19, Customs Duties, and enacting provisions set out as notes under this section and sections 802, 872, and 971 of this title, section 994 of Title 28, Judiciary and Judicial Procedure, and section 290aa–4 of Title 42, The Public Health and Welfare] may be cited as the 'Comprehensive Methamphetamine Control Act of 1996'."

Short Title of 1994 Amendment

Pub. L. 103–322, title XVIII, §180201(a), Sept. 13, 1994, 108 Stat. 2046, provided that: "This section [enacting section 849 of this title, amending section 841 of this title, and enacting provisions set out as a note under section 994 of Title 28, Judiciary and Judicial Procedure] may be cited as the 'Drug Free Truck Stop Act'."

Short Title of 1993 Amendment

Pub. L. 103–200, §1, Dec. 17, 1993, 107 Stat. 2333, provided that: "This Act [enacting section 814 of this title, amending sections 802, 821 to 824, 830, 843, 880, 957, 958, 960, and 971 of this title, and enacting provisions set out as a note under section 802 of this title] may be cited as the 'Domestic Chemical Diversion Control Act of 1993'."

Short Title of 1990 Amendment

Pub. L. 101–647, title XIX, §1901, Nov. 29, 1990, 104 Stat. 4851, provided that: "This Act [probably means title XIX of Pub. L. 101–647, which amended sections 333, 802, 812, and 844 of this title and section 290aa–6 of Title 42, The Public Health and Welfare, repealed section 333a of this title, and enacted provisions set out as notes under sections 802 and 829 of this title] may be cited as the 'Anabolic Steroids Control Act of 1990'."

Short Title of 1988 Amendment

Pub. L. 100–690, title VI, §6001, Nov. 18, 1988, 102 Stat. 4312, provided that: "This title [see Tables for classification] may be cited as the 'Anti-Drug Abuse Amendments Act of 1988'."

Pub. L. 100–690, title VI, §6051, Nov. 18, 1988, 102 Stat. 4312, provided that: "This subtitle [subtitle A (§§6051–6061) of title VI of Pub. L. 100–690, enacting section 971 of this title, amending sections 802, 830, 841 to 843, 872, 876, 881, 960, and 961 of this title, and enacting provisions set out as notes under sections 802 and 971 of this title] may be cited as the 'Chemical Diversion and Trafficking Act of 1988'."

Pub. L. 100–690, title VI, §6071, Nov. 18, 1988, 102 Stat. 4320, provided that: "This subtitle [subtitle B (§§6071–6080) of title VI of Pub. L. 100–690, enacting sections 881–1, 887, and 1509 of this title, amending section 881 of this title, section 1594 of Title 19, Customs Duties, section 524 of Title 28, Judiciary and Judicial Procedure, and section 782 of former Title 49, Transportation, and enacting provisions set out as notes under section 881 of this title] may be cited as the 'Asset Forfeiture Amendments Act of 1988'."

Short Title of 1986 Amendment

Pub. L. 99–570, §1, Oct. 27, 1986, 100 Stat. 3207, provided that: "This Act [see Tables for classification] may be cited as the 'Anti-Drug Abuse Act of 1986'."

Pub. L. 99–570, title I, §1001, Oct. 27, 1986, 100 Stat. 3207–2, provided that: "This subtitle [subtitle A (§§1001–1009) of title I of Pub. L. 99–570, amending sections 802, 841, 845, 845a, 848, 881, 960, and 962 of this title, sections 3553 and 3583 of Title 18, Crimes and Criminal Procedure, rule 35 of the Federal Rules of Criminal Procedure, Title 18, Appendix, and section 994 of Title 28, Judiciary and Judicial Procedure, and enacting provisions set out as notes under section 841 of this title, sections 3553 and 3583 of Title 18, and rule 35 of the Federal Rules of Criminal Procedure] may be cited as the 'Narcotics Penalties and Enforcement Act of 1986'."

Pub. L. 99–570, title I, §1051, Oct. 27, 1986, 100 Stat. 3207–8, provided that: "This subtitle [subtitle B (§§1051, 1052) of title I of Pub. L. 99–570, amending section 844 of this title] may be cited as the 'Drug Possession Penalty Act of 1986'."

Pub. L. 99–570, title I, §1101, Oct. 27, 1986, 100 Stat. 3207–10, provided that: "This subtitle [subtitle C (§§1101–1105) of title I of Pub. L. 99–570, enacting section 845b of this title and amending sections 841, 845, and 845a of this title] may be cited as the 'Juvenile Drug Trafficking Act of 1986'."

Pub. L. 99–570, title I, §1201, Oct. 27, 1986, 100 Stat. 3207–13, provided that: "This subtitle [subtitle E (§§1201–1204) of title I of Pub. L. 99–570, enacting section 813 of this title and amending section 802 of this title] may be cited as the 'Controlled Substance Analogue Enforcement Act of 1986'."

Pub. L. 99–570, title I, §1251, Oct. 27, 1986, 100 Stat. 3207–14, provided that: "This subtitle [subtitle F (§§1251–1253) of title I of Pub. L. 99–570, amending section 848 of this title] may be cited as the 'Continuing Drug Enterprises Act of 1986'."

Pub. L. 99–570, title I, §1301, Oct. 27, 1986, 100 Stat. 3207–15, provided that: "This subtitle [subtitle G (§§1301, 1302) of title I of Pub. L. 99–570, amending section 960 of this title] may be cited as the 'Controlled Substances Import and Export Penalties Enhancement Act of 1986'."

Pub. L. 99–570, title I, §1821, Oct. 27, 1986, 100 Stat. 3207–51, which provided that subtitle O (§§1821–1823) of title I of Pub. L. 99–570, enacting section 857 of this title and provisions set out as a note under section 857 of this title, was to be cited as the "Mail Order Drug Paraphernalia Control Act", was repealed by Pub. L. 101–647, title XXIV, §2401(d), Nov. 29, 1990, 104 Stat. 4859.

Pub. L. 99–570, title I, §1991, Oct. 27, 1986, 100 Stat. 3207–59, provided that: "This subtitle [subtitle U (§§1991, 1992) of title I of Pub. L. 99–570, amending section 881 of this title] may be cited as the 'Federal Drug Law Enforcement Agent Protection Act of 1986'."

Short Title of 1984 Amendment

Pub. L. 98–473, title II, §501, Oct. 12, 1984, 98 Stat. 2068, provided that: "This chapter [chapter V (§§501–525) of title II of Pub. L. 98–473, enacting section 845a of this title, amending sections 802, 811, 812, 822–824, 827, 841, 843, 845, 873, 881, 952, 953, 957, 958, 960, and 962 of this title, and enacting provisions set out as a note under this section] may be cited as the 'Controlled Substances Penalties Amendments Act of 1984'."

Pub. L. 98–473, title II, §506(a), Oct. 12, 1984, 98 Stat. 2070, provided that: "This part [part B of chapter V (§§506–525) of title II of Pub. L. 98–473, amending sections 802, 811, 812, 822–824, 827, 843, 873, 881, 952, 953, 957, and 958 of this title] may be cited as the 'Dangerous Drug Diversion Control Act of 1984'."

Short Title of 1978 Amendment

Pub. L. 95–633, §1, Nov. 10, 1978, 92 Stat. 3768, provided: "That this Act [enacting sections 801a, 830, and 852 of this title, amending sections 352, 802, 811, 812, 823, 827, 841 to 843, 872, 881, 952, 953, and 965 of this title and section 242a of Title 42, The Public Health and Welfare, repealing section 830 of this title (effective Jan. 1, 1981), and enacting provisions set out as notes under sections 801a, 812, and 830 of this title] may be cited as the 'Psychotropic Substances Act of 1978'."

Short Title of 1974 Amendment

Pub. L. 93–281, §1, May 14, 1974, 88 Stat. 124, provided: "That this Act [amending sections 802, 823, 824, and 827 of this title] may be cited as the 'Narcotic Addict Treatment Act of 1974'."

Short Title

Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, provided: "That this Act [enacting this chapter and sections 257a, 2688l–1, 2688n–1, and 3509 of Title 42, The Public Health and Welfare, amending sections 162, 198a, 321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114, 1952, and 4251 of Title 18, Crimes and Criminal Procedure, sections 1584, 2078, 2079, and 2080 of Title 19, Customs Duties, sections 4901, 4905, 6808, 7012, 7103, 7326, 7607, 7609, 7641, 7651, and 7655 of Title 26, Internal Revenue Code, section 2901 of Title 28, Judiciary and Judicial Procedure, section 304m of former Title 40, Public Buildings, Property, and Works, sections 201, 225a, 242, 242a, 246, 257, 258, 259, 260, 261, 261a, 2688k, 2688l, 2688m, 2688n, 2688o, 2688r, and 3411 of Title 42, The Public Health and Welfare, section 239a of former Title 46, Shipping, and section 787 of Title 49, Appendix, Transportation, repealing sections 171 to 174, 176 to 185, 188 to 188n, 191 to 193, 197, 198, 199, 360a, and 501 to 517 of this title, sections 1401 to 1407 and 3616 of Title 18, sections 4701 to 4707, 4711 to 4716, 4721 to 4726, 4731 to 4736, 4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to 4776, 7237, 7238, and 7491 of Title 26, sections 529a and 529g of former Title 31, Money and Finance, and section 1421m of Title 48, Territories and Insular Possessions, and enacting provisions set out as notes under this section and sections 171, 321, 822, 951, and 957 of this title] may be cited as the 'Comprehensive Drug Abuse Prevention and Control Act of 1970'."

Pub. L. 91–513, title II, §100, Oct. 27, 1970, 84 Stat. 1242, provided that: "This title [enacting this subchapter, repealing section 360a of this title, amending sections 321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114 and 1952 of Title 18, Crimes and Criminal Procedure, and section 242 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under this section and sections 321 and 822 of this title] may be cited as the 'Controlled Substances Act'."

For short title and complete classification of title III of Pub. L. 91–513, which enacted subchapter II of this chapter, as the "Controlled Substances Import and Export Act", see section 1000 of Pub. L. 91–513, set out as a note under section 951 of this title.

Severability

Pub. L. 106–310, div. B, title XXXVI, §3673, Oct. 17, 2000, 114 Stat. 1246, provided that: "Any provision of this title [see Short Title of 2000 Amendments note above] held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed as to give the maximum effect permitted by law, unless such provision is held to be utterly invalid or unenforceable, in which event such provision shall be severed from this title and shall not affect the applicability of the remainder of this title, or of such provision, to other persons not similarly situated or to other, dissimilar circumstances."

Continuation of Orders, Rules, and Regulations

Pub. L. 91–513, title II, §705, Oct. 27, 1970, 84 Stat. 1284, provided that: "Any orders, rules, and regulations which have been promulgated under any law affected by this title [see Short Title note above] and which are in effect on the day preceding enactment of this title [Oct. 27, 1970] shall continue in effect until modified, superseded, or repealed."

Doctor-Patient Relationship

Pub. L. 117–215, title III, §301, Dec. 2, 2022, 136 Stat. 2265, provided that: "It shall not be a violation of the Controlled Substances Act (21 U.S.C. 801 et seq.) for a State-licensed physician to discuss—

"(1) the currently known potential harms and benefits of marijuana derivatives, including cannabidiol, as a treatment with the legal guardian of the patient of the physician if the patient is a child; or

"(2) the currently known potential harms and benefits of marijuana and marijuana derivatives, including cannabidiol, as a treatment with the patient or the legal guardian of the patient of the physician if the patient is a legal adult."

[For definitions of "State", "marijuana", and "cannabidiol" as used in section 301 of Pub. L. 117–215, set out above, see section 2(a) of Pub. L. 117–215, set out below.]

Anti-Drug Messages on Federal Government Internet Sites

Pub. L. 106–391, title III, §320, Oct. 30, 2000, 114 Stat. 1597, provided that: "Not later than 90 days after the date of the enactment of this Act [Oct. 30, 2000], the Administrator [of the National Aeronautics and Space Administration], in consultation with the Director of the Office of National Drug Control Policy, shall place anti-drug messages on Internet sites controlled by the National Aeronautics and Space Administration."

Pub. L. 106–310, div. B, title XXXVI, §3671, Oct. 17, 2000, 114 Stat. 1245, provided that: "Not later than 90 days after the date of the enactment of this Act [Oct. 17, 2000], the head of each department, agency, and establishment of the Federal Government shall, in consultation with the Director of the Office of National Drug Control Policy, place antidrug messages on appropriate Internet websites controlled by such department, agency, or establishment which messages shall, where appropriate, contain an electronic hyperlink to the Internet website, if any, of the Office."

Protocols for Investigations and Prosecutions Relating to Date-Rape Drugs and Other Controlled Substances; Annual Report; National Awareness Campaign

Pub. L. 106–172, §§6, 7, Feb. 18, 2000, 114 Stat. 11, as amended by Pub. L. 111–8, div. G, title I, §1301(d), Mar. 11, 2009, 123 Stat. 829, provided that:

"SEC. 6. DEVELOPMENT OF MODEL PROTOCOLS, TRAINING MATERIALS, FORENSIC FIELD TESTS, AND COORDINATION MECHANISM FOR INVESTIGATIONS AND PROSECUTIONS RELATING TO GAMMA HYDROXYBUTYRIC ACID, OTHER CONTROLLED SUBSTANCES, AND DESIGNER DRUGS.

"(a) In General.—The Attorney General, in consultation with the Administrator of the Drug Enforcement Administration and the Director of the Federal Bureau of Investigation, shall—

"(1) develop—

"(A) model protocols for the collection of toxicology specimens and the taking of victim statements in connection with investigations into and prosecutions related to possible violations of the Controlled Substances Act [21 U.S.C. 801 et seq.] or other Federal or State laws that result in or contribute to rape, other crimes of violence, or other crimes involving abuse of gamma hydroxybutyric acid, other controlled substances, or so-called 'designer drugs'; and

"(B) model training materials for law enforcement personnel involved in such investigations; and

"(2) make such protocols and training materials available to Federal, State, and local personnel responsible for such investigations.

"(b) Grant.—

"(1) In general.—The Attorney General shall make a grant, in such amount and to such public or private person or entity as the Attorney General considers appropriate, for the development of forensic field tests to assist law enforcement officials in detecting the presence of gamma hydroxybutyric acid and related substances.

"(2) Authorization of appropriations.—There are authorized to be appropriated such sums as may be necessary to carry out this subsection.

"(c) Report.—Not later than 180 days after the date of the enactment of this Act [Feb. 18, 2000], the Attorney General shall submit to the Committees on the Judiciary of the Senate and House of Representatives a report on current mechanisms for coordinating Federal, State, and local investigations into and prosecutions related to possible violations of the Controlled Substances Act [21 U.S.C. 801 et seq.] or other Federal or State laws that result in or contribute to rape, other crimes of violence, or other crimes involving the abuse of gamma hydroxybutyric acid, other controlled substances, or so-called 'designer drugs'. The report shall also include recommendations for the improvement of such mechanisms.

"SEC. 7. ANNUAL REPORT REGARDING DATE-RAPE DRUGS; NATIONAL AWARENESS CAMPAIGN.

"(a) Annual Report.—The Secretary of Health and Human Services (in this section referred to as the 'Secretary') shall periodically submit to Congress reports each of which provides an estimate of the number of incidents of the abuse of date-rape drugs (as defined in subsection (c)) that occurred during the most recent 1-year period for which data are available. The first such report shall be submitted not later than January 15, 2000, and subsequent reports shall be submitted annually thereafter.

"(b) National Awareness Campaign.—

"(1) Development of plan; recommendations of advisory committee.—

"(A) In general.—The Secretary, in consultation with the Attorney General, shall develop a plan for carrying out a national campaign to educate individuals described in subparagraph (B) on the following:

"(i) The dangers of date-rape drugs.

"(ii) The applicability of the Controlled Substances Act [21 U.S.C. 801 et seq.] to such drugs, including penalties under such Act.

"(iii) Recognizing the symptoms that indicate an individual may be a victim of such drugs, including symptoms with respect to sexual assault.

"(iv) Appropriately responding when an individual has such symptoms.

"(B) Intended population.—The individuals referred to in subparagraph (A) are young adults, youths, law enforcement personnel, educators, school nurses, counselors of rape victims, and emergency room personnel in hospitals.

"(C) Advisory committee.—Not later than 180 days after the date of the enactment of this Act [Feb. 18, 2000], the Secretary shall establish an advisory committee to make recommendations to the Secretary regarding the plan under subparagraph (A). The committee shall be composed of individuals who collectively possess expertise on the effects of date-rape drugs and on detecting and controlling the drugs.

"(2) Implementation of plan.—Not later than 180 days after the date on which the advisory committee under paragraph (1) is established, the Secretary, in consultation with the Attorney General, shall commence carrying out the national campaign under such paragraph in accordance with the plan developed under such paragraph. The campaign may be carried out directly by the Secretary and through grants and contracts.

"(c) Definition.—For purposes of this section, the term 'date-rape drugs' means gamma hydroxybutyric acid and its salts, isomers, and salts of isomers and such other drugs or substances as the Secretary, after consultation with the Attorney General, determines to be appropriate."

Congressional Findings Regarding Methamphetamine Manufacture and Abuse

Pub. L. 104–237, §2, Oct. 3, 1996, 110 Stat. 3100, provided that: "The Congress finds the following:

"(1) Methamphetamine is a very dangerous and harmful drug. It is highly addictive and is associated with permanent brain damage in long-term users.

"(2) The abuse of methamphetamine has increased dramatically since 1990. This increased use has led to devastating effects on individuals and the community, including—

"(A) a dramatic increase in deaths associated with methamphetamine ingestion;

"(B) an increase in the number of violent crimes associated with methamphetamine ingestion; and

"(C) an increase in criminal activity associated with the illegal importation of methamphetamine and precursor compounds to support the growing appetite for this drug in the United States.

"(3) Illegal methamphetamine manufacture and abuse presents an imminent public health threat that warrants aggressive law enforcement action, increased research on methamphetamine and other substance abuse, increased coordinated efforts to prevent methamphetamine abuse, and increased monitoring of the public health threat methamphetamine presents to the communities of the United States."

Support for International Efforts To Control Methamphetamine and Precursors

Pub. L. 104–237, title I, §101, Oct. 3, 1996, 110 Stat. 3100, provided that: "The Attorney General, in consultation with the Secretary of State, shall coordinate international drug enforcement efforts to decrease the movement of methamphetamine and methamphetamine precursors into the United States."

Interagency Methamphetamine Task Force

Pub. L. 104–237, title V, §501, Oct. 3, 1996, 110 Stat. 3111, provided for the establishment of a Methamphetamine Interagency Task Force to design and implement education, prevention, and treatment strategies with respect to methamphetamine and other synthetic stimulants and for the task force to terminate 4 years after Oct. 3, 1996.

Suspicious Orders Task Force

Pub. L. 104–237, title V, §504, Oct. 3, 1996, 110 Stat. 3112, directed the Attorney General to establish a Suspicious Orders Task Force which would develop proposals to define suspicious orders of listed chemicals for registrants to use in determining if an order was a suspicious order that must be reported to DEA and would terminate upon presentation of its report to the Attorney General, or two years after Oct. 3, 1996, whichever was sooner.

Joint Federal Task Force on Illegal Drug Laboratories

Pub. L. 100–690, title II, §2405, Nov. 18, 1988, 102 Stat. 4231, provided that:

"(a) Establishment of Task Force.—There is established the Joint Federal Task Force on Illegal Drug Laboratories (hereafter in this section referred to as the 'Task Force').

"(b) Appointment and Membership of Task Force.—The members of the Task Force shall be appointed by the Administrators of the Environmental Protection Agency and the Drug Enforcement Administration (hereafter in this section referred to as the 'Administrators'). The Task Force shall consist of at least 6 and not more than 20 members. Each Administrator shall appoint one-half of the members as follows: (1) the Administrator of the Environmental Protection Agency shall appoint members from among Emergency Response Technicians and other appropriate employees of the Agency; and (2) the Administrator of the Drug Enforcement Administration shall appoint members from among Special Agents assigned to field divisions and other appropriate employees of the Administration.

"(c) Duties of Task Force.—The Task Force shall formulate, establish, and implement a program for the cleanup and disposal of hazardous waste produced by illegal drug laboratories. In formulating such program, the Task Force shall consider the following factors:

"(1) The volume of hazardous waste produced by illegal drug laboratories.

"(2) The cost of cleaning up and disposing of hazardous waste produced by illegal drug laboratories.

"(3) The effectiveness of the various methods of cleaning up and disposing of hazardous waste produced by illegal drug laboratories.

"(4) The coordination of the efforts of the Environmental Protection Agency and the Drug Enforcement Administration in cleaning up and disposing of hazardous waste produced by illegal drug laboratories.

"(5) The dissemination of information to law enforcement agencies that have responsibility for enforcement of drug laws.

"(d) Guidelines.—The Task Force shall recommend to the Administrators guidelines for cleanup of illegal drug laboratories to protect the public health and environment. Not later than 180 days after the date of the enactment of this subtitle [Nov. 18, 1988], the Administrators shall formulate and publish such guidelines.

"(e) Demonstration Projects.—

"(1) The Attorney General shall make grants to, and enter into contracts with, State and local governments for demonstration projects to clean up and safely dispose of substances associated with illegal drug laboratories which may present a danger to public health or the environment.

"(2) The Attorney General may not under this subsection make a grant or enter into a contract unless the applicant for such assistance agrees to comply with the guidelines issued pursuant to subsection (d).

"(3) The Attorney General shall, through grant or contract, provide for independent evaluations of the activities carried out pursuant to this subsection and shall recommend appropriate legislation to the Congress.

"(f) Funding.—Of the amounts made available to carry out the Controlled Substances Act [21 U.S.C. 801 et seq.] for fiscal year 1989, not less than $5,000,000 shall be made available to carry out subsections (d) and (e).

"(g) Reports.—After consultation with the Task Force, the Administrators shall—

"(1) transmit to the President and to each House of Congress not later than 270 days after the date of the enactment of this subtitle [Nov. 18, 1988] a report describing the program established by the Task Force under subsection (c) (including an analysis of the factors specified in paragraphs (1) through (5) of that subsection);

"(2) periodically transmit to the President and to each House of Congress reports describing the implementation of the program established by the Task Force under subsection (c) (including an analysis of the factors specified in paragraphs (1) through (5) of that subsection) and the progress made in the cleanup and disposal of hazardous waste produced by illegal drug laboratories; and

"(3) transmit to each House of Congress a report describing the findings made as a result of the evaluations referred to in subsection (e)(3)."

Great Lakes Drug Interdiction

Pub. L. 100–690, title VII, §7404, Nov. 18, 1988, 102 Stat. 4484, provided that:

"(a) Interagency Agreement.—The Secretary of Transportation and the Secretary of the Treasury shall enter into an agreement for the purpose of increasing the effectiveness of maritime drug interdiction activities of the Coast Guard and the Customs Service in the Great Lakes area.

"(b) Negotiations With Canada on Drug Enforcement Cooperation.—The Secretary of State is encouraged to enter into negotiations with appropriate officials of the Government of Canada for the purpose of establishing an agreement between the United States and Canada which provides for increased cooperation and sharing of information between United States and Canadian law enforcement officials with respect to law enforcement efforts conducted on the Great Lakes between the United States and Canada."

[For transfer of authorities, functions, personnel, and assets of the Coast Guard, including the authorities and functions of the Secretary of Transportation relating thereto, to the Department of Homeland Security, and for treatment of related references, see sections 468(b), 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.]

[For transfer of functions, personnel, assets, and liabilities of the United States Customs Service of the Department of the Treasury, including functions of the Secretary of the Treasury relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see sections 203(1), 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. For establishment of U.S. Customs and Border Protection in the Department of Homeland Security, treated as if included in Pub. L. 107–296 as of Nov. 25, 2002, see section 211 of Title 6, as amended generally by Pub. L. 114–125, and section 802(b) of Pub. L. 114–125, set out as a note under section 211 of Title 6.]

GAO Study of Capabilities of United States To Control Drug Smuggling Into United States

Pub. L. 100–180, div. A, title XII, §1241, Dec. 4, 1987, 101 Stat. 1162, directed Comptroller General of the United States to conduct a comprehensive study regarding smuggling of illegal drugs into United States and current capabilities of United States to deter such smuggling, with special consideration given to issues involving use of military and National Guard units along with Customs Service in cooperative drug smuggling interdiction efforts, and to issue, not later than Apr. 30, 1988, and Mar. 31, 1989, reports to Congress outlining results of this study.

Compliance With Budget Act

Pub. L. 99–570, §3, Oct. 27, 1986, 100 Stat. 3207–1, provided that: "Notwithstanding any other provision of this Act [see Tables for classification], any spending authority and any credit authority provided under this Act shall be effective for any fiscal year only to such extent or in such amounts as are provided in appropriation Acts. For purposes of this Act, the term 'spending authority' has the meaning provided in section 401(c)(2) of the Congressional Budget Act of 1974 [2 U.S.C. 651(c)(2)] and the term 'credit authority' has the meaning provided in section 3(10) of the Congresssional [sic] Budget Act of 1974 [2 U.S.C. 622(10)]."

Drug Interdiction

Pub. L. 99–570, title III, §§3001–3003, 3301, Oct. 27, 1986, 100 Stat. 3207–73, 3207–74, 3207–98, as amended by Pub. L. 104–66, title I, §1091(a), Dec. 21, 1995, 109 Stat. 722, provided that:

"SEC. 3001. SHORT TITLE.

"This title [enacting section 379 of Title 10, Armed Forces, sections 1590, 1628, 1629, and 2081 of Title 19, Customs Duties, and section 312a of Title 47, Telecommunications, amending section 959 of this title, sections 374 and 911 of Title 10, sections 507, 1401, 1433, 1436, 1454, 1459, 1497, 1509, 1584 to 1586, 1594 to 1595a, 1613, 1613b, 1619, and 1622 of Title 19, section 5316 of Title 31, Money and Finance, section 12109 of Title 46, Shipping, sections 1901 to 1904 of Title 46, Appendix, Shipping, and sections 1401, 1472, 1474, and 1509 of former Title 49, Transportation, repealing section 1460 of Title 19, enacting provisions set out as notes under section 801 of this title, sections 371, 374, 525, and 9441 of Title 10, sections 1613b and 1654 of Title 19, section 403 of Title 23, Highways, section 1901 of Title 46, Appendix, section 11344 of Title 49, and section 1509 of former Title 49, and repealing provisions set out as a note under section 89 of Title 14, Coast Guard] may be cited as the 'National Drug Interdiction Improvement Act of 1986'.

"SEC. 3002. FINDINGS.

"The Congress hereby finds that—

"(1) a balanced, coordinated, multifaceted strategy for combating the growing drug abuse and drug trafficking problem in the United States is essential in order to stop the flow and abuse of drugs within our borders;

"(2) a balanced, coordinated, multifaceted strategy for combating the narcotics drug abuse and trafficking in the United States should include—

"(A) increased investigations of large networks of drug smuggler organizations;

"(B) source country drug eradication;

"(C) increased emphasis on stopping narcotics traffickers in countries through which drugs are transshipped;

"(D) increased emphasis on drug education programs in the schools and workplace;

"(E) increased Federal Government assistance to State and local agencies, civic groups, school systems, and officials in their efforts to combat the drug abuse and trafficking problem at the local level; and

"(F) increased emphasis on the interdiction of drugs and drug smugglers at the borders of the United States, in the air, at sea, and on the land;

"(3) funds to support the interdiction of narcotics smugglers who threaten the transport of drugs through the air, on the sea, and across the land borders of the United States should be emphasized in the Federal Government budget process to the same extent as the other elements of a comprehensive antidrug effort are emphasized;

"(4) the Department of Defense and the use of its resources should be an integral part of a comprehensive, natonal [national] drug interdiction program;

"(5) the Federal Government civilian agencies engaged in drug interdiction, particularly the United States Customs Service and the Coast Guard, currently lack the aircraft, ships, radar, command, control, communications, and intelligence (C3I) system, and manpower resources necessary to mount a comprehensive attack on the narcotics traffickers who threaten the United States;

"(6) the civilian drug interdiction agencies of the United States are currently interdicting only a small percentage of the illegal, drug smuggler penetrations in the United States every year;

"(7) the budgets for our civilian drug interdiction agencies, primarily the United States Customs Service and the Coast Guard, have not kept pace with those of the traditional investigative law enforcement agencies of the Department of Justice; and

"(8) since the amendment of the Posse Comitatus Act (18 U.S.C. 1385) in 1981, the Department of Defense has assisted in the effort to interdict drugs, but they can do more.

"SEC. 3003. PURPOSES.

"It is the purpose of this title—

"(1) to increase the level of funding and resources available to civilian drug interdiction agencies of the Federal Government;

"(2) to increase the level of support from the Department of Defense as consistent with the Posse Comitatus Act [18 U.S.C. 1385], for interdiction of the narcotics traffickers before such traffickers penetrate the borders of the United States; and

"(3) to improve other drug interdiction programs of the Federal Government.

"SEC. 3301. ESTABLISHMENT OF A UNITED STATES-BAHAMAS DRUG INTERDICTION TASK FORCE

"(a) Authorization of Appropriations.—

"(1) Establishment of a united states-bahamas drug interdiction task force.—(A) There is authorized to be established a United States-Bahamas Drug Interdiction Task Force to be operated jointly by the United States Government and the Government of the Bahamas.

"(B) The Secretary of State, the Commandant of the Coast Guard, the Commissioner of Customs, the Attorney General, and the head of the National Narcotics Border Interdiction System (NNBIS), shall upon enactment of this Act [Oct. 27, 1986], immediately commence negotiations with the Government of the Bahamas to enter into a detailed agreement for the establishment and operation of a new drug interdiction task force, including plans for (i) the joint operation and maintenance of any drug interdiction assets authorized for the task force in this section and section 3141 [see 19 U.S.C. 2075], and (ii) any training and personnel enhancements authorized in this section and section 3141.

"(2) Amounts authorized.—There are authorized to be appropriated, in addition to any other amounts authorized to be appropriated in this title [see section 3001 of Pub. L. 99–570 set out above], $10,000,000 for the following:

"(A) $9,000,000 for 3 drug interdiction pursuit helicopters for use primarily for operations of the United States-Bahamas Drug Interdiction Task Force established under this section; and

"(B) $1,000,000 to enhance communications capabilities for the operation of a United States-Bahamas Drug Interdiction Task Force established under this section.

"(3) Coast guard-bahamas drug interdiction docking facility.—(A) There is authorized to be appropriated for acquisition, construction, and improvements for the Coast Guard for fiscal year 1987, $5,000,000, to be used for initial design engineering, and other activities for construction of a drug interdiction docking facility in the Bahamas to facilitate Coast Guard and Bahamian drug interdiction operations in and through the Bahama Islands. Of the amounts authorized to be appropriated in this subsection, such sums as may be necessary shall be available for necessary communication and air support.

"(B) The Commandant of the Coast Guard shall use such amounts appropriated pursuant to the authorization in this paragraph as may be necessary to establish a repair, maintenance, and boat lift facility to provide repair and maintenance services for both Coast Guard and Bahamian marine drug interdiction equipment, vessels, and related assets.

"(b) Concurrence by Secretary of State.—Programs authorized by this section may be carried out only with the concurrence of the Secretary of State."

Information on Drug Abuse at the Workplace

Pub. L. 99–570, title IV, §4303, Oct. 27, 1986, 100 Stat. 3207–154, directed Secretary of Labor to collect such information as is available on the incidence of drug abuse in the workplace and efforts to assist workers, including counseling, rehabilitation and employee assistance programs, to conduct such additional research as is necessary to assess the impact and extent of drug abuse and remediation efforts, and submit the findings of such collection and research to Congress no later than two years from Oct. 27, 1986.

Interagency Coordination

Pub. L. 99–570, title IV, §4304, Oct. 27, 1986, 100 Stat. 3207–154, provided that:

"(a) The Secretary of Education, the Secretary of Health and Human Services, and the Secretary of Labor shall each designate an officer or employee of the Departments of Education, Health and Human Services, and Labor, respectively, to coordinate interagency drug abuse prevention activities to prevent duplication of effort.

"(b) Within one year after enactment of this Act [Oct. 27, 1986], a report shall be jointly submitted to the Congress by such Secretaries concerning the extent to which States and localities have been able to implement non-duplicative drug abuse prevention activities."

Substance Abuse Coverage Study

Pub. L. 99–570, title VI, §6005, Oct. 27, 1986, 100 Stat. 3207–160, as amended by Pub. L. 100–690, title II, §2058(c), Nov. 18, 1988, 102 Stat. 4214, directed Secretary of Health and Human Services to contract with Institute of Medicine of National Academy of Sciences to conduct a study of extent to which cost of drug abuse treatment is covered by private insurance, public programs, and other sources of payment, and adequacy of such coverage for the rehabilitation of drug abusers, and not later than 18 months after execution of such contract to transmit to Congress a report of results of study, including recommendations of means to meet the needs identified in such study.

Health Insurance Coverage for Drug and Alcohol Treatment

Pub. L. 99–570, title VI, §6006, Oct. 27, 1986, 100 Stat. 3207–160, provided that:

"(a) Findings.—The Congress finds that—

"(1) drug and alcohol abuse are problems of grave concern and consequence in American society;

"(2) over 500,000 individuals are known heroin addicts; 5 million individuals use cocaine; and at least 7 million individuals regularly use prescription drugs, mostly addictive ones, without medical supervision;

"(3) 10 million adults and 3 million children and adolescents abuse alcohol, and an additional 30 to 40 million people are adversely affected because of close family ties to alcoholics;

"(4) the total cost of drug abuse to the Nation in 1983 was over $60,000,000,000; and

"(5) the vast majority of health benefits plans provide only limited coverage for treatment of drug and alcohol addiction, which is a fact that can discourage the abuser from seeking treatment or, if the abuser does seek treatment, can cause the abuser to face significant out of pocket expenses for the treatment.

"(b) Sense of Congress.—It is the sense of Congress that—

"(1) all employers providing health insurance policies should ensure that the policies provide adequate coverage for treatment of drug and alcohol addiction in recognition that the health consequences and costs for individuals and society can be as formidable as those resulting from other diseases and illnesses for which insurance coverage is much more adequate; and

"(2) State insurance commissioners should encourage employers providing health benefits plans to ensure that the policies provide more adequate coverage for treatment of drug and alcohol addiction."

Commission on Marihuana and Drug Abuse

Pub. L. 91–513, title II, §601, Oct. 27, 1970, 84 Stat. 1280, as amended by Pub. L. 92–13, May 14, 1971, 85 Stat. 37, provided that:

"(a) [Establishment; composition] There is established a commission to be known as the Commission on Marihuana and Drug Abuse (hereafter in this section referred to as the 'Commission'). The Commission shall be composed of—

"(1) two Members of the Senate appointed by the President of the Senate;

"(2) two Members of the House of Representatives appointed by the Speaker of the House of Representatives; and

"(3) nine members appointed by the President of the United States.

At no time shall more than one of the members appointed under paragraph (1), or more than one of the members appointed under paragraph (2), or more than five of the members appointed under paragraph (3) be members of the same political party.

"(b) [Chairman; Vice Chairman; compensation of members; meetings] (1) The President shall designate one of the members of the Commission as Chairman and one as Vice Chairman. Seven members of the Commission shall constitute a quorum, but a lesser number may conduct hearings.

"(2) Members of the Commission who are Members of Congress or full-time officers or employees of the United States shall serve without additional compensation but shall be reimbursed for travel, subsistence, and other necessary expenses incurred in the performance of the duties vested in the Commission. Members of the Commission from private life shall receive $100 per diem while engaged in the actual performance of the duties vested in the Commission, plus reimbursement for travel, subsistence, and other necessary expenses incurred in the performance of such duties.

"(3) The Commission shall meet at the call of the Chairman or at the call of a majority of the members thereof.

"(c) [Personnel; experts; information from departments and agencies] (1) The Commission shall have the power to appoint and fix the compensation of such personnel as it deems advisable, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, and the provisions of chapter 51 and subchapter III of chapter 53 of such title, relating to classification and General Schedule pay rates.

"(2) The Commission may procure, in accordance with the provisions of section 3109 of title 5, United States Code, the temporary or intermittent services of experts or consultants. Persons so employed shall receive compensation at a rate to be fixed by the Commission, but not in excess of $75 per diem, including traveltime. While away from his home or regular place of business in the performance of services for the Commission, any such person may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703(b) of title 5, United States Code, for persons in the Government service employed intermittently.

"(3) The Commission may secure directly from any department or agency of the United States information necessary to enable it to carry out its duties under this section. Upon request of the Chairman of the Commission, such department or agency shall furnish such information to the Commission.

"(d) [Marihuana study; report to the President and the Congress] (1) The Commission shall conduct a study of marihuana including, but not limited to, the following areas:

"(A) the extent of use of marihuana in the United States to include its various sources of users, number of arrests, number of convictions, amount of marihuana seized, type of user, nature of use;

"(B) an evaluation of the efficacy of existing marihuana laws;

"(C) a study of the pharmacology of marihuana and its immediate and long-term effects, both physiological and psychological;

"(D) the relationship of marihuana use to aggressive behavior and crime;

"(E) the relationship between marihuana and the use of other drugs; and

"(F) the international control of marihuana.

"(2) Within one year after the date on which funds first become available to carry out this section, the Commission shall submit to the President and the Congress a comprehensive report on its study and investigation under this subsection which shall include its recommendations and such proposals for legislation and administrative action as may be necessary to carry out its recommendations.

"(e) [Study and investigation of causes of drug abuse; report to the President and the Congress; termination of Commission] The Commission shall conduct a comprehensive study and investigation of the causes of drug abuse and their relative significance. The Commission shall submit to the President and the Congress such interim reports as it deems advisable and shall within two years after the date on which funds first become available to carry out this section submit to the President and the Congress a final report which shall contain a detailed statement of its findings and conclusions and also such recommendations for legislation and administrative actions as it deems appropriate. The Commission shall cease to exist sixty days after the final report is submitted under this subsection.

"(f) [Limitation on expenditures] Total expenditures of the Commission shall not exceed $4,000,000."

Definitions

Pub. L. 117–215, §2(a), Dec. 2, 2022, 136 Stat. 2257, provided that:

"(a) In General.—In this Act [see Short Title of 2022 Amendment note set out above]—

"(1) the term 'appropriately registered' means that an individual or entity is registered under the Controlled Substances Act (21 U.S.C. 801 et seq.) to engage in the type of activity that is carried out by the individual or entity with respect to a controlled substance on the schedule that is applicable to cannabidiol or marijuana, as applicable;

"(2) the term 'cannabidiol' means—

"(A) the substance, cannabidiol, as derived from marijuana that has a delta-9-tetrahydrocannabinol level that is greater than 0.3 percent; and

"(B) the synthetic equivalent of the substance described in subparagraph (A);

"(3) the terms 'controlled substance', 'dispense', 'distribute', 'manufacture', 'marijuana', and 'practitioner' have the meanings given such terms in section 102 of the Controlled Substances Act (21 U.S.C. 802), as amended by this Act;

"(4) the term 'covered institution of higher education' means an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) that—

"(A)(i) has highest or higher research activity, as defined by the Carnegie Classification of Institutions of Higher Education; or

"(ii) is an accredited medical school or an accredited school of osteopathic medicine; and

"(B) is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.);

"(5) the term 'drug' has the meaning given the term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1));

"(6) the term 'medical research for drug development' means medical research that is—

"(A) a preclinical study or clinical investigation conducted in accordance with section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or otherwise permitted by the Department of Health and Human Services to determine the potential medical benefits of marijuana or cannabidiol as a drug; and

"(B) conducted by a covered institution of higher education, practitioner, or manufacturer that is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.); and

"(7) the term 'State' means any State of the United States, the District of Columbia, and any territory of the United States."

Executive Documents

Executive Order No. 11599

Ex. Ord. No. 11599, June 17, 1971, 36 F.R. 11793, which established the Special Action Office for Drug Abuse Prevention, was superseded. See Prior Provisions notes set out under section 1111 of this title.

Executive Order No. 11641

Ex. Ord. No. 11641, Jan. 28, 1972, 37 F.R. 2421, which established the Office for Drug Abuse Law Enforcement, was revoked by Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, set out below.

Executive Order No. 11676

Ex. Ord. No. 11676, July 27, 1972, 37 F.R. 15125, which established the Office of National Narcotics Intelligence, was revoked by Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, set out below.

Ex. Ord. No. 11727. Drug Law Enforcement

Ex. Ord. No. 11727, July 6, 1973, 38 F.R. 18357, provided:

Reorganization Plan No. 2 of 1973 [set out in the Appendix to Title 5, Government Organization and Employees], which becomes effective on July 1, 1973, among other things establishes a Drug Enforcement Administration in the Department of Justice. In my message to the Congress transmitting that plan, I stated that all functions of the Office for Drug Abuse Law Enforcement (established pursuant to Executive Order No. 11641 of January 28, 1972) and the Office of National Narcotics Intelligence (established pursuant to Executive Order No. 11676 of July 27, 1972) would, together with other related functions, be merged in the new Drug Enforcement Administration.

NOW, THEREFORE, by virtue of the authority vested in me by the Constitution and laws of the United States, including section 5317 of title 5 of the United States Code, as amended, it is hereby ordered as follows:

Section 1. The Attorney General, to the extent permitted by law, is authorized to coordinate all activities of executive branch departments and agencies which are directly related to the enforcement of laws respecting narcotics and dangerous drugs. Each department and agency of the Federal Government shall, upon request and to the extent permitted by law, assist the Attorney General in the performance of functions assigned to him pursuant to this order, and the Attorney General may, in carrying out those functions, utilize the services of any other agencies, Federal and State, as may be available and appropriate.

Sec. 2. Executive Order No. 11641 of January 28, 1972, is revoked and the Attorney General shall provide for the reassignment of the functions of the Office for Drug Abuse Law Enforcement and for the abolishment of that Office.

Sec. 3. Executive Order No. 11676 of July 27, 1972, is hereby revoked and the Attorney General shall provide for the reassignment of the functions of the Office of National Narcotics Intelligence and for the abolishment of that Office.

Sec. 4. Section 1 of Executive Order No. 11708 of March 23, 1973, as amended [set out as a note under section 5317 of Title 5, Government Organization and Employees], placing certain positions in level IV of the Executive Schedule is hereby further amended by deleting—

(1) "(6) Director, Office for Drug Abuse Law Enforcement, Department of Justice."; and

(2) "(7) Director, Office of National Narcotics Intelligence, Department of Justice."

Sec. 5. The Attorney General shall provide for the winding up of the affairs of the two offices and for the reassignment of their functions.

Sec. 6. This order shall be effective as of July 1, 1973.

Richard Nixon.      

Combatting the National Drug Demand and Opioid Crisis

Memorandum of President of the United States, Oct. 26, 2017, 82 F.R. 50305, provided:

Memorandum for the Heads of Executive Departments and Agencies

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby directed as follows:

Section 1. Policy. It shall be the policy of the United States to use all lawful means to combat the drug demand and opioid crisis currently afflicting our country. Individuals, families, and communities across the United States continue to be devastated by an unprecedented epidemic of drug abuse and overdose, including of prescription opioids, heroin, and illicit synthetic opioids. Last year, we lost at least 64,000 of our fellow Americans to drug overdose, primarily from opioids. This is an increase of approximately 12,000 people over the year before and more than ever recorded in United States history. Drug overdoses now kill more Americans than motor vehicle crashes or gun-related incidents, and more than 300,000 Americans have died of an opioid overdose since 2000. Further, more than 2.1 million of our fellow citizens are addicted to opioids, and in 2014 more than 1,500 people were treated each day in emergency departments for opioid-related emergencies.

This crisis has devastated our communities. It has been particularly harmful for children affected by their parents' drug abuse. The number of infants born drug-dependent increased by nearly 500 percent from 2000 to 2012. The number of children being placed into foster care due, at least in part, to parental drug abuse is increasing, and accounted for almost a third of all child removals in Fiscal Year 2015. Serious drug users are also more likely to be arrested for crimes such as burglary, robbery, and handling stolen goods. Moreover, the drug trafficking that supplies illegal drugs to our country is associated with other illegal activities, including murder and other violent crimes. All of this devastates lives and harms communities in both the United States and foreign countries involved in the illegal drug supply chain. Federal, State, and local governments; law enforcement; first responders; the medical, public health, and substance abuse treatment community; and faith-based and community organizations are working tirelessly and have even expanded their efforts to combat the drug demand and opioid crisis.

Three factors are driving the opioid aspect of this crisis in particular. First, since the 1990s, there has been a dramatic rise in opioid pain medication prescriptions. Second, heroin from Mexico has flooded the country. Third, the illicit manufacture and illegal importation of fentanyl—an extremely deadly synthetic opioid—and its analogues and related compounds have proliferated. Fentanyl is currently manufactured almost exclusively in China, and it is either shipped into the United States or smuggled across the southern border by drug traffickers. Between 2013 and 2016, the amount of fentanyl seized by Customs and Border Protection at the border increased more than 200 times over. Dealers are increasingly lacing fentanyl into other drugs and pressing it into counterfeit opioid pills. Because fentanyl is lethal in even miniscule doses, this is an extremely deadly tactic, as it too often causes users to ingest a fatal amount unknowingly.

Sec. 2. Agency Action. The Secretary of Health and Human Services shall, consistent with section 319 of the Public Health Service Act, 42 U.S.C. 247d, consider declaring that the drug demand and opioid crisis described in section 1 of this memorandum constitutes a Public Health Emergency. Additionally, the heads of executive departments and agencies, as appropriate and consistent with law, shall exercise all appropriate emergency authorities, as well as other relevant authorities, to reduce the number of deaths and minimize the devastation the drug demand and opioid crisis inflicts upon American communities.

Sec. 3. General Provisions. (a) Nothing in this memorandum shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The Secretary of Health and Human Services is hereby authorized and directed to publish this memorandum in the Federal Register.

Donald J. Trump.
21 U.S.C. § 2110 (2024) — Title 21: FOOD AND DRUGS / Chapter 26: FOOD SAFETY / Section 2110: Rule of construction
Rule of construction
Status: in_force

Nothing in this chapter (or an amendment made by this chapter) shall be construed to affect—

(1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public Law 103–417); or

(2) the adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109–462).

(Pub. L. 110–85, title X, §1011, Sept. 27, 2007, 121 Stat. 971.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title X of Pub. L. 110–85, Sept. 27, 2007, 121 Stat. 962, which enacted this chapter and section 350f of this title, amended sections 321 and 331 of this title, and enacted provisions set out as notes under this section and section 350f of this title. For complete classification of title X to the Code, see Tables.

The Dietary Supplement Health and Education Act of 1994, referred to in par. (1), is Pub. L. 103–417, Oct. 25, 1994, 108 Stat. 4325, which enacted sections 343–2 and 350b of this title and section 287c–11 of Title 42, The Public Health and Welfare, amended sections 321, 331, 342, 343, and 350 of this title and section 281 of Title 42, and enacted provisions set out as notes under sections 321 and 343 of this title. For complete classification of this Act to the Code, see Short Title of 1994 Amendments note set out under section 301 of this title and Tables.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act, referred to in par. (2), is Pub. L. 109–462, Dec. 22, 2006, 120 Stat. 3469, which enacted sections 379aa and 379aa–1 of this title, amended sections 331, 343, 352, and 381 of this title, and enacted provisions set out as notes under sections 331, 343, 352, 379aa, and 381 of this title. For complete classification of this Act to the Code, see Short Title of 2006 Amendment note set out under section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Construction

Pub. L. 110–85, title X, §1005(g), Sept. 27, 2007, 121 Stat. 969, provided that: "Nothing in this title [enacting this chapter and section 350f of this title, amending sections 321 and 331 of this title, and enacting provisions set out as notes under section 350f of this title], or an amendment made by this title, shall be construed to alter the jurisdiction between the Secretaries of Agriculture and of Health and Human Services, under applicable statutes and regulations."
21 U.S.C. § 802 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 802: Definitions
Definitions
Status: in_force

As used in this subchapter:

(1) The term "addict" means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction.

(2) The term "administer" refers to the direct application of a controlled substance to the body of a patient or research subject by—

(A) a practitioner (or, in his presence, by his authorized agent), or

(B) the patient or research subject at the direction and in the presence of the practitioner,

whether such application be by injection, inhalation, ingestion, or any other means.

(3) The term "agent" means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier's or warehouseman's business.

(4) The term "Drug Enforcement Administration" means the Drug Enforcement Administration in the Department of Justice.

(5) The term "control" means to add a drug or other substance, or immediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise.

(6) The term "controlled substance" means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.

(7) The term "counterfeit substance" means a controlled substance which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person or persons who in fact manufactured, distributed, or dispensed such substance and which thereby falsely purports or is represented to be the product of, or to have been distributed by, such other manufacturer, distributor, or dispenser.

(8) The terms "deliver" or "delivery" mean the actual, constructive, or attempted transfer of a controlled substance or a listed chemical, whether or not there exists an agency relationship.

(9) The term "depressant or stimulant substance" means—

(A) a drug which contains any quantity of barbituric acid or any of the salts of barbituric acid; or

(B) a drug which contains any quantity of (i) amphetamine or any of its optical isomers; (ii) any salt of amphetamine or any salt of an optical isomer of amphetamine; or (iii) any substance which the Attorney General, after investigation, has found to be, and by regulation designated as, habit forming because of its stimulant effect on the central nervous system; or

(C) lysergic acid diethylamide; or

(D) any drug which contains any quantity of a substance which the Attorney General, after investigation, has found to have, and by regulation designated as having, a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect.

(10) The term "dispense" means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term "dispenser" means a practitioner who so delivers a controlled substance to an ultimate user or research subject.

(11) The term "distribute" means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical. The term "distributor" means a person who so delivers a controlled substance or a listed chemical.

(12) The term "drug" has the meaning given that term by section 321(g)(1) of this title.

(13) The term "felony" means any Federal or State offense classified by applicable Federal or State law as a felony.

(14) The term "isomer" means the optical isomer, except as used in schedule I(c) and schedule II(a)(4). As used in schedule I(c), the term "isomer" means any optical, positional, or geometric isomer. As used in schedule II(a)(4), the term "isomer" means any optical or geometric isomer.

(15) The term "manufacture" means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice. The term "manufacturer" means a person who manufactures a drug or other substance.

(16)(A) Subject to subparagraph (B), the terms "marihuana" and "marijuana" mean all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.

(B) The terms "marihuana" and "marijuana" do not include—

(i) hemp, as defined in section 1639o of title 7; or

(ii) the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

(17) The term "narcotic drug" means any of the following whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(A) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium.

(B) Poppy straw and concentrate of poppy straw.

(C) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed.

(D) Cocaine, its salts, optical and geometric isomers, and salts of isomers.

(E) Ecgonine, its derivatives, their salts, isomers, and salts of isomers.

(F) Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subparagraphs (A) through (E).

(18) The term "opiate" or "opioid" means any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.

(19) The term "opium poppy" means the plant of the species Papaver somniferum L., except the seed thereof.

(20) The term "poppy straw" means all parts, except the seeds, of the opium poppy, after mowing.

(21) The term "practitioner" means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.

(22) The term "production" includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance.

(23) The term "immediate precursor" means a substance—

(A) which the Attorney General has found to be and by regulation designated as being the principal compound used, or produced primarily for use, in the manufacture of a controlled substance;

(B) which is an immediate chemical intermediary used or likely to be used in the manufacture of such controlled substance; and

(C) the control of which is necessary to prevent, curtail, or limit the manufacture of such controlled substance.

(24) The term "Secretary", unless the context otherwise indicates, means the Secretary of Health and Human Services.

(25) The term "serious bodily injury" means bodily injury which involves—

(A) a substantial risk of death;

(B) protracted and obvious disfigurement; or

(C) protracted loss or impairment of the function of a bodily member, organ, or mental faculty.

(26) The term "State" means a State of the United States, the District of Columbia, and any commonwealth, territory, or possession of the United States.

(27) The term "ultimate user" means a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household.

(28) The term "United States", when used in a geographic sense, means all places and waters, continental or insular, subject to the jurisdiction of the United States.

(29) The term "maintenance treatment" means the dispensing, for a period in excess of twenty-one days, of a narcotic drug in the treatment of an individual for dependence upon heroin or other morphine-like drugs.

(30) The term "detoxification treatment" means the dispensing, for a period not in excess of one hundred and eighty days, of a narcotic drug in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period.

(31) The term "Convention on Psychotropic Substances" means the Convention on Psychotropic Substances signed at Vienna, Austria, on February 21, 1971; and the term "Single Convention on Narcotic Drugs" means the Single Convention on Narcotic Drugs signed at New York, New York, on March 30, 1961.

(32)(A) Except as provided in subparagraph (C), the term "controlled substance analogue" means a substance—

(i) the chemical structure of which is substantially similar to the chemical structure of a controlled substance in schedule I or II;

(ii) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II; or

(iii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II.

(B) The designation of gamma butyrolactone or any other chemical as a listed chemical pursuant to paragraph (34) or (35) does not preclude a finding pursuant to subparagraph (A) of this paragraph that the chemical is a controlled substance analogue.

(C) Such term does not include—

(i) a controlled substance;

(ii) any substance for which there is an approved new drug application;

(iii) with respect to a particular person any substance, if an exemption is in effect for investigational use, for that person, under section 355 of this title to the extent conduct with respect to such substance is pursuant to such exemption; or

(iv) any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance.

(33) The term "listed chemical" means any list I chemical or any list II chemical.

(34) The term "list I chemical" means a chemical specified by regulation of the Attorney General as a chemical that is used in manufacturing a controlled substance in violation of this subchapter and is important to the manufacture of the controlled substances, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following:

(A) Anthranilic acid, its esters, and its salts.

(B) Benzyl cyanide.

(C) Ephedrine, its salts, optical isomers, and salts of optical isomers.

(D) Ergonovine and its salts.

(E) Ergotamine and its salts.

(F) N-Acetylanthranilic acid, its esters, and its salts.

(G) Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers.

(H) Phenylacetic acid, its esters, and its salts.

(I) Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers.

(J) Piperidine and its salts.

(K) Pseudoephedrine, its salts, optical isomers, and salts of optical isomers.

(L) 3,4-Methylenedioxyphenyl-2-propanone.

(M) Methylamine.

(N) Ethylamine.

(O) Propionic anhydride.

(P) Isosafrole.

(Q) Safrole.

(R) Piperonal.

(S) N-Methylephedrine.

(T) N-methylpseudoephedrine.

(U) Hydriodic acid.

(V) Benzaldehyde.

(W) Nitroethane.

(X) Gamma butyrolactone.

(Y) Any salt, optical isomer, or salt of an optical isomer of the chemicals listed in subparagraphs (M) through (U) of this paragraph.

(35) The term "list II chemical" means a chemical (other than a list I chemical) specified by regulation of the Attorney General as a chemical that is used in manufacturing a controlled substance in violation of this subchapter, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following chemicals:

(A) Acetic anhydride.

(B) Acetone.

(C) Benzyl chloride.

(D) Ethyl ether.

(E) Repealed. Pub. L. 101–647, title XXIII, §2301(b), Nov. 29, 1990, 104 Stat. 4858.

(F) Potassium permanganate.

(G) 2-Butanone (or Methyl Ethyl Ketone).

(H) Toluene.

(I) Iodine.

(J) Hydrochloric gas.

(36) The term "regular customer" means, with respect to a regulated person, a customer with whom the regulated person has an established business relationship that is reported to the Attorney General.

(37) The term "regular importer" means, with respect to a listed chemical, a person that has an established record as an importer of that listed chemical that is reported to the Attorney General.

(38) The term "regulated person" means a person who manufactures, distributes, imports, or exports a listed chemical, a tableting machine, or an encapsulating machine or who acts as a broker or trader for an international transaction involving a listed chemical, a tableting machine, or an encapsulating machine.

(39) The term "regulated transaction" means—

(A) a distribution, receipt, sale, importation, or exportation of, or an international transaction involving shipment of, a listed chemical, or if the Attorney General establishes a threshold amount for a specific listed chemical, a threshold amount, including a cumulative threshold amount for multiple transactions (as determined by the Attorney General, in consultation with the chemical industry and taking into consideration the quantities normally used for lawful purposes), of a listed chemical, except that such term does not include—

(i) a domestic lawful distribution in the usual course of business between agents or employees of a single regulated person;

(ii) a delivery of a listed chemical to or by a common or contract carrier for carriage in the lawful and usual course of the business of the common or contract carrier, or to or by a warehouseman for storage in the lawful and usual course of the business of the warehouseman, except that if the carriage or storage is in connection with the distribution, importation, or exportation of a listed chemical to a third person, this clause does not relieve a distributor, importer, or exporter from compliance with section 830 of this title;

(iii) any category of transaction or any category of transaction for a specific listed chemical or chemicals specified by regulation of the Attorney General as excluded from this definition as unnecessary for enforcement of this subchapter or subchapter II;

(iv) any transaction in a listed chemical that is contained in a drug that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], subject to clause (v), unless—

(I) the Attorney General has determined under section 814 of this title that the drug or group of drugs is being diverted to obtain the listed chemical for use in the illicit production of a controlled substance; and

(II) the quantity of the listed chemical contained in the drug included in the transaction or multiple transactions equals or exceeds the threshold established for that chemical by the Attorney General;

(v) any transaction in a scheduled listed chemical product that is a sale at retail by a regulated seller or a distributor required to submit reports under section 830(b)(3) of this title; or

(vi) any transaction in a chemical mixture which the Attorney General has by regulation designated as exempt from the application of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance and that the listed chemical or chemicals contained in the mixture cannot be readily recovered; and

(B) a distribution, importation, or exportation of a tableting machine or encapsulating machine.

(40) The term "chemical mixture" means a combination of two or more chemical substances, at least one of which is not a list I chemical or a list II chemical, except that such term does not include any combination of a list I chemical or a list II chemical with another chemical that is present solely as an impurity.

(41)(A) The term "anabolic steroid" means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes—

(i) androstanediol—

(I) 3β,17β-dihydroxy-5α-androstane; and

(II) 3α,17β-dihydroxy-5α-androstane;

(ii) androstanedione (5α-androstan-3,17-dione);

(iii) androstenediol—

(I) 1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene);

(II) 1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene);

(III) 4-androstenediol (3β,17β-dihydroxy-androst-4-ene); and

(IV) 5-androstenediol (3β,17β-dihydroxy-androst-5-ene);

(iv) androstenedione—

(I) 1-androstenedione ([5α]-androst-1-en-3,17-dione);

(II) 4-androstenedione (androst-4-en-3,17-dione); and

(III) 5-androstenedione (androst-5-en-3,17-dione);

(v) bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);

(vi) boldenone (17β-hydroxyandrost-1,4,-diene-3-one);

(vii) calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);

(viii) clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one);

(ix) dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one);

(x) Δ1-dihydrotestosterone (a.k.a. "1-testosterone") (17β-hydroxy-5α-androst-1-en-3-one);

(xi) 4-dihydrotestosterone (17β-hydroxy-androstan-3-one);

(xii) drostanolone (17β-hydroxy-2α-methyl-5α-androstan-3-one);

(xiii) ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene);

(xiv) fluoxymesterone (9-fluoro-17α-methyl-11β,17β-dihydroxyandrost-4-en-3-one);

(xv) formebolone (2-formyl-17α-methyl-11α,17β-dihydroxyandrost-1,4-dien-3-one);

(xvi) furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]-furazan);

(xvii) 13β-ethyl-17β-hydroxygon-4-en-3-one;

(xviii) 4-hydroxytestosterone (4,17β-dihydroxy-androst-4-en-3-one);

(xix) 4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-en-3-one);

(xx) mestanolone (17α-methyl-17β-hydroxy-5α-androstan-3-one);

(xxi) mesterolone (1α-methyl-17β-hydroxy-[5α]-androstan-3-one);

(xxii) methandienone (17α-methyl-17β-hydroxyandrost-1,4-dien-3-one);

(xxiii) methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene);

(xxiv) methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one);

(xxv) 17α-methyl-3β, 17β-dihydroxy-5α-androstane;

(xxvi) 17α-methyl-3α,17β-dihydroxy-5α-androstane;

(xxvii) 17α-methyl-3β,17β-dihydroxyandrost-4-ene.

(xxviii) 17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one);

(xxix) methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one);

(xxx) methyltrienolone (17α-methyl-17β-hydroxyestra-4,9-11-trien-3-one);

(xxxi) methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one);

(xxxii) mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one);

(xxxiii) 17α-methyl-Δ1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. "17-α-methyl-1-testosterone");

(xxxiv) nandrolone (17β-hydroxyestr-4-en-3-one);

(xxxv) norandrostenediol—

(I) 19-nor-4-androstenediol (3β, 17β-dihydroxyestr-4-ene);

(II) 19-nor-4-androstenediol (3α, 17β-dihydroxyestr-4-ene);

(III) 19-nor-5-androstenediol (3β, 17β-dihydroxyestr-5-ene); and

(IV) 19-nor-5-androstenediol (3α, 17β-dihydroxyestr-5-ene);

(xxxvi) norandrostenedione—

(I) 19-nor-4-androstenedione (estr-4-en-3,17-dione); and

(II) 19-nor-5-androstenedione (estr-5-en-3,17-dione;

(xxxvii) norbolethone (13β,17α-diethyl-17β-hydroxygon-4-en-3-one);

(xxxviii) norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one);

(xxxix) norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3-one);

(xl) normethandrolone (17α-methyl-17β-hydroxyestr-4-en-3-one);

(xli) oxandrolone (17α-methyl-17β-hydroxy-2-oxa-[5α]-androstan-3-one);

(xlii) oxymesterone (17α-methyl-4,17β-dihydroxyandrost-4-en-3-one);

(xliii) oxymetholone (17α-methyl-2-hydroxymethylene-17β-hydroxy-[5α]-androstan-3-one);

(xliv) stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);

(xlv) stenbolone (17β-hydroxy-2-methyl-[5α]-androst-1-en-3-one);

(xlvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);

(xlvii) testosterone (17β-hydroxyandrost-4-en-3-one);

(xlviii) tetrahydrogestrinone (13β,17α-diethyl-17β-hydroxygon-4,9,11-trien-3-one);

(xlix) trenbolone (17β-hydroxyestr-4,9,11-trien-3-one);

(l) 5α-Androstan-3,6,17-trione;

(li) 6-bromo-androstan-3,17-dione;

(lii) 6-bromo-androsta-1,4-diene-3,17-dione;

(liii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;

(liv) 4-chloro-17α-methyl-androst-4-ene-3β,17β-diol;

(lv) 4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one;

(lvi) 4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione;

(lvii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;

(lviii) 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one;

(lix) 2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one;

(lx) 2α,3α-epithio-17α-methyl-5α-androstan-17β-ol;

(lxi) [3,2-c]-furazan-5α-androstan-17β-ol;

(lxii) 3β-hydroxy-estra-4,9,11-trien-17-one;

(lxiii) 17α-methyl-androst-2-ene-3,17β-diol;

(lxiv) 17α-methyl-androsta-1,4-diene-3,17β-diol;

(lxv) Estra-4,9,11-triene-3,17-dione;

(lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one;

(lxvii) 6α-Methyl-androst-4-ene-3,17-dione;

(lxviii) 17α-Methyl-androstan-3-hydroxyimine-17β-ol;

(lxix) 17α-Methyl-5α-androstan-17β-ol;

(lxx) 17β-Hydroxy-androstano[2,3-d]isoxazole;

(lxxi) 17β-Hydroxy-androstano[3,2-c]isoxazole;

(lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5α-androstan-17β-ol;

(lxxiii) [3,2-c]pyrazole-androst-4-en-17β-ol;

(lxxiv) [3,2-c]pyrazole-5α-androstan-17β-ol; and

(lxxv) any salt, ester, or ether of a drug or substance described in this paragraph.

The substances excluded under this subparagraph may at any time be scheduled by the Attorney General in accordance with the authority and requirements of subsections (a) through (c) of section 811 of this title.

(B)(i) Except as provided in clause (ii), such term does not include an anabolic steroid which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the Secretary of Health and Human Services for such administration.

(ii) If any person prescribes, dispenses, or distributes such steroid for human use, such person shall be considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of subparagraph (A).

(C)(i) Subject to clause (ii), a drug or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed in subparagraph (A) and is derived from, or has a chemical structure substantially similar to, 1 or more anabolic steroids listed in subparagraph (A) shall be considered to be an anabolic steroid for purposes of this chapter if—

(I) the drug or substance has been created or manufactured with the intent of producing a drug or other substance that either—

(aa) promotes muscle growth; or

(bb) otherwise causes a pharmacological effect similar to that of testosterone; or

(II) the drug or substance has been, or is intended to be, marketed or otherwise promoted in any manner suggesting that consuming it will promote muscle growth or any other pharmacological effect similar to that of testosterone.

(ii) A substance shall not be considered to be a drug or hormonal substance for purposes of this subparagraph if it—

(I) is—

(aa) an herb or other botanical;

(bb) a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical; or

(cc) a combination of 2 or more substances described in item (aa) or (bb);

(II) is a dietary ingredient for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and

(III) is not anabolic or androgenic.

(iii) In accordance with section 885(a) of this title, any person claiming the benefit of an exemption or exception under clause (ii) shall bear the burden of going forward with the evidence with respect to such exemption or exception.

(42) The term "international transaction" means a transaction involving the shipment of a listed chemical across an international border (other than a United States border) in which a broker or trader located in the United States participates.

(43) The terms "broker" and "trader" mean a person that assists in arranging an international transaction in a listed chemical by—

(A) negotiating contracts;

(B) serving as an agent or intermediary; or

(C) bringing together a buyer and seller, a buyer and transporter, or a seller and transporter.

(44) The term "felony drug offense" means an offense that is punishable by imprisonment for more than one year under any law of the United States or of a State or foreign country that prohibits or restricts conduct relating to narcotic drugs, marihuana, anabolic steroids, or depressant or stimulant substances.

(45)(A) The term "scheduled listed chemical product" means, subject to subparagraph (B), a product that—

(i) contains ephedrine, pseudoephedrine, or phenylpropanolamine; and

(ii) may be marketed or distributed lawfully in the United States under the Federal, Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] as a nonprescription drug.

Each reference in clause (i) to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical.

(B) Such term does not include a product described in subparagraph (A) if the product contains a chemical specified in such subparagraph that the Attorney General has under section 811(a) of this title added to any of the schedules under section 812(c) of this title. In the absence of such scheduling by the Attorney General, a chemical specified in such subparagraph may not be considered to be a controlled substance.

(46) The term "regulated seller" means a retail distributor (including a pharmacy or a mobile retail vendor), except that such term does not include an employee or agent of such distributor.

(47) The term "mobile retail vendor" means a person or entity that makes sales at retail from a stand that is intended to be temporary, or is capable of being moved from one location to another, whether the stand is located within or on the premises of a fixed facility (such as a kiosk at a shopping center or an airport) or whether the stand is located on unimproved real estate (such as a lot or field leased for retail purposes).

(48) The term "at retail", with respect to the sale or purchase of a scheduled listed chemical product, means a sale or purchase for personal use, respectively.

(49)(A) The term "retail distributor" means a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to ephedrine, pseudoephedrine, or phenylpropanolamine products are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales.

(B) For purposes of this paragraph, entities are defined by reference to the Standard Industrial Classification (SIC) code, as follows:

(i) A grocery store is an entity within SIC code 5411.

(ii) A general merchandise store is an entity within SIC codes 5300 through 5399 and 5499.

(iii) A drug store is an entity within SIC code 5912.

(50) The term "Internet" means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio.

(51) The term "deliver, distribute, or dispense by means of the Internet" refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet.

(52) The term "online pharmacy"—

(A) means a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet; and

(B) does not include—

(i) manufacturers or distributors registered under subsection (a), (b), (e), or (f) of section 823 of this title who do not dispense controlled substances to an unregistered individual or entity;

(ii) nonpharmacy practitioners who are registered under section 823(g) of this title and whose activities are authorized by that registration;

(iii) any hospital or other medical facility that is operated by an agency of the United States (including the Armed Forces), provided such hospital or other facility is registered under section 823(g) of this title;

(iv) a health care facility owned or operated by an Indian tribe or tribal organization, only to the extent such facility is carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.];

(v) any agent or employee of any hospital or facility referred to in clause (iii) or (iv), provided such agent or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of health care facilities specified in clause (iv), only to the extent such individuals are furnishing services pursuant to the contracts or compacts described in such clause;

(vi) mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance;

(vii) a person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribution, or dispensing of a controlled substance by means of the Internet to any person in the United States;

(viii) a pharmacy registered under section 823(g) of this title whose dispensing of controlled substances via the Internet consists solely of—

(I) refilling prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (55); or

(II) filling new prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (56); or

(ix) any other persons for whom the Attorney General and the Secretary have jointly, by regulation, found it to be consistent with effective controls against diversion and otherwise consistent with the public health and safety to exempt from the definition of an "online pharmacy".

(53) The term "homepage" means the opening or main page or screen of the website of an online pharmacy that is viewable on the Internet.

(54) The term "practice of telemedicine" means, for purposes of this subchapter, the practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1395m(m) of title 42, which practice—

(A) is being conducted—

(i) while the patient is being treated by, and physically located in, a hospital or clinic registered under section 823(g) of this title; and

(ii) by a practitioner—

(I) acting in the usual course of professional practice;

(II) acting in accordance with applicable State law; and

(III) registered under section 823(g) of this title in the State in which the patient is located, unless the practitioner—

(aa) is exempted from such registration in all States under section 822(d) of this title; or

(bb) is—

(AA) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and

(BB) registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;

(B) is being conducted while the patient is being treated by, and in the physical presence of, a practitioner—

(i) acting in the usual course of professional practice;

(ii) acting in accordance with applicable State law; and

(iii) registered under section 823(g) of this title in the State in which the patient is located, unless the practitioner—

(I) is exempted from such registration in all States under section 822(d) of this title; or

(II) is—

(aa) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and

(bb) registered under section 823(g) of this title in any State or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;

(C) is being conducted by a practitioner—

(i) who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act [25 U.S.C. 5301 et seq.];

(ii) acting within the scope of the employment, contract, or compact described in clause (i); and

(iii) who is designated as an Internet Eligible Controlled Substances Provider by the Secretary under section 831(g)(2) of this title;

(D)(i) is being conducted during a public health emergency declared by the Secretary under section 247d of title 42; and

(ii) involves patients located in such areas, and such controlled substances, as the Secretary, with the concurrence of the Attorney General, designates, provided that such designation shall not be subject to the procedures prescribed by subchapter II of chapter 5 of title 5;

(E) is being conducted by a practitioner who has obtained from the Attorney General a special registration under section 831(h) of this title;

(F) is being conducted—

(i) in a medical emergency situation—

(I) that prevents the patient from being in the physical presence of a practitioner registered under section 823(g) of this title who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor;

(II) that prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title;

(III) during which the primary care practitioner of the patient or a practitioner otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and

(IV) that requires immediate intervention by a health care practitioner using controlled substances to prevent what the practitioner reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and

(ii) by a practitioner that—

(I) is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;

(II) is registered under section 823(g) of this title in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 823(g) of this title; and

(III) issues a controlled substance prescription in this emergency context that is limited to a maximum of a 5-day supply which may not be extended or refilled; or

(G) is being conducted under any other circumstances that the Attorney General and the Secretary have jointly, by regulation, determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.

(55) The term "refilling prescriptions for controlled substances in schedule III, IV, or V"—

(A) means the dispensing of a controlled substance in schedule III, IV, or V in accordance with refill instructions issued by a practitioner as part of a valid prescription that meets the requirements of subsections (b) and (c) of section 829 of this title, as appropriate; and

(B) does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed.

(56) The term "filling new prescriptions for controlled substances in schedule III, IV, or V" means filling a prescription for an individual for a controlled substance in schedule III, IV, or V, if—

(A) the pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid prescription of a practitioner that meets the applicable requirements of subsections (b) and (c) of section 829 of this title (in this paragraph referred to as the "original prescription");

(B) the pharmacy contacts the practitioner who issued the original prescription at the request of that individual to determine whether the practitioner will authorize the issuance of a new prescription for that individual for the controlled substance described in subparagraph (A); and

(C) the practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription.

(57) The term "suspicious order" may include, but is not limited to—

(A) an order of a controlled substance of unusual size;

(B) an order of a controlled substance deviating substantially from a normal pattern; and

(C) orders of controlled substances of unusual frequency.

(58) The term "serious drug felony" means an offense described in section 924(e)(2) of title 18 for which—

(A) the offender served a term of imprisonment of more than 12 months; and

(B) the offender's release from any term of imprisonment was within 15 years of the commencement of the instant offense.

(59) The term "serious violent felony" means—

(A) an offense described in section 3559(c)(2) of title 18 for which the offender served a term of imprisonment of more than 12 months; and

(B) any offense that would be a felony violation of section 113 of title 18, if the offense were committed in the special maritime and territorial jurisdiction of the United States, for which the offender served a term of imprisonment of more than 12 months.

(Pub. L. 91–513, title II, §102, Oct. 27, 1970, 84 Stat. 1242; Pub. L. 93–281, §2, May 14, 1974, 88 Stat. 124; Pub. L. 95–633, title I, §102(b), Nov. 10, 1978, 92 Stat. 3772; Pub. L. 96–132, §16(a), Nov. 30, 1979, 93 Stat. 1049; Pub. L. 98–473, title II, §507(a), (b), Oct. 12, 1984, 98 Stat. 2071; Pub. L. 98–509, title III, §301(a), Oct. 19, 1984, 98 Stat. 2364; Pub. L. 99–514, §2, Oct. 22, 1986, 100 Stat. 2095; Pub. L. 99–570, title I, §§1003(b), 1203, 1870, Oct. 27, 1986, 100 Stat. 3207–6, 3207–13, 3207–56; Pub. L. 99–646, §83, Nov. 10, 1986, 100 Stat. 3619; Pub. L. 100–690, title VI, §6054, Nov. 18, 1988, 102 Stat. 4316; Pub. L. 101–647, title XIX, §1902(b), title XXIII, §2301, title XXXV, §3599I, Nov. 29, 1990, 104 Stat. 4852, 4858, 4932; Pub. L. 103–200, §§2(a), 7–9(a), Dec. 17, 1993, 107 Stat. 2333, 2340; Pub. L. 103–322, title IX, §90105(d), title XXXIII, §330024(a), (b), (d)(1), Sept. 13, 1994, 108 Stat. 1988, 2150; Pub. L. 104–237, title II, §§204(a), 209, title IV, §401(a), (b), Oct. 3, 1996, 110 Stat. 3102, 3104, 3106, 3107; Pub. L. 104–294, title VI, §§604(b)(4), 607(j), Oct. 11, 1996, 110 Stat. 3506, 3512; Pub. L. 105–115, title I, §126(c)(3), Nov. 21, 1997, 111 Stat. 2328; Pub. L. 106–172, §§3(c), 5(a), Feb. 18, 2000, 114 Stat. 9, 10; Pub. L. 106–310, div. B, title XXXVI, §3622(a), Oct. 17, 2000, 114 Stat. 1231; Pub. L. 107–273, div. B, title IV, §4002(c)(1), Nov. 2, 2002, 116 Stat. 1808; Pub. L. 108–358, §2(a), Oct. 22, 2004, 118 Stat. 1661; Pub. L. 109–162, title XI, §1180, Jan. 5, 2006, 119 Stat. 3126; Pub. L. 109–177, title VII, §§711(a)(1), (2)(A), 712(a)(1), Mar. 9, 2006, 120 Stat. 256, 257, 263; Pub. L. 110–425, §3(a), Oct. 15, 2008, 122 Stat. 4821; Pub. L. 113–260, §2(a), Dec. 18, 2014, 128 Stat. 2929; Pub. L. 114–198, title III, §303(a)(2), July 22, 2016, 130 Stat. 722; Pub. L. 115–271, title III, §§3202(c), 3292(a), Oct. 24, 2018, 132 Stat. 3945, 3956; Pub. L. 115–334, title XII, §12619(a), Dec. 20, 2018, 132 Stat. 5018; Pub. L. 115–391, title IV, §401(a)(1), Dec. 21, 2018, 132 Stat. 5220; Pub. L. 117–215, §2(b), title I, §103(b)(1)(A), Dec. 2, 2022, 136 Stat. 2258, 2262; Pub. L. 118–189, §1, Dec. 23, 2024, 138 Stat. 2652.)

Editorial Notes

References in Text

Schedules I, II, III, IV, and V, referred to in pars. (6), (14), (32)(A), (52)(B)(viii), (55), and (56), are set out in section 812(c) of this title.

This subchapter, referred to in introductory provisions and in pars. (34), (35), (39)(A)(iii), (vi), and (54), was in the original "this title", meaning title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, and is popularly known as the "Controlled Substances Act". For complete classification of title II to the Code, see second paragraph of Short Title note set out under section 801 of this title and Tables.

Subchapter II, referred to in par. (39)(A)(iii), (vi), was in the original "title III", meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises subchapter II of this chapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in pars. (39)(A)(iv), (41)(C)(ii)(II), and (45)(A)(ii), 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.

This chapter, referred to in par. (41)(C)(i), was in the original "this Act", meaning Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Indian Self-Determination and Education Assistance Act, referred to in pars. (52)(B)(iv) and (54)(C)(i), is Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to chapter 46 (§5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

Amendments

2024—Pars. (57) to (59). Pub. L. 118–189 redesignated pars. (57) defining the term "serious drug felony" and (58) as (58) and (59), respectively, and realigned margins.

2022—Par. (16)(A). Pub. L. 117–215, §2(b)(1), substituted "the terms 'marihuana' and 'marijuana' mean" for "the term 'marihuana' means".

Par. (16)(B). Pub. L. 117–215, §2(b)(2), substituted "The terms 'marihuana' and 'marijuana' do not" for "The term 'marihuana' does not" in introductory provisions.

Par. (52)(B). Pub. L. 117–215, §103(b)(1)(A)(i)(I), substituted "823(g)" for "823(f)" wherever appearing.

Par. (52)(B)(i). Pub. L. 117–215, §103(b)(1)(A)(i)(II), substituted "(e), or (f)" for "(d), or (e)".

Par. (54). Pub. L. 117–215, §103(b)(1)(A)(ii), substituted "823(g)" for "823(f)" wherever appearing.

2018—Par. (16). Pub. L. 115–334 designated first sentence as subpar. (A), substituted "Subject to subparagraph (B), the" for "The", inserted subpar. (B) designation, introductory provisions, and cl. (i), designated second sentence as cl. (ii) of subpar. (B), and substituted "the" for "Such term does not include the" in cl. (ii).

Par. (24). Pub. L. 115–271, §3202(c), substituted "Health and Human Services" for "Health, Education, and Welfare".

Par. (57). Pub. L. 115–391, §401(a)(1), added par. (57) defining the term "serious drug felony".

Pub. L. 115–271, §3292(a), added par. (57) defining the term "suspicious order".

Par. (58). Pub. L. 115–391, §401(a)(1), added par. (58).

2016—Par. (18). Pub. L. 114–198 inserted "or 'opioid' " after "The term 'opiate' ".

2014—Par. (41)(A)(l) to (lxxv). Pub. L. 113–260, §2(a)(1), added cls. (l) to (lxxiv) and redesignated former cl. (xlx) as (lxxv).

Par. (41)(C). Pub. L. 113–260, §2(a)(2), added subpar. (C).

2008—Pars. (50) to (56). Pub. L. 110–425 added pars. (50) to (56).

2006—Par. (39)(A)(iv). Pub. L. 109–177, §712(a)(1)(A)(i), amended cl. (iv) generally. Prior to amendment, cl. (iv) related to transactions involving drugs containing ephedrine, pseudoephedrine, or phenylpropanolamine.

Par. (39)(A)(v), (vi). Pub. L. 109–177, §712(a)(1)(A)(ii), (iii), added cl. (v) and redesignated former cl. (v) as (vi).

Par. (41)(A)(xvii). Pub. L. 109–162, §1180(1), substituted "13β-ethyl-17β-hydroxygon-4-en-3-one;" for "13β-ethyl-17α-hydroxygon-4-en-3-one;".

Par. (41)(A)(xliv). Pub. L. 109–162, §1180(2), substituted "(17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);" for "(17α-methyl-17α-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole);".

Par. (45). Pub. L. 109–177, §§711(a)(1)(B), 712(a)(1)(B), added par. (45) and struck out former par. (45) which defined "ordinary over-the-counter pseudoephedrine or phenylpropanolamine product".

Pars. (46) to (48). Pub. L. 109–177, §§711(a)(1)(B), added pars. (46) to (48). Former par. (46) redesignated (49).

Par. (49). Pub. L. 109–177, §711(a)(1)(A), (2)(A), redesignated par. (46) as (49), substituted "ephedrine, pseudoephedrine, or" for "pseudoephedrine or" in subpar. (A), redesignated subpar. (C) as (B), and struck out former subpar. (B) which read as follows: "For purposes of this paragraph, sale for personal use means the sale of below-threshold quantities in a single transaction to an individual for legitimate medical use."

2004—Par. (41). Pub. L. 108–358, §2(a)(1), realigned margins, added subpar. (A), and struck out former subpar. (A) which defined "anabolic steroid".

Par. (44). Pub. L. 108–358, §2(a)(2), inserted "anabolic steroids," after "marihuana,".

2002—Pars. (43), (44). Pub. L. 107–273 repealed Pub. L. 104–294, §§604(b)(4), 607(j)(2). See 1996 Amendment note below.

2000—Par. (32)(A). Pub. L. 106–172, §5(a)(1), substituted "subparagraph (C)" for "subparagraph (B)" in introductory provisions.

Par. (32)(B), (C). Pub. L. 106–172, §5(a)(2), (3), added subpar. (B) and redesignated former subpar. (B) as (C).

Par. (34)(X), (Y). Pub. L. 106–172, §3(c), added subpar. (X) and redesignated former subpar. (X) as (Y).

Par. (39)(A)(iv)(II). Pub. L. 106–310 substituted "9 grams" for "24 grams" in two places and inserted before semicolon at end "and sold in package sizes of not more than 3 grams of pseudoephedrine base or 3 grams of phenylpropanolamine base".

1997—Par. (9)(A). Pub. L. 105–115 redesignated cl. (i) as subpar. (A) and struck out cl. (ii) which read as follows: "any derivative of barbituric acid which has been designated by the Secretary as habit forming under section 352(d) of this title; or".

1996—Par. (26). Pub. L. 104–294, §607(j)(1), amended par. (26) generally. Prior to amendment, par. (26) read as follows: "The term 'State' means any State, territory, or possession of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Trust Territory of the Pacific Islands, and the Canal Zone."

Par. (34)(P), (S), (U). Pub. L. 104–237, §209(1), substituted "Isosafrole" for "Insosafrole" in subpar. (P), "N-Methylephedrine" for "N-Methylepherdrine" in subpar. (S), and "Hydriodic acid" for "Hydriotic acid" in subpar. (U).

Par. (35)(G). Pub. L. 104–237, §209(2), amended subpar. (G) generally, inserting "(or Methyl Ethyl Ketone)" before period at end.

Par. (35)(I), (J). Pub. L. 104–237, §204(a), added subpars. (I) and (J).

Par. (39)(A)(iv)(I)(aa). Pub. L. 104–237, §401(a)(1), (b)(1), substituted ", pseudoephedrine or its salts, optical isomers, or salts of optical isomers, or phenylpropanolamine or its salts, optical isomers, or salts of optical isomers unless otherwise provided by regulation of the Attorney General issued pursuant to section 814(e) of this title, except that any sale of ordinary over-the-counter pseudoephedrine or phenylpropanolamine products by retail distributors shall not be a regulated transaction (except as provided in section 401(d) of the Comprehensive Methamphetamine Control Act of 1996);" for "as the only active medicinal ingredient or contains ephedrine or its salts, optical isomers, or salts of optical isomers and therapeutically insignificant quantities of another active medicinal ingredient;".

Par. (39)(A)(iv)(II). Pub. L. 104–237, §401(a)(2), (b)(2), inserted ", pseudoephedrine, phenylpropanolamine," after "ephedrine" and inserted before semicolon ", except that the threshold for any sale of products containing pseudoephedrine or phenylpropanolamine products by retail distributors or by distributors required to submit reports by section 830(b)(3) of this title shall be 24 grams of pseudoephedrine or 24 grams of phenylpropanolamine in a single transaction".

Pars. (43), (44). Pub. L. 104–294, §§604(b)(4), 607(j)(2), which provided for amendment to section identical to Pub. L. 104–237, §401(b)(3), below, were repealed by Pub. L. 107–273, §4002(c)(1).

Pub. L. 104–237, §401(b)(3), redesignated par. (43), relating to felony drug offense, as (44).

Pars. (45), (46). Pub. L. 104–237, §401(b)(4), added pars. (45) and (46).

1994—Par. (34)(V), (W). Pub. L. 103–322, §330024(b), realigned margins and capitalized first letter.

Par. (35). Pub. L. 103–322, §330024(d)(1), made technical correction to directory language of Pub. L. 103–200, §2(a)(4)(B). See 1993 Amendment note below.

Par. (39)(A)(iv)(II). Pub. L. 103–322, §330024(a), substituted "; or" for period at end.

Par. (43). Pub. L. 103–322, §90105(d), added par. (43) defining "felony drug offense".

1993—Par. (33). Pub. L. 103–200, §2(a)(1), substituted "any list I chemical or any list II chemical" for "any listed precursor chemical or listed essential chemical".

Par. (34). Pub. L. 103–200, §2(a)(2), substituted "list I chemical" for "listed precursor chemical" and "important to the manufacture" for "critical to the creation" in introductory provisions.

Par. (34)(A), (F), (H). Pub. L. 103–200, §2(a)(3), inserted ", its esters," before "and".

Par. (34)(O). Pub. L. 103–200, §8(1), (2), redesignated subpar. (P) as (O) and struck out former subpar. (O) which read as follows: "D-lysergic acid."

Par. (34)(P) to (S). Pub. L. 103–200, §8(2), redesignated subpars. (Q) to (T) as (P) to (S), respectively. Former subpar. (P) redesignated (O).

Par. (34)(T). Pub. L. 103–200, §8(2), redesignated subpar. (V) as (T). Former subpar. (T) redesignated (S).

Par. (34)(U). Pub. L. 103–200, §8(1), (2), redesignated subpar. (X) as (U) and struck out former subpar. (U) which read as follows: "N-ethylephedrine."

Par. (34)(V). Pub. L. 103–200, §8(2), (4), added subpar. (V) and redesignated former subpar. (V) as (T).

Par. (34)(W). Pub. L. 103–200, §8(1), (4), added subpar. (W) and struck out former subpar. (W) which read as follows: "N-ethylpseudoephedrine."

Par. (34)(X). Pub. L. 103–200, §8(2), (3), redesignated subpar. (Y) as (X) and substituted "through (U)" for "through (X)".

Par. (34)(Y). Pub. L. 103–200, §8(2), redesignated subpar. (Y) as (X).

Par. (35). Pub. L. 103–200, §2(a)(4)(A), (C), substituted "list II chemical" for "listed essential chemical" and struck out "as a solvent, reagent, or catalyst" before "in manufacturing".

Pub. L. 103–200, §2(a)(4)(B), as amended by Pub. L. 103–322, §330024(d)(1), inserted "(other than a list I chemical)" before "specified" the first time appearing.

Par. (37). Pub. L. 103–200, §9(a), amended par. (37) generally. Prior to amendment, par. (37) read as follows: "The term 'regular supplier' means, with respect to a regulated person, a supplier with whom the regulated person has an established business relationship that is reported to the Attorney General."

Par. (38). Pub. L. 103–200, §2(a)(5), inserted before period at end "or who acts as a broker or trader for an international transaction involving a listed chemical, a tableting machine, or an encapsulating machine".

Par. (39)(A). Pub. L. 103–200, §§2(a)(6)(A), 7, in introductory provisions, substituted "importation, or exportation of, or an international transaction involving shipment of," for "importation or exportation of" and inserted "a listed chemical, or if the Attorney General establishes a threshold amount for a specific listed chemical," before "a threshold amount,".

Par. (39)(A)(iii). Pub. L. 103–200, §2(a)(6)(B), inserted "or any category of transaction for a specific listed chemical or chemicals" after "transaction".

Par. (39)(A)(iv). Pub. L. 103–200, §2(a)(6)(C), amended cl. (iv) generally. Prior to amendment, cl. (iv) read as follows: "any transaction in a listed chemical that is contained in a drug that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act; or".

Par. (39)(A)(v). Pub. L. 103–200, §2(a)(6)(D), inserted before semicolon at end "which the Attorney General has by regulation designated as exempt from the application of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance and that the listed chemical or chemicals contained in the mixture cannot be readily recovered".

Par. (40). Pub. L. 103–200, §2(a)(7), substituted "list I chemical or a list II chemical" for "listed precursor chemical or a listed essential chemical" in two places.

Pars. (42), (43). Pub. L. 103–200, §2(a)(8), added pars. (42) and (43).

1990—Par. (32)(A). Pub. L. 101–647, §3599I, substituted "the stimulant" for "the stimulent" in cl. (ii) and "a stimulant" for "a stimulent" in cl. (iii).

Par. (34)(M) to (Y). Pub. L. 101–647, §2301(a), added subpars. (M) to (Y).

Par. (35)(E). Pub. L. 101–647, §2301(b), struck out subpar. (E) "Hydriodic acid."

Par. (41). Pub. L. 101–647, §1902(b), added par. (41).

1988—Par. (8). Pub. L. 100–690, §6054(1), inserted "or a listed chemical" after "a controlled substance".

Par. (11). Pub. L. 100–690, §6054(2), inserted "or a listed chemical" after "a controlled substance" in two places.

Pars. (33) to (40). Pub. L. 100–690, §6054(3), added pars. (33) to (40).

1986—Par. (6). Pub. L. 99–514 substituted "Internal Revenue Code of 1986" for "Internal Revenue Code of 1954".

Par. (14). Pub. L. 99–570, §1870, and Pub. L. 99–646 amended par. (14) identically, substituting "any optical" for "the optical" in second and third sentences.

Par. (25). Pub. L. 99–570, §1003(b)(1), added par. (25). Former par. (25) redesignated (26).

Pars. (26) to (31). Pub. L. 99–570, §1003(b)(2), redesignated pars. (25) to (30) as (26) to (31), respectively.

Par. (32). Pub. L. 99–570, §1203, added par. (32).

1984—Pars. (14) to (16). Pub. L. 98–473, §507(a), added par. (14) and redesignated former pars. (14) to (16) as (15) to (17), respectively.

Par. (17). Pub. L. 98–473, §507, redesignated former par. (16) as (17), and expanded and revised definition of "narcotic drug", including within term poppy straw, cocaine, and ecgonine. Former par. (17) redesignated (18).

Pars. (18) to (28). Pub. L. 98–473, §507(a), redesignated former pars. (17) to (27) as (18) to (28), respectively.

Par. (29). Pub. L. 98–509 which directed the substitution of "one hundred and eighty" for "twenty-one" in par. (28), was executed to par. (29) in view of the redesignation of par. (28) as par. (29) by Pub. L. 98–473.

Pub. L. 98–473, §507(a), redesignated former par. (28) as (29). Former par. (29) redesignated (30).

Par. (30). Pub. L. 98–473, §507(a), redesignated former par. (29) as (30).

1979—Par. (4). Pub. L. 96–132 substituted provisions defining "Drug Enforcement Administration" for provisions defining "Bureau of Narcotics and Dangerous Drugs".

1978—Par. (29). Pub. L. 95–633 added par. (29).

1974—Pars. (27), (28). Pub. L. 93–281 added pars. (27) and (28).

Statutory Notes and Related Subsidiaries

Effective Date of 2018 Amendment

Pub. L. 115–391, title IV, §401(c), Dec. 21, 2018, 132 Stat. 5221, provided that: "This section [amending this section and sections 841 and 960 of this title], and the amendments made by this section, shall apply to any offense that was committed before the date of enactment of this Act [Dec. 21, 2018], if a sentence for the offense has not been imposed as of such date of enactment."

Effective Date of 2008 Amendment

Pub. L. 110–425, §3(j), Oct. 15, 2008, 122 Stat. 4832, provided that:

"(1) In general.—Except as provided in paragraph (2), the amendments made by this Act [enacting section 831 of this title and amending this section and sections 823, 827, 829, 841, 843, 882 and 960 of this title] shall take effect 180 days after the date of enactment of this Act [Oct. 15, 2008].

"(2) Definition of practice of telemedicine.—

"(A) In general.—Until the earlier of 3 months after the date on which regulations are promulgated to carry out section 311(h) of the Controlled Substances Act [21 U.S.C. 831(h)], as amended by this Act, or 15 months after the date of enactment of this Act—

"(i) the definition of the term 'practice of telemedicine' in subparagraph (B) of this paragraph shall apply for purposes of the Controlled Substances Act [21 U.S.C. 801 et seq.]; and

"(ii) the definition of the term 'practice of telemedicine' in section 102(54) of the Controlled Substances Act [21 U.S.C. 802(54)], as amended by this Act, shall not apply.

"(B) Temporary phase-in of telemedicine regulation.—During the period specified in subparagraph (A), the term 'practice of telemedicine' means the practice of medicine in accordance with applicable Federal and State laws by a practitioner (as that term is defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), if the practitioner is using an interactive telecommunications system that satisfies the requirements of section 410.78(a)(3) of title 42, Code of Federal Regulations.

"(C) Rule of construction.—Nothing in this subsection may be construed to create a precedent that any specific course of conduct constitutes the 'practice of telemedicine' (as that term is defined in section 102(54) of the Controlled Substances Act, as amended by this Act) after the end of the period specified in subparagraph (A)."

Effective Date of 2004 Amendment

Pub. L. 108–358, §2(d), Oct. 22, 2004, 118 Stat. 1664, provided that: "The amendments made by this section [amending this section, section 811 of this title, and provisions set out as a note under this section] shall take effect 90 days after the date of enactment of this Act [Oct. 22, 2004]."

Effective Date of 2002 Amendment

Pub. L. 107–273, div. B, title IV, §4002(c)(1), Nov. 2, 2002, 116 Stat. 1808, provided that the amendment made by section 4002(c)(1) is effective Oct. 11, 1996.

Effective Date of 2000 Amendment

Pub. L. 106–310, div. B, title XXXVI, §3622(b), Oct. 17, 2000, 114 Stat. 1231, provided that: "The amendments made by subsection (a) [amending this section] shall take effect 1 year after the date of the enactment of this Act [Oct. 17, 2000]."

Effective Date of 1997 Amendment

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

Effective Date of 1996 Amendments

Amendment by section 604(b)(4) of Pub. L. 104–294 effective Sept. 13, 1994, see section 604(d) of Pub. L. 104–294, set out as a note under section 13 of Title 18, Crimes and Criminal Procedure.

Pub. L. 104–237, title IV, §401(g), Oct. 3, 1996, 110 Stat. 3110, provided that: "Notwithstanding any other provision of this Act [see section 1(a) of Pub. L. 104–237, set out as a Short Title of 1996 Amendments note under section 801 of this title], this section [amending this section and section 814 of this title and enacting provisions set out as a note below] shall not apply to the sale of any pseudoephedrine or phenylpropanolamine product prior to 12 months after the date of enactment of this Act [Oct. 3, 1996], except that, on application of a manufacturer of a particular pseudoephedrine or phenylpropanolamine drug product, the Attorney General may, in her sole discretion, extend such effective date up to an additional six months. Notwithstanding any other provision of law, the decision of the Attorney General on such an application shall not be subject to judicial review."

Effective Date of 1994 Amendment

Pub. L. 103–322, title XXXIII, §330024(f), Sept. 13, 1994, 108 Stat. 2151, provided that: "The amendments made by this section [amending this section and sections 824, 960, and 971 of this title] shall take effect as of the date that is 120 days after the date of enactment of the Domestic Chemical Diversion Control Act of 1993 [Dec. 17, 1993]."

Effective Date of 1993 Amendment

Pub. L. 103–200, §11, Dec. 17, 1993, 107 Stat. 2341, provided that: "This Act [enacting section 814 of this title, amending this section and sections 821 to 824, 830, 843, 880, 957, 958, 960, and 971 of this title, and enacting provisions set out as a note under section 801 of this title] and the amendments made by this Act shall take effect on the date that is 120 days after the date of enactment of this Act [Dec. 17, 1993]."

Effective Date of 1990 Amendment

Pub. L. 101–647, title XIX, §1902(d), Nov. 29, 1990, 104 Stat. 4852, provided that: "This section [amending this section and section 812 of this title and enacting provisions set out as a note under section 829 of this title] and the amendment made by this section shall take effect 90 days after the date of enactment of this Act [Nov. 29, 1990]."

Effective Date of 1988 Amendment

Pub. L. 100–690, title VI, §6061, Nov. 18, 1988, 102 Stat. 4320, provided that: "Except as otherwise provided in this subtitle, this subtitle [subtitle A (§§6051–6061) of title VI of Pub. L. 100–690, enacting section 971 of this title, amending this section and sections 830, 841 to 843, 872, 876, 881, 960, and 961 of this title, and enacting provisions set out as notes under this section and section 971 of this title] shall take effect 120 days after the enactment of this Act [Nov. 18, 1988]."

Effective Date of 1978 Amendment

Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title.

Regulations

Pub. L. 110–425, §3(k)(1), Oct. 15, 2008, 122 Stat. 4833, provided that: "The Attorney General may promulgate and enforce any rules, regulations, and procedures which may be necessary and appropriate for the efficient execution of functions under this Act [see Short Title of 2008 Amendment note set out under section 801 of this title] or the amendments made by this Act, and, with the concurrence of the Secretary of Health and Human Services where this Act or the amendments made by this Act so provide, promulgate any interim rules necessary for the implementation of this Act or the amendments made by this Act, prior to its effective date [see Effective Date of 2008 Amendment note above]."

Pub. L. 98–509, title III, §301(b), Oct. 19, 1984, 98 Stat. 2364, provided that: "The Secretary of Health and Human Services shall, within ninety days of the date of the enactment of this Act [Oct. 19, 1984], promulgate regulations for the administration of section 102(28) of the Controlled Substances Act [21 U.S.C. 802(29)] as amended by subsection (a) and shall include in the first report submitted under section 505(b) [503(b)] of the Public Health Service Act [former 42 U.S.C. 290aa–2(b)] after the expiration of such ninety days the findings of the Secretary with respect to the effect of the amendment made by subsection (a)."

Construction of 2008 Amendment

Pub. L. 110–425, §4, Oct. 15, 2008, 122 Stat. 4834, provided that: "Nothing in this Act [see Short Title of 2008 Amendment note set out under section 801 of this title] or the amendments made by this Act shall be construed as authorizing, prohibiting, or limiting the use of electronic prescriptions for controlled substances."

Preservation of State Authority To Regulate Scheduled Listed Chemicals

Pub. L. 109–177, title VII, §711(g), Mar. 9, 2006, 120 Stat. 263, provided that: "This section [amending this section and sections 830, 841, 842, and 844 of this title and enacting provisions set out as notes under sections 830 and 844 of this title] and the amendments made by this section may not be construed as having any legal effect on section 708 of the Controlled Substances Act [21 U.S.C. 903] as applied to the regulation of scheduled listed chemicals (as defined in section 102(45) of such Act [21 U.S.C. 802(45)])."

Report on Diversion of Ordinary, Over-the-Counter Pseudoephedrine and Phenylpropanolamine Products

Pub. L. 106–310, div. B, title XXXVI, §3642, Oct. 17, 2000, 114 Stat. 1237, provided that:

"(a) Study.—The Attorney General shall conduct a study of the use of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products in the clandestine production of illicit drugs. Sources of data for the study shall include the following:

"(1) Information from Federal, State, and local clandestine laboratory seizures and related investigations identifying the source, type, or brand of drug products being utilized and how they were obtained for the illicit production of methamphetamine and amphetamine.

"(2) Information submitted voluntarily from the pharmaceutical and retail industries involved in the manufacture, distribution, and sale of drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine, including information on changes in the pattern, volume, or both, of sales of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products.

"(b) Report.—

"(1) Requirement.—Not later than 1 year after the date of the enactment of this Act [Oct. 17, 2000], the Attorney General shall submit to Congress a report on the study conducted under subsection (a).

"(2) Elements.—The report shall include—

"(A) the findings of the Attorney General as a result of the study; and

"(B) such recommendations on the need to establish additional measures to prevent diversion of ordinary, over-the-counter pseudoephedrine and phenylpropanolamine (such as a threshold on ordinary, over-the-counter pseudoephedrine and phenylpropanolamine products) as the Attorney General considers appropriate.

"(3) Matters considered.—In preparing the report, the Attorney General shall consider the comments and recommendations including the comments on the Attorney General's proposed findings and recommendations, of State and local law enforcement and regulatory officials and of representatives of the industry described in subsection (a)(2).

"(c) Regulation of Retail Sales.—

"(1) In general.—Notwithstanding section 401(d) of the Comprehensive Methamphetamine Control Act of 1996 [Pub. L. 104–237] (21 U.S.C. 802 note) and subject to paragraph (2), the Attorney General shall establish by regulation a single-transaction limit of not less than 24 grams of ordinary, over-the-counter pseudoephedrine or phenylpropanolamine (as the case may be) for retail distributors, if the Attorney General finds, in the report under subsection (b), that—

"(A) there is a significant number of instances (as set forth in paragraph (3)(A) of such section 401(d) for purposes of such section) where ordinary, over-the-counter pseudoephedrine products, phenylpropanolamine products, or both such products that were purchased from retail distributors were widely used in the clandestine production of illicit drugs; and

"(B) the best practical method of preventing such use is the establishment of single-transaction limits for retail distributors of either or both of such products.

"(2) Due process.—The Attorney General shall establish the single-transaction limit under paragraph (1) only after notice, comment, and an informal hearing."

Regulation of Retail Sales of Certain Precursor Chemicals; Effect on Thresholds; Combination Ephedrine Products

Pub. L. 104–237, title IV, §401(d)–(f), Oct. 3, 1996, 110 Stat. 3108, which authorized the Attorney General to establish a single-transaction limit of 24 grams for pseudoephedrine, phenylpropanolamine, and combination ephedrine products for retail distributors, was repealed by Pub. L. 109–177, title VII, §712(b), Mar. 9, 2006, 120 Stat. 264.

Exemption for Substances in Paragraph (41)

Pub. L. 101–647, title XIX, §1903, Nov. 29, 1990, 104 Stat. 4853, as amended by Pub. L. 108–358, §2(c), Oct. 22, 2004, 118 Stat. 1663, provided that:

"(a) Drugs for Treatment of Rare Diseases.—If the Attorney General finds that a drug listed in paragraph (41) of section 102 of the Controlled Substances Act (as added by section 2 [1902] of this Act) is—

"(1) approved by the Food and Drug Administration as an accepted treatment for a rare disease or condition, as defined in section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb); and

"(2) does not have a significant potential for abuse, the Attorney General may exempt such drug from any production regulations otherwise issued under the Controlled Substances Act as may be necessary to ensure adequate supplies of such drug for medical purposes.

"(b) Date of Issuance of Regulations.—The Attorney General shall issue regulations implementing this section not later than 45 days after the date of enactment of this Act [Nov. 29, 1990], except that the regulations required under section 3(a) [former 1903(a)] shall be issued not later than 180 days after the date of enactment of this Act."