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Controlled Substances in the Laboratory

MIT, 2011 Controlled Substances Act was put into place by Congress in 1970.

Nixon creates the Drug Enforcement Administration (DEA) in 1973

1973/1974• 1,470 Special Agents• <$75 mil budget• 43 foreign offices in 31 countries

AdministratorJohn R. Bartels, Jr.Former federalprosecutor

2011• 5,235 Special Agents• >$2.3 bil budget• 87 foreign offices in 63 countries

AdministratorMichele LeonhartCareer DEA Agent

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Analgesia/AnesthesiaPsychoactive studiesBiosynthesis of drugsDisease treatment & prevention

DEA Registrations at MIT (16)

Established in 1975 to meet legal mandates and federal guidelines for the care and maintenance of laboratory animals.

Only distributer of controlled substances for research at MIT.

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Neuroscience 

Engineering

HST

Koch Inst

Biology

Analgesics & Anesthetics ONLY to prevent pain and distress in animals.

Two DCM pharmacies are staffed by full-time pharmacy technicians.

DCM collaborates with EHS on record-keeping, security and disposal.

DEA regulates 5 schedules (I-V) based on potential to be habit forming and usefulness in medicine.

Massachusetts DPH also regulates schedule I-VI materials – VI being prescription drugs not falling into any other schedule.

High potential for abuseNo accepted medical use in the USLack of accepted safety parameters, even under medical supervision

GHB

Peyote

LSD

Ecstasy

Heroin

Marijuana

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High potential for abuseMedical use with severe restrictions Abuse may lead to serious dependence.

Cocaine

Opium

Morphine

Codeine

Pentobarbital(Nembutal)

Adderall

Potential for abuseAccepted medical use. Abuse may lead to moderate or low dependence

Anabolic steroids

Ketamine

Buprenorphine

Telazol

Low potential for abuseAccepted use in medicine.

Chloral Hydrate

Midazolam

Diazepam

Barbital

Limited dependence Medical usage comparable to schedule IV

Robitussin A-C(codiene 200mg/100ml)

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Prescription medications not covered in I-V

Isoflurane

Other prescription drugs

In Massachusetts, researchers must register with both the DEA and the Massachusetts Dept of Public Health, Division of Food and Drugs.

Information needed for MA DPH form:◦ contact information◦ project purpose◦ controlled substance needed◦ location & Security measures◦ Source of controlled substances◦ IRB/IACUC approval letters, if applicable◦ SSN#

$150 registration fee

Researchers must fill out a DEA form #225

Information needed:◦ contact information◦ project purpose◦ controlled substance needed◦ location & security measures◦ SSN#◦ copy of state license.

DEA responds to registration with detailed security questionnaire. $184 registration fee

The drug safe must weigh at least 750 lbs OR be bolted or cemented to the floor or wall in such a way that it cannot be readily removed

AND be equipped with an alarm system.

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Schedule II ◦ “double lock” drug safe or ◦ lockbox that is secured within a locked,

substantially constructed cabinet.Schedules III-V ◦ Securely locked, substantially constructed drawer or

cabinet.

Schedules I and II Form #222 is filled out in triplicate – keep one.Submit to Procurement

Two copies signed form #222MIT requisition with DEA Registration # indicated

Once drug is received, annotate lab copy of form #222 with amount and date rec’d.

Schedules III-V: normal procurement procedures with DEA # indicated on Requisition.

Schedule VI can get a little tricky. No DEA license required. Many companies do not realize we can order for research without DEA license.

Continuous inventory must be kept a minimum of two years from date of record.

DCM provides inventory template when dispensing.

CAC inspects inventory & security in labs receiving drugs from DCM

◦ Registration forms #225, 225a (renewal)

◦ Executed order forms

◦ Inventory records, both continuous and biennial must be kept a minimum of 2 years from date of record

◦ Copies of DEA Form #106 if a theft/loss occurs

◦ Form 41 disposal record

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OPTION 1: Reverse Distribution - to a DEA approved Pharmaceutical Returns Processor for re-use, re-sale or destruction.

OPTION 2:Witness Burn- transport to a DEA-approved incinerator & destroy in the presence of the PI, a federal official and local law enforcement official.

OPTION MIT: Witness Destruction –The materials are rendered unrecoverable with Sodium Hydroxide and sent out for incineration as hazardous waste.

Biosafety Program, Environmental Management Program & Triumvirate Environmental conduct quarterly drug destructions according to previously approved methods.

BSP coordinates with registrants/DCM pharmacyEMP coordinates with Triumvirate personnel.

DEA Approved Witnesses: Claudia MickelsonHeidi MontanariShawna MacDonald

EHS submits DEA form #41 and provides registrants with a copy.

The answer is NO.

Return to DCM pharmacyorContact EHS to schedule destruction

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List 1: 29 Precursor chemicals. Chemicals that can be directly converted to a controlled substance

List 2: 11 Essential chemicals. These chemicals are the solvents, catalysts and reagents that are used in the drug manufacturing process.

Certain transactions of List I and List II chemicals are regulated by the CSA.

anthrallic acidbenzyl Cyanidebenzaldehydeephedrineergonovineergotaminehydroiodic acid hypophosphorous acidN-acetylanthranilic acidnitroethanenorpseudoephedrinephenylacetic acidphenylacetonephenylpropanolaminePhosphorus (white or red)piperidinepseudoephedrine

gamma butyrolactoneN-Phenethyl-4-piperidinone3,4-Methylenedioxyphenyl-2-propanonemethylamineethylaminepropionic anhydrideisosafrolesafrolepiperonalN-methylephedrineN-methylpseudoephedrineiodine

Acetic anhydride Acetone Benzyl chloride Ethyl ether Potassium permanganate 2-Butanone (or Methyl Ethyl Ketone or MEK) Toluene Hydrochloric acid Sulfuric acid Methyl Isobutyl Ketone Sodium Permanganate

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Researchers may need to register with the DEA if they are importing, exporting or distributing List I or List II chemicals above threshold values.

Domestic transactions may also be regulated if quantities are above domestic threshold.

Other exemptions may apply.

Export waivers apply for certain concentrations (greater than 35%) of Toluene, Acetone, Methyl Isobutyl Ketone.

Mixtures having >15% Sodium Permanganate are subject to regulations

Exemptions also apply for chemical mixtures including Iodine tinctures (Wescodine, Betadine, etc.)

Thresholds apply for domestic and international transactions.

Domestic Import/ExportMethylamine 1 kg 1 kgPhosphorus‐any color 0 0Acetic Anhydride 1,023 kg 1,023 kgAcetone 150 kg 1,500 kgHydrochloric Acid N/C 50 galMethyl Isobutyl Ketone N/C 1,523 kg

Potassium Permanganate 55 kg 500 kgSulfuric Acid N/C 50 galToluene 159 kg 1,591 kg

All transactions which meet or exceed these quantities shall be considered regulated transactions.Researchers, as end users, do not have to obtain a registration for domestic transactions as long as it is not redistributed or exported.

May need to complete Authorized Purchaser form◦ Requires Authorization Signature of Contact person (VP,

Director, Manager, Chair, etc.) should be the PI signature.

EHS will no longer sign off on these forms, nor should Procurement.

Backup signature may be DLC chair.

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Purchaser

PI

International collaborator ships white phosphorus to MIT PI.Customs needs DEA Form 486 to release List I chemical.Storage fees accumulate over $10kMIT legal manages to reduce charges.PI finds local company to receive material on PI’s behalf.

Shawna MacDonaldshawna@mit.edu

Ext:3-3844