Controlled Substances - FAQ

Controlled substances are drugs or chemicals that have the potential to be addictive or habit-forming. The DEA divides controlled substances into 5 categories called Schedules based upon substances’ potential for abuse and addictiveness and its’ usefulness in medicine. The Drug Scheduling document can be viewed at https://www.deadiversion.usdoj.gov/schedules/

Note: This page is a general reference and not a comprehensive list. This list describes the basic or parent chemical and does not describe the salts, isomers, and salts of isomers, esters, ethers and derivatives which may also be controlled substances.

These lists describe the basic or parent chemical and do not describe the salts, isomers, salts of isomers, esters, ethers, and derivatives which may be controlled substances. These are not comprehensive lists so please note that a substance need not be listed as a controlled substance to be treated as a scheduled substance for criminal prosecution. It is important to do your due diligence if you are purchasing a substance that falls under one of the below categories or is a derivative of a chemical on the DEA controlled substance list. IF you are unsure, consult with EH&S for assistance.

The compliance requirements for obtaining controlled substances and for managing their possession vary based on their schedule. Below is a discussion of the different Schedules:

• Schedule I
  • Have no current accepted medical use in the United States
  • Lack of accepted safety for use under medical supervision
  • Have a high potential for Abuse
  • Examples: marijuana and all cannabinoid derivatives, GHB, peyote, ecstasy, LSD, heroin
  • Note: Although marijuana has been legalized in some states, the DEA continues to regulate marijuana and cannabinoid derivatives as Schedule I controlled substances

• Schedule II
  • Have a high potential for abuse
  • May lead to severe psychological or physical dependence
  • Are only used in medicine under special circumstances and under severe restrictions
  • Examples: cocaine, morphine, opium, Adderall, codeine, Sodium pentobarbital anesthetics (Nembutal®) and Sodium Pentobarbital based euthanasia solutions (Fatal-Plus® and Pentasol®).

• Schedule III
  • Have a lower potential for abuse than Schedule I and II substances
  • Abuse may lead to low to moderate physical dependence or high psychological dependence
  • Are widely used in medicine as pain killers
  • Have less stringent restrictions than Schedule I and II substances
  • Examples: Combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), buprenorphine, ketamine, Telazol®, anabolic steroids, and testosterone. Combination phenytoin and sodium pentobarbital mixtures used for veterinary euthanasia (Beuthanasia-D®, and Euthasol®).

• Schedule IV
  • Have a low potential for abuse
  • Are widely accepted in medical use
  • Examples: Diazepam, Alprazolam, Midazolam, Xanax®, Midazolam, Butorphanol, chloral hydrate, Soma®, Darvon®, Darvocet®, Valium, Ativan®, Talwin, and Ambien®.

• Schedule V
  • Have a lower potential for abuse than Schedule IV substances
  • Consist primarily of preparations containing limited quantities of certain narcotics
  • Very widely accepted in medical use
  • Examples: cough preparations with less than 200 milligrams of codeine per 100 milliliters (Robitussin-AC), Lomotil, Motofen, Lyrica, Parepectolin, and ephedrine.

• Schedule VI
  • Includes all prescription medications not already covered in DEA Schedules I-V

Examples: penicillin, Dilantin, Meloxicam

A Practitioner Registration from the DEA allows for clinical research and instructional activities with the Controlled Substances for which Registration was granted. A Practitioner Registration does not authorize use of Controlled Substances for animal research or chemical analysis. A separate researcher registration is required for these activities. Those individuals who wish to use a controlled substance in their research must register independently with the DEA. The individual registration can be processed by submitting Form 225 to the DEA.

DEA’s Exempt List, which includes more than 350 products that are specifically given a DEA exemption from classification as a controlled substance.

Use of exempt chemical preparations is intended for laboratory, industrial, or educational purposes and not for immediate or subsequent administration to a human being or other animal. No DEA Registration is required for ordering or using exempt chemical preparations.

Prior to working with a controlled substance, researchers are required to take OSU’s Controlled Substance Guideline Training Module for Researchers and the acknowledgment, initially and every 3 years.

Prior to working with a controlled substance, researchers are required to develop a DEA lab-specific SOP. EH&S has a template for Controlled Substance Lab SOP can be used as a starting point.

PI’s are responsible for training authorized users in the following:

• The nature of Controlled Substance hazards including local and systemic toxicity.
• The specific research procedures that could result in exposure.
• Importance of properly securing Controlled Substances, usage log, and incident procedures for lost and/or missing drugs and Inventory.
• Conditions and situations that could result in personal exposure.
• Lab Specific DEA Controlled Substance SOP training is provided by the PI that holds the DEA registration and includes a review of the lab-specific SOP. • All authorized users must read and be allowed to ask questions about the Lab Specific DEA Controlled Substance SOP. Once training is complete, authorized users must sign and date the training log that is kept with the DEA Controlled Substance SOP.

Yes. A Federal DEA registration is required for research with Schedule 1-V substances.

PI’s are responsible to complete their own applications. Registrations must be renewed on an annual basis.

Researchers at OSU who intend to use DEA Controlled Substances in their work must first apply for a license. DEA issues licenses directly to the Registrant (researcher).

• For Schedule II-V substances:

o Complete the DEA new registration form 225 or apply for a new DEA registration online.

Note: Researchers with Schedule I drugs only must submit DEA 225 PDF application via certified mail and the following as attachments. See DEA Form 225 Instructions.

o Inform the EH&S of the new registration by sending an email to [email protected]

ATTACHMENTS Required for Schedule I drugs:

The researcher must attach 3 copies of protocol, including curriculum vitae, to conduct research with schedule 1 controlled substances. For clinical investigations, the researcher must first submit to FDA a "Notice of Claimed Investigational Exemption for New Drug (IND)". See DEA web site or CFR 1301.18 for details.

• Name, address, DEA registration number (if any)
• Institutional or company affiliation
• Qualifications, including curriculum vitae (CV) with a list of publications
• Research Project:

• Title of project
• Statement of the purpose

- Name of controlled substances (CS) involved amount (with justification) of each needed and source.
- Research protocol (detailed description of procedures), including number and species of research subjects, dosage to be administered, route and method of administration, and duration of the project.

• The location where research will be conducted.
• Statement of security provisions for storing and dispensing the CS(s) in order to prevent diversion.
• If investigator plans to manufacture or import the CS(s), statement of quantity to be manufactured or imported and sources of chemicals to be used or substance to be imported.

Authority (if applicable):

• Institutional approval
• Approval of a Human Research Committee for human studies.

- Indication of an approved active Notice of Claimed Investigational Exemption for a New Drug (IND) (number).

• Indication of an approved funded grant (number) if any. DEA 225 forms should be mailed to:

Drug Enforcement Administration
Registration Section/DRR
P.O. Box 2639
Springfield, VA 22152-2639

The average processing time for a new DEA registration is four to six weeks provided that the application is complete and there are no issues. Applicants may call the DEA at 1-800-882-9539 to check on the status of their application or call their nearest DEA Field Office.

Do not handle any controlled substances until a DEA registration is received. Controlled substances may only be handled at the location indicated on DEA registration. A copy of your DEA registration must be maintained and made readily available upon DEA and EH&S inspections.

For Routine Registration assistance about new applications, renewal applications, order forms, or changes to an application or DEA registration: contact a Registration Program Specialist during normal business hours.

For Investigative Matters or Tactical Diversion Squads (TDS): contact a Diversion Investigator or Special Agent during normal business hours.

TDS PORTLAND DISTRICT OFFICE
100 SW MAIN STREET SUITE 500
PORTLAND, OR 97204

Registration Assistance:
Phone: (888) 219 4261
Fax: (503) 721 6602

Investigative Matters or TDS:
Phone: (503) 721 6660
Fax: (503) 721 6605

Obtaining a letter of exemption with Oregon Board of Pharmacy

Researchers are required by the state of Oregon to possess a practitioner’s license (physician, veterinarian, or pharmacist) if they wish to store and use controlled substances in a clinical setting. In lieu of such a license, researchers may request a Letter of Exemption from the Oregon Board of Pharmacy (Oregon Administrative Rule 855-80-0095). The following are instructions on obtaining a Letter of Exemption:

• First, the DEA Registrant must obtain a DEA controlled substance license as a researcher.
• Second, the Registrant needs to submit a letter to the Oregon Board of Pharmacy. The title of the letter should be: "Letter Requesting an Exemption of Licensing." Pursuant to Oregon Revised Statutes (OAR) 475.125(3).

o The letter needs to explain who they are, the research they are performing, and how controlled substances are used and secured, and provide a copy of the DEA Registrant License.
o Letters are to be addressed to the Oregon Board of Pharmacy, Executive Director, Joe Schnabel and emailed to Rachel Melvin, Executive Support Specialist, [email protected]

Practitioners (physician, veterinarian, or pharmacist) that conduct research must have a DEA Researcher Controlled Substance license and a letter of exemption with the Oregon Board of Pharmacy.

DEA Registration Renewal Summary:

1. Access the DEA Registration Renewal Form Login online and fill in all fields. Click the “Login” button.

2. Complete DEA Form 225A.

NOTE: If your original certificate is misplaced, illegible, or destroyed, you may obtain a Duplicate Certificate.

3. Forward a copy of your updated DEA registration to [email protected]

As of January 1, 2017, the DEA will only send out one renewal notification to DEA Registrants in accordance with Title 21, Code of Federal Regulations, Section 1301.13(e) (1). The renewal notification will be sent to the “mail to” address for each DEA registrant approximately 65 days prior to the expiration date. No other DEA reminders to renew the DEA registration will be mailed.

Renewal/reinstatement of registration by the DEA is usually a four to six-week process and is contingent upon the following criteria:

• A renewal application submitted PRIOR to the expiration date. The registrant may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application.

• A renewal application submitted AFTER expiration date. The DEA will allow the reinstatement of an expired registration for one calendar month after the expiration date. If the registration is not renewed within that calendar month, an application for a new DEA registration will be required.

Note that federal law prohibits the handling of controlled substances. It is the responsibility of the DEA Registrant (Researcher or PI) to renew his/her registration prior to its expiration and provide EH&S with a copy.

Once your application is in the DEA queue, the DEA office will want to review and expedite the application in a timely manner. The DEA will need to interact directly with the faculty applicant. Faculty are strongly advised to have their projects well planned before initiating the application process, in order to promptly answer questions posed by the DEA investigator. The DEA office processes hundreds of applications, and any delay in responding to requests for follow-up information may result in significant delays in processing your application.

Failure to respond in a timely manner and/or with incomplete information may result in rejection of the application or a significant delay in the application.

You must obtain a DEA registration number prior to purchasing a controlled substance. The vendor, manufacturer or DEA authorized supplier will require your DEA registration number at the time of purchase.

There may be cases where a researcher can obtain a DEA controlled substance from another university located outside of the USA. If this is the case, DEA Form 357, must be completed in triplicate. For more information see information and Instruction, DEA-357.

Researchers at OSU are responsible for obtaining and maintaining the following information for all Controlled Substance purchased:

• A copy of the invoice

• A copy of the purchase order

• A copy of the shipping document

• A copy of the packing slip

• The name, address, and DEA number of the company from which the Controlled Substance was purchased

• The name of the Controlled Substance purchased

• The size and strength of the Controlled Substance purchased

• The amount purchased (which should match the amount received)

• Schedule 1 and 2 drugs only: Once the drug is received, the registrant must annotate their copy of the DEA form 222 with:

o The date the substance was received, and

o The amount of substance received.

Access to Controlled Substances is restricted to authorized personnel only. Authorized personnel is defined as individuals who have been given access to controlled substances for research approved by the PI. Secure storage prevents unauthorized access to controlled substances which could be used for illicit or illegal purposes.

The kind of secure storage depends on the Schedule of the substance stored.

• Schedule I substances specific requirements:

o Schedule I substances must have a drug safe that weighs at least 750 lb. safe or drug safe bolted or cemented to the floor or wall in such a way that it cannot be easily removed

o In some cases, the drug safe must be equipped with an alarm system, depending upon the quantity of substance it stores

o The DEA will visit to inspect and determine if security is adequate

• Schedule II-V substances specific requirements:

o Schedule II-V substances must be securely stored in one of the following ways:

- Inside of a double-locked safe

- or inside a securely locked box that is tethered or attached to the inside of a substantially constructed, locked drawer or locked cabinet

o No bicycle locks, clasp locks or any other locking structure that can be easily cut off the cabinet can be used.

• Access to storage and use areas must be strictly limited to the authorized individuals assigned by the PI. Authorized individuals must be listed on the Authorized User Signature log Form and Authorized User Screening Form.

• When the areas might be accessed by unauthorized individuals, such as cleaning and maintenance staff, the drugs will be secured.

• All controlled substances must be under the control of a designated, authorized individual.

• The storage cabinet or safe must be adequately sized to maintain stock containers and waste materials.

• Controlled Substances should never be given to non-registrants without a proper designation from the DEA.

For more information see DEA Security Outline of the Controlled Substances Act of 1970.

Record keeping that is accurate, up-to-date, and complete is a critical component to DEA compliance. Failure to maintain proper documentation is the most common cause of a DEA inspection violation. The following records must be maintained by the PI and Lab as identified on the registration. Record retention requirements vary slightly depending on how the substance was obtained (example Imported for Scientific Purposes (DEA FORM 357 or ordered from a US vendor, etc.).

• Substances obtained by PI Registration:

o All records must be kept on hand for at least 2 years from the date of record (the date on which you received the substance).

o All completed order forms

- A copy of the invoice

- A copy of the purchase order

- A copy of the shipping document

- A copy of the packing slip

- The name, address, and DEA number of the company from which the Controlled Substance was purchased

- The name of the Controlled Substance purchased

- The size and strength of the Controlled Substance purchased

- The amount purchased (which should match the amount received)

o Inventory forms: (All inventory forms must be kept on file in the lab where the substance is used)

- Controlled Substance Use Log - Every container of a controlled substance in your possession must have an associated use log that is kept in the same locked and secure place. Controlled substances must each have a log sheet to record the amount removed to make dilutions or solutions.

- Dilution solutions log - if the staff has diluted a product for use, and uses it all during one application, there is no need to create an inventory for that dilution. If any diluted material remains for the intended use at a later date, a new inventory page must be created, as it is considered a “new product” and dilution.

- Transfer Log - To track the transfer of controlled substances from one authorized person or location to another.

- Biennial Inventory Form - A full inventory of all DEA controlled substances must be completed every two years. Any product that is in the lab at that time must be inventoried, even if it has not been in the lab’s possession for the full two years.

- Entries are made when the substance is dispensed and are hand-written in ink.

- Waste bottles: If the lab makes a dilution of the product and does not use all of it in their work, the remaining portion is now considered waste. A new inventory form for the dilution must be initiated and kept for any amounts of that same dilution. Lab staff cannot add different dilutions to this waste bottle.

o Record of the destruction of a lab’s DEA materials on the DEA Form 41. This form will be sent to the DEA regional manager and a copy sent to the individual PI.

o A Lab Specific SOP for DEA Controlled Substance Use and record of training completion must be on file.

o Authorized User

- Authorized User Screening Form, if a Registrant wishes to grant a lab member access to the CS storage area as an Authorized User Screening must be completed.

- Authorized User Signature Log Form, if a Registrant wishes to grant a lab member access to the CS storage area as an Authorized User Form must be completed.

Neither the PI nor her/his authorized staff can self-transport these products from one location to another if neither location is on the PI’s DEA registrations. If the location is designated on the DEA registration, an authorized user may transport the controlled substance in a locked container to that approved location. The transfer log must be used and kept with the controlled substance.

The controlled substance shall not be stored at this new location unless it is also designated on the DEA registration.

Labs and individuals cannot dilute any controlled substance to a lower concentration to eliminate the need to have any product registered. This would be considered “manufacturing” of the substance and is not allowable under the law. Once a product is a DEA controlled substance, it is always a DEA controlled substance, regardless of how the lab alters or dilutes it.

There are certain diluted substances available for purchase that have been approved by the DEA for vendors to sell at a very low concentration for use as a testing standard, etc. This process and dilution have been vetted through the DEA for that purpose and the substances would not require a DEA registration for use. Labs cannot make their own diluted standards to avoid DEA regulations.

A PI with a DEA registration or an authorized user cannot give DEA controlled substances to another PI to have it compounded, diluted, tested, etc. This would be considered manufacturing by an unregistered individual and would be punishable by fines and prison.

A PI with a DEA registration or an authorized user cannot make a solution and transport it to a different location other than the locations designated in the registration and give it to a non-registered/ unauthorized individual to use. This would constitute illegal trafficking of the products and the PI may be subject to fines and imprisonment.

If any changes occur with the use of the controlled substance, such as deleting the use of one or more product, or if the lab moves locations where they will be used, the PI will be responsible for amending the DEA registration. Failure to do an amendment is a potential felony under the DEA regulations.

If the lab changes locations (labs within the same building or a different building) where the products will be used, the PI must send an addendum to DEA with the expected move date. The registration is specific to the labs in which the controlled substances will be used and stored. Without this amendment, the PI will be in violation of the regulations and subject to fines and possible imprisonment.

If the PI or lab is moving from OSU to another university, the products cannot be moved. It would be easier for the PI to dispose of all drug products before the move and buy new once at the new location and the new DEA registration for the new university is obtained.

The DEA regulations do allow PIs to have two valid registrations at one time. To have dual registrations, it is strongly suggested that the PI contact the DEA for their assistance with this. It is important to note that DEA Controlled Substances cannot be transported from one registration site to the other. The multiple sites are considered “coincidental activities” and both sites must be considered independent from each other. Each site must have complete sets of purchase, use, dilution, and disposal recordkeeping.

The PI can modify the DEA license via DEA website. No letter to the DEA is required. Registration Change request Enter the changes as needed. A DEA investigator will contact the PI to verify the changes. Use this for changes to drug codes, schedule, name, or address.

The PI does not need to amend a registration if different staff is authorized (or withdrawn) to use the drug products or if a different vendor is used for supplying the products. This information should be noted on the record log.

Federal regulations require that registrants notify the DEA Field Division Office in their area, in writing, of the theft or significant loss of any controlled substance within one business day of discovery of such loss or theft. The registrant shall also complete and submit to the Field Division Office in their area, DEA Form 106, "Report of Theft or Loss of Controlled Substances" regarding the theft or loss. (21 C.F.R. § 1301.76(b))

Complete and submit EH&S controlled substance discrepancy report Form

DEA controlled substance registrants are strongly encouraged to complete and submit the DEA Form 106 online. In addition to being more convenient, completing the form online results in fewer errors. A link to the online DEA Form 106 is provided below.

In order to better track controlled substances reported as lost or stolen, DEA has incorporated the use of the National Drug Code (NDC) number in the DEA Form 106. The NDC number identifies the manufacturer, product, dosage form, and package size. Entry of the NDC number will prompt the system to auto-populate additional fields such as the name of the product, dosage form, dosage strength, and quantity per container.

If a registrant does not have internet access, a paper copy of the DEA-106 form can be requested by writing to:

• Notify Public Safety/ OSP immediately 541-737-1000

• Notify EH&S immediately 541-737-2273

• Registrant must report suspected thefts or significant losses to the local DEA within one business day. 503-399-5902

Breakage, spills, or other witnessed DEA controlled substance losses do not need to be reported. This type of loss, however, must be documented by the registrant and witness on the inventory record. Controlled Substances that can be recovered after a spill, but cannot be used because of contamination (e.g., tablets), must be placed in the disposal/destruction waste stream as described in the section How do I dispose of my samples Section below. If the spilled Controlled Substance is not recoverable (e.g., liquids), the registrant must document the circumstances in their inventory records and the witnesses must sign. Photos should be taken.

Controlled Substances consumed in a reaction or converted into a hazardous waste mixture from which a Controlled Substance is not recoverable may be disposed of through routine waste disposal procedures from Environmental Health & Safety.

Registrants and authorized agents should only purchase and store those quantities of controlled substances needed for current research or instructional activities. Damaged, expired, unwanted, unusable, or nonreturnable controlled substances must be accounted for, stored, and disposed of in accordance with applicable state and federal regulations.

Disposal of a controlled substance must render it non-retrievable. Though the DEA does not specify destruction methods, it does state, “the process utilized to render a substance ‘non-retrievable’ shall permanently alter the substance’s physical or chemical condition or state through irreversible means and thereby render the substance unavailable and unusable for all practical purposes. A substance is considered ‘non-retrievable’ when it cannot be transformed to a physical or chemical condition or state as a controlled substance.”

If the lab is closing or the PI is retiring, the PI must dispose of those controlled substances prior to closing the lab or before allowing the DEA registration to expire. Just abandoning them for someone else to deal with is a violation of the DEA regulations and the PI who owns them may be subject to punishment which may include fines and imprisonment.

Disposal Options:
There are Three disposal options for expired or unwanted Controlled Substances.

1. Contact the Supplier:
Some suppliers will take back pharmaceuticals for credit. If possible, this is the best means of Controlled Substance disposal.

2. Reverse distribution:
All reverse distributors have their own slightly different methods and requirements. The process typically involves most if not all of the following:

• Contact a Reverse Distribution Vendor to register.

• Complete the vendor’s application for approval to ship material – either in paper form and sent by mail/fax or in electronic form (both require current DEA registration).

• DEA Form 41, see below for more information

• Additional Forms – Completing DEA-222 form if necessary (for Schedule I & II controlled substances)

• Payment – payment or payment information is required with application, current cost is around $200.00 (2019).

• Shipping – once authorized, items are packaged and shipped by you via an approved shipper (Fed-Ex or UPS usually)

• Always request documentation of return/disposal/destruction

3. Destruction by other means: contact EH&S for a consult.

INSTRUCTIONS
Registrant Record of Controlled Substances Destroyed - DEA Form 41
It is recommended that registrants review 21 CFR §1317 — Disposal

1. Section A. REGISTRANT INFORMATION: The registrant destroying the controlled substance(s) shall provide their DEA registration number and the name and address indicated on their valid DEA registration, in addition to a current telephone number and a contact name, if different from the name on the valid DEA registration.

2. Section B. (1) Inventory: This part shall be used by registrants destroying lawfully possessed controlled substances, other than those described in Section B(2). In each row, indicate the National Drug Code (NDC) for the controlled substance destroyed, or if the substance has no NDC, indicate the DEA Controlled Substances Code Number for the substance; if the substance destroyed is in bulk form, indicate the batch number, if available. In each row, indicate the name, strength, and form of the controlled substance destroyed, and the number of capsules, tablets, etc., that are in a full package (pkg. qty.). If destroying the full quantity of the controlled substance, indicate the number of packages destroyed (number of full pkgs.). If destroying a partial package, indicate the partial count of the capsules, tablets, etc. destroyed (partial pkg. count). If destroying a controlled substance in bulk form, indicate that the substance is in bulk form (form) and the weight of the substance destroyed (pkg. qty.). In each row, indicate the total number of each controlled substance destroyed (total destroyed).

3. Section B. (2) Collected Substances: This part shall be used by registrants destroying controlled substances obtained through an authorized collection activity in accordance with 21 U.S.C. 822(g). In each row, indicate whether the registrant is destroying a mail-back package or an inner liner. If destroying a mail-back package, enter each unique identification number separated by a comma and/or as a list in a sequential range and total quantity of packages being destroyed. If destroying an inner liner, enter each unique identification number separated by a comma and/or as a list in a sequential range based on the size of the liners destroyed and the total quantity of inner liners being destroyed. In the case of mail-back packages or inner liners received from a law enforcement agency which do not have a unique identification number or clearly marked size, include the name of the law enforcement agency and, if known, the size of the inner liner or package. DO NOT OPEN ANY MAIL-BACK PACKAGE OR INNER LINER; AN INVENTORY OF THE CONTENTS OF THE PACKAGES OR LINERS IS PROHIBITED BY LAW AND IS NOT REQUIRED BY THIS FORM.

4. If additional space is needed for items destroyed in Section B, attach to this form additional page(s) containing the requested information for each controlled substance destroyed.

5. Section C. METHOD OF DESTRUCTION: Provide the date, location, and method of destruction. The method of destruction must render the controlled substance to a state of non-retrievable and meet all applicable destruction requirements.

6. Section D. WITNESSES: Two authorized employees must declare by signature, under penalty of perjury, that such employees personally witnessed the destruction of the controlled substances listed in Section B in the manner described in Section C.

7. You are not required to submit this form to DEA unless requested to do so. This form must be kept as a record of destruction and be available by the registrant for at least two years in accordance with 21 U.S.C. 827.

Disposal of dilutions and mixtures
When a dilution or mixture of a controlled substance is generated, the quantity of controlled substance used in the dilution or mixture should be removed from your controlled substances inventory. Because the quantity of controlled substance that was used to create the dilution or mixture is removed from inventory, the dilution or mixture is no longer considered a controlled substance. Even though a drug dilution or mixture is no longer considered a controlled substance, it must not be poured down a drain for disposal. Disposal of dilutions and mixtures that have not been used or that can no longer be used must be disposed of through the EH&S hazardous waste program by completing a Hazardous Waste label.

Disposal of other Pharmaceuticals
All pharmaceutical substances, including those that are not considered controlled substances, must be properly disposed of. Some are considered a regulated hazardous waste by the Environmental Protection Agency (EPA). However, even materials that are not regulated as hazardous waste can pose hazards when released into the environment. Because many of these materials were not specifically regulated by the EPA or DOT as hazardous materials when researchers found themselves with unwanted pharmaceutical drugs their approach has traditionally been to flush the unwanted materials down the drain. However, drain disposal of waste pharmaceuticals is illegal and is a violation of the campus wastewater discharge permit.

Unfortunately, pharmaceutical wastes aren’t captured and treated by wastewater treatment facility processes. As a result, the water discharged from these facilities is laced with untreated pharmaceutical drugs which make their way into drinking water supplies and overtime have detrimental effects on ecosystems and aquatic life. As the news media and recent research have highlighted, this pharmaceutical pollution (coupled with the drugs that pass through our digestive systems and also make their way through sewage treatment systems) may have long term health effects that we are only now beginning to study.

To ensure your lab is in compliance with regulations and to avoid polluting the environment and our drinking water, arrange for disposal of unwanted pharmaceuticals the same way you would dispose of any other chemical waste - submit a Hazardous Material/Waste Tag to EH&S for disposal.

Orphaned Controlled Substances: When a controlled substance is found but the “owner” is not known (e.g. a PI who has retired or left the university, or a substance(s) purchased prior to being classified as a controlled agent) then it is classified as “orphaned”. In these circumstances, upon discovery call OSU Dispatch and report you have found controlled substances.  An Officer will take custody of the controlled substances, log it into evidence, and then have it destroyed by their current vendor.

A PI terminates their DEA registration when the research no longer requires the use of the controlled substance.

• Verify all Controlled Substance is properly disposed of.

• Notify EH&S of intent to close out the registration.

• Return to the DEA all remaining blank DEA Form 222.

• Return to the DEA the original DEA registration.

• Arrange for record retention within the Department. Please contact EHS to confirm records transfer. Records should be kept on hand for 2 years.

The DEA can conduct routine, unannounced inspections for your lab to determine if controlled substances are securely stored and if all required records are available, accurate, and up-to-date. Inspectors should show proper identification when they arrive, but you may and should ask to see proper identification if it is not presented.

DEA inspectors will ask to speak with the license holder (PI). Authorized users may be asked to provide Social Security Number (SSN), phone number, address, date of birth (DOB), and job title. DEA inspectors will only ask for documentation from the previous 2 years, which may include:

• Copies of the PI’s DEA registration.

• Executed order forms (DEA 222 forms) for Schedule I or Schedule II substances

• Invoices for controlled substances.

• Floor plan of facility/location of controlled substance storage.

• Drug safe specifications including the serial number.

• SOP and distribution records/dispensing (log sheets).

• DEA-Form 41 (record of destruction).

• Any DEA-1066 Theft or Loss Reports.

Your role during an inspection is to ensure the smooth execution of the inspection. To do this:

• Contact EH&S immediately at 541-737-2273 if a DEA inspector knocks on your door.

• Be courteous and cooperative.

• Answer only the questions that the inspectors ask.

• EH&S can assist with the inspection process.

At least 2 years from the final disposition of the controlled substance.

Within one month of the PIs DEA registration approval date, and biennially thereafter, the PI must conduct a thorough physical inventory—using the form Biennial Controlled Inventory Template—and forward the results of that inventory to the EH&S Department. On alternate years, the Controlled Substance Program Manager may conduct an inventory, during which the PI must be present.

PI must enter their controlled substances in EHSA chemical inventory, do not enter any dilution mixtures.

To view the current OSU policies regarding Marijuana click on the link.

Oregon State policy prohibits faculty from conducting research that involves the possession, use, or distribution of marijuana unless such research is in compliance with already established guidelines set forth by federal agencies, including the Drug Enforcement Administration, Federal Drug Administration and National Institute of Drug Abuse. At this time, OSU policy allows faculty to perform research on industrial hemp in compliance with established federal guidelines.

Additional guidance on industrial hemp can be found at:
Oregon Administrative Rules 603-048: Industrial Hemp
OAR 603-048: Industrial Hemp

Oregon Revised Statute Chapter 571
ORS 571.300 to 571.348

Testing rules for industrial hemp
There is a reporting requirement for failed tests on consumable commodities or products by a laboratory. Testing rules are based on requirements provided by the Oregon Health Authority (OHA).

OAR 333-007 Marijuana Labeling, Concentration Limits, and Testing
OAR 333-064 Accreditation of Laboratories

Chemicals that can be used to manufacture a controlled substance are termed, precursors. Precursor chemicals are chemicals used at OSU in the course of legitimate research that can also potentially be used in the illicit production controlled substances such as methamphetamine, cocaine, heroin, and MDMA (ecstasy). One mission of the DEA and the OSP is to disrupt the illicit production of controlled substances by preventing diversion of precursor chemicals.

DEA Listed chemicals are separately classified based on their use and importance to the illicit manufacture of controlled substances (list I or list II chemicals). Listed chemicals Regulated under the Controlled Substance Act (see 21 CFR 1309, 1310, 1313 and 1314 for details). DEA registration, record keeping and suspicious order reporting requirements apply to importers, exporters, manufacturers, distributors and certain retailers of 42 Listed Chemicals.

There are two Federal DEA lists, List I and List II, which differ by import/export/sales reporting thresholds.

DEA List I: Chemical A chemical specified by regulation that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act and is important to the manufacture of a controlled substance.

DEA List II: Chemical A chemical, other than a List I chemical, specified by regulation that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act.

Oregon Precursor Chemicals: Oregon Law (2017 ORS 475.940) also has a list of chemicals based on their use and importance to the illicit manufacture of controlled substances.

No regulatory burden exists on the OSU researcher unless they are importing or distributing listed chemicals above threshold values as determined by the DEA and International regulatory bodies. Chemical distributers (e.g. Sigma-Aldrich) may request a completed Authorized Purchaser form. Both the person placing the order and the PI need to sign this form and return it to the chemical distributor (e.g. Sigma-Aldrich). Chemical distributors (e.g. Sigma-Aldrich) will call or email the PI before the order will be released.

Regarding the use of DEA Listed Chemicals, please refer to the OSU Chemical Hygiene Plan, or contact the EH&S for information pertaining to the safe handling of these chemicals. According to the OSU Chemical Hygiene Plan, access to all hazardous chemicals, including toxic substances, should be restricted. Specifically, these materials should be stored in laboratories or storerooms that are kept locked when laboratory personnel are not present.

List I

• DEA registration is NOT required if you are going to purchase the product for research purposes.

• The vendor you purchase from must have an Authorized Purchase Form that includes the intended use. This form must be updated annually.

• The Authorized Purchase Form with intended use MUST be updated annually.

• Keep records of the purchase date, quantity, and method of transfer

• Report to DEA suspicious purchases and/or unusual or excessive losses of the listed chemicals

• Quantities may be restricted per order.

LIST II

• DEA registration is NOT required.

• Keep records of the purchase date, quantity, and method of transfer

• Report to DEA suspicious purchases and/or unusual or excessive losses of the listed chemicals.

• Quantities may be restricted per order

No. The requirements of the OSU Controlled Substance Program apply only to DEA “scheduled” drugs.

Initially, each vendor requires an annual Authorized Purchasing Form with a statement of use from purchasing. Contact Purchasing for assistance in meeting vendor requirements.

DEA Listed/Precursor substance must be stored according to hazard class, following the OSU hazardous material storage requirements. No specific security is required.

• For more information regarding the DES Controlled Substance Program, visit the DEA Website: DEA Office of Diversion Control

• For Information on Identifying Your Material: DEA Briefs & Background, Drug Policy, Drug Scheduling

• For the definition of reverse distribution: Reverse Distribution