Researcher MCSR

Research projects involving an investigational new drug as defined in 21 CFR 312.3, or the investigational use of any drug in schedules I-VI where it will be administered or dispensed.  Each research project must be in possession of federally required approvals where applicable prior to applying for an MCSR.  These may include, an FDA Form 1572 and an IRB or IACUC letter of approval.

Who can apply:

The principal investigator of a research project, or the direct supervisor, department chair or chief academic officer of such person.

Can more than one research project be listed on a single application?

• Yes, any and all projects that share a drug storage location can be listed on a single application. 

The following items will be the subject of an onsite inspection prior to the approval of any Researcher MCSR application.

Brief Project/Study Overview

Organizational Chart

Location Overview, including:

• Floor Plan and Square Footage
• General Hours of Operation
• Visitor Policy (i.e.: access to building: escorted, non-escorted, etc.)
• Other occupants, who are they?

Supplier Information:

• Source of Research Drug
• Name or person ordering
• Process of Ordering
• Process of Receiving/Deliveries
• Process for Reverse Distribution/Destruction

Security Standard Operating Procedures and Policies

• Access to the facility (individualized key cards, keys, etc.)
• Access to limited areas/lab within facilities (Individualized key cards, keys, etc.)

Storage of controlled substances:

• Safe/steel cabinet

• Security of storage area (if applicable surveillance cameras, motion sensors, contact switches, glass break detectors, panic buttons, etc.)
• Alarm Company Information
• Who will be contacted if a breach occurs?

Recording Keeping:

• How, where and for how long will the records be kept (bounded logbooks, electronic system, etc.)

Important information for Researchers

• DEA researcher manual
• Retail Pharmacy Participation in Research Drug Studies (PDF) | (DOC)