University of Maryland, Baltimore (UMB) investigators who use drugs or substances controlled by the Drug Enforcement Administration (“Controlled Substances,” defined below) for research must comply with applicable federal and state laws. UMB must oversee research use of Controlled Substances at UMB and in off-campus facilities controlled by UMB. This Policy establishes responsibilities and procedures for exercise of UMB’s oversight of research use of Controlled Substances

This Policy does not authorize any person to engage in any act that the individual is not authorized or permitted to do under federal or state laws or regulations. In the event of any conflict between this Policy and applicable laws or regulations, the laws or regulations will take precedence.

 

2.     SCOPE

This Policy applies to acquisition, use, manufacture, storage, and disposal and lawful disposition of Controlled Substances used for research purposes. This Policy applies to all Registrants and Authorized Persons as defined below. All other employees, students, and other persons using UMB facilities or visiting at UMB are prohibited from having access to, and using for any purpose, Controlled Substances intended for research use.

This Policy does not apply to Licensed Practitioners (as defined below) with respect to (a) dispensing Controlled Substances in the course of their professional practices, as authorized by their licenses as health care practitioners, or (b) dispensing Controlled Substances in the course of human subjects research within any hospital in the University of Maryland Medical Center, at the Baltimore Veterans’ Administration Medical Center, or at any other health care facility which takes responsibility for the inventory and control of the Controlled Substances being used in research.

3.     DEFINITIONS

Authorized Persons - A UMB faculty member, staff, or student subordinate to a Registrant and authorized by HRS to have access to or use for research Controlled Substances held in a Registered Location under the responsibility of that Registrant. Volunteers and visitors may not be Authorized Persons. No one under the age of 21 may be an Authorized Person.

AVP – UMB Associate Vice President for Human Resources.

Controlled Substance - Any substance listed in the Controlled Substances Act, Code ofFederal Regulations (21 CFR, part 1300 to end) or Article 27, §279 Annotated Code of Maryland.

DEA – Drug Enforcement Administration, the section of the United States Department of Justice that establishes regulations for the handling and use of Controlled Substances.

EHS – UMB Office of Environmental Health and Safety.

Federal/State Registration - Formal grant of authority to handle and use Controlled Substances. The term refers collectively to Federal Registration issued by the DEA and State Registration issued by the MD DDC. The registration processes are separate.

HRS – UMB Office of Human Resource Services.

Inventory - An accurate, continuous and current record made by a Registrant, or by an Authorized Person under a Registrant’s supervision, and used to track the acquisition, use and disposal of Controlled Substances for which the Registrant has responsibility under law and this Policy.

Licensed Practitioner - A physician, dentist, veterinarian, nurse practitioner,or other individual licensed, registered or otherwise permitted by the United States and, if required by State law, the jurisdiction in which the individual practices, to dispense a controlled substance in the course of professional practice.

Manufacture – The production, preparation, propagation, compounding or processing of a drug or other substance either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by combination of extraction and chemical synthesis.

MD DDC – The Maryland Division of Drug Control, the Division of the Maryland Department of Health and Mental Hygiene that establishes regulations for handling and use of Controlled Substances in Maryland.

Public Safety – The UMB Department of Public Safety, which includes the UMB Police Department.

Registered Location - A building, room or set of contiguous or adjacent rooms identified in a UMB Registration where Controlled Substances are stored or used or where the Manufacture of Controlled Substances takes place. A Registered Location is managed by a single Registrant, and has a single address.

Registrant - A person employed by UMB who has obtained UMB Registration from EHS, as well as Federal/State Registration, to acquire, store, Manufacture,use and dispose of Controlled Substances.

Radioactive Materials Quantity of Concern - The list of radioactive materials and their quantity of concern limits identified by the Nuclear Regulatory Commission as requiring personnel with access to be determined to be trustworthy and reliable.

Select Agents – Biological agents and toxins identified by the Department of Health and Human Services and the Department of Agriculture as requiring personnel with access to undergo a security risk assessment.

UMB Registration – Registration issued by EHS to UMB employees.UMB Registration is required to do research at UMB involving Controlled Substances, to acquire or Manufacture Controlled Substances, to maintain an Inventory, and to use EHS resources regarding management and disposal of Controlled Substances.

Provost - Executive Vice President, Provost and Dean of the Graduate School 

4.    RESPONSIBILITIES

a.    Registrant –

i.     Complete EHS training for Controlled Substances.

ii.    Obtain and maintain Federal/State Registration and UMB Registration.

iii.   Establish and implement facilities and procedures for proper procurement, storage, use, and disposal of Controlled Substances.

iv.   Conduct and maintain an accurate Inventory.

v.    Identify for HRS approval Authorized Persons subordinate to the Registrant.

vi.   Provide and maintain a current list of Authorized Persons on file with EHS.

vii.  Cooperate with EHS in training Authorized Persons.

viii.  Supervise access to and use of Controlled Substances by Authorized Persons the Registrant has identified to EHS, and prohibit access to and use of Controlled Substances by other persons.

ix.   Notify EHS whenever an Authorized Person leaves UMB or ceases to have responsibilities for Controlled Substances for which the Registrant is responsible. If applicable, notify EHS of the replacement for such an Authorized Person.

x.    Conduct an Inventory at each of the Registrant’s Registered Locations as required by the conditions of the Registrant’s Federal/State Registration and UMB Registration.

xi.    Upon discovery, report any known or reasonably suspected inventory discrepancies or diversion, theft or loss of Controlled Substances to the DEA, Public Safety and EHS.

xii.   Initiate disciplinary action against any Authorized Person or other employee or student who does not follow this Policy and the procedures required by the Registrant.

xiii.   Notify EHS immediately if federal or state authorities begin an investigation of the Registrant’s use of Controlled Substances or initiate any administrative or legal action that may result in revocation of Federal/State Registration.

xiv.   Pay or arrange for payment of state and federal registrations fees. Pay or arrange for the cost of commercial disposal of Controlled Substances under their Registration, if applicable.

b.     Authorized Person –

i.     Complete EHS training for Controlled Substances.

ii.     Observe all requirements of this Policy and policies and procedures of the Registrant’s research unit concerning use of Controlled Substances.

iii.    Notify EHS, Public Safety, and the Registrant upon discovery of any known or reasonably suspected inventory discrepancies or diversion, theft or loss of Controlled Substances.

iv.    Report upon discovery to the Registrant any unauthorized access to or use of Controlled Substances in the Registrant’s Inventory.

v.     Upon leaving employment or being reassigned to responsibilities that do not involve Controlled Substances, cooperate with the Registrant to carry out a final Inventory of Controlled Substances managed by the Authorized Person and to transition responsibilities to the Registrant or to another Authorized Person designated by the Registrant.

c.     EHS –

i.       Provide guidance to investigators on obtaining Federal/State Registration and UMB Registration. Identify any persons who need to become Registrants so that each Authorized Person will be subordinate to a Registrant.

ii.     Maintain a current list of all Registrants and Authorized Persons, a schedule for renewal of UMB Registration, and a schedule for review of the background checks of Authorized Persons.

iii.     Maintain a current list of all Registered Locations.

iv.     Review each Registrant’s purchasing process, Inventory, and security measures, including both facilities and procedures.

v.      Conduct annual audits.

vi.     Conduct a final inspection when a UMB Registration or Registered Location becomes inactive.

vii.    Establish procedures for disposal or other lawful disposition of Controlled Substances.

viii.   Provide training for Registrants and Authorized Persons on the management of Controlled Substances. Counsel Registrants and Authorized Persons concerning violations of law and policy regarding Controlled Substances.

ix.     Report violations of law and policies to the Provost and to appropriate supervisors for disciplinary action.

x.     Notify the Academic Dean and intermediate academic supervisors (e.g., chairman or director of institute) of Registrants and Authorized Persons who demonstrate inability or unwillingness to follow applicable laws, policies, and research procedures. After consultation with the Academic Dean, revoke Registration or Authorized Person status for individuals who are not compliant with laws, policies and procedures applicable to use of Controlled Substances.

d.    Public Safety –

i.     Consult with EHS and Registrants on security of storage facilities for Controlled Substances.

ii.     Investigate reports of Inventory discrepancies or diversion, theft or loss of Controlled Substances.

e.    HRS –

i.     Obtain background investigation reports concerning individuals for whom status as an Authorized Person is sought, and obtain repeat background investigations at the intervals required by this Policy.

ii.    Evaluate background reports received.

iii.   Determine whether persons who have, or seek, status as Authorized Persons, are approved for that status.

f.    Academic Deans -

i.    Require that Registrants follow this Policy.

ii.   Take or initiate appropriate action (e.g., suspension of research, termination of employment) against those who do not follow this Policy.

iii.   Notify the Provost and EHS of actions taken under the preceding paragraph.

g.   Provost–

i.    Oversee the administration of this Policy by EHS.

ii.   Consult with EHS and Academic Deans regarding actions to be taken affecting the responsibilities or employment of individuals who do not comply with the requirements of this Policy.

5.   REQUIREMENTS

a.   UMB Registration

Investigators who seek UMB Registration for the conduct of research involving Controlled Substances at or under the auspices of UMB must first register with EHS. (Investigators who were registered with DEA and MD DDC prior to the effective date of this Policy must complete the EHS process to receive UMB Registration within 60 days after the effective date.)

Investigators must provide to EHS a description of current or proposed use of each Controlled Substance, current and proposed Authorized Persons, and current and proposed Registered Locations. This description will not be used for scientific review or evaluation of the need to use Controlled Substances in research. EHS must be notified whenever there is a change (addition or deletion) in Authorized Persons, a change in Registered Locations, a change in UMB Registration, or a change in Federal/State Registration. EHS provides a form to be used for providing notice.

The background investigation and approval process for Federal/State Registration is rigorous. UMB does not repeat the investigations undertaken by the regulatory bodies responsible for Federal/State Registration of UMB faculty researchers. A researcher who loses Federal/State Registration will automatically lose UMB Registration.

A Registrant must notify EHS immediately of any investigations or other actions undertaken by the DEA or other State or federal agencies that relate to the Registrant’s Federal/State Registration and/or may result in revocation of the Registrant’s Federal/State Registration.

b.   Human Resource Services Approval

HRS must approve designation of individuals as Authorized Persons who can have access to Controlled Substances and can use them for research.

For a current employee proposed to be an Authorized Person, HRS’s action will be based upon the pre-hire background investigation report concerning the person that is on file at HRS. If any person proposed as an Authorized Person does not have a pre-hire report on file (i.e., is a new hire, or was hired before UMB began seeking pre-hire background reports), or the report on file is more than five (5) years old, HRS will request a new background investigation report. The report requested will be consistent in scope with reports required by UMB for new employees.

A background check less than five (5) years old made for purposes of gaining approval for an employee to have access to Select Agents or Radioactive Materials Quantity of Concern may be substituted for the pre-hire background investigation.

If the AVP or designee determines that an individual should not be approved as an Authorized Person based upon information in a background investigation report, HRS will notify the individual who is the subject of the report (“subject”), EHS, and the concerned Registrant. HRS will include in its notice information sufficient to explain in general terms the reason for the negative decision, but will not disclose specific criminal history information to EHS or the Registrant.

If the subject denied Authorized Person status is a current employee or student who had responsibilities involving Controlled Substances upon implementation of this Policy, or is a current employee or student being considered for new responsibilities involving Controlled Substances, the subject may request a meeting with a representative of HRS to review the reason for the decision. A request must be made in writing to the AVP within ten (10) business days after HRS provides notice of a negative decision. With the subject’s consent, the Registrant and a representative of the Human Resources staff of the Registrant’s school will be invited to attend the meeting.

c.   Recordkeeping

Inventories of Controlled Substances at each Registered Location are the responsibility of the Registrant for that Registered Location. The Registrant must carry out, or verify that an Authorized Person has carried out, each responsibility of the Registrant related to Inventory.

Each Registrant, or an assigned Authorized Person, must keep Inventories and other records to account for Controlled Substances used in any research activity. Each Inventory and other record must be kept for two years from the date the Inventory or record is made. If a Registrant leaves UMB employment during the two-year period, the Inventories and records of that Registrant must be transferred to EHS. If an Authorized Person assigned responsibility for Inventory is not responsible for Inventory throughoutthe two-year period, the Registrant must verify the Inventory at the time of departure and assume Inventory responsibility or assign the responsibility to another Authorized Person.

An initial Inventory of Controlled Substances is required on the date the Registrant first takes possession of the Controlled Substances. Each Inventory must be a complete and accurate record of all Controlled Substances received, used, and disposed of at the Registrant’s Location. The Inventory must be maintained on an EHS-approved form at the Registered Location.

The Registrant shall maintain separate Inventories and records for each Registered Location. Registrants must assess their Inventory for each Registered Location annually, document that action, and report any known or reasonably suspected discrepancy, diversion, theft or loss to DEA, the Department of Public Safety, and EHS upon discovery.

EHS will review Inventories and other records when it conducts reviews of the UMB Registration. EHS may require more frequent assessment of Inventories and other records in response to Inventory control issues or other factors that are judged by the Director of EHS to increase risk of non-compliance with laws and regulations applicable to Controlled Substances.

All signatures in the Inventory and records must be legible and dated.

d.   Receiving Controlled Substances

A Registrant must verify the accuracy of a shipment of Controlled Substances from a supplier immediately upon receipt. Discrepancies must be reported to the DEA, the Department of Public Safety, EHS, and the supplier upon discovery.

e.   Storage and Security Controls

Registrants must provide effective controls and procedures to guard against theft and diversion of Controlled Substances stored or used at Registered Locations. Specifications for security are set forth in the federal and state regulations. Public Safety will review proposed security systems upon request and may require adjustments in security systems.

f.   Disposal and Transfer of Controlled Substances Inventories

Registrants are responsible for documenting the disposal of Controlled Substances. EHS will establish procedures for disposal of Controlled Substances in accordance with federal and state regulations.

Registrants leaving UMB must notify EHS 30 days prior to their termination of employment so that records can be reconciled and unused Controlled Substances can be disposed of properly or transferred in a timely manner to the Inventory of another Registrant at UMB. If one Registrant transfers Controlled Substances to another Registrant, the transfer must be documented to EHS and all Inventory records and other records pertaining to the Inventory must be transferred to the next Registrant responsible for the Controlled Substances. The Registrant receiving the Controlled Substances must verify the accuracy of the Inventory of transferred Controlled Substances.

In the event of death or extended absence of a Registrant, the Registrant’s supervisor must notify EHS, which will either arrange for the Department of Public Safety to take custody of the Registrant’s Controlled Substances and dispose of them, or work with the Registrant’s school to arrange for another Registrant to assume responsibility for them.

g.   Diversion, Theft or Loss of Controlled Substances

Anyone having knowledge or reasonable suspicion of Inventory irregularities or diversion, theft or loss of Controlled Substances from a Registered Location or other site has an obligation to report such information to Public Safety, EHS, and the Registrant (if the Registrant is not the person reporting). The Registrant shall notify the DEA Field Division Office of any theft or significant diversion or loss of any Controlled Substances upon discovery of the theft, loss, or diversion.

h.   Oversight

EHS will review each Registrant’s management of Controlled Substances and compliance with this Policy at least once every 12 months. More frequent reviews are at EHS’s discretion. More frequent reviews may be initiated by EHS due to concerns about compliance with this Policy and the law, and also may be requested by a Registrant, or a Registrant’s supervisor or Dean, if there are concerns about compliance with this Policy.