{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3434.05.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3434.05.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3434.05.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3434.05.html"}],"law_id":80945,"edition_id":1,"section_id":80945,"structure_id":15232,"section_number":"54.1-3434.05","catch_line":"Permit to act as an outsourcing facility","history":"2015, c. 300.","full_text":"A\n\nNo person shall act as an outsourcing facility without first obtaining a permit from the Board.B\n\nApplications for a permit to act as an outsourcing facility shall be made on a form provided by the Board and signed by a pharmacist who will be in full and actual charge of the outsourcing facility and who will be fully engaged in the compounding performed at the location designated on the application. Such application shall be accompanied by a fee determined by the Board in regulation. All permits shall expire annually on a date determined by the Board in regulation. No permit shall be issued or renewed for an outsourcing facility unless the facility can demonstrate compliance with all applicable federal and state laws and regulations governing outsourcing facilities.C\n\nAs a prerequisite to obtaining or renewing a permit from the Board, the outsourcing facility shall (i) register as an outsourcing facility with the U.S. Secretary of Health and Human Services in accordance with 21 U.S.C. § 353b and (ii) submit a copy of a current inspection report resulting from an inspection conducted by the U.S. Food and Drug Administration that indicates compliance with the requirements of state and federal law and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.\n\t\t\tThe inspection report required pursuant to clause (ii) shall be deemed current for the purposes of this section if the inspection was conducted (a) no more than one year prior to the date of submission of an application for a permit to the Board or (b) no more than two years prior to the date of submission of an application for renewal of a permit to the Board. However, if the outsourcing facility has not been inspected by the U.S. Food and Drug Administration within the required period, the Board may accept an inspection report or other documentation from another entity that is satisfactory to the Board, or the Board may cause an inspection to be conducted by its duly authorized agent and may charge an inspection fee in an amount sufficient to cover the costs of the inspection.D\n\nEvery outsourcing facility shall compound in compliance with the requirements of state and federal law and regulations except § 54.1-3410.2, to include all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.E\n\nAn outsourcing facility shall not engage in compounding of drug products to be dispensed pursuant to a valid prescription for a specific patient without first obtaining a permit to operate a pharmacy.","order_by":null,"text":{"0":{"id":290152,"text":"No person shall act as an outsourcing facility without first obtaining a permit from the Board.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":290153,"text":"Applications for a permit to act as an outsourcing facility shall be made on a form provided by the Board and signed by a pharmacist who will be in full and actual charge of the outsourcing facility and who will be fully engaged in the compounding performed at the location designated on the application. Such application shall be accompanied by a fee determined by the Board in regulation. All permits shall expire annually on a date determined by the Board in regulation. No permit shall be issued or renewed for an outsourcing facility unless the facility can demonstrate compliance with all applicable federal and state laws and regulations governing outsourcing facilities.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":290154,"text":"As a prerequisite to obtaining or renewing a permit from the Board, the outsourcing facility shall (i) register as an outsourcing facility with the U.S. Secretary of Health and Human Services in accordance with 21 U.S.C. § 353b and (ii) submit a copy of a current inspection report resulting from an inspection conducted by the U.S. Food and Drug Administration that indicates compliance with the requirements of state and federal law and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.\n\t\t\tThe inspection report required pursuant to clause (ii) shall be deemed current for the purposes of this section if the inspection was conducted (a) no more than one year prior to the date of submission of an application for a permit to the Board or (b) no more than two years prior to the date of submission of an application for renewal of a permit to the Board. However, if the outsourcing facility has not been inspected by the U.S. Food and Drug Administration within the required period, the Board may accept an inspection report or other documentation from another entity that is satisfactory to the Board, or the Board may cause an inspection to be conducted by its duly authorized agent and may charge an inspection fee in an amount sufficient to cover the costs of the inspection.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"3":{"id":290155,"text":"Every outsourcing facility shall compound in compliance with the requirements of state and federal law and regulations except § 54.1-3410.2, to include all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug Administration.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C","next_prefix":"E"},"4":{"id":290156,"text":"An outsourcing facility shall not engage in compounding of drug products to be dispensed pursuant to a valid prescription for a specific patient without first obtaining a permit to operate a pharmacy.","type":"section","prefixes":["E"],"prefix":"E","entire_prefix":"E","prefix_anchor":"E","level":1,"prior_prefix":"D"}},"ancestry":[{"id":15232,"edition_id":1,"name":"Permitting of Pharmacies","identifier":"2","label":"article","depth":4,"order_by":1,"parent_id":13240,"metadata":{},"date_created":"2026-06-26 03:53:13","date_modified":"2026-06-26 03:53:13","permalink":{"id":243439,"object_type":"structure","relational_id":15232,"identifier":"2","token":"54.1\/III\/34\/2","url":"\/54.1\/III\/34\/2\/","edition_id":1,"permalink":0,"preferred":1}},{"id":13240,"edition_id":1,"name":"Drug Control Act","identifier":"34","label":"chapter","depth":3,"order_by":1,"parent_id":12758,"metadata":{},"date_created":"2026-06-26 03:44:30","date_modified":"2026-06-26 03:44:30","permalink":{"id":243223,"object_type":"structure","relational_id":13240,"identifier":"34","token":"54.1\/III\/34","url":"\/54.1\/III\/34\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12758,"edition_id":1,"name":"Professions and Occupations Regulated by Boards Within the Department of Health Professions","identifier":"III","label":"subtitle","depth":2,"order_by":1,"parent_id":12754,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":241105,"object_type":"structure","relational_id":12758,"identifier":"III","token":"54.1\/III","url":"\/54.1\/III\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12754,"edition_id":1,"name":"Professions and Occupations","identifier":"54.1","label":"title","depth":1,"order_by":1,"parent_id":null,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":239313,"object_type":"structure","relational_id":12754,"identifier":"54.1","token":"54.1","url":"\/54.1\/","edition_id":1,"permalink":0,"preferred":1}}],"structure_contents":[{"id":76730,"structure_id":15232,"section_number":"54.1-3432","catch_line":"Supervision by pharmacist","url":"\/54.1-3432\/","token":"54.1\/III\/34\/2\/54.1-3432","metadata":false},{"id":67247,"structure_id":15232,"section_number":"54.1-3433","catch_line":"Certain advertising and signs unlawful","url":"\/54.1-3433\/","token":"54.1\/III\/34\/2\/54.1-3433","metadata":false},{"id":72686,"structure_id":15232,"section_number":"54.1-3434","catch_line":"Permit to conduct pharmacy","url":"\/54.1-3434\/","token":"54.1\/III\/34\/2\/54.1-3434","metadata":false},{"id":73909,"structure_id":15232,"section_number":"54.1-3434.01","catch_line":"Notice of pharmacy closing; change of ownership; penalty","url":"\/54.1-3434.01\/","token":"54.1\/III\/34\/2\/54.1-3434.01","metadata":false},{"id":57997,"structure_id":15232,"section_number":"54.1-3434.02","catch_line":"Automated drug dispensing systems and remote dispensing systems","url":"\/54.1-3434.02\/","token":"54.1\/III\/34\/2\/54.1-3434.02","metadata":false},{"id":65752,"structure_id":15232,"section_number":"54.1-3434.03","catch_line":"Continuous quality improvement program","url":"\/54.1-3434.03\/","token":"54.1\/III\/34\/2\/54.1-3434.03","metadata":false},{"id":59011,"structure_id":15232,"section_number":"54.1-3434.04","catch_line":"Automatic review of certain case decisions","url":"\/54.1-3434.04\/","token":"54.1\/III\/34\/2\/54.1-3434.04","metadata":false},{"id":80945,"structure_id":15232,"section_number":"54.1-3434.05","catch_line":"Permit to act as an outsourcing facility","url":"\/54.1-3434.05\/","token":"54.1\/III\/34\/2\/54.1-3434.05","metadata":false}],"previous_section":{"id":59011,"structure_id":15232,"section_number":"54.1-3434.04","catch_line":"Automatic review of certain case decisions","url":"\/54.1-3434.04\/","token":"54.1\/III\/34\/2\/54.1-3434.04","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3434.05\/","history_text":"

This law was first created in 2015. The record of its establishment is cataloged in chapter 300<\/a> of that year\u2019s edition of \u201cActs of Assembly,\u201d the annual state publication listing all changes made to the Code of Virginia in that year.<\/p>","references":false,"refers_to":[{"id":84268,"section_number":"54.1-3410.2","catch_line":"Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements","order_by":null,"url":"\/54.1-3410.2\/"}],"permalink":{"id":243469,"object_type":"law","relational_id":80945,"identifier":"54.1-3434.05","token":"54.1\/III\/34\/2\/54.1-3434.05","url":"\/54.1-3434.05\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3434.05\/","token":"54.1\/III\/34\/2\/54.1-3434.05","dublin_core":{"Title":"Permit to act as an outsourcing facility","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3434.05","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> No person<\/span> shall act as an outsourcing facility<\/span> without first obtaining a permit from the Board<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> Applications for a permit to act as an outsourcing facility<\/span> shall be made on a form provided by the Board<\/span> and signed by a pharmacist who will be in full and actual charge of the outsourcing facility<\/span> and who will be fully engaged in the compounding<\/span> performed at the location designated on the application. Such application shall be accompanied by a fee determined by the Board<\/span> in regulation. All permits shall expire annually on a date determined by the Board<\/span> in regulation. No permit shall be issued or renewed for an outsourcing facility<\/span> unless the facility can demonstrate compliance with all applicable federal and state laws<\/span> and regulations governing outsourcing facilities. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> As a prerequisite to obtaining or renewing a permit from the Board<\/span>, the outsourcing facility<\/span> shall (i) register as an outsourcing facility<\/span> with the U.S. Secretary of Health and Human Services in accordance with 21 U.S.C. § 353b and (ii) submit a copy of a current inspection report resulting from an inspection conducted by the U.S. Food and Drug<\/span> Administration that indicates compliance with the requirements of state and federal law<\/span> and regulations, including all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug<\/span> Administration.\n\t\t\tThe inspection report required pursuant to clause (ii) shall be deemed current for the purposes of this section if the inspection was conducted (a) no more than one year prior to the date of submission of an application for a permit to the Board<\/span> or (b) no more than two years prior to the date of submission of an application for renewal of a permit to the Board<\/span>. However, if the outsourcing facility<\/span> has not been inspected by the U.S. Food and Drug<\/span> Administration within the required period, the Board<\/span> may accept an inspection report or other documentation from another entity that is satisfactory to the Board<\/span>, or the Board<\/span> may cause an inspection to be conducted by its duly authorized agent<\/span> and may charge an inspection fee in an amount sufficient to cover the costs of the inspection. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> Every outsourcing facility<\/span> shall compound in compliance with the requirements of state and federal law<\/span> and regulations except § 54.1-3410.2<\/a>, to include all applicable guidance documents and Current Good Manufacturing Practices published by the U.S. Food and Drug<\/span> Administration. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

E.<\/span> An outsourcing facility<\/span> shall not engage in compounding<\/span> of drug products<\/span> to be dispensed pursuant to a valid prescription<\/span> for a specific patient without first obtaining a permit to operate a pharmacy. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nPERMIT TO ACT AS AN OUTSOURCING FACILITY (\u00a7 54.1-3434.05)\n\nA. No person shall act as an outsourcing facility without first obtaining a\npermit from the Board.\n\nB. Applications for a permit to act as an outsourcing facility shall be made on\na form provided by the Board and signed by a pharmacist who will be in full and\nactual charge of the outsourcing facility and who will be fully engaged in the\ncompounding performed at the location designated on the application. Such\napplication shall be accompanied by a fee determined by the Board in regulation.\nAll permits shall expire annually on a date determined by the Board in\nregulation. No permit shall be issued or renewed for an outsourcing facility\nunless the facility can demonstrate compliance with all applicable federal and\nstate laws and regulations governing outsourcing facilities.\n\nC. As a prerequisite to obtaining or renewing a permit from the Board, the\noutsourcing facility shall (i) register as an outsourcing facility with the U.S.\nSecretary of Health and Human Services in accordance with 21 U.S.C. § 353b\nand (ii) submit a copy of a current inspection report resulting from an\ninspection conducted by the U.S. Food and Drug Administration that indicates\ncompliance with the requirements of state and federal law and regulations,\nincluding all applicable guidance documents and Current Good Manufacturing\nPractices published by the U.S. Food and Drug Administration.\n\t\t\tThe inspection report required pursuant to clause (ii) shall be deemed\ncurrent for the purposes of this section if the inspection was conducted (a) no\nmore than one year prior to the date of submission of an application for a\npermit to the Board or (b) no more than two years prior to the date of\nsubmission of an application for renewal of a permit to the Board. However, if\nthe outsourcing facility has not been inspected by the U.S. Food and Drug\nAdministration within the required period, the Board may accept an inspection\nreport or other documentation from another entity that is satisfactory to the\nBoard, or the Board may cause an inspection to be conducted by its duly\nauthorized agent and may charge an inspection fee in an amount sufficient to\ncover the costs of the inspection.\n\nD. Every outsourcing facility shall compound in compliance with the requirements\nof state and federal law and regulations except § 54.1-3410.2, to include\nall applicable guidance documents and Current Good Manufacturing Practices\npublished by the U.S. Food and Drug Administration.\n\nE. An outsourcing facility shall not engage in compounding of drug products to\nbe dispensed pursuant to a valid prescription for a specific patient without\nfirst obtaining a permit to operate a pharmacy.\n\nHISTORY: 2015, c. 300.","edition":{"id":1,"name":"2025","slug":"2025","date_created":"2026-06-21 22:39:22","date_modified":"2026-06-21 22:39:22","current":1,"order_by":1,"last_import":null}}