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Management of Drug Precursor Chemicals in China

By Little Pro on 2015-12-29 Views:  Update:2017-01-18

Drug precursors are certain chemicals which can be used in the illicit manufacture of narcotic drugs and psychotropic substances. Examples of such chemicals include acetic anhydride, acetone, hydrochloric acid, and sulfuric acid.

China has ratified the UN Convention on Drug Precursors. Precursor chemicals are subject to strict license requirements on production, sales, purchase and transportation in China. In addition to that, China implements a pre-import and pre-export notification system for dual-use precursor chemicals.

In China, precursor chemicals are mainly controlled by the following administrative regulations and department rules:

  • Narcotics Control Law of the People's Republic of China (2007);
  • Regulation on the Administration of Precursor Chemicals (2005) - State Council Decree 445;
  • Provisions on the Administration of the Import and Export of Precursor Chemicals (2006) ? Order 7 of the Ministry of Commerce ;
  • Provisions on the Administration of International Check upon the Import and Export of Precursor Chemicals (2006) ? Order 8 of the Ministry of Commerce and the Ministry of Public Security;
  • Measures for the Licensing for Production and Operation of Non-pharmaceutical Precursor Chemicals (2006) ? Order 5 of the State Administration of Work Safety (SAWS);

List of Regulated Drug Precursor Chemicals in China

The State Council maintains a list of regulated precursor chemicals in China called the Catalogue of Precursor Chemicals. The Catalogue is updated regularly. The latest Catalogue includes 27 drug precursor chemicals and clarifies them into 3 categories (updated in April 2015):

Category 1 - High Risk Substances
  1. 1-phenyl-2-propanone, CAS 103-79-7
  2. 3,4-Methylenedioxyphenyl-2-propanone, CAS 4676-39-5
  3. Piperonal, CAS 120-57-0
  4. Safrole, CAS 94-59-7
  5. Sassafras oil
  6. Iso-safrole, CAS 120-58-1
  7. N-Acetylanthranilic Acid, CAS 89-52-1
  8. O-amino benzoic acid, CAS 118-92-3
  9. Ergotic acid*, CAS 82-58-6
  10. Ergotamine*, CAS 113-15-5
  11. Ergobasine*, CAS 60-79-712
  12. Ephedrine, pseudo ephedrine, mesoephedrine, phenylpropanolamine, methylephedrine, ephedrine extractum, ephedrine extractum powder and other ephedrine substances(*)
  13. Hydroxylimine, CAS 90717-16-1 and its salts(added in 2008);
  14. 2-Chlorophenyl cyclopentyl ketone, CAS 6740-85-8 (added in 2012);
  15. 1-Phenyl-2-Bromo-1-Propanol, CAS 2114-00-3 (added in 2014);
  16. 3-oxo-2-phenylbutyronitrile, CAS 4468-48-8 (added in 2014);
Category 2 - Precursors
  1. Phenylacetic acid, CAS 103-82-2
  2. Acetic anhydride, CAS 108-24-7
  3. Chloroform, CAS 67-66-3
  4. Aether, CAS 60-29-7
  5. Piperidine, CAS 110-89-4
Category 3 - Other Raw Materials
  1. Toluene, CAS 108-88-3
  2. Acetone, CAS 67-64-1
  3. Methyl ether ketone, CAS 78-93-3
  4. Potassium permanganate, CAS 7722-64-7
  5. Sulphuric acid, CAS 7664-93-9
  6. Hydrochloric acid, CAS 7647-01-0

 

It shall be noted that:

  • The salts of category 1 & 2 precursors are also regarded as listed in the Catalogue;
  • The items marked with * belong to pharmaceutical precursors;
  • Different categories of precursors are subject to different regulatory requirements;
  • Mixtures containing above chemicals may also fall within the scope of drug precursor regulations;

Regulatory Requirements for Drug Precursor Chemicals in China

The production, trading (including sales and purchase), import, export, and transport of precursor chemicals are controlled by various licensing and reporting requirements. The table below summarizes how drug precursors are regulated in China.

Production
  • Category 1: Apply for production license (生产许可证) issued by provincial food and drug authority for Pharma precursors or production license(生产许可证) issued by provincial work safety administration authority for non-Pharma precursors;
  • Category 2 & 3: Declare product name, category and quantity to local work safety authority within 30 days since the date of production;
Sales & Operation
  • Category 1: Apply for operation licenses (经营许可证) issued by provincial food and drug authority for pharma precursors or operation licenses(经营许可证) issued by provincial work safety administration authority for non-Pharma precursors;
  • Category 1: Declare products sold, category, quantity and flow info to local public security bureau within 5 days since the transaction;
  • Category 2 & 3: Declare product name, category and quantity to local work safety authority within 30 days since the date of operation (安监备案);
  • Category 2 & 3: Declare products sold, category, quantity and flow info to public security bureau at county level within 30 days since the date of transaction(公安备案);
  • Check buyers’ purchase permits and personal identity info of the handlers before sales;
  • Build solid sales record for inspections;
Purchase
  • Require purchase permit (购买许可证) or purchase record certificate (购买备案证明) before purchase;
  • Category 1 Pharma precursors: Apply for purchase permit from provincial food and drug administration authority;
  • Category 1 Non-Pharma Precursors: Apply for purchase permit from provincial police authority;
  • Category 2 & 3: Declare precursor chemicals planned to buy to police authority at county level and obtain purchase record certificate before purchase;
  • Private individuals are not allowed to buy category 1 and category 2 precursors;
Import & Export
  • Apply for import and export certificate for dual use-items and technologies (两用物项和技术出口许可证) from provincial commerce commission before import and export;
  • The certificate is only valid for one batch of goods at one port;
  • Mixtures containing less than 40% toluene, or acetone, or methyl ether ketone, or sulfuric acid or mixtures containing less than 10% Hydrochloric acid do not require import and expert certificate ? Order 23 of the Ministry of Commerce in 2007;
Transport
  • Category 1: Apply for transport permit issued by public security bureau at city level;
  • Category 2: Apply for transport permit issued by public security bureau at county level;

It shall be noted that if one precursor chemical is also a hazardous chemical, it has to comply with the requirements of Decree 591 Regulations on Safe Management of Hazardous Chemicals.

 

 Tags: Topics - ChinaControlled Chemicals Trade

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