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| RESTRICTED SUBSTANCES LIST –20th March 2010 |
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All Previous Versions Should Be Destroyed Or Marked Obsolete. A: RESTRICTED UNDER THE CONVENTION ON INTERNATIONAL TRADE IN ENDANGERED SPECIES (CITES) Herbs which are endangered in the wild are restricted but may be traded with the appropriate CITES certification. In the case of Appendix I this is normally only permitted for scientific purposes if at all. Suppliers can trade in Appendix II herbs but only from authenticated cultivated supply. An example of this is XI YANG SHEN which is available from farmed sources. APPENDIX I HU GU (Os tigris) SHE XIANG (Secreto Moschus) XI JIAO (Cornu Rhinoceri) XIONG DAN (Vesica Fellea Ursi) BAO GU (Os Leopardis) DAI MAO (Carapax Ertmochelydis) MU XIANG (Saussurea lappa) NOTE: Vladimira species are permitted as a substitute herb. APPENDIX II CHUAN SHAN JIA (Squama Mantis Pentadactylae) HOU ZAO (Calculus Macacae) LING YANG JIAO (Cornu Antelopis) GUI BAN (Chinemys reevesii) SHI HU (Dendrobium species) BAI JI (Bletilla striata) TIAN MA (Gastrodia elata) GOU JI (Cibotium barometz) LU HUI (Aloe ferox) XIAO YE LIAN (Podophyllum emodii) ROU CONG RONG (Cistanches deserticola) XI YANG SHEN (Panax quinquefolius) NOTE: Only applies to the whole and sliced root. HU HUANG LIAN (Picrorrhiza kurroa) B: RESTRICTIONS UNDER STATUTORY INSTRUMENTS SI 2130 1997 These herbs were listed as an addition to the 1968 Medicines Act as being potent and hence in need of dosage regulation. In some cases they are forbidden at any internal dosage. MD= Maximum single dose MDD=Maximum Daily Dose FU ZI/CAO WU (Aconitum species) NOTE: Permitted to use externally at a dose of 1.3% or below. Internal use prohibited. SHI LIU PI (Punica granitum). Internal use prohibited. BING LANG (Areca catechu) Pharmacy use only. DA FU PI (Areca catechu) Pharmacy use only MA HUANG (Ephedra sinica). MDD: 1800 mg. MD: 600 mg. YANG JIN HUA (Datura stramonium). MDD: 150 mg. MD: 50 mg. DIAN QIE CAO (Atropa belladona). MDD: 150 mg. MD: 50 mg. TIAN XIAN ZI (Hyocyamus niger). MDD: 300 mg. MD: 100 mg. NOTE: SI 2130 also applies to other herbs not employed in Chinese medicine. S1 1841 2002 This ban relates to all Aristolochia species but also includes herbs which have been confused with Aristolochic species due to poor quality assurance. The sale, supply and importation of the following is banned: MU TONG (Aristolochia manshuriensis). NOTE: this ban also applies to Akebia quinata, Akebia trifoliata, Clematis montana and Clematis armandii. FANG JI (Aristolochia fangji). NOTE: this ban also applies to Stephania tetrandra, Cocculus laurifolius, Cocculus orbiculatus and Cocculus Trilobus MA DOU LING (Aristolochia contorta, Aristolochia debilis) TIAN XIAN TENG (Aristolochia contorta, Aristolochia debilis) QING MU XIANG (Aristolochia debilis) SI 548 2008 All species of Senecio are prohibited for internal use due to the presence of toxic pyrrolizidine alkaloids (PA). This mainly applies to the use of Senecio scandens QIAN LI GUANG C: RCHM VOLUNTARY RESTRICTION Due the presence of Aristolochic Acid in Asarum species the RCHM has issued a voluntary ban on the use of: XI XIN (Asarum species) D: RESTRICTIONS UNDER THE 1968 MEDICINES ACT Under Section 12(1) of the 1968 Medicines Act, ‘herbal remedies’ which are administered after a one-to-one consultation with a practitioner do not require a medicines licence (marketing authorisation). This legislation was enacted before traditional medicines from non-European cultures, which use non-plant substances, had any significant presence in the UK. Since the term ‘herbal remedies’ refers to plant materials, the MHRA has stated in its guidance on medicines law that the use of mineral and animal substances, which do not have a marketing authorisation, is illegal. Section 12(1) is currently under review and the RCHM is working to re-establish the use of animal and mineral products. It is also expected that this redefinition of what constitutes a ‘herb’ will be clarified in European and UK legislation in the near future to include non-plant medicines. In the meantime, members are warned that the use of these products may result in legal action by the MHRA and absence of insurance cover in the case of a claim. Hence all animal and mineral products should not be used until otherwise informed by the RCHM. Whatever the outcome of this process, the following must never be used in any form: ZHU SHA (Mercuric sulphide) Cinnabar QING FEN (Mercuric chloride) Calomel HONG FEN (Mercuric oxide) Realgar HEI XI Lead PRESCRIPTION ONLY MEDICINES (POM) It is strictly prohibited to include any drug which is made available only through prescription by a registered medical doctor. This includes the following: YING SU KE (Papaver somnifera) MA QIAN ZI (Strychnos nux vomica) STEROIDS Including external use in creams such as PI YAN PING or 999 SKIN CREAMS. FU ZI Internal use E: PATENT FORMULAE It should be noted that several patent formulae traditionally contain some of the above restricted herbs and toxic minerals, and recently some have been found to contain drugs. These include the following, which may present a health risk if used as a patent: NIU HUANG JIE DU PIAN (May contain arsenic) TIAN WANG BU XIN DAN (May contain mercuric salts) It is the responsibility of the practitioner to ensure that all patent formulae are obtained from ‘bonafide’ suppliers such as those listed under the RCHM Approved Suppliers List. In practice this means that all ingredients are listed and none of the above are included in the formula.
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