{"identifier":"/us/usc/t21/s356f","title_num":"21","num":"§ 356f.","heading":"Hospital repackaging of drugs in shortage","status":null,"guid":"id5f09bbad-9e8b-11ee-8da9-e6a1cd721768","source_credit":"(June 25, 1938, ch. 675, § 506F, as added Pub. L. 112–144, title X, § 1007, July 9, 2012, 126 Stat. 1106.)","seq_in_title":175,"parent_identifier":"/us/usc/t21/ch9/schV/ptA","ancestors":[{"identifier":"/us/usc/t21","level":"title","num":"Title 21—","heading":"FOOD AND DRUGS","status":null,"is_section":false},{"identifier":"/us/usc/t21/ch9","level":"chapter","num":"CHAPTER 9—","heading":"FEDERAL FOOD, DRUG, AND COSMETIC ACT","status":null,"is_section":false},{"identifier":"/us/usc/t21/ch9/schV","level":"subchapter","num":"SUBCHAPTER V—","heading":"DRUGS AND DEVICES","status":null,"is_section":false},{"identifier":"/us/usc/t21/ch9/schV/ptA","level":"part","num":"Part A—","heading":"Drugs and Devices","status":null,"is_section":false}],"xml":"<section xmlns=\"http://xml.house.gov/schemas/uslm/1.0\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\" xmlns:dc=\"http://purl.org/dc/elements/1.1/\" xmlns:dcterms=\"http://purl.org/dc/terms/\" style=\"-uslm-lc:I80\" id=\"id28db263b-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f\"><num value=\"356f\">§ 356f.</num><heading> Hospital repackaging of drugs in shortage</heading><subsection style=\"-uslm-lc:I19\" class=\"indent2 firstIndent-2\" id=\"id28db263c-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/a\"><num value=\"a\" class=\"bold\">(a)</num><heading class=\"bold\"> Definitions</heading><chapeau style=\"-uslm-lc:I11\" class=\"indent0\">In this section:</chapeau><paragraph style=\"-uslm-lc:I79\" class=\"indent3 firstIndent-2\" id=\"id28db263d-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/a/1\"><num value=\"1\" class=\"bold\">(1)</num><heading class=\"bold\"> Drug</heading><content><p style=\"-uslm-lc:I12\" class=\"indent1\">The term “drug” excludes any controlled substance (as such term is defined in <ref href=\"/us/usc/t21/s802\">section 802 of this title</ref>).</p>\n</content>\n</paragraph>\n<paragraph style=\"-uslm-lc:I79\" class=\"indent3 firstIndent-2\" id=\"id28db263e-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/a/2\"><num value=\"2\" class=\"bold\">(2)</num><heading class=\"bold\"> Health system</heading><content><p style=\"-uslm-lc:I12\" class=\"indent1\">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.</p>\n</content>\n</paragraph>\n<paragraph style=\"-uslm-lc:I79\" class=\"indent3 firstIndent-2\" id=\"id28db263f-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/a/3\"><num value=\"3\" class=\"bold\">(3)</num><heading class=\"bold\"> Repackage</heading><chapeau style=\"-uslm-lc:I12\" class=\"indent1\">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—</chapeau><subparagraph style=\"-uslm-lc:I13\" class=\"indent2\" id=\"id28db2640-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/a/3/A\"><num value=\"A\">(A)</num><content> extend the supply of a drug in response to the placement of the drug on a drug shortage list under <ref href=\"/us/usc/t21/s356e\">section 356e of this title</ref>; and</content>\n</subparagraph>\n<subparagraph style=\"-uslm-lc:I13\" class=\"indent2\" id=\"id28db2641-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/a/3/B\"><num value=\"B\">(B)</num><content> facilitate access to the drug by hospitals within the same health system.</content>\n</subparagraph>\n</paragraph>\n</subsection>\n<subsection style=\"-uslm-lc:I19\" class=\"indent2 firstIndent-2\" id=\"id28db2642-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/b\"><num value=\"b\" class=\"bold\">(b)</num><heading class=\"bold\"> Exclusion from registration</heading><chapeau style=\"-uslm-lc:I11\" class=\"indent0\">Notwithstanding any other provision of this chapter, a hospital shall not be considered an establishment for which registration is required under <ref href=\"/us/usc/t21/s360\">section 360 of this title</ref> 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)—</chapeau><paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id28db2643-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/b/1\"><num value=\"1\">(1)</num><content> during any period in which the drug is listed on the drug shortage list under <ref href=\"/us/usc/t21/s356e\">section 356e of this title</ref>; or</content>\n</paragraph>\n<paragraph style=\"-uslm-lc:I12\" class=\"indent1\" id=\"id28db2644-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/b/2\"><num value=\"2\">(2)</num><content> during the 60-day period following any period described in paragraph (1).</content>\n</paragraph>\n</subsection>\n<subsection style=\"-uslm-lc:I19\" class=\"indent2 firstIndent-2\" id=\"id28db2645-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/c\"><num value=\"c\" class=\"bold\">(c)</num><heading class=\"bold\"> Conditions</heading><chapeau style=\"-uslm-lc:I11\" class=\"indent0\">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:</chapeau><paragraph style=\"-uslm-lc:I79\" class=\"indent3 firstIndent-2\" id=\"id28db2646-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/c/1\"><num value=\"1\" class=\"bold\">(1)</num><heading class=\"bold\"> Drug for intrasystem use only</heading><content><p style=\"-uslm-lc:I12\" class=\"indent1\">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.</p>\n</content>\n</paragraph>\n<paragraph style=\"-uslm-lc:I79\" class=\"indent3 firstIndent-2\" id=\"id28db2647-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/c/2\"><num value=\"2\" class=\"bold\">(2)</num><heading class=\"bold\"> Compliance with State rules</heading><content><p style=\"-uslm-lc:I12\" class=\"indent1\">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.</p>\n</content>\n</paragraph>\n</subsection>\n<subsection style=\"-uslm-lc:I19\" class=\"indent2 firstIndent-2\" id=\"id28db2648-09a0-11eb-a78d-da6bfa680960\" identifier=\"/us/usc/t21/s356f/d\"><num value=\"d\" class=\"bold\">(d)</num><heading class=\"bold\"> Termination</heading><content><p style=\"-uslm-lc:I11\" class=\"indent0\">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.</p>\n</content>\n</subsection>\n<sourceCredit id=\"id28db2649-09a0-11eb-a78d-da6bfa680960\">(<ref href=\"/us/act/1938-06-25/ch675/s506F\">June 25, 1938, ch. 675, § 506F</ref>, as added <ref href=\"/us/pl/112/144/tX/s1007\">Pub. L. 112–144, title X, § 1007</ref>, <date date=\"2012-07-09\">July 9, 2012</date>, <ref href=\"/us/stat/126/1106\">126 Stat. 1106</ref>.)</sourceCredit>\n</section>","provision":null,"duplicates":[],"release":{"label":"118-44","currency_date":"2024-03-18","congress":118,"law_num":44,"excluded_laws":[],"update_num":null,"seq":322,"is_partial":false,"caveat":null,"titles_affected":["01","02","05","07","08","10","11","12","15","16","18","20","21","22","23","28","30","31","33","34","36","38","42","43","48","49","51","54"],"ingested_titles":[]},"served_from":{"label":"118-44","currency_date":"2024-03-18","congress":118,"law_num":44,"excluded_laws":[],"update_num":null,"seq":322,"is_partial":false,"caveat":null,"titles_affected":["01","02","05","07","08","10","11","12","15","16","18","20","21","22","23","28","30","31","33","34","36","38","42","43","48","49","51","54"],"ingested_titles":[]},"content_first_seen":{"label":"116-163","currency_date":"2020-10-02","congress":116,"law_num":163,"excluded_laws":[],"update_num":null,"seq":214,"is_partial":false,"caveat":null,"titles_affected":["01","02","03","06","07","08","10","15","17","18","21","22","23","26","28","31","35","36","38","40","42","45","49","50"],"ingested_titles":[]},"is_exact":true,"note":null}