National Health Service, England Citation and commencement 1 These Regulations may be cited as the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2018 and come into force on 4th December 2018. Amendment of the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 2 1 The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 are amended as follows. 2 For regulation 2 substitute— Drugs, medicines and other substances that may not be ordered 2 1 The following drugs, medicines and other substances may not be ordered for patients in the provision of medical services under a general medical services contract— a a drug, medicine or other substance which is listed in Schedule 1; b any gluten-free food; or c any very low gluten food. 2 But— a paragraph (1)(b) does not apply to gluten-free bread or a gluten-free food mix; b paragraph (1)(c) does not apply to very low gluten bread or a very low gluten food mix. 3 For the purposes of this regulation— a a food is gluten-free if the food, as sold to the final consumer— i contains no more than 20mg/ kg of gluten, and ii where it contains oats has been specially produced, prepared and or processed in a way to avoid contamination by wheat, rye, barley or their crossbred varieties; b a food is very low gluten if the food, as sold to the final consumer, contains no more than 100mg/kg of gluten and consists of, or contains, one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been specially processed to reduce the gluten content, and where it contains oats— i it has been specially produced, prepared or processed in a way to avoid contamination by wheat, rye, barley or their crossbred varieties, and ii the gluten content of the oats does not exceed 20mg/kg. 4 In this regulation— “food mix” means a mixture of two or more ingredients which is to be— combined with any one or more additional ingredients; and baked or otherwise cooked; “gluten” means a protein fraction from wheat, rye, barley, oats or their crossbred varieties and derivatives, which is insoluble in water and 0.5 M sodium chloride solution. . 3 In Schedule 1 (drugs, medicines and other substances not to be ordered under a general medical services contract) omit the entries for— Appleford’s Gluten-Free Rice Cakes; Clara’s Kitchen Gluten-Free Porridge; Ener-G Gluten-free and Soya-free Macaroon Cookies; Ener-G Gluten-free Rice Peanut-Butter Cookies; Ener-G Gluten-free Rice Walnut Cookies; Glutafin Gluten-Free Chocolate Chip Cookies; Glutafin Gluten-Free Custard Cream Biscuits; Glutafin Gluten-Free Gingernut Cookies; Glutafin Gluten-Free Milk Chocolate Biscuits; Glutafin Gluten-Free Milk Chocolate Digestive Biscuits; Glutafin Gluten-Free Shortcake Biscuits; Glutano Gluten-Free Chocolate Hazelnut Wafer Bar; Glutano Gluten-Free Muesli; Glutano Gluten-Free Pretzel; Glutano Gluten-Free Wafer; Glutano Gluten-Free Wafer, Cream Filled; Gratis Gluten-Free Tricolour Pasta; Juvela Gluten-Free Mince Pies; Juvela Gluten-Free Sage & Onion Stuffing Mix; Rite-Diet Gluten-Free Baking Powder; Rite-Diet Gluten-Free Banana Cake; Rite-Diet Gluten-Free Bourbon Biscuits; Rite-Diet Gluten-Free Christmas Pudding; Rite-Diet Gluten-Free Coconut Cookies; Rite-Diet Gluten-Free Date & Walnut Cake; Rite-Diet Gluten-Free Gingernut Cookies; Rite-Diet Gluten-Free Half Covered Chocolate Digestive Biscuits; Rite-Diet Gluten-Free Lemon Madeira Cake; Rite-Diet Gluten-Free Muesli Cookies; Rite-Diet Gluten-Free Rich Fruit Cake; Rite-Diet Gluten-Free Wheat-Free Mince Pies; Schar Gluten Free Sponge Cake; Sunnyvale Gluten-Free Rich Plum Pudding; Sun Yums Gluten Free & Dairy Free Almond & Coconut Cake; Sun Yums Gluten Free & Dairy Free Banana & Sesame Cake; Sun Yums Gluten Free & Dairy Free Carob & Mint Cake; Sun Yums Gluten Free & Dairy Free Ginger & Pecan Nut Cake; Sun Yums Gluten Free & Dairy Free Jaffa Spice Cake. Signed by authority of the Secretary of State for Health and Social Care. O’Shaughnessy Parliamentary Under-Secretary of State, Department of Health and Social Care 1st November 2018