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Policy 7.25
Research Use of Controlled Substances

Responsible Official: VP for Research Administration
Administering Division/Department: Research Compliance
Effective Date: March 01, 2012
Last Revision: March 17, 2016

Policy Sections:

Overview

Emory’s Controlled Substances Policy covers all persons at Emory who conduct non-human subjects research that uses Controlled Substances. Other policies cover human subject clinical research involving Controlled Substances.

¿  Both the State of Georgia and the United States federal government regulate Controlled Substances used in Research

¿  The drugs that are considered to be Controlled Substances are listed in the following laws/regulations: (i) Schedules I to V of Official Code of Georgia Annotated (OCGA) Sections 16-13-25 to 16-13-29 at http://www.lexisnexis.com/hottopics/gacode/; and (ii) Schedules I to V of Title 21 of the Code of Federal Regulations ( CFR) Section 1308. Scheduled drugs are listed at http://www.deadiversion.usdoj.gov/schedules/index.html.

¿  To use Controlled Substances for Research, a researcher must register with the State of Georgia Board of Pharmacy (GBP) and the federal Drug Enforcement Administration (DEA).

¿  Registration is required for each separate physical location at which Controlled Substances Research takes place. The Georgia Drugs and Narcotics Agency (GDNA) will conduct a site inspection before a GBP registration is issued; the DEA may also conduct a site inspection in response to application.

¿  Registration has to be maintained at all times while Controlled Substances are being used in Research or in the user’s possession.

¿  Researchers must use the Controlled Substances they order exclusively for their own Research. These drugs can’t be shared or transferred to others not supervised directly by the researcher.

¿  Researchers have to supervise their employees, students and other agents who assist them in their Controlled Substances research. Supervising personnel includes: explaining what and how Controlled Substances will be used in the Research; ensuring personnel are trained in Controlled Substances security and record-keeping procedures; and actively monitoring personnel’s use of Controlled Substances in Research to ensure that this Policy and applicable laws/regulations are being followed.

¿  Researchers must order Controlled Substances through Emory’s Procurement and Payment Services.

¿  Researchers must keep Controlled Substances in a secure locked cabinet or safe and control access to the Controlled Substances.

¿  Researchers must keep accurate records on the receipt and use of Controlled Substances. Researchers also must keep an initial and biennial inventory of their Controlled Substances. Records for Schedule I and II Controlled Substances must be kept separately. Researchers must only dispose of Controlled Substances through a reverse distributor or approved on-campus event.

¿  Researchers must immediately report any theft or significant loss of Controlled Substances to DEA and the GDNA government regulatory agencies and the Emory Office of Compliance (OC).

¿  Forms: This Policy has a number of forms associated with it that can be found at http://www.compliance.emory.edu under the “Use of Controlled Substances in Research Information” tab. The best way a Registrant can ensure compliance with the Policy and laws/regulation is to correctly use these forms.

¿  Failure to follow this Policy can result in loss of ability to conduct Research using Controlled Substances at Emory, disciplinary sanctions, or referral for prosecution.

Applicability

What is Covered by this Policy?

This Policy covers researchers who use Controlled Substances in Research activities at Emory that are not Human Clinical Research (HCR) activities. HCR activities are governed by Emory Institutional Review Board policies. For purposes of this Policy, the term Research is defined as follows: “Any type of scientific investigation other than Human Clinical Research.”

This Policy applies to the acquisition, use, storage, disposal and/or related activities, including record-keeping, that involve the acquisition, use, storage, and/or disposal of Controlled Substances in Research that takes place at Emory facilities. As previously noted, different rules cover the use of Controlled Substances in HCR.

This Policy does not cover activities such as drug manufacture, distribution or analysis. The federal Drug Enforcement Agency (DEA) has separate rules and registration requirements for these activities.

 

Purpose of this Policy:

This Policy is designed to set forth the major requirements of the applicable laws and regulations that apply to Research involving Controlled Substances and to assist Emory researchers in complying with those laws/regulations and this Policy. It does not set forth every detail of every law and regulation with which persons who use Controlled Substances in Research must comply. Instead, this Policy attempts to reflect accurately the major requirements of applicable laws and regulations. In the event of a conflict between this Policy and applicable laws and regulations, the more restrictive will govern.

 

Who is Covered by this Policy?

Each Emory employee and student, as well as any visiting researcher, who is authorized to use Controlled Substances in his/her Research at Emory University is covered by this Policy.

 

Who is Not Covered by this Policy?

This Policy does not cover the use of Controlled Substances by a physician, pharmacist, dentist, podiatrist, or veterinarian (a Practitioner) in providing health/veterinary care for his/her patients or clients. It also does not cover a Practitioner’s use of Controlled Substances in HCR.

 

Summary of Responsibility under this Policy:

Any person who uses Controlled Substances in his/her Research at Emory is responsible for knowing and following all applicable federal, state and local laws/regulations and Emory policies, including the applicable laws and regulations noted below. Supervisors are responsible for making sure that any person who works for them also follow these laws/regulations and Emory policies. 

Consequences for Failure to Follow this Policy:

If a person who uses Controlled Substances in Research at Emory facilities does not follow this Policy and/or the applicable laws and regulations, such failure may result in any or all of the following consequences: (a) immediate loss of the ability to conduct Research using Controlled Substances at Emory facilities; (b) disciplinary action being taken against that person, up to and including termination of employment; and/or (c) referral for prosecution by law enforcement officials.

 

Updates to Policy:

This Policy shall be reviewed periodically and updated to ensure accuracy and conformity with the laws in this area.

Policy Details

The Policy Details Section is divided into the following subject matter areas: (A) Applicable Laws and Regulations; (B) Scope; and (C) Requirements for Use of Controlled Substances in Research. Defined words and acronyms in the Policy are shown as capitalized, italicized terms and listed in the Definitions Section.

Forms referenced in this Policy are available at the Office of Compliance website under at http://compliance.emory.edu/ under the “Controlled Substances” tab.

 

Researchers should use these forms to ensure Policy compliance.

 

A.           Applicable Laws and Regulations

 

Researchers who use drugs that are classified as Controlled Substances in their Research must follow applicable laws and regulations including those set forth below, which can be found at the listed websites:

 

·         Federal Controlled Substances Act (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) at http://www.deadiversion.usdoj.gov/21cfr/21usc/index.html  .

 

·          Federal Regulations at Title 21 Code of Federal Regulations (CFR) Parts 1300

1321 at http://www.deadiversion.usdoj.gov/21cfr/cfr/index.html.

 

·         Georgia Controlled Substances Act, Official Code of Georgia Annotated ( OCGA), Sections 16-13-1 to 16-13-43 at http://www.lexisnexis.com/hottopics/gacode/.

 

·         Applicable provisions of the Rules and Regulations of the Georgia Board of Pharmacy, Chapt. 480 at

http://rules.sos.state.ga.us/cgi-bin/page.cgi?g=GEORGIA_STATE_BOARD_OF_P HARMACY%2Findex.html&d=1.

 

NOTE: As defined in this Policy, Research does not include Human Clinical Research (HCR). HCR is governed by different laws, rules, regulations and policies.

 

B.           Scope

 

Drugs to which this Policy Applies. This Policy applies to the following drugs, which are referred to as Controlled Substances in this Policy:

 

(a)        All drugs, substances or immediate chemical precursors listed in:

 

(i)  Schedules I to V of OCGA Sections 16-13-25 to 16-13-29 at http://www.lexisnexis.com/hottopics/gacode/;     and

 

(ii)  Schedules I to V of Title 21 of the Code of Federal Regulations (CFR) Section 1308. Scheduled drugs are listed at http://www.deadiversion.usdoj.gov/schedules/index.html  .

 

Drug Schedules. The “Schedules” noted above refer to the categories into which Controlled Substances are divided under federal and state law. Specifically, drugs with addictive potential are divided into categories called “schedules” or “classes” based on potential for abuse and existence of medicinal use. There are five Schedules (I-V), as well as separate groupings for pre-cursor chemicals. Each Controlled Substance is specifically listed by name within the Schedule to which it has been assigned by regulators. Classification at the state level may differ from classification at the federal level. Schedule I Controlled Substances are not considered to have any medicinal use, and therefore, regulations for these substances are more restrictive than for substances falling under other Schedules. Drugs in Schedules II through V have medicinal use, but the potential for abuse and public health hazards increases as the Schedule number decreases (i.e., a Schedule II drug is considered to have greater abuse potential than a Schedule III drug). Each DEA registration will specifically describe the Schedules that the registration holder (Registrant) is permitted to use. A Practitioner registration does not include authorization to possess, prescribe or administer Schedule I Controlled Substances because they are not considered to have any medicinal use.

 

References: Controlled Substances Act, 21 USC Chapt. 13, §801, et. seq.; 21 CFR Part 1308; OCGA §16-13-1 to 16-13-43; Rules and Regulations of the Georgia Board of Pharmacy, Chapt. 480. NOTE: Section III, Subject Matter Area A contains links to websites for state and federal laws/regulations.

 

C.           Requirements for Use of Controlled Substances in Research

 

This Policy area covers the basic requirements that a researcher must fulfill in order to use Controlled Substances in Research at Emory. It is divided into the following five subsections: (i) Registration; (ii) Security and Storage; (iii) Ordering and Procurement; (iv) Disposal; and (v) Records.

 

Subsection (i): Registration

Overview: All persons at Emory who want to do Research using Controlled Substances must: (1) register with the Georgia Board of Pharmacy (GBP); and (2) register with the DEA as a Researcher. This dual registration requirement applies to both Practitioners who wish to do non-human subjects research using controlled substances and to non-Practitioners.  Per instructions from DEA, Practitioners who have DEA registrations that permit them to prescribe Controlled Substances for clinical practice and human clinical research ALSO MUST HAVE researcher’s permits issued by both the DEA and the GBP in order to conduct non-human subjects Research using Controlled Substances.   Registration must be continuously maintained and not permitted to lapse while in possession of Controlled Substances to be used in Research.  A Registrant may only use those Controlled Substances and perform those activities that are permitted by his/her registration.

Registration with the GBP: All persons who want to use Controlled Substances for Research at Emory must have a Georgia researcher’s permit. The application for a Georgia researcher’s permit can be found on the GBP website at http://gbp.georgia.gov using: (a) Online Services; (b) Apply Online; (c) Embedded "forms" link; (d) Pharmacy Facility Application (see pages 3, 6, 7, 17, 18 and 19).

Researchers must first apply for a researcher’s permit from the GBP. A description of the Research protocol must be submitted to the GBP. Proof of U.S. citizenship or qualified alien status also must be submitted. The GBP permit number is required for the DEA application.

Registration with the DEA: All persons who want to use Controlled Substances for non-human subjects Research at Emory also must register with the DEA.   DEA registration information and application forms can be found on DEA’s website at http://www.deadiversion.usdoj.gov/drugreg/index.html#1.    Researchers should use DEA Form 225 for their initial application and Form 225a for renewals.  A Practitioners’ registration (using DEA Form 224) only permits use of controlled substances in clinical practice and human subjects clinical research.

All State of Georgia requirements must first be satisfied in order to obtain a DEA registration. All Researchers must obtain a Georgia researcher permit before applying for a DEA Researcher permit. For Research using Schedule I Controlled Substances, a copy of the Research protocol containing the information set forth in 21 CFR §1301.18 must be provided to DEA. If the protocol requires approval from an Emory University committee such as the IACUC, IBC or RHSC, then this approval must be obtained before the registration application is submitted to the DEA. A copy of the committee’s approval for the protocol must be submitted to DEA along with the protocol and registration application.

Location of Registration: ALL Registrations ARE location specific, i.e., a researcher must obtain a separate registration for each site at which Research using Controlled Substances is performed. Controlled Substances only may be shipped to the specific location listed on a registration, for use by the Registrant according to the permitted use.

Pre-Registration Inspections: The Georgia Drugs and Narcotics Agency (GDNA) must inspect a site before the GBP issues a registration. The Registrant is responsible for contacting the GDNA to arrange for an inspection only after the GBP has notified the Registrant that his/her application has been processed.  The inspection is performed to insure that facilities and processes are in place to satisfy all regulatory requirements, such as security and record-keeping requirements. Contact information for the GDNA can be found at the agency’s website: http://gdna.georgia.gov/contact-us-0. The GDNA agent will leave a copy of the completed inspection form with the applicant, which must be retained by the Registrant.

The DEA also may conduct an inspection of an applicant (21 CFR §§1301.31, 1316) but generally relies on the GDNA inspection.

Registration for Employees/Agents who Assist in Controlled Substances Research: Employees or students working for the Registrant may be authorized to work with the Controlled Substances in carrying out their usual course of employment/course of study, provided they are under the supervision and control of the Registrant.  Supervision includes explaining to personnel: what Controlled Substances will be used in the Research; how the Controlled Substances will be used in the Research; security measures that must be taken with regard to the Controlled Substances; record-keeping activities, such as inventories and use logs, that must be followed with respect to the Controlled Substances; and procedures for reporting any suspected loss or diversion of Controlled Substances. Supervision also requires the Registrant actively monitor personnel’s use of Controlled Substances in Research to ensure that this Policy and applicable laws/regulations are being followed.

References: 21 CFR Part 1301; OCGA §§16-13-35 to -38; 26-4-49; Rules and Regulations of the State of Georgia §480-20-.01. NOTE: Section III, Subject Matter Area A contains links to websites for state and federal laws/regulations.

 

Subsection (ii):

 

Security And Storage Of Controlled Substances

 

The Registrant is responsible for making sure that the Controlled Substances used in his/her Research are kept secure to prevent theft, loss, unauthorized access or removal. The Registrant must follow all applicable security requirements specified in the applicable laws and regulations listed above. Particular attention should be paid to the requirements set forth in 21 CFR §§1301.71, 1301.75-.76 at http://www.deadiversion.usdoj.gov/21cfr/cfr/index.html. A Security Checklist -- FORM 1 is available at http://compliance.emory.edu/; use of this checklist will assist Registrant’s compliance with physical and personnel security requirements.

 

Physical Security. Under the applicable laws and regulations, Practitioners and non-Practitioners who use Controlled Substances in Research follow the same security requirements. The DEA and GDNA evaluate physical security measures based on the type and amount of Controlled Substances on hand; the Registrant’s location in a high or low crime area; the number of persons who have access to the Controlled Substance storage area; the presence and use of an alarm system; and any prior history of drug diversion. Basic physical security requirements include the following:

(1)       Containers: Controlled Substances should be stored in their original, labeled containers, and they should be stored separate from general chemicals.

(2)       Schedule I Substances: Schedule I Controlled Substances must be kept in a securely locked, substantially constructed cabinet. A strong metal cabinet or safe securely fastened to the floor or wall in a manner that prevents it from being readily removed is generally acceptable.

(3)       Schedule II V Substances: Except as noted below, Schedule II, III, IV and V Controlled Substances must be stored in a securely locked, substantially constructed cabinet. [NOTE: Although the pertinent regulations specify a securely locked, substantially constructed cabinet, State inspectors in pre-registration inspections have permitted small amounts of these substances to be kept in a securely locked drawer of substantial construction. Use of a drug lock box is encouraged.]

(a)  Carfentanil Etorphine Hydrochloride and Diprenorphine: These Schedule II Controlled Substances must be kept in a safe or a steel cabinet equivalent to a U.S. Government Class V security container. These containers are a type of safe or locked cabinet that is able to withstand forced entry. Class V containers must provide the following security protection: (a) 30 man minutes against surreptitious entry; (b) 10 man minutes against forced entry; (c) 20 man hours against lock manipulation; and (d) 20 man hours against radiological attack. Class V containers are available for purchase through Emory Procurement via Fisher Scientific.

(b) Cabinets and Drawers: The cabinet (or for small amounts, drawer) used to store controlled substances must have a key or combination lock. It addition, it is preferable for it to: (b) be constructed so that forced entry is easily detectable; (c) be of a size and weight that makes it difficult to transport or conceal and limit the chances of removal; and (d) be located in a place in which unauthorized access would be noticed. Cabinets and lock boxes are available for purchase through Emory Procurement via Fisher Scientific.

(4)       Rooms in Which Controlled Substances are Stored: Rooms in which Controlled Substances are stored must be locked when authorized personnel are not present in the room. Registrant must control access to the room and keep a list of all persons to whom the Registrant has issued a key, key card, or key code for room access. An Access Log -- FORM 2 is available at http://compliance.emory.edu/ and may be used for this purpose. Registrant must immediately disable access for persons who no longer require access to perform job duties; persons who no longer work for Registrant and/or Emory; and persons whose access to Controlled Substances must be terminated because of security concerns.

(5)       Compromise of Security: Registrant must immediately report loss or theft of access control devices/measures (e.g., keys, combinations, codes) to the EPD and to EHSO. Contact information for this unit is set forth below in Section VII, Contact Information. Registrant must instruct all those who work for him/her and whose work involves Controlled Substances to immediately report to Registrant any loss, theft or compromise of access control devices/measures. Registrant is responsible for ensuring that compromised access control devices/measures are replaced (e.g., re-key lock; change authorization code, etc.). Reporting of loss or diversion of Controlled Substances is discussed below under the heading Reporting Loss or Diversion of Controlled Substances.

 

Personnel Security Requirements.

(1)       Employees and Agents: The Registrant cannot hire or utilize any employee or agent whose work requires them to have access to Controlled Substances if that person has been convicted of a felony relating to Controlled Substances, or has had a DEA registration denied, revoked or surrendered for cause. The Registrant must require all employees and students or other agents who will be working with Controlled Substances to complete and sign the Emory University Employee and Agent Screening Statement -- FORM 3 (available at http://compliance.emory.edu/) prior to beginning their work. In addition, employees will be expected to undergo any criminal background or any other checks routinely required of employees by Emory University’s Division of Human Resources.

Employees and agents who work with Controlled Substances in Research and who are convicted of a felony relating to Controlled Substances or have a DEA registration denied, revoked or surrendered for cause while working for Registrant, must immediately report such events to Registrant, and Registrant immediately must terminate their access to Controlled Substances at Emory. Registrants are encouraged to keep a log of the persons working for them who Registrant has authorized to work with Controlled Substances. The Controlled Substances Authorized User Signature Log -- FORM 4 (available at http://compliance.emory.edu/) may be used for this purpose.

(2)       Transfer or Distribution of Controlled Substances is Prohibited: Emory University requires that the Registrant utilize any Controlled Substance ordered under his/her registration solely for his/her Research as described to DEA and/or GBP. Emory does not permit the Registrant to transfer or provide Controlled Substances to any other persons for use in those persons’ Research or for any other use; provided, however, Yerkes animal resources units may transfer certain anesthetic and/or euthanasia agents to a Registrant provided that his/her registration is on file with Yerkes.

 

Reporting Loss or Diversion of Controlled Substances: Emory employees and students have a duty to report any suspected loss or theft of Controlled Substances to their supervisors, who in turn must immediately notify the Registrant. Reports also may be made directly to the Registrant, OC or EHSO. The Registrant must promptly report any theft or significant loss of any Controlled Substance to the following entities:

·         Emory Entities: Promptly on discovery, notify Emory Police Department ( EPD); EHSO and OC. EHSO and OC can provide assistance to Researchers in completing reports to DEA and GDNA and researchers are advised to contact either of these before submitting reports to DEA/GDNA. Reports to Emory units should be made using the Controlled Substances Discrepancy Report Form FORM 5 (available at http://compliance.emory.edu/). Contact information for Emory units to which reports should be made is listed in Section III, Subject Matter Area A.

·         DEA: Within one business day of discovery, complete DEA Form 106, found on-line at http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html.

·          GDNA: Within 48 hours of discovery, fax copy of completed DEA Form 106 to

GDNA at (404) 651-8210.

 

Inspections: By law, inspection of registered sites may be conducted by agents of the DEA, GBP, GDNA or other authorized licensing, police or law enforcement agencies. A pre-registration site inspection will be conducted by the GDNA and, potentially, the DEA. The Registrant should request appropriate identification from government inspectors, if they do not initially provide it. The Registrant should promptly notify OC via email to compliance@emory.edu or phone call to (404)

727-2398 of any inspection or pending inspection, and subsequently provide OC with a copy of any inspection report received. Site inspections of programs conducted under the auspices of Emory University also may be conducted by EHSO; the IACUC (for Research involving animals); the IBC; RHSC; OC; or EPD. Emory University requires that the research use of controlled substances that occurs on Emory University property is in compliance with federal and state requirements, therefore registrants and their employees and agents must fully cooperate with all inspections and provide copies of any requested documentation pertaining to Controlled Substances Research or registration upon request. Emory requires that employees consult with the Office of the General Counsel before signing any affidavits or providing any other written statements to governmental agencies concerning activities at Emory. If any inspectors from governmental agencies ask the Registrant or his/her employees or agents to sign/provide a written statement or affidavit, the Registrant should refrain from signing/providing the statement; advise the inspectors that Emory policy requires the Registrant to first contact the Office of General Counsel; and immediately contact the Office of the General Counsel at (404) 727-6011.

 

Training: Training regarding use of Controlled Substances for Research at Emory is provided via OC. The Emory University IACUC mandates this training for all Registrants and their employees and agents who work for them on Controlled Substances Research involving animals. The training is highly recommended for all other Registrants and their employees and agents. To access training materials contact OC at (404) 727-2398 or compliance@emory.edu.

References: 21 CFR §§1301.71, .75-.76; OCGA §§ 16-13-44, -46 & 26-4-49;

Theft or Loss of Controlled Substances at http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html;

DEA Questions & Answers - Registration at http://www.deadiversion.usdoj.gov/drugreg/faq.htm;

DEA Controlled Substances Security Manual at http://www.deadiversion.usdoj.gov/pubs/manuals/sec/index.html;  

Security Outline of the Controlled Substances Act of 1970 at  http://www.deadiversion.usdoj.gov/pubs/manuals/sec/sec_non_prac.htm. NOTE: Section III, Subject Matter Area A contains links to websites for state and federal laws/regulations.

 

Subsection (iii)

Ordering & Procurement

Emory University administers and facilitates the ordering and purchase of Controlled Substances for use in Research through its Procurement Department. Registrants who wish to purchase Controlled Substances for Research must follow Procurement’s procedures outlined on the following website: https://www.finance.emory.edu/home/Procure%20and%20Pay/how_to_buy_in_the_marketplace/ind ex_procure_pay_mckessonfordrugs.html.

For Schedule I or II Controlled Substances, a Registrant must order drugs himself/herself, or alternatively, delegate a responsible person to perform ordering by signing a Power of Attorney form (FORM 10). For Schedule III to V Controlled Substances, a power of attorney is not required, but Registrant is encouraged to document persons to whom authority for ordering Schedule III to V Controlled Substances has been delegated. In all cases, Registrant is responsible for supervising any person to whom he/she delegates the authority to procure Controlled Substances and for periodically reviewing orders and inventory/usage.

A Registrant may use the Power of Attorney Form to authorize a responsible individual to obtain and execute DEA Forms 222. To order Schedule I and II Controlled Substances, the Registrant or his/her delegate specified on the Power of Attorney Form must complete DEA Form 222.

The Power of Attorney Form must be signed by the Registrant, the individual to whom the Power of Attorney is delegating authorization, and two witnesses. The Power of Attorney Form should be filed with executed DEA Form 222. A copy of the Power of Attorney Form should be provided to the purchasing department. The Power of Attorney Form is not submitted to DEA, but it must be available for inspection upon request.

 

A person to whom authority to order Controlled Substances has been granted by a Power of Attorney must be a full-time Emory employee. The Registrant shall advise the delegate named in the Power of Attorney of the following information:

¿  The scope of power of attorney

¿  Pertinent state and federal regulations regarding DEA 222 forms

¿  Effective date of power of attorney

The Registrant may revoke the power of attorney at any time by executing a Notice of Revocation, which is included at the bottom of FORM 10. A copy of the Notice of Revocation shall be provided to purchasing department at the time that it is signed.  The Registrant must immediately inform the delegate named in the Power of Attorney Form that revocation of the Power of Attorney has occurred.  

Emory University does not permit purchasing cards, personal credit cards, personal checks, or cash to be used to purchase Controlled Substances. Controlled Substances only may be delivered to the address specified on the Registrant’s registration. For security reasons,

Registrants orders should be limited to the amount of Controlled Substances necessary to perform their Research, or a 6-month supply, whichever is less.

 

Subsection References: 21 CFR Part 1205; DEA Questions & Answers -- Form 222 at http://www.deadiversion.usdoj.gov/faq/dea222.htm. NOTE: Section III, Subject Matter Area A contains links to websites for state and federal laws/regulations.

 

Subsection (iv) Disposal

The Registrant is responsible for making sure that all Controlled Substances are properly disposed when the substances expire; or the Registrant’s DEA registration is not renewed; or when the Registrant no longer conducts research at Emory University using Controlled Substances or leaves Emory University. The Registrant can establish an account with an approved Reverse Distributor vendor, e.g. EXP Pharmaceutical Services, and arrange with the DEA registered reverse-distributor to accept and dispose of Controlled Substances. Authorized on-campus drug destruction events may be held annually.

The Registrant should keep a biennial inventory of Controlled substances in his/her possession, and the order, receipt and shipping records for materials in inventory, as well as any records evidencing disposition of the substances for 3 years (current year +2 years) from date record was created.

 

Subsection References: 21 CFR § 1307.21; DEA Practitioner’s Manual at http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section4.htm.   

NOTE:   Section   III,   Subject Matter Area A contains links to websites for state and federal laws/regulations.

 

Subsection (v) Records

General Requirements for All Records:

 

Separate Records: Registrant must keep records pertaining to Schedule I and Schedule II Controlled Substances separately from all other Controlled Substance and ordinary business records. Registrant must keep all records pertaining to Schedule III to V Controlled Substances separately from all other ordinary business records.

 

Retention Period: Per Emory University’s records retention schedule, Registrant must keep all records relating to Controlled Substance ordering, procurement, and inventory for 3 years: the current year in which the document is generated, plus an additional two years. The record retention schedule is at

http://records.emory.edu/content/records/research-and-teaching-drug-inventory-records.

 

Inspection Records: Completed inspection forms/materials provided to the Researcher by the GDNA and/or the DEA for application approval must be perpetually retained with the respective active registration.

 

Inventory: Registrant must perform a baseline written initial inventory of all Controlled Substances on hand when a Registrant begins work with Controlled Substances. The inventory must be maintained at the registered site, and a separate inventory is required for each registered site. After the initial inventory is taken, Registrant must perform a biennial inventory thereafter, on or before 24 months following the date of the initial inventory. The time (either “beginning of business” or “close of business”) and the date of the inventory must be noted on each inventory sheet. Inventory criteria that must be included are set forth in 21 CFR §1304.11(e)(3) and discussed at http://www.deadiversion.usdoj.gov/21cfr/cfr/1304/1304_11.htm. The template Controlled Substances Inventory -- FORM 6 (available at http://compliance.emory.edu/) contains all elements required to be included in the inventory.

 

Use Logs: Registrant must maintain a current, running use and disposition log that shows type and amount of Controlled Substances dispensed/administered; name and initials of person who dispensed/administered them; date dispensed/administered; and purpose of use. Each entry on the log must be initialed by the person who dispensed/administered the Controlled Substance. A template Controlled Substance Current Use & Disposition Log FORM 7 (available at http://www.compliance.emory.edu/) contains the required elements. A separate log must be kept for each container of a Controlled Substance.

 

Purchasing and Receipt Documentation: Registrant must maintain all documents relating to the ordering, purchasing and delivery of all Controlled Substances. DEA Form 222 must be used to place hard-copy orders of Schedule I and II Controlled Substances, and Registrant must keep a copy of this form. Registrant should keep a log showing each Controlled Substances order and receipt thereof. A template log entitled Order/Receipt Log for Controlled Substances Schedules I &II -- FORM 8, and a template log entitled Order/Receipt Log for Controlled Substances Schedules III-V -- FORM 9 are available at http://www.compliance.emory.edu/.

 

Disposal: Registrant must maintain all documentation relating to the transfer and disposal of all Controlled Substances for 3 years (current year + 2 years) after disposal/transfer to a DEA registered Reverse Distributor or authorized agent.

 

Inspection: All records pertaining to the acquisition, use and disposition of Controlled Substances must be made available to appropriate governmental and university officials for inspection.

 

Subsection References: 21 CFR Part 1304; OCGA §§ 16-13-39 & 21-4-49. NOTE: Section III, Subject Matter Area A contains links to websites for state and federal laws/regulations.

 

Registration for Employees/Agents who Assist in Controlled Substances Research: Employees or students working for the Registrant may be authorized to work with the Controlled Substances in carrying out their usual course of employment/course of study, provided they are under the supervision and control of the Registrant.  Supervision includes explaining to personnel: what Controlled Substances will be used in the Research; how the Controlled Substances will be used in the Research; security measures that must be taken with regard to the Controlled Substances; record-keeping activities, such as inventories and use logs, that must be followed with respect to the Controlled Substances; and procedures for reporting any suspected loss or diversion of Controlled Substances. Supervision also requires the Registrant actively monitor personnel’s use of Controlled Substances in Research to ensure that this Policy and applicable laws/regulations are being followed.

 

References: 21 CFR Part 1301; OCGA §§16-13-35 to -38; 26-4-49;

Rules and Regulations of the State of Georgia §480-20-.01.

NOTE: Section III, Subject Matter Area A contains links to websites for state and federal laws/regulations.


Definitions

Defined Terms & Acronyms Used in this Policy

CFR: Code of Federal Regulations

Controlled Substances: All drugs, substances or immediate chemical precursors listed in Schedules I to V of OCGA Sections 16-13-25 to 16-13-29; and Schedules I to V of Title 21 of the Code of Federal Regulations (CFR) Section 1308.

DAR: Emory Division of Animal Resources

DEA: United States Drug Enforcement Agency.

EHSO: Emory Environmental Health and Safety Office

EPD: Emory Police Department

GBP: Georgia Board of Pharmacy

GDNA: Georgia Drugs and Narcotics Agency

Human Clinical Research or HCR: Clinical research involving human subjects.

IACUC: Emory Institutional Animal Care and Use Committee

IBC: Emory Institutional Biosafety Committee

OCGA: Official Code of Georgia Annotated

OC: Office of Compliance

Practitioner: A licensed physician, dentist, podiatrist, pharmacist or veterinarian.

Registrant: A person who registers with the DEA and Georgia Board of Pharmacy to use Controlled Substances.

Registration: The permit obtained from the DEA and/or the Georgia Board of Pharmacy to use Controlled Substances.

Research: Any type of scientific investigation other than Human Clinical Research.

RHSC: Research Health and Safety Committee

Related Links

Contact Information

SubjectContactPhoneEmail
Compliance Director  Kris West  404-727-2398  compliance@emory.edu 
Compliance Specialist  Christine Cramer  404-727-2398  compliance@emory.edu 
Environmental Health & Safety Main Campus  Scott Thomaston  404-727-1349  sthom07@emory.edu 
Environmental Health & Safety Yerkes Locations  Maureen Thompson  404-727-8012  mthomp2@emory.edu 
Emory Policy Department  Lt. Cheryl Elliott  404-727-8005  celliot@emory.edu 

Revision History

  • Version Published on: Mar 17, 2016
  • Version Published on: Sep 04, 2014 (Update website links.)
  • Version Published on: Nov 07, 2013 (additional drug destruction/disposition update)
  • Version Published on: Nov 05, 2013 (drug destruction/disposition update)
  • Version Published on: Jul 10, 2013 (Corrected inconsistencies)
  • Version Published on: Jul 03, 2013 (Updated website links in Section C in Policy Details)
  • Version Published on: Apr 19, 2013 (Edited "Subsection (i): Registration" to reflect current practices.)
  • Version Published on: Oct 22, 2012 (Addition regarding Power of Attorney in Subsection iii)
  • Version Published on: Feb 21, 2012 (Original Publication)