{"id":65,"date":"2024-05-15T17:16:17","date_gmt":"2024-05-15T16:16:17","guid":{"rendered":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/nhs-borders\/specials-unlicensed-medicines\/"},"modified":"2025-09-24T09:17:50","modified_gmt":"2025-09-24T08:17:50","slug":"specials-unlicensed-medicines","status":"publish","type":"page","link":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/pages\/specials-unlicensed-medicines\/","title":{"rendered":"Specials (Unlicensed Medicines)"},"content":{"rendered":"\n<p>Specials are unlicensed medicines manufactured or sourced to meet specific clinical needs.<\/p>\n\n\n\n<p>NHS Circular <a href=\"https:\/\/www.publications.scot.nhs.uk\/files\/pca2015-p-17.pdf\">PCA(P)(2015)17<\/a> requires community pharmacy contractors to seek Health Board authorisation before ordering or dispensing specials and imported unlicensed medicines. This applies when the products are not listed in Part 7S\/7U of the Drug Tariff or are unavailable from an NHS manufacturing unit in Scotland, England, or Wales. Both the pharmacist and the prescriber carry increased legal responsibility when supplying unlicensed medicines.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Before Ordering a Special<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Confirm clinical need<\/strong>: Discuss with the prescriber that an unlicensed medicine has been prescribed. Consider licensed or &#8220;off-label&#8221; alternatives (e.g. opening capsules, dispersing tablets in water etc.).<\/li>\n\n\n\n<li><strong>Inform the patient<\/strong>: Ensure the patient is aware the product is unlicensed.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How to Request Authorisation<\/strong><\/h3>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li><strong>Complete <\/strong>the <a href=\"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-content\/uploads\/sites\/14\/NHS-LOTHIAN-EMAIL-AUTHORISATION-FORM-v10-July-2025.docx\">NHS Lothian Specials Authorisation Form<\/a><\/li>\n\n\n\n<li><strong>Email to<\/strong>: <a href=\"mailto:loth.specials@nhs.scot\">loth.specials@nhs.scot<\/a><br><em>(<strong>Must <\/strong>be sent from an NHS email for secure patient data handling)<\/em><\/li>\n\n\n\n<li><strong>Processing times<\/strong>: Requests will be processed within 48 hours, during the hours of 10am \u2013 4pm Monday to Friday (except Public Holidays)<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Forms &amp; Resources<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-content\/uploads\/sites\/14\/NHS-LOTHIAN-EMAIL-AUTHORISATION-FORM-v10-July-2025.docx\">Special Authorisation Request Form<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-content\/uploads\/sites\/14\/Community-Pharmacy-Specials-Authorisation-in-5-easy-steps-July-2025.docx\" title=\"Community Pharmacy- Specials Authorisation in 5 easy steps July 2025\" class=\"link-to-media\"><a href=\"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-content\/uploads\/sites\/14\/Community-Pharmacy-Specials-Authorisation-in-5-easy-steps-July-2025.docx\">Specials Authorisation in 5 easy steps <\/a><\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.communitypharmacy.scot.nhs.uk\/media\/1486\/pca2015-p-17_annexa.pdf\">PCA(P)(2015)17 Part A<\/a> (Generic Framework for Specials Authorisation Process)<\/li>\n\n\n\n<li><a href=\"https:\/\/www.communitypharmacy.scot.nhs.uk\/media\/1487\/pca2015-p-17_annexb.pdf\">PCA(P)(2015)17 Part B<\/a> (FAQs)<\/li>\n\n\n\n<li><a href=\"https:\/\/assets.publishing.service.gov.uk\/media\/645e19f5ad8a03000c38b3bc\/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf\">MHRA Guidance Note 14<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.rpharms.com\/Portals\/0\/RPS%20document%20library\/Open%20access\/Support\/toolkit\/professional-standards---prescribing-specials.pdf\">RPS Prescribing Specials Guidance<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/policyonline.nhslothian.scot\/wp-content\/uploads\/2023\/03\/Use_of_Unlicensed_Medicines_Procedure.pdf\">NHS Lothian Procedure for the Use of Unlicensed Medicines<\/a> <\/li>\n\n\n\n<li><a href=\"https:\/\/cdn.bad.org.uk\/uploads\/2021\/12\/29200146\/BAD-Specials-Booklet-2018-FINAL.pdf\">BAD Preferred Specials List<\/a><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Important Notes<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Authorisation is valid for up to <strong>12 months only<\/strong>.<\/li>\n\n\n\n<li>If the item price varies by more than <strong>20%<\/strong> within the 12 month period, reauthorisation is required.<\/li>\n\n\n\n<li><strong>An authorisation is required for every patient<\/strong><\/li>\n\n\n\n<li><strong>Do not send<\/strong> certificates of analysis (COA), conformity (COC), or invoices.<\/li>\n\n\n\n<li>This process <strong>applies only to unlicensed medicines<\/strong> \u2013 not ACBS products, foodstuffs, stoma items, or high-cost licensed drugs.<\/li>\n<\/ul>\n\n\n\n<p>For queries, contact: <a href=\"mailto:loth.specials@nhs.scot\">loth.specials@nhs.scot<\/a><\/p>\n\n\n\n<p>. <\/p>\n\n\n\n<p>Last updated 28\/07\/25 JN<\/p>\n","protected":false},"excerpt":{"rendered":"<p class=\"nhsuk-card__description\">Specials are unlicensed medicines manufactured or sourced to meet specific clinical needs. NHS Circular PCA(P)(2015)17 requires community pharmacy contractors to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":15,"menu_order":27,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-65","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-json\/wp\/v2\/pages\/65","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-json\/wp\/v2\/comments?post=65"}],"version-history":[{"count":11,"href":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-json\/wp\/v2\/pages\/65\/revisions"}],"predecessor-version":[{"id":945,"href":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-json\/wp\/v2\/pages\/65\/revisions\/945"}],"up":[{"embeddable":true,"href":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-json\/wp\/v2\/pages\/15"}],"wp:attachment":[{"href":"https:\/\/www.communitypharmacy.scot.nhs.uk\/nhs-lothian\/wp-json\/wp\/v2\/media?parent=65"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}