This policy is superseded by 516-7 Controlled Substances for Research, Teaching and Veterinary Care

I. REFERENCES

A. Systemwide Business and Finance Bulletin (B&FB), BUS-50: Acquisition and Use of Narcotics and Dangerous Drugs

B. Public Law 91-513, Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to as Federal Controlled Substances Act.

C. Regulations Implementing the Comprehensive Drug Abuse Prevention and Control Act of 1970. 21 CFR, Chapter II, Drug Enforcement Administration, Department of Justice

D. California Uniform Controlled Substances Act, Division 10 of the California Health and Safety Code

E. Letter of August 14, 1972, from Vice President McCorkle to Chancellors and Laboratory Directors: Delegation of Authority--Registration and Acquisition of Narcotics and Dangerous Drugs

F. Letter of September 2, 1981, from President Saxon to Chancellors and Others: University Policy on the Protection of Human Subjects in Research

G. Letter of September 2, 1981, from President Saxon to Vice President Frazer: Delegation of Authority -- Protection of Human Subjects in Research

H. Annual Reports of the California Research Advisory Panel

II. SCOPE

This section sets forth in detail the special requirements and procedures applicable to the procurement, receipt, storage, control, biennial inventory, and disposal of Narcotics/Chemicals Carcinogens.

III. DEFINITIONS

A. Narcotics

A narcotic is any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

1. Opium, coca leaves, and opiates.

2. A compound, manufacture, salt, derivative, or preparation of opium, coca leaves, or opiates.

3. A substance (any compound, manufacture, salt, derivative, or preparation thereof) which is chemically identical with any of the substances referred to above. Not included are decocanized coca leaves or extracts of coca leaves which do not contain cocaine or ecocaine.

B. Dangerous Drugs

Dangerous drugs include, but are not necessarily limited to, depressant, stimulant, or hallucinogenic substances such as the following:

1. Any drug which contains any quantity of barbituric acid, any of the salts of barbituric acid, or any derivative of barbituric acid which has been designated by the Secretary of Health, Education, and Welfare as habit forming under Section 502 (d) of the Federal Food, Drug, and Cosmetic Act.

2. Any drug which contains any quantity of amphetamine or any of its optical isomers, any salt of amphetamine, or any substance which the U.S. Attorney General has found to have and by regulation is designated as having a potential for abuse because of its depressant or stimulant effect on the central nervous system.

3. Lysergic acid diethylamide.

4. Any drug which contains any quantity of a substance which the U.S. Attorney General has found to have and by regulation is designated as having a potential for abuse because of its depressant or stimulant effect on the central nervous system or because of its hallucinogenic effect.

C. Schedules of Controlled Substances

Schedules of controlled substances are lists of narcotics and dangerous drugs ranked according to their potential for abuse and other relevant factors. They were established by Public Law 91-513, the Comprehensive Drug Abuse Prevention Act of 1970 (1980 Revision), in order to provide clear guidelines for the implementation of controls on the manufacture, procurement, and use of narcotics and dangerous drugs. Information concerning the assignment of particular substances to specific schedules may be obtained by calling the Purchasing Division of the Materiel Management Department.

D. Chemical Carcinogens

Chemical carcinogens are any chemicals identified as causing cancer in humans as evidenced by Division 20, Chapter 2 of the California Health and Safety Code. Information concerning the assignment of a particular chemical to the chemical carcinogen list may be obtained by calling Environmental Health & Safety (EH&S).

E. Projects

Projects shall include an actual research project and/or an authorized dispensing facility such as the campus Student Health Services or UCSD Medical Center Pharmacy.

IV. POLICY

A. Registration

Authority to dispense narcotics or dangerous drugs or to utilize them in conjunction with research or instructional activities shall be requested from the U.S. Department of Justice, Drug Enforcement Administration. This is to be done in the name of the University of California by the Materiel Manager, and each registration covers one geographical location.

Additional registrations must be secured 1) for operations conducted at sites removed from the area covered by the campus registration, 2) for the manufacture of controlled substances, 3) for hospital/clinic operations, 4) for conducting research using Schedule I controlled substances, and 5) for conducting chemical analysis with controlled substances.

Any project which proposes to use in human research a Schedule II controlled substance, except those listed under ``Stimulants'', must first be reviewed by the State of California Research Advisory Panel. (See Section VI.H.)

All projects involved in the handling or use of controlled substances shall be covered under an applicable University registration. All purchases of such materials using University-controlled funds shall be made only by the Purchasing Division of the Materiel Management Department under such registration.

B. Approval of Projects

Use of narcotics and dangerous drugs under University Registration is restricted to projects where such use has been specifically authorized by the appropriate Department Chair. In his/her absence, this may be delegated to one individual of a comparable level of authority such as a Management Services Officer (MSO). In these instances, this individual would be delegated the authority to sign as a Department Chair Alternate. (See Section VI.B. below.)

C. Orders for Controlled Substances

Authority to sign orders for controlled substances under the regulation of the Drug Enforcement Administration is granted by the Administration. Purchase requests must be forwarded to the Purchasing Division of Materiel Management for order placement only by those individuals authorized by the Materiel Manager under such registration. No orders may be placed by departmental personnel directly with vendors by telephone, departmental purchase orders, or any other means.

D. Penalties for Non-Compliance

Possible penalties for violations of regulations of the Drug Enforcement Administration include the rescinding of University registrations authorizing the use of controlled substances, the imposition of heavy fines, and the imprisonment of those responsible.

V. RESPONSIBILITY

A. Materiel Management

The Materiel Manager is assigned administrative responsibility for overall coordination of this policy and specific responsibility for the purchase, receipt, delivery of product to authorized department representative or UCSD Medical Center Pharmacy for issuance to authorized department representatives, return of controlled substances to the original vendor/supplier, disposal of controlled substances, and biennial inventory notification to Department Chair and/or designated Principal Investigator for inventory of controlled substances. The above information shall be available to the DEA upon request.

B. Department

1. The Department Chair is assigned responsibility for approving projects involving the use of controlled substances by departmental personnel; for authorizing personnel to receipt for shipments from Materiel Management or the UCSD Medical Center Pharmacy; for notifying Materiel Management if a new Principal Investigator arrives on campus with controlled substances, when a Principal Investigator authorized to experiment with controlled substances dies or intends to terminate employment; and for preparation of such reports as may be required.

2. The Department Chair is responsible for assuring that a current inventory of all controlled substances under his/her control is maintained by the Principal Investigator on the Inventory Log Sheet, Exhibit C, in a separate book for periodic audit by Materiel Management and/or the DEA.

3. The Department Chair and the Principal Investigator are assigned joint responsibility for determining the need for and signing all requisitions for controlled substances, for assuring that a current inventory of all controlled substances under his/her control is maintained, that inventory forms are submitted upon notification by and at the request of Materiel Management, that a list is maintained in the laboratory of those individuals handling controlled substances in the laboratory, and that all DEA security regulations are being followed.

4. The Department Chair and/or Principal Investigator is assigned responsibility for the preparation and submission of Research Protocol and all information required for Schedule I controlled substances per instructions contained in VI.A.1., and VI.H.

C. Environmental Health and Safety

The EH&S Officer is assigned responsibility for authorizing his/her staff that have access to drugs during the storage location approval process and for approving all storage locations.

D. Storehouse

The Storehouse Division of Materiel Management is assigned responsibility for maintaining a central storage and pickup area for incoming shipments, and for obtaining appropriate signatures of authorized receipt persons designated under University of California, San Diego Controlled Substances Authorization Form, Exhibit A.

E. UCSD Medical Center Pharmacy

The UCSD Medical Center Pharmacy is assigned responsibility for maintaining a central storage pick-up area for incoming shipments, and for obtaining appropriate signatures of authorized receipt persons designated under University of California, San Diego Controlled Substances Authorization Form, Exhibit A.

VI. PROCEDURE

A. Additional Registrations

The existing University registrations with the Drug Enforcement Administration provide for use of controlled substances in Schedules II through V for Non-Human research on Campus, at the UCSD Medical Center, and at Scripps Institution of Oceanography.

Additional registrations are required for 1) use of Schedule I controlled substances at any location, 2) use of Schedule II through V controlled substances at locations other than the Campus, UCSD Medical Center, and Scripps Institution of Oceanography, 3) the manufacture of controlled substances, 4) hospital/clinic operations, 5) conducting research using Schedule I controlled substances, and 6) conducting chemical analysis with controlled substances.

In addition to a separate registration, additional approvals may also be required for controlled substance research or drug abuse treatment involving humans.

1. NON-HUMAN Research Using Schedule I Controlled Substances, HUMAN Research Using Schedule I or Schedule II Controlled Substances, and Research Projects Concerning Drug Abuse Treatment

At least 6 to 8 weeks, or longer whenever possible, before controlled substances are to be ordered, a complete written Research Application must be submitted simultaneously by the Principal Investigator to the Materiel Manager (one copy) and to the State of California Research Advisory Panel (ten copies). (See Section VI.H.) The general requirements are as outlined below:

a. Complete information describing the purpose, design and extent of the intended studies (a grant application does not necessarily satisfy this requirement).

b. The names of all individuals who will participate in the program and the facilities available to the Principal Investigator.

c. The reasons for using a particular drug.

d. Specific methods to be used in the study.

e. The approving signature of the Department Chair.

For complete instructions, refer to BUS-50, Appendix “C”, “D”, and “E”, respectively.

2. Schedules II through V

Requests to use Schedule II through V controlled substances for NON-HUMAN research at locations other than the Campus, UCSD Medical Center, or Scripps Institution of Oceanography are to be sent by the Principal Investigator via the Materiel Manager to the Office of Environmental Health and Safety (EH&S). EH&S will determine that safety and security regulations are satisfied and return the request, so indicating, to the Materiel Manager for processing.

3. Manufacturing of Controlled Substances

The University of California, as a research institution, is exempt from the restrictions normally imposed by the Drug Enforcement Administration on those manufacturing controlled substances. A separate registration is required and should include a project protocol. The project protocol should define the items being manufactured and the reason(s) for and/or need to manufacture the controlled substances.

4. Hospital/Clinic Operations

Hospitals/Clinics at a location apart from the UCSD Medical Center may require a separate registration. Contact the Purchasing Division to determine if said registration is required.

5. Chemical Analysis

A separate registration to conduct chemical analysis with controlled substances listed in any schedule is required. Contact the Purchasing Division for instructions.

6. Application to DEA

Upon receipt of necessary Research Applications, as outlined in IV.A. and VI.A.1. above, from the Principal Investigator, the Materiel Manager will prepare the application forms for registration, along with a cover letter which will be forwarded to the California Research Advisory Panel, and simultaneously, to the Drug Enforcement Administration (DEA).

Schedule II through V applications will be sent directly to the Drug Enforcement Administration by the Materiel Manager.

7. Notification of Approval

Upon notification of action on the registration application, the Materiel Manager will notify the requestor.

B. Campus Authorization Requirements

Before Materiel Management can honor any Purchase Requisition for controlled substances, the Department Chair must notify Materiel Management by means of a Controlled Substance Authorization Form, Exhibit A. Authorizations will be issued annually by project to a specific Principal Investigator. The budget number and current budget period termination date will be used as identification to a specific project. Renewal authorizations must be submitted for subsequent budget years of a project. Separate authorization is required for each individual project. The following information is required.

1. The Department name and Principal Investigator's name, signature, mail code, and extension.

2. The project budget number, current budget period, and the grant termination date.

3. Persons authorized to receipt for shipment from the Storehouse Division or the UCSD Medical Center Pharmacy including name, signature, mail code(s), and extension(s). (See Exhibit A, Part I).

4. The Department Chair or, in his/her absence, the one individual of a comparable level of authority, such as a Management Services Officer (MSO), delegated the authority to approve projects. (See Exhibit A, Part II).

All applicants and authorizing parties must answer the questions concerning 1) convictions of a felony in connection with controlled substances and 2) surrendering previous registrations or having a registration revoked, suspended, or denied.

The Purchasing Division will provide the Storehouse Division and the UCSD Medical Center Pharmacy with a listing of individuals authorized to receive controlled substances. The Controlled Substance Authorization Form is to be used to update and keep current the above information.

C. Purchasing Controlled Substances

1. All requests for narcotics or dangerous drugs, including gifts and/or gratuities, shall be submitted via Purchase Requisition, Exhibit B. Controlled substances and non-controlled substances are to be ordered separately. CONTROLLED SUBSTANCES ARE NOT TO BE PURCHASED ON A LOW VALUE PURCHASE ORDER. The following information must be included on the requisition:

a. A statement that the substance requested is subject to the Comprehensive Drug Abuse Prevention and Control Act of 1970 (1980 Revision).

b. A full description of the item requested, including quantity, size of a package, potency, name of the narcotic or drug and, if known, the number of Federal Schedule of Controlled Substances to which it is assigned.

c. A detailed statement of the purpose and/or manner of use which is planned. This statement must be specific (e.g., ``to anesthetize rats''). A phrase such as ``research and/or teaching'' is not sufficient explanation.

d. The names of the individuals authorized to use or dispense the substance.

e. The signature of the Department Chair or Principal Investigator approving the Purchase Requisitions for narcotics and dangerous drugs.

2. Purchase Requisitions should be forwarded in the usual manner to the Purchasing Division for processing.

3. After the Controlled Substances Authorization Form has been placed on file by the Purchasing Division and the specific storage location has been approved by EH&S, Purchase Requisitions may be processed by Purchasing without prior referral to EH&S.

4. The Purchasing Division will maintain a file identifying the name, address, and registration number of the person (vendor) from whom the controlled substance(s) were received.

D. Delivery

All shipments of controlled substances purchased with campus funds shall be sent to the Receiving Division of the Materiel Management Department. The Receiving Division will route all such shipments to the Storehouse Division or UCSD Medical Center Pharmacy, which in turn notifies the requestor for pick up. Each shipment shall be accompanied by a Controlled Substance Delivery Form, Exhibit D, which will provide for the signature of each individual through whose hands a controlled substance passes, including the authorized departmental recipient whose signature serves as acknowledgement of delivery and assumption of responsibility for ensuring storage and use in accordance with applicable regulations. The Storehouse Division or UCSD Medical Center Pharmacy, upon receiving the above signatures, shall forward the Delivery form to the Purchasing Division. The Purchasing Division shall maintain a file to identify all controlled substances purchased.

To pick up controlled substances at the Storehouse Division or the UCSD Medical Center Pharmacy, an individual must identify him/herself as a UCSD employee with a current UCSD Identification card.

Individuals using a vehicle to pick up the controlled substances must also carry a valid California driver's license and the appropriate receipt documents to be able to identify him/herself as a UCSD employee conducting University business, if necessary.

Recipient(s) (maximum of two) shall be designated by each Principal Investigator and approved by the respective Department Chair (see Exhibit A, Part I).

E. Storage, Control, and Biennial Inventory

1. Each ordering department shall have adequate security for storage and control as inspected and approved by EH&S in accordance with the following standards:

a. The cabinet shall be equipped with a pin-tumbler type or combination lock.

b. If a padlock or combination lock is used, the hasp shall be installed so that there is no access to the mounting screws or bolts when the door is closed and the lock is fastened.

c. Hinges shall be installed in such a manner as to prevent access to mounting screws or bolts or to the hinge pins when the door is closed.

d. The combination or key (if any) shall at all times remain in the physical custody of the individual authorized by the Department Chair to maintain a storage cabinet for controlled substances. When a storage cabinet is shared by users, responsibility for the key is given to the authorized individual in possession of the storage cabinet.

2. CORRIDOR STORAGE OF CONTROLLED SUBSTANCES IS PROHIBITED.

3. The Purchasing Division shall maintain a file of all new controlled substances purchased for each Principal Investigator and incorporate these controlled substances into the next inventory cycle.

4. It is the responsibility of each Department Chair to ensure that a current inventory of all controlled substances under his/her control is maintained by the Principal Investigator on the Inventory Log Sheet, Exhibit C, in a separate book for periodic audit by Materiel Management and/or the DEA. The following information must be included in these inventory records for controlled substances:

a. Name of substance.

b. Identification of each finished form (e.g., 10 mg. tablet, 10 mg. concentration per fluid ounce or milliliter) and the number of units or total volume of each finished form in each commercial container.

c. The purchase order number; the number of each finished form received; the date of and number of containers in each receipt, the name of the source from which the containers were received.

d. The amount of each finished form dispensed or used, including the name and location of the person(s) to whom it was dispensed, the date of dispensing, the printed or typewritten name or initials of the individuals who dispensed or administered the substance, and the reason it was dispensed or used.

e. The number of units or volume of the finished form and/or commercial containers disposed of in any other manner, as well as the date and manner of disposal. (See VI.F.)

Any breakage of containers shall be noted on the Inventory Log Sheet and initialed by the individual responsible for the breakage and co-signed by the Principal Investigator.

Receipts of controlled substances shall be noted on the Inventory Log Sheet. Purchase order numbers and supplier names shall be shown. Actual purchase order, receipt, and disposal documents shall be maintained by the Principal Investigator and shall be available upon request.

5. Transfers of controlled substances to other departments or individuals are allowed only when approved and coordinated by the Purchasing Division. A current authorization form must be on file with the Purchasing Division for the individual requesting the transferred controlled substance(s).

Once approved, the transaction for the transfer of controlled substances must be documented on each respective Inventory Log Sheet. The individual transferring the substances notes the person to whom the transfer was made and the date, and has the individual receiving the substance sign the Inventory Log Sheet to indicate acceptance of the quantity and the related responsibilities. The individual receiving the transfer logs the substance on their Inventory Log Sheet, indicating the transfer and the source in the ``Supplier'' column. Copies of both log sheets are to be forwarded to the Purchasing Division.

6. Controlled substances shall not be transferred from the original containers for storage and/or inventory purposes.

7. Access to controlled substances shall be denied to any individual who has had a personal application for registration with the DEA denied or revoked at any time. The Principal Investigator shall maintain a list in the laboratory of those individuals handling controlled substances.

8. It is the responsibility of each department head to notify the Materiel Manager immediately of any theft, loss, or mysterious disappearance of controlled substances. The Materiel Manager is responsible for notifying the DEA Regional Office and the University of California Police Department.

9. Department Chairs are responsible for notifying Materiel Management immediately if a new Principal Investigator arrives on campus with controlled substances. Materiel Management shall then contact the DEA to determine the appropriate action. Controlled Substance Authorization Forms shall be submitted as necessary. Additionally, the Department Chair must notify Materiel Management when a Principal Investigator authorized to experiment with controlled substances dies or intends to terminate employment. Controlled substances in possession at that time will be disposed of as specified in Section VI.G.

10. It is the responsibility of each Department Chair and Principal Investigator upon notification by and with directions from the Purchasing Division, to conduct an inventory of all controlled substances.

F. Returns to Suppliers/Vendors`

To make arrangements to return controlled substances to the supplier/vendor, the Purchasing Division must be contacted for instructions. The Purchasing Division will contact the supplier/vendor, identify the documentation needed, and advise the appropriate individuals of the procedure necessary to facilitate the return.

G. Disposal

To make arrangements for disposal of controlled substances in any manner other than the dispensation or use for which they were procured, the Purchasing Division must be contacted for instructions. The Purchasing Division will receive the substances for disposal, indicate on the respective Inventory Log Sheet that they have been received for disposal and issue a copy to the laboratory as a temporary receipt. The Purchasing Division will hold the substances, pending disposal by the DEA. The Purchasing Division shall compile the disposal information, submit the appropriate documentation to the Drug Enforcement Administration, schedule, and conduct the disposal witnessed by or as otherwise specified by the DEA. Once executing the disposal, each participating location will receive a copy which must be attached to their respective Inventory Log Sheet and retained for a minimum of two (2) years.

Disposal must be arranged when:

1. A project has been closed or terminated and controlled substances are still in supply.

2. A Controlled Substance Authorization Form has expired and a renewal has not been submitted.

3. A Principal Investigator determines that the controlled substance is no longer required.

4. The controlled substance has expired.

5. A Principal Investigator maintaining controlled substances terminates employment.

6. A Principal Investigator maintaining controlled substances dies.

In the instances of terminating employment or death of a Principal Investigator, and in addition to the requirement to dispose of any remaining controlled substances, inventory records, including Inventory Log Sheets, must be forwarded to Materiel Management for record retention.

H. Research Advisory Panel

The Research Advisory Panel (established under Sec. 11480 of the State Health and Safety Code) meets in January, March, July, September, and November to consider new protocols. To be eligible for consideration, research applications must be received by the fifteenth day of the month preceding a meeting and must be in conformance with the requirements set forth in Appendix ``C'', ``D'', or ``E'', respectively, of BUS-50. Procedures for submission of proposals to the Research Advisory Panel are set forth in said Appendices. The following types of activities require approval of the Panel:

1. Research of any nature involving use of controlled substances listed in Schedule I. (See Section VI.A.1.)

2. Human research involving use of controlled substances listed in Schedule II, except those items listed under ``stimulants'' which have a stimulant effect on the central nervous system. (See Section VI.A.1.)

3. Research involving use of any substance which concerns the treatment of abuse of controlled substances, such as the evaluation of propoxyphene napsylate in addict maintenance.

The Principal Investigator of each approved program must submit to the Research Advisory Panel an annual progress report by December 31 of each year, or if the program has been completed or discontinued, a final project report. More frequent reporting is required in cases where the health and safety of human subjects are involved. Severe adverse drug reactions or significant unexpected pharmacological findings in human subjects should be reported promptly to the Research Advisory Panel.

I. Chemical Carcinogens

Chemical carcinogens shall not be purchased by departmental personnel directly with vendors by telephone, department purchase orders or any other means.

Information concerning the identification and/or storage and handling requirements of chemical carcinogens may be obtained by calling EH&S.

EH&S is responsible for supplying the Purchasing Division with the current list of chemical carcinogens.

The Purchasing Division shall forward a copy of all purchase orders for chemical carcinogens to EH&S for information.

VII. REQUIREMENTS OF OTHER AGENCIES

If approval of any other Federal or State agency is required for the use of any controlled substance, application for such approval shall be filed by the Principal Investigator or researcher and evidence of approval submitted to the Materiel Manager.