Download HG067-2.31_Handling Controlled Substances

Handling Controlled
Substances
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Course Objectives
 Detail
compliance requirements for
manufacturers, distributors and individuals
conducting activities with Drug
Enforcement Agency (DEA) controlled
substances and List I & II Chemicals
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.
Origins of the Laws and Regulations

Chemical Diversion and Trafficking Act (CDTA) of
1988


Domestic Chemical Diversion Control Act of 1993
(DCDCA)

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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.
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
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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.
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:
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obtaining proof of identity from their customers
maintaining retrievable receipt and distribution records
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
provide controls and procedures to guard against theft
and diversion.
Pg 8
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.
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.
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
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.
Examples

Schedule I
 Not for medical use in
US

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GHB
Cannibas(Marijuana)
Heroin
MDMA(3,4
methylenedioxymetha
mphetamine)

Schedule II
 Cleared for medical
use in US

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Fentanyl
Cocaine (topical)
Methylphenidate
(Ritalin)
Codeine (pure)
Phencyclidine (PCP)
Phenobarbital
Examples

Schedule III

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Schedule IV

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Anabolic Steroids
Dihydrocodeine
Xyrem (prep of GHB)
Xanax
Valium
Schedule V


Cough Suppressant
(codeine)
Diphenoxylate (diarr[h]ea)
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.
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.
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
LIST I Chemicals (cont’d)
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(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
LIST I Chemcials (cont’d)
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(23) Nitroethane
(24) Gamma-Butyrolactone (Other names include:
GBL; Dihydro-2 (3H)-furanone; 1,2-Butanolide; 1,4Butanolide; 4-Hydroxybutanoic acid lactone;
gamma-hydroxybutyric acid lactone)
(25) Red 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
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
Methamphetamine:
“Perhaps more than any other drug this country has experienced,
methamphetamine affects everybody in the community.
 The first challenge of the meth trade is that we can’t blame it on
our South American neighbors….It is locally produced in
clandestine laboratories.
 The second challenge meth presents is that international traffickers
are aggressively targeting rural areas…Traffickers think they can
escape law enforcement in rural areas. But we have to make sure
that’s not true.
 The third challenge of methamphetamine lies in the very nature of
this drug. It is intense, it is highly addictive, and it is
overwhelmingly dangerous…The drug has a phenomenal rate of
addiction, with some experts saying users often get hooked after
just one use. Recent studies have demonstrated that
methamphetamine causes more damage to the brain than heroin,
alcohol, or cocaine. Methamphetamine takes over the whole
person. One former user described its effect on her life by saying,
‘I went against every moral and every belief I ever had when I was
on meth.’”
Current Major Drug Threats
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Methamphetamine
Street Names: Meth, Speed, Ice, Chalk, Crank, Fire, Glass, and Crystal.
Physical Effects: Methamphetamine is a toxic, addictive stimulant. Meth
use dilates the pupils and produces temporary hyperactivity, euphoria, a
sense of increased energy, and tremors.
Dangers: Methamphetamine use increases the heart rate, blood pressure,
body temperature, and rate of breathing, and it frequently results in
violent behavior in users. Methamphetamine is neurotoxic, meaning that
it causes damage to the brain. High doses or chronic use have been
associated with increased nervousness, irritability, and paranoia.
Withdrawal from high doses produces severe depression. Chronic abuse
produces a psychosis similar to schizophrenia and is characterized by
paranoia, picking at the skin, self absorption, and auditory and visual
hallucinations. Violent and erratic behavior is frequently seen among
chronic, high-dose methamphetamine abusers.
Description: Meth can be smoked, snorted, injected, or taken orally, and
its appearance varies depending on how it is used. Typically, it is a white,
odorless, bitter-tasting powder that easily dissolves in beverages. Another
common form of the drug is crystal meth, or “ice,”named for its
appearance (that of clear, large chunky crystals resembling rock candy).
Crystal meth is smoked in a manner similar to crack cocaine and about
10 to 15 “hits” can be obtained from a single gram of the substance.
Distribution Methods: Meth is frequently sold through social networks
and is rarely sold on the streets.
What are the Closed System of
Controls?
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Registration
Receipt
Reporting
Storage
Disposal
Registration
Disposal
Receipt/Handling
Security/Storage
Reporting
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

distribution of a List I chemical
importation 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.
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Registration

Entities manufacturing, distributing and/or
dispensing controlled substances and/or
List I or II chemicals need to register with
DEA. (21CFR 1301 & 1309)
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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
Include administration controlled
substances code #
Annual registration (for manufacturers)
Fee based on type of business activity
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.
Documentation & Records
Requirements
 Labeling


Containers should have labels of appropriate
size & location - visible from shelf
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
Documentation & Records
Requirements
 Recordkeeping
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Keep records of said transactions for 2 years
after transactions
Located at site with transactions (can be
centralized if approved)
Need to be retrievable
Ensure tracking to satisfy application
indications and manufacturing levels/quotas if
specified. (21 CFR 1310.04)
Documentation & Records
Requirements
 Report
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to DEA special agent:
Transactions with extraordinary quantities
Atypical methods of payment or delivery
Any transaction with and entity noted by DEA
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.
Security (1301.71, 1309.71)

Limited Access
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Physical means or electronic monitoring
System should consider type/form/quantity of
substance
Location of site factored into security needs
Type of building/construction
Electronic detection/alarms
Appropriate supervision
Procedures for handling guest/visitors in areas with
controlled substances/chemicals
Tracking system for receipt, distribution,
manufacture and disposition
Security (1301.71, 1309.71)
 Limited Access

Modifications to facility/construction will need
to maintain security integrity. (May need to be
approved)
Reporting
 Annual

Reports
Submitted to Drug & Chemical Evaluation
Section of DEA on or before March 15 of next
year
• Tracking information
• Manufacturing & Inventory Data
• Use Data
Company Responsibilities
 Evaluate
personnel who will work in
controlled substance/drug/chemical
environment;

Background checks
 Evaluate
continued employment of
personnel conducting illicit activity.
 Maintain confidentiality of personnel that
inform appropriate points of contacts of
illicit activity.
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.
Inspections
 Administrator

has authority to inspect
Inspect, copy, verify recordkeeping
• Receipt, Inventory, distribution
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Inspections at reasonable hours
Typically 1 visit per year (I &II)
• III- V frequency as needed
Ensuring Closed System of
Controls

Disposal
Security/Storage
Reporting
Maintain awareness
of regulations
Registration
 Establish and enforce
policies and
procedures
 Conduct internal
audits
Receipt/Handling
 Implement follow-up
actions to enhance
controls.