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Chemical Handler's Manual

SECTION I – INTRODUCTION

Disclaimer

This Chemical Handler's Manual is intended to summarize and explain the basic requirements for the handling of List I and List II chemicals under the Controlled Substances Act (CSA), Title 21 United States Code (21 U.S.C.) §§ 801-904; the Controlled Substances Import and Export Act (CSIEA), 21 U.S.C. §§ 951-971; and the DEA regulations, Title 21 Code of Federal Regulations (21 C.F.R.), Parts 1300 to End. Pertinent citations to the law and regulations are included in this manual.

This manual is not a legal document. It is a guide to explain select DEA regulations concerning those chemicals regulated by the DEA. Readers should refer to the most current copy of the laws (CSA and CSIEA), regulations (C.F.R.), and Federal Register notices to obtain a complete and accurate representation of regulated chemical laws and regulations.

Printed copies of the complete regulations implementing the CSA (21 C.F.R. Parts 1300 to End) may be obtained from:

Superintendent of Documents
U.S. Government Printing Office
Washington, DC 20402
1-866-512-1800

Both the C.F.R. and the Federal Register (which includes proposed and final rules implementing the CSA) are available on the Internet through the U.S. Government Printing Office (GPO) website. This website, which provides information by section, citation, and keywords, can be accessed at:

https://www.gpo.gov/fdsys/

Unofficial copies of pertinent C.F.R. citations and this chemical handler's manual may be found on the Internet within the DEA's Diversion Control Division website:

www.DEAdiversion.usdoj.gov

Should any pertinent provisions of the law or regulations be modified in the future, the DEA will issue a revised electronic version of this document, which will be posted on the DEA Diversion Control Division website.

If you encounter errors in this document, please notify:

Editor, DEA Chemical Handler's Manual
Attn: Liaison and Policy Section/ODL
Drug Enforcement Administration
8701 Morrissette Drive
Springfield, VA 22152

Inquiries regarding topics within this document may be addressed with your local DEA Diversion Field Office (listed in Appendix P) or the address above.


Authorization for Public Dissemination

All material in this document is in the public domain and may be reproduced without the express permission of the Drug Enforcement Administration.


Message from the Deputy Assistant Administrator

The Drug Enforcement Administration, Diversion Control Division, is pleased to provide you with the 2013 edition of the Chemical Handler's Manual.

The Diversion Control Division carries out the mandates of the Controlled Substances Act (21 U.S.C. §§ 801-971) by preventing the diversion of controlled substances and listed chemicals into the illicit market while ensuring a sufficient supply of these substances and chemicals for legitimate medical, scientific, research, and industrial purposes.

The listed chemicals ephedrine, pseudoephedrine, and phenylpropanolamine are used in, and are important to, the illicit manufacture of methamphetamine. Methamphetamine is a highly addictive drug with potent central nervous system stimulant properties. Control as a Schedule II substance and the removal of methamphetamine injectable formulations from the United States market, combined with a better appreciation for its high abuse potential, led to a drastic reduction in the abuse of this drug in 1971. However, a resurgence of methamphetamine abuse occurred in the 1980s, and it is currently considered a major drug of abuse. The widespread availability of methamphetamine today is largely fueled by illicit production in large and small clandestine laboratories throughout the United States and illegal production and importation from Mexico.

Since 2004, Congress has passed three laws relating to the regulation of listed chemicals used in the illicit production of methamphetamine and other controlled substances. The Combat Methamphetamine Epidemic Act of 2005 (CMEA) (Pub. L. 109-177) contained new requirements relating to self-certification for retail sales of scheduled listed chemical products, instituted production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine, and imposed enhanced criminal penalties for methamphetamine production and trafficking.

The Methamphetamine Production Prevention Act of 2008 (Pub. L. 110-415) facilitated the use of electronic CMEA-mandated logbooks by allowing greater flexibility regarding the capture of logbook information.

The Combat Methamphetamine Enhancement Act of 2010 (Pub. L. 111-268) extended CMEA's self-certification requirements to include mail-order distributors and made it unlawful to distribute a scheduled listed chemical product to a regulated seller or mail-order distributor who is not currently on the list of self-certified persons maintained by the Drug Enforcement Administration.

I hope that you will find the Chemical Handler's Manual useful and informative. Your role in the proper handling of listed chemicals is critical to protect the public from drug abuse and diversion.

Sincerely,

Louis J.Milione, Deputy Assistant Administrator

Louis J.Milione
Deputy Assistant Administrator
Office of Diversion Control
Drug Enforcement Administration


Preface

In October 1970, Congress passed the Comprehensive Drug Abuse Prevention and Control Act, better known as the Controlled Substances Act (CSA), to consolidate and replace more than 50 pieces of national drug legislation. The CSA went into effect on May 1, 1971. The DEA was established in 1973 to serve as the single Federal agency to coordinate the Federal government's drug control activities.

Large quantities of chemicals are required to synthesize, extract, and purify most illicit drugs. The DEA has long recognized the need to monitor these chemicals as part of its overall drug control strategy. During the 1980s there was a tremendous increase in the clandestine production of controlled substances, particularly methamphetamine. There was also a proliferation of clandestine laboratories producing controlled substance analogues, very potent and dangerous variations of controlled narcotics, stimulants, and hallucinogens. Furthermore, the DEA learned that U.S. firms were exporting large quantities of chemicals, such as acetone, methyl ethyl ketone, and potassium permanganate to cocaine producing countries. Significant amounts of these chemicals ultimately were diverted to clandestine cocaine laboratories. It became clear that mandatory restrictions were needed to control the distribution of these chemicals to have an impact on the clandestine laboratory problem.

The DEA embarked upon a broad chemical control program in 1989 that was based on the Chemical Diversion and Trafficking Act (CDTA) of 1988. The CDTA regulated 12 precursor chemicals (now referred to as List I chemicals), 8 essential chemicals (now referred to as List II chemicals), tableting machines, and encapsulating machines by imposing recordkeeping and reporting requirements on certain transactions. It resulted in reducing the supply of illicit methamphetamine as evidenced by a reduction in the number of clandestine laboratories seized in the first three years following the law's implementation. Maintaining this success requires continuous effort to thwart traffickers' never-ending search for new methods of diversion.

The foundation of the Federal government's program to prevent chemical diversion includes additional laws such as the Domestic Chemical Diversion Control Act of 1993 (DCDCA), the Comprehensive Methamphetamine Control Act of 1996 (MCA), the Methamphetamine Anti-Proliferation Act of 2000 (MAPA), the Combat Methamphetamine Epidemic Act of 2005 (CMEA), the Methamphetamine Production Prevention Act of 2008 (MPPA), and the Combat Methamphetamine Enhancement Act of 2010 (MEA). Some highlights of the successes of these laws are discussed below.

  • When the quantity of U.S. chemicals shipped to cocaine manufacturing countries declined due to CDTA, chemical suppliers from other parts of the world emerged as new sources of supply. The U.S. government then undertook an aggressive international campaign to educate and elicit the support of other nations in establishing chemical controls. Today, there is a broad level of international agreement regarding the actions that must be taken to achieve chemical control. Many nations have passed laws to prevent the diversion of chemicals.
  • As a result of government controls, ephedrine and other chemicals used to manufacture methamphetamine became more difficult to obtain. Traffickers began using over-the-counter capsules and tablets that contained ephedrine since these products were not regulated under CDTA requirements. In 1993 the DCDCA closed this loophole and required DEA registration for all manufacturers, distributors, importers and exporters of List I chemicals. It also established recordkeeping and reporting requirements for transactions of single-entity ephedrine products.
  • When single-entity ephedrine products became regulated, drug traffickers turned to pseudoephedrine. This change in strategy was addressed by the MCA which expanded regulatory control of lawfully marketed drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine.
  • MAPA focused on the continuing retail level diversion by restricting retail transactions of pseudoephedrine and phenylpropanolamine drug products. It reduced the threshold for such transactions from 24 grams to 9 grams of pseudoephedrine base or phenylpropanolamine base in a single transaction and limited package sizes to contain no more than 3 grams of pseudoephedrine base or phenylpropanolamine base. The Act also increased penalties for chemical diversion and provided for restitution to the government for clandestine laboratory cleanup costs. (Due to concerns regarding harmful side effects that phenylpropanolamine can have, on November 6, 2000, the Food and Drug Administration issued a public health advisory and requested that all drug companies discontinue marketing products containing phenylpropanolamine.)
  • The CMEA further restricted retail level transactions by redefining nonprescription products that contain ephedrine, pseudoephedrine, or phenylpropanolamine as "scheduled listed chemical products (SLCP)." Effective September 30, 2006, the CMEA required all regulated sellers of SLCPs to complete a training and self-certification process. On this date, regulated sellers were mandated to keep all SLCPs behind the counter or in a locked cabinet. Consumers wishing to purchase SLCPs are now required to show identification and sign a logbook for each purchase. The Act also established daily sales limits of 3.6 grams per customer for each chemical and limits purchases of these products to 9 grams in a 30 day period by any person. Furthermore, mail-order limits were set at 7.5 grams per customer for each chemical in a 30 day period.
  • The MPPA amended the existing language of the CMEA to facilitate the creation of electronic logbooks. Several options were provided for obtaining signatures of purchasers and recording transactions at the time of sale.
  • The MEA established new requirements for mail-order distributors of SLCPs. Mail-order distributors who sell SLCPs at retail must now train their employees and complete a self-certification process similar to that of a regulated seller.

All these Federal laws (CDTA, DCDCA, MCA, MAPA, CMEA, MPPA, and MEA) imposed varying degrees of requirements on the chemical and pharmaceutical industries. Yet the involvement of private industry as well as the general public should not be limited to the laws enacted by Congress. The voluntary support by industry forms a powerful resource for protecting the health and safety of the nation. The DEA encourages each firm to be vigilant and to become a partner in combating the diversion of chemicals and tableting and encapsulating machines used in illegal drug production.

It is the DEA's goal to effectively regulate while maintaining a positive working relationship with the regulated community. The DEA seeks to inform and educate industry on the CSA and its implementing regulations. The DEA understands that it can best serve the public interest by working in voluntary cooperation with the chemical and pharmaceutical industries in developing programs designed to prevent the diversion of legal pharmaceutical controlled substances and regulated chemicals into the illicit market.

 

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