1. Handling Controlled Substances This product was funded by a grant awarded under the President’s High Growth Job Training Initiative as implemented by the U.S. Department of Labor’s Employment & Training Administration. The information contained in this product was created by a grantee organization and does not necessarily reflect the official position of the U.S. Department of Labor. All references to non-governmental companies or organizations, their services, products, or resources are offered for informational purposes and should not be construed as an endorsement by the Department of Labor. This product is copyrighted by the institution that created it and is intended for individual organizational, non-commercial use only.

2. Course Objectives  Detail compliance requirements for manufacturers, distributors and individuals conducting activities with Drug Enforcement Agency (DEA) controlled substances and List I & II Chemicals

3. Diversion of Controlled Chemicals Most of the drugs in the illicit traffic are products of illicit processing or synthesis. Cocaine, for example, can be extracted and converted to its preferred form only by using a tremendous quantity of industrial chemicals. Heroin must be synthesized by using an acetylating agent after the morphine has been extracted from raw, harvested opium. Methamphetamine, PCP, LSD, MDMA and methaqualone are purely synthetic drugs manufactured from chemical precursors. Until recently, there were virtually no legal impediments to obtaining the chemicals necessary to manufacture drugs of abuse, no records required to be maintained for inspection, and no penalties for negligence or willful diversion.

4. Origins of the Laws and Regulations Origins of the Laws and Regulations  Chemical Diversion and Trafficking Act (CDTA) of 1988 As a result of government controls, ephedrine and other chemicals used to manufacture methamphetamine became more difficult to divert. Traffickers then began using over-the-counter capsules and tablets that contained these ingredients. As a result of government controls, ephedrine and other chemicals used to manufacture methamphetamine became more difficult to divert. Traffickers then began using over-the-counter capsules and tablets that contained these ingredients.  Domestic Chemical Diversion Control Act of 1993 (DCDCA) closed the loophole of over-the-counter capsules and tablets that contained List I Chemicals, and required DEA registration for all manufacturers, distributors, importers and exporters of List I chemicals. closed the loophole of over-the-counter capsules and tablets that contained List I Chemicals, and required DEA registration for all manufacturers, distributors, importers and exporters of List I chemicals.  Comprehensive Methamphetamine Control Act of 1996 (MCA) expanded regulatory control of lawfully marketed drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine Pg 6 expanded regulatory control of lawfully marketed drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine Pg 6

5. Chemical Program The mission of DEA's Chemical Control Program is to disrupt the illicit production of controlled substances by preventing diversion of chemicals used to make drugs. The production of illegal drugs such as methamphetamine, cocaine, heroin, and MDMA (ecstasy) requires enormous quantities of precursor and essential chemicals. The Chemical Control Program seeks to minimize the regulatory burden on the legitimate chemical industry while instituting effective anti-diversion policies. DEA registration, record keeping and suspicious order reporting requirements apply to importers, exporters, manufacturers, distributors and certain retailers of 34 listed chemicals. Through a combination of industry outreach and voluntary compliance measures, DEA strives to control chemical diversion in partnership with industry and the public.

6. Principal Provisions of the Chemical Diversion Control Laws and Regulations  The laws and regulations require regulated persons (manufacturers, distributors, importers, and exporters of listed chemicals) to implement measures which prevent diversion by: obtaining proof of identity from their customers obtaining proof of identity from their customers maintaining retrievable receipt and distribution records maintaining retrievable receipt and distribution records reporting to the Drug Enforcement Administration (DEA) any suspicious orders reporting to the Drug Enforcement Administration (DEA) any suspicious orders  Manufacturers who distribute or export, distributors, importers, and exporters of List I chemicals are also required to : register with DEA register with DEA provide controls and procedures to guard against theft and diversion. Pg 8 provide controls and procedures to guard against theft and diversion. Pg 8

7. Controlled Substances Act (CSA) Controlled Substances Act  The law that regulates the prescribing and dispensing of dangerous substances, especially psychoactive drugs, including narcotics, hallucinogens, depressants and stimulants.

8. Controlled Substances Act (CSA)  The CSA mandates that DEA prevent, detect and investigate the diversion of legally manufactured controlled substances and make sure legitimate medical needs are met.

9. Schedule I - V  The CSA established five schedules into which controlled substances are separated according to their approved medical use and abuse potential.  Schedule I – NP, HA II – P, HA III – V Prescription and decreasing potential for abuse

10. CSA  Schedule I controlled substances are those deemed not to have legitimate medical uses and have a very high potential for abuse.  Schedule II substances are approved for medical use and also have a very high abuse potential.  Schedules III, IV and V include controlled substances that have all been approved for medical use and have diminishing potential for abuse.

11. Examples  Schedule I  Not for medical use in US GHB GHB Cannibas(Marijuana) Cannibas(Marijuana) Heroin Heroin MDMA(3,4 methylenedioxymetha mphetamine) MDMA(3,4 methylenedioxymetha mphetamine)  Schedule II  Cleared for medical use in US Fentanyl Cocaine (topical) Methylphenidate (Ritalin) Codeine (pure) Phencyclidine (PCP) Phenobarbital

12. Examples  Schedule III Anabolic Steroids Anabolic Steroids Dihydrocodeine Dihydrocodeine Xyrem (prep of GHB) Xyrem (prep of GHB)  Schedule IV Xanax Valium  Schedule V Cough Suppressant (codeine) Cough Suppressant (codeine) Diphenoxylate (diarr[h]ea) Diphenoxylate (diarr[h]ea)

13. CSA  The CSA also established a closed system of distribution that includes the registration of controlled substances handlers, including manufacturers, distributors, importers, exporters, practitioners and pharmacists.

14. What are List I & II Chemicals ?  The Chemical Diversion & Trafficking Act (CDTA) also cites chemicals that are used in the manufacture of controlled substances/illicit drugs. These chemicals are also subject to regulation and control measures.

15. LIST I Chemicals  (1) Anthranilic acid, its esters, and its salts (2) Benzyl cyanide  (3) Ephedrine, its salts, optical isomers, and salts of optical isomers  (4) Ergonovine and its salts  (5) Ergotamine and its salts  (6) N-Acetylanthranilic acid, its esters, and its salts (7) Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers  (8) Phenylacetic acid, its esters, and its salts (9) Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers  (10) Piperidine and its salts  (11) Pseudoephedrine, its salts, optical isomers, and salts of optical isomers

16. LIST I Chemicals (cont’d)  (12) 3,4-Methylenedioxyphenyl-2-propanone  (13) Methylamine and its salts  (14) Ethylamine and its salts  (15) Propionic anhydride  (16) Isosafrole  (17) Safrole  (18) Piperonal  (19) N-Methylephedrine, its salts, optical isomers, and salts of optical isomers (N-Methylephedrine)  (20) N-Methylpseudoephedrine, its salts, optical somers, and salts of optical isomers  (21) Hydriodic Acid  (22) Benzaldehyde

17. LIST I Chemcials (cont’d)  (23) Nitroethane  (24) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2 (3H)-furanone; 1,2-Butanolide; 1,4- Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid lactone)  (25) Red Phosphorus  (26) White phosphorus (Other names: Yellow Phosphorus)  (26) White phosphorus (Other names: Yellow Phosphorus)  (27) Hypophosphorous acid and its salts (including ammonium hypophosphite, calcium hypophosphite, iron hypophosphite, potassium hypophosphite, manganese hypophosphite, magnesium hypophosphite, and sodium hypophosphite

18. LIST II Chemicals  1) Acetic anhydride  (2) Acetone  (3) Benzyl chloride  (4) Ethyl ether  (5) Potassium permanganate  (6) 2-Butanone (or Methyl Ethyl Ketone or MEK)  (7) Toluene  (8) Hydrochloric acid (including anhydrous hydrogen chloride)  (9) Sulfuric acid  (10) Methyl Isobutyl Ketone (MIBK)  (11) Iodine

19. Methamphetamine:

20. Current Major Drug Threats

22. What are the Closed System of Controls?  Registration  Receipt  Reporting  Storage  Disposal Registration Receipt/Handling Reporting Security/Storage Disposal

23. Registration Who Must Register  Every person (unless specifically exempted below) who engages or proposes to engage in any of the following activities is required to register annually with DEA: manufacturing a List I chemical for distribution manufacturing a List I chemical for distribution distribution of a List I chemical distribution of a List I chemical importation of a List I chemical importation of a List I chemical exportation of a List I chemical exportation of a List I chemical Separate Registration for Separate Locations  A separate registration is required for each principal place of business where a List I chemical is manufactured for distribution, distributed, imported, or exported. Pg 15

24. Registration  Entities manufacturing, distributing and/or dispensing controlled substances and/or List I or II chemicals need to register with DEA. (21CFR 1301 & 1309) Assigned forms based on business activity (Form 225/225a or 510/510a) Assigned forms based on business activity (Form 225/225a or 510/510a) Separate registrations for separate sites unless approved for under control of one location Separate registrations for separate sites unless approved for under control of one location Include administration controlled substances code # Include administration controlled substances code # Annual registration (for manufacturers) Annual registration (for manufacturers) Fee based on type of business activity Fee based on type of business activity

25. Documentation  Production quotas as well as recordkeeping and security requirements are designed to enable DEA to track and safeguard potentially dangerous controlled substances as they are transferred from the manufacturer to the ultimate user.

26. Documentation & Records Requirements  Labeling Containers should have labels of appropriate size & location - visible from shelf Containers should have labels of appropriate size & location - visible from shelf Sealed to determine if opened or tampering Sealed to determine if opened or tampering  Recordkeeping Records should be kept of manufacturing and other transactions involving controlled substances or listed chemicals – tableting machines, encapsulating machines Records should be kept of manufacturing and other transactions involving controlled substances or listed chemicals – tableting machines, encapsulating machines

27. Documentation & Records Requirements  Recordkeeping Keep records of said transactions for 2 years after transactions Keep records of said transactions for 2 years after transactions Located at site with transactions (can be centralized if approved) Located at site with transactions (can be centralized if approved) Need to be retrievable Need to be retrievable Ensure tracking to satisfy application indications and manufacturing levels/quotas if specified. (21 CFR 1310.04) Ensure tracking to satisfy application indications and manufacturing levels/quotas if specified. (21 CFR 1310.04)

28. Documentation & Records Requirements  Report to DEA special agent: Transactions with extraordinary quantities Transactions with extraordinary quantities Atypical methods of payment or delivery Atypical methods of payment or delivery Any transaction with and entity noted by DEA Any transaction with and entity noted by DEA Any unusual or excessive loss/disappearance of listed chemicals. Any unusual or excessive loss/disappearance of listed chemicals. If loss is in transit, supplier is responsible to notify agency, verbally ASAP and in writing within 15 days.If loss is in transit, supplier is responsible to notify agency, verbally ASAP and in writing within 15 days.

29. Security (1301.71, 1309.71)  Limited Access Physical means or electronic monitoring Physical means or electronic monitoring System should consider type/form/quantity of substance System should consider type/form/quantity of substance Location of site factored into security needs Location of site factored into security needs Type of building/construction Type of building/construction Electronic detection/alarms Electronic detection/alarms Appropriate supervision Appropriate supervision Procedures for handling guest/visitors in areas with controlled substances/chemicals Procedures for handling guest/visitors in areas with controlled substances/chemicals Tracking system for receipt, distribution, manufacture and disposition Tracking system for receipt, distribution, manufacture and disposition

30. Security (1301.71, 1309.71)  Limited Access Modifications to facility/construction will need to maintain security integrity. (May need to be approved) Modifications to facility/construction will need to maintain security integrity. (May need to be approved)

31. Reporting  Annual Reports Submitted to Drug & Chemical Evaluation Section of DEA on or before March 15 of next year Submitted to Drug & Chemical Evaluation Section of DEA on or before March 15 of next year Tracking informationTracking information Manufacturing & Inventory DataManufacturing & Inventory Data Use DataUse Data

32. Company Responsibilities  Evaluate personnel who will work in controlled substance/drug/chemical environment; Background checks Background checks  Evaluate continued employment of personnel conducting illicit activity.  Maintain confidentiality of personnel that inform appropriate points of contacts of illicit activity.

33. Employee Responsibilities  Working in such a controlled environment, employees subject themselves to State & Federal prosecution for any illicit activity (violating regulations).  Employee is responsible to report illicit activity to security point of contact (POC). Failure to do so may jeopardize employment.

34. Inspections  Administrator has authority to inspect Inspect, copy, verify recordkeeping Inspect, copy, verify recordkeeping Receipt, Inventory, distributionReceipt, Inventory, distribution Inspections at reasonable hours Inspections at reasonable hours Typically 1 visit per year (I &II) Typically 1 visit per year (I &II) III- V frequency as neededIII- V frequency as needed

35. Ensuring Closed System of Controls Registration Receipt/Handling Reporting Security/Storage Disposal  Maintain awareness of regulations  Establish and enforce policies and procedures  Conduct internal audits  Implement follow-up actions to enhance controls.