Federal and State Registrations Required to Conduct Research with Controlled Substances

1
Federal and State Registrations Required to
Conduct Research with Controlled Substances

• May 13, 2008

2
Objective

• To summarize two new polices that have been
  written to address the registration (license)
  of investigators and procurement of controlled
  substances by the research community, pursuant to
  regulations of the Commonwealth of Massachusetts
  and the Federal Drug Enforcement Administration.
• Research areas using controlled substances
• Clinical
• Types of controlled substances used
  chemotherapeutic agents, HIV medications, cardiac
  medications
• Animal/Bench Laboratory
• Examples of controlled substances used Fentanyl,
  Pentobarbital, Ketamine, Buprenex

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RESEARCHER REGISTRATIONS REQUIRED

• Federal DEA Registration
• Schedules I V
• Investigational Drugs
• State Mass. Controlled Substances
  Registration MCSR),
• Schedules I V and Schedule VI (all prescription
  legend drugs)
• Investigational Drugs

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Registrations Required for Research

• Massachusetts Controlled Substance Registration
• Investigators must hold a Massachusetts
  Controlled Substance Registration (MCSR) with the
  Department of Public Health (DPH) as a
  Researcher to procure, store, use any
  controlled substance for research purposes, which
  in Massachusetts, includes all prescription drugs
  (CII-CVI) and IND agents.

• Federal DEA Registration, as a Researcher
• Investigators must hold a Drug Control
  Registration (DEA Form 225, Researcher) from the
  Drug Enforcement Administration to procure,
  store, use Schedule I V Controlled Substances
  and INDs for research.

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Reasons for the New Policies

• Regulatory deficiencies were identified by
  research sponsors (both federal and industry),
  where proper researcher registrations were not in
  place.
• The BIDMC pharmacy and at least one researcher
  were notified that BIDMC can no longer provide
  controlled substances to Research areas, unless
  for use in patients of the medical center.
• Animal and bench research areas must procure all
  drugs directly from vendor(s), not from BIDMC
  Pharmacy.

6
Current Practice

• Federal DEA registrations are held by individual
  investigators
• Issue The Researcher DEA often not applied for
  by the investigator.
• The Department Chiefs hold the Researcher MCSRs
  for Clinical and Animal/ Bench Lab Researchers.
• Issue This practice inconsistent dept to dept,
  as of today, only the dept of medicine has
  maintained this registration.

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Going Forward for Clinical Research

• Investigators must have
• Federal DEA Registration as a Researcher or as a
  Practioner, (unless using a Schedule I Controlled
  Substance, where they must hold a separate
  Federal Research DEA Registration).
• State Researcher MCSR, where controlled
  substances/ study agents will be stored and
  dispensed from the BIDMC pharmacy, the MCSR may
  be held by the Chief Academic Officer
• The pharmacy will submit annually a report to
  the CAO.

8
Going forward for Animal/ Bench Lab Research

• Investigators must have
• Federal DEA Registration as a Researcher, which,
  if feasible, may be held by one designated
  individual for each research lab area.
• This individual will be responsible for the
  proper procurement, storage, security,
  documentation of use and destruction of all
  controlled substances in that lab area
• Note The address of the research lab area where
  the controlled substances are being stored MUST
  match the address on the DEA Registration.

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Going forward for Animal/ Bench Lab Research
(continued)

• Investigators must have
• State Researcher MCSR, which, if feasible, may be
  held by one designated individual for each
  research lab area.
• This individual will be responsible for the
  proper procurement, storage, security,
  documentation of use and destruction of all
  controlled substances in that lab area.
• Note The address of the research lab area where
  the controlled substances are being stored MUST
  match the address on the MCSR.

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Procurement of Controlled Substances for
Animal/Bench Lab Research

• Investigators will use the Peoplesoft system to
  order controlled substances directly from the
  vendor (i.e. Webster Veterinary).
• The vendor will request copies of Registrations
  before opening an account, and before shipping
  the controlled substances. The shipping address
  MUST match the address on the controlled
  substance registration.

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Implementation

• Global email
• Mailer to all researchers
• Web reference page
• In-services for investigators

12
Activation of New Policy

• August 1, 2008 September 1, 2008