Browse Arkansas Code titles and sections
21 U.S.C. § 356f — Hospital repackaging of drugs in shortage
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **Drug** — The term “drug” excludes any controlled substance (as such term is defined in [section 802 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802&num=0&edition=prelim)).
(2) **Health system** — The term “health system” means a collection of hospitals that are owned and operated by the same entity and that share access to databases with drug order information for their patients.
(3) **Repackage** — For the purposes of this section only, the term “repackage”, with respect to a drug, means to divide the volume of a drug into smaller amounts in order to—
(A) extend the supply of a drug in response to the placement of the drug on a drug shortage list under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim); and
(B) facilitate access to the drug by hospitals within the same health system.
**(b) Exclusion from registration** Notwithstanding any other provision of this chapter, a hospital shall not be considered an establishment for which registration is required under [section 360 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360&num=0&edition=prelim) solely because it repackages a drug and transfers it to another hospital within the same health system in accordance with the conditions in subsection (c)—
(1) during any period in which the drug is listed on the drug shortage list under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim); or
(2) during the 60-day period following any period described in paragraph (1).
**(c) Conditions** Subsection (b) shall only apply to a
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356f
Stored review status: release_metadata_unconfirmed. A text match is a research starting point; applicability is not established.
Original supplied file — preserved unchanged
Download original Markdown file
File SHA-256: 2271088c49c09336c398e9265644177b6bd29a67a1a98025846539efae0fa124. The original may include catalog metadata, neighboring provisions, or embedded records outside this collection's scope. Search shows only the selected federal record. Historical editions and unverified snapshots are not a statement of current law.
Authority boundary: historical or unconfirmed source not current law verified.
Open the recorded source website ↗
Record provenance
Stable record: federal_law:legal_authorities:record_usc_a801342d3a40137d3f2b07d7
Source file: Laws/federal/codes/united-states-code/title-21/section-356f-hospital-repackaging-of-drugs-in-shortage--d2a1aa9188.md
Pages: Not recorded – Not recorded
Passage SHA-256: 28ff851e055607d4aba95d355ea0aea1718681dc27f3067a16bc7e6aae1eb4f7
Source location: Title 21, Chapter 9, § 356f; chapter-009-federal-food-drug-and-cosmetic-act.md
Stored source content
**(a) Definitions** In this section:
(1) **Drug** — The term “drug” excludes any controlled substance (as such term is defined in [section 802 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802&num=0&edition=prelim)).
(2) **Health system** — The term “health system” means a collection of hospitals that are owned and operated by the same entity and that share access to databases with drug order information for their patients.
(3) **Repackage** — For the purposes of this section only, the term “repackage”, with respect to a drug, means to divide the volume of a drug into smaller amounts in order to—
(A) extend the supply of a drug in response to the placement of the drug on a drug shortage list under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim); and
(B) facilitate access to the drug by hospitals within the same health system.
**(b) Exclusion from registration** Notwithstanding any other provision of this chapter, a hospital shall not be considered an establishment for which registration is required under [section 360 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360&num=0&edition=prelim) solely because it repackages a drug and transfers it to another hospital within the same health system in accordance with the conditions in subsection (c)—
(1) during any period in which the drug is listed on the drug shortage list under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim); or
(2) during the 60-day period following any period described in paragraph (1).
**(c) Conditions** Subsection (b) shall only apply to a hospital, with respect to the repackaging of a drug for transfer to another hospital within the same health system, if the following conditions are met:
(1) **Drug for intrasystem use only** — In no case may a drug that has been repackaged in accordance with this section be sold or otherwise distributed by the health system or a hospital within the system to an entity or individual that is not a hospital within such health system.
(2) **Compliance with State rules** — Repackaging of a drug under this section shall be done in compliance with applicable State requirements of each State in which the drug is repackaged and received.
**(d) Termination** This section shall not apply on or after the date on which the Secretary issues final guidance that clarifies the policy of the Food and Drug Administration regarding hospital pharmacies repackaging and safely transferring repackaged drugs to other hospitals within the same health system during a drug shortage.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** As used in this section—
(1) the term “manufacture, preparation, propagation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user; and
(2) the term “name” shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation.
**(b) Annual registration**
(1) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address.
(2) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a device or devices shall register with the Secretary his name, places of business, and all such establishments.
(3) The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the pr
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment** The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States.
**(b) Contents** For each drug on such list, the Secretary shall include the following information:
(1) The name of the drug in shortage, including the National Drug Code number for such drug.
(2) The name of each manufacturer of such drug.
(3) The reason for the shortage, as determined by the Secretary, selecting from the following categories:
(A) Requirements related to complying with good manufacturing practices.
(B) Regulatory delay.
(C) Shortage of an active ingredient.
(D) Shortage of an inactive ingredient component.
(E) Discontinuance of the manufacture of the drug.
(F) Delay in shipping of the drug.
(G) Demand increase for the drug.
(4) The estimated duration of the shortage as determined by the Secretary.
**(c) Public availability**
(1) **In general** — Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available.
(2) **Trade secrets and confidential information** — Nothing in this section alters or amends [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim) or [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).
(3) **Public health exception** — The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or [section 356c(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c/c&num=0&edition=prelim) if the Secretary determines that disclosure of such information would advers
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356e
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
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 labelin
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 802
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
Page 288
TITLE 21—FOOD AND DRUGS
§ 356e
(1) be subject to judicial review; or
(2) be construed to establish a defense to an
enforcement action by the Secretary.
(f) Temporary sunset
Subsection (a) shall cease to be effective on
the date that is 5 years after July 9, 2012. Sub-
sections (b), (c), and (e) shall not be in effect
during the period beginning 5 years after July 9,
2012, and ending on December 29, 2022. Sub-
sections (b), (c), and (e) shall be in effect begin-
ning on December 29, 2022.
(g) Coordination
The Secretary shall ensure timely and effec-
tive internal coordination and alignment among
the field investigators of the Food and Drug Ad-
ministration and the staff of the Center for Drug
Evaluation and Research’s Office of Compliance
and Drug Shortage Program regarding—
(1) the reviews of reports shared pursuant to
section 374(b)(2) of this title; and
(2) any feedback or corrective or preventive
actions in response to such reports.
(June 25, 1938, ch. 675, § 506D, as added Pub. L.
112–144, title X, § 1003, July 9, 2012, 126 Stat. 1103;
amended Pub. L. 117–328, div. FF, title III,
§ 3616(a), Dec. 29, 2022, 136 Stat. 5874.)
Editorial Notes
AMENDMENTS
2022—Subsec. (f). Pub. L. 117–328, § 3616(a)(2), amended
subsec. (f) generally. Prior to amendment, text read as
follows: ‘‘Subsections (a), (b), (c), and (e) shall cease to
be effective on the date that is 5 years after July 9,
2012.’’
Subsec. (g). Pub. L. 117–328, § 3616(a)(1), added subsec.
(g).
§ 356e. Drug shortage list
(a) Establishment
The Secretary shall maintain an up-to-date
list of drugs that are determined by the Sec-
retary to be in shortage in the United States.
(b) Contents
For each drug on such list, the Secretary shall
include the following information:
(1) The
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 356f
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.