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21 U.S.C. § 357 — Qualification of drug development tools
Federal law — U.S. Code and appendices · legal_authorities
**(a) Process for qualification**
(1) **In general** — The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which—
(A)
(i) a requestor initiates such process by submitting a letter of intent to the Secretary; and
(ii) the Secretary accepts or declines to accept such letter of intent;
(B)
(i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and
(ii) the Secretary accepts or declines to accept the qualification plan; and
(C)
(i) if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package;
(ii) the Secretary determines whether to accept such qualification package for review; and
(iii) if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section.
(2) **Acceptance and review of submissions**
(A) *In general* — Subparagraphs (B), (C), and (D) shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as “qualification submissions”).
(B) *Acceptance factors; nonacceptance* — The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use.
(C) *Prioritization of qualification review* — The Secretary may prioritize the review of
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Source location: Title 21, Chapter 9, § 357; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Process for qualification**
(1) **In general** — The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which—
(A)
(i) a requestor initiates such process by submitting a letter of intent to the Secretary; and
(ii) the Secretary accepts or declines to accept such letter of intent;
(B)
(i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and
(ii) the Secretary accepts or declines to accept the qualification plan; and
(C)
(i) if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package;
(ii) the Secretary determines whether to accept such qualification package for review; and
(iii) if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section.
(2) **Acceptance and review of submissions**
(A) *In general* — Subparagraphs (B), (C), and (D) shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as “qualification submissions”).
(B) *Acceptance factors; nonacceptance* — The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use.
(C) *Prioritization of qualification review* — The Secretary may prioritize the review of a full qualification package submitted under paragraph (1) with respect to a drug development tool, based on factors determined appropriate by the Secretary, including—
(i) as applicable, the severity, rarity, or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition; and
(ii) the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority.
(D) *Engagement of external experts* — The Secretary may, for purposes of the review of qualification submissions, through the use of cooperative agreements, grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph (1) or the review of any full qualification package under paragraph (3).
(3) **Review of full qualification package** — The Secretary shall—
(A) conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and
(B) determine whether the drug development tool at issue is qualified for its proposed context of use.
(4) **Qualification** — The Secretary shall determine whether a drug development tool is qualified for a proposed context of use based on the scientific merit of a full qualification package reviewed under paragraph (3).
**(b) Effect of qualification**
(1) **In general** — A drug development tool determined to be qualified under subsection (a)(4) for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph (2).
(2) **Use of a drug development tool** — Subject to paragraph (3), a drug development tool qualified under this section may be used for—
(A) supporting or obtaining approval or licensure (as applicable) of a drug or biological product (including in accordance with [section 356(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/c&num=0&edition=prelim)) under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)]; or
(B) supporting the investigational use of a drug or biological product under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) or section 351(a)(3) of the Public Health Service Act [[42 U.S.C. 262(a)(3)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a/3&num=0&edition=prelim)].
(3) **Rescission or modification**
(A) *In general* — The Secretary may rescind or modify a determination under this section to qualify a drug development tool if the Secretary determines that the drug development tool is not appropriate for the proposed context of use specified by the requestor. Such a determination may be based on new information that calls into question the basis for such qualification.
(B) *Meeting for review* — If the Secretary rescinds or modifies under subparagraph (A) a determination to qualify a drug development tool, the requestor involved shall, on request, be granted a meeting with the Secretary to discuss the basis of the Secretary’s decision to rescind or modify the determination before the effective date of the rescission or modification.
**(c) Transparency**
(1) **In general** — Subject to paragraph (3), the Secretary shall make publicly available, and update on at least a biannual basis, on the Internet website of the Food and Drug Administration the following:
(A) Information with respect to each qualification submission under the qualification process under subsection (a), including—
(i) the stage of the review process applicable to the submission;
(ii) the date of the most recent change in stage status;
(iii) whether external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package; and
(iv) submissions from requestors under the qualification process under subsection (a), including any data and evidence contained in such submissions, and any updates to such submissions.
(B) The Secretary’s formal written determinations in response to such qualification submissions.
(C) Any rescissions or modifications under subsection (b)(3) of a determination to qualify a drug development tool.
(D) Summary reviews that document conclusions and recommendations for determinations to qualify drug development tools under subsection (a).
(E) A comprehensive list of—
(i) all drug development tools qualified under subsection (a); and
(ii) all surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product (including in accordance with [section 356(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/c&num=0&edition=prelim)) under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)].
(2) **Relation to Trade Secrets Act** — Information made publicly available by the Secretary under paragraph (1) shall be considered a disclosure authorized by law for purposes of [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim).
(3) **Applicability**
(A) *In general* — Nothing in this section shall be construed as authorizing or directing the Secretary to disclose—
(i) any information contained in an application submitted under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)] that is confidential commercial or trade secret information subject to [section 552(b)(4) of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/4&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim); or
(ii) in the case of a drug development tool that may be used to support the development of a qualified countermeasure, security countermeasure, or qualified pandemic or epidemic product, as defined in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act [[42 U.S.C. 247d–6a](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6a&num=0&edition=prelim), 247d–6b, 247d–6d], any information that the Secretary determines has a significant potential to affect national security.
(B) *Public acknowledgment* — In the case that the Secretary, pursuant to subparagraph (A)(ii), does not make information publicly available, the Secretary shall provide on the internet website of the Food and Drug Administration an acknowledgment of the information that has not been disclosed, pursuant to subparagraph (A)(ii).
**(d) Rule of construction** Nothing in this section shall be construed—
(1) to alter the standards of evidence under subsection (c) or (d) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), including the substantial evidence standard in such subsection (d), or under section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)] (as applicable); or
(2) to limit the authority of the Secretary to approve or license products under this chapter or the Public Health Service Act [[42 U.S.C. 201](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim) et seq.], as applicable (as in effect before December 13, 2016).
**(e) Definitions** In this section:
(1) **Biomarker** — The term “biomarker”—
(A) means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and
(B) includes a surrogate endpoint.
(2) **Biomedical research consortia** — The term “biomedical research consortia” means collaborative groups that may take the form of public-private partnerships and may include government agencies, institutions of higher education (as defined in [section 1001(a) of title 20](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title20-section1001/a&num=0&edition=prelim)), patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals.
(3) **Clinical outcome assessment** — The term “clinical outcome assessment” means—
(A) a measurement of a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions; and
(B) includes a patient-reported outcome.
(4) **Context of use** — The term “context of use” means, with respect to a drug development tool, the circumstances under which the drug development tool is to be used in drug development and regulatory review.
(5) **Drug development tool** — The term “drug development tool” includes—
(A) a biomarker;
(B) a clinical outcome assessment; and
(C) any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.
(6) **Patient-reported outcome** — The term “patient-reported outcome” means a measurement based on a report from a patient regarding the status of the patient’s health condition without amendment or interpretation of the patient’s report by a clinician or any other person.
(7) **Qualification** — The terms “qualification” and “qualified” mean a determination by the Secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this chapter.
(8) **Requestor** — The term “requestor” means an entity or entities, including a drug sponsor or a biomedical research consortia, seeking to qualify a drug development tool for a proposed context of use under this section.
(9) **Surrogate endpoint** — The term “surrogate endpoint” means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and—
(A) is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or
(B) is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with [section 356(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356/c&num=0&edition=prelim).
Cross-references
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 201
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Biologics license**
(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless—
(A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and
(B) each package of the biological product is plainly marked with—
(i) the proper name of the biological product contained in the package;
(ii) the name, address, and applicable license number of the manufacturer of the biological product; and
(iii) the expiration date of the biological product.
(2)
(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.
(B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)].
(C) The Secretary shall approve a biologics license application—
(i) on the basis of a demonstration that—
(I) the biological product that is the subject of the application is safe, pure, and potent; and
(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and
(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).
(D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 262
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general**
(1) **Authority** — In conducting and supporting research and development activities regarding countermeasures under [section 247d–6(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6/e&num=0&edition=prelim), the Secretary may conduct and support such activities in accordance with this section and, in consultation with the Director of the National Institutes of Health, as part of the program under [section 285f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section285f&num=0&edition=prelim), if the activities concern qualified countermeasures.
(2) **Definitions** — In this section:
(A) *Qualified countermeasure* — The term “qualified countermeasure” means a drug (as that term is defined by [section 321(g)(1) of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/g/1&num=0&edition=prelim)), biological product (as that term is defined by [section 262(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/i&num=0&edition=prelim)), or device (as that term is defined by [section 321(h) of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/h&num=0&edition=prelim)), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)—
(i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security;
(ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d–6a
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
The following acts and the causing thereof are prohibited:
**(a)** The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
**(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
**(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
**(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title.
**(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm).
**(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
**(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
*
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 331
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Federal law — U.S. Code and appendices · legal_authorities
A drug or device shall be deemed to be misbranded—
**(a) False or misleading label**
(1) If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indication approved under section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for such drug or device, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug or device under section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). The requirements set forth in section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request.
(2)
(A) For purposes of th
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 352
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Regulations for goods to be processed, labeled, or repacked elsewhere** The Secretary is directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.
**(b) Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws**
(1) A drug intended for use by man which—
(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or
(B) is limited by an approved application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) to use under the professional supervision of a practitioner licensed by law to administer such drug;
shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 353
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Request by sponsor; response by Secretary** The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before—
(1) it may be approved for such disease or condition under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or
(2) if the drug is a biological product, it may be licensed for such disease or condition under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim).
If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or licensing of such drug for such disease or condition under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim).
**(b) Regulations** The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360aa
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.