USE OF CONTROLLED SUBSTANCES AN OVERVIEW FOR RESEARCHERS

Transcription

1 USE OF CONTROLLED SUBSTANCES AN OVERVIEW FOR RESEARCHERS

2 APPLICABILITY (WITH REGARD TO CONTROLLED SUBSTANCES) This presentation is applicable to: Animal and non-animal research This presentation is mostly applicable to: Teaching and analytical testing (please contact EH&S for specifics) This presentation is not applicable to: Human Research Weill Cornell Medical College Clinical/Hospital/Individual Medical, Pharmaceutical or Veterinary Practice

3 RESOURCE This training is an OVERVIEW For details, links and forms, see the EH&S guidance document: Research Use of Controlled Substances

4 REGULATIONS

5 REGULATORS Controlled substances are regulated by the: United States Federal Drug Enforcement Agency (DEA) New York State Department of Health (NYSDOH), Bureau of Narcotic Enforcement (BNE)

6 REGULATIONS Each has written laws and regulations: DEA Regulation: Title 21 CFR, Part Law: Title 21 USC, Controlled Substances Act NYSDOH Regulation: Part 80. Rules and Regulations on Controlled Substances Law: Article 33. Controlled Substances

7 RESEARCH USE Research use and possession of controlled substances requires: NYSDOH licensing DEA registration Adherence to all controlled substances laws and regulations

8 CONTROLLED SUBSTANCES DEFINITION & SCHEDULES

9 CONTROLLED SUBSTANCES DEFINITION A controlled substance is: a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V (CSA, Title 21, Section 802, (6)) The five schedules (I-V) range from Schedule I - the most stringently controlled (primarily illegal drugs) Schedule V - the least restrictive

10 SCHEDULES I-V Drugs or substances are assigned to schedules based on their current acceptable medical use and abuse/dependency potential

11 DEA & NYSDOH SCHEDULES Both the DEA and NYSDOH have schedule lists for drugs In general, the NYSDOH controlled substances listings reflect the DEA list BUT there are exceptions

12 NOTABLE EXCEPTIONS Some notable exceptions: Human chorionic gonadotropin (HCG) HCG is NOT a DEA controlled substance HCG IS a NYSDOH controlled substance (schedule III) Anabolic Steroids (example: testosterone) DEA schedule III NYSDOH schedule II The stricter definition takes precedence. Thus, A controlled substance license is needed to purchase HCG in NYS Testosterone must be ordered, stored and used as a schedule II drug in NYS

13 SCHEDULE MISMATCHES When NYSDOH and DEA schedules differ, so will license and registration schedule privileges: To purchase HCG in NYS NYSDOH License: schedule III privileges DEA Registration: not required To purchase testosterone in NYS: NYSDOH License: schedule II privileges DEA Registration: schedule III privileges. This can cause confusion when a NYSDOH license holder applies for DEA registration. NYSDOH handles this on a case-by-case basis if DEA rejects the application because of scheduling mismatches.

14 LICENSING AND REGISTRATION

15 NYSDOH LICENSING License Class There are different license classes depending on the work being conducted: Class 4 - Researcher (Schedules II-V) Class 5 - Instructional Activities (Schedules II-V) Class 7 - Research and Instructional Activities (Schedule I) Class 8 - Analytical Laboratory Researchers may have to have more than one license, depending on the work being conducted Researcher with schedule I substances Special procedures apply. Please contact EH&S for guidance Typical research license at Cornell is Class 4

16 NYSDOH LICENSE TYPES There are 2 main types of research licenses Individual Institutional Note that Cornell University does NOT hold an Institutional License An Institutional License here means a license held by a Department or Unit

17 NYSDOH INDIVIDUAL LICENSE Individual assumes complete responsibility for activities conducted under the license Must be a Faculty Member or Senior Staff Member to hold a license Research protocols must be submitted to NYSDOH for approval Protocols must be that of the Licensee Controlled substance activities are limited to the scope of the approved protocol(s)

18 NYSDOH INSTITUTIONAL LICENSE Department or unit must have an Oversight Committee to administer the program which includes: Maintaining the NYSDOH license and DEA registration Assuming responsibility for researchers operating under the license Reviewing protocols, giving use authorization, reporting to NYSDOH Ordering, receiving, storage, disposal, recordkeeping, security, training

19 INSTITUTIONAL LICENSE CONSIDERATIONS The responsibilities of administering an Institutional License are not insignificant Departments or units interested in applying for institutional licensing must first contact EH&S for guidance

20 LICENSE APPLICATION & RENEWAL New applicants (individual and institutional) Contact EH&S for guidance before applying Must obtain the NYSDOH license BEFORE applying for DEA registration NYSDOH will make a site visit Renewals Licenses must be renewed every 2 years

21 DEA REGISTRATION There are 2 main types of research DEA registrations Researcher with schedule II-V substances Almost all research at Cornell will be covered under schedules II-V The applicant selects the schedules of the drugs to be allowed on the registration Researcher with schedule I substances Special procedures apply. Please contact EH&S for guidance

22 DEA REGISTRATION The DEA does not have categories for Individual and Institutional Licenses. However, NYSDOH Individual Licensees register as an individual NYSDOH Institutional Licensees register as a business Protocols do not have to be submitted EXCEPT for research with schedule I substances Expect DEA to follow up with questions, especially regarding security

23 REGISTRATION APPLICATION & RENEWAL New applicants (DEA Form 225) Again, all new applicants must obtain a NYSDOH license BEFORE applying for a DEA registration DEA will make a site visit at their discretion Renewals (DEA Form 225a) Registration must be renewed every year DEA prefers this done on-line

24 PROFESSIONAL MEDICAL LICENSES Many researchers at Cornell are medical professionals (e.g. DVM, MD) and hold professional NYS licenses and DEA registrations that allow them to use or prescribe controlled substances as part of their medical practice Research use of controlled substances IS NOT covered under these licenses/registrations Medical professionals must obtain research NYSDOH licenses and research DEA registrations separate from their professional license/registration in order to conduct research using controlled substances (sorry!)

25 MIXING AND MATCHING LICENSES AND REGISTRATIONS Each NYSDOH license must have a corresponding DEA registration associated with it No mixing/matching of individual/institutional/professional licenses or registrations is allowed Examples of combinations NOT allowed An institutional NYSDOH research license and an individual research DEA registration An individual NYSDOH research license and an individual medical professional DEA registration

26 USE IN RESEARCH

27 DEFINITIONS OF ROLES AT CORNELL Licensee person or department/unit holding an individual or institutional NYSDOH license and corresponding DEA registration. The licensee has signature authority (can not be delegated) Supervisor of Controlled Substance Activity (Responsible Individual) at Cornell, this role is assumed by the Licensee Individual Licensee - Licensee acts as Supervisor of Controlled Substance Activity and Signatory Institutional Licensee Department Chair act as Supervisor of Controlled Substance Activity, Signatory, and Chair of Oversight Committee

28 DEFINITIONS OF ROLES AT CORNELL CONTINUED Material Manager manages DEFINED and LIMITED day-to-day activities under the license Not required if the Licensee assumes the responsibilities directly Should be a staff member (not student) Role should be part of job description Does not have signature authority Must fill out an Personnel Screening form Authorized User an individual (faculty, staff or graduate student) authorized by the Licensee to work with controlled substances in defined project(s) Must fill out an Personnel Screening form

29 ADDITIONAL DEFINITIONS SPECIFIC FOR INSTITUTIONAL LICENSEES Oversight Committee The committee overseeing an Institutional License. The Department Chair serves as the Chair of the Oversight Committee, Signatory and Supervisor of the Institutional License. Senior Authorized User Faculty or senior staff member approved by the Oversight Committee to work with controlled substances under the Institutional License Must fill out a Personnel Screening form May in turn appoint members of their laboratory as Authorized Users

30 SCOPE Only Licensee s and Authorized/Senior Authorized Users may work with controlled substances Controlled substance work is limited to the scope of the approved protocol Work only with drugs specified in the protocol Work only on the approved protocol

31 TRAINING - REQUIRED EH&S Overview Course (what you are taking now) Review CU EH&S document Research Use of Controlled Substances Familiarity with DEA and NYSDOH controlled substance rules and regulations Training specific to the protocol and license (given by the Licensee or Senior Authorized User to Authorized Users working under their license)

32 SAFETY Some controlled substances may also present safety hazards to the user. For example: Injections may expose the user to biosafety hazards Chloral hydrate (schedule IV) may cause irritation, burns and central nervous system depression Please read the MSDS, the Cornell Laboratory Safety Manual, and take appropriate EH&S safety training when biological, chemical or physical hazards are present

33 PURCHASING Licensee must place (sign) the order Senior Authorized Users, working under an Institutional License, must submit orders to the Supervisor of Controlled Substance Activities (assigned by the Licensee) Orders must be placed with suppliers and manufacturers, NOT through a pharmacy All purchases must be accompanied by license and/or registration information Suppliers typically require a copy of the DEA registration Obtaining drugs for research using a prescription is NOT ALLOWED (NYSDOH rules)

34 PURCHASING SCHEDULES I & II Orders for schedule I and II drugs must be accompanied by DEA Form 222 The DEA gives the Licensee these forms Once the drug has been ordered, copies of Form 222 must be kept along with the other schedule I & II records

35 RECEIVING All purchases must be delivered to the Licensee s address For Institutional Licensees Purchases must be shipped to the address on the DEA application (not individual Senior Authorized Users) Main stocks should be kept in department central storage Working stocks may be allocated to Senior Authorized Users

36 INVENTORY & RECORD KEEPING The main components are: Record of Receipt Record of Use (including disposal) Biennial Inventory Records for schedules I and II drugs must be kept separate from all other records All records must be kept for 5 years from the date of the last transaction Records must be readily retrievable

37 RECORDS OF RECEIPT ( RECEIPT LOG ) Record must contain date of receipt, name and address of vendor, and the type and quantity of controlled substance received An invoice from the vendor is sufficient, provided it contains the above information Records must be kept in a separate file Such as a notebook specific for controlled substances Records for schedules I and II drugs must be kept separate from all other records Duplicate copies of DEA form 222 (for schedule I and II drugs) must also be kept

38 RECORD OF USE ( USE LOG ) The record ( Use Log ) must include: Name of the person(s) allowed to control and use the drug and type, form and initial quantity of the drug Amount dispensed, purpose, date, signature of user, and balance left Record of disposal including: Lost or stolen Spilled Disposed (such as unused or expired) Destroyed

39 INVENTORY Biennial Inventory (once every 2 years) required by NYSDOH and DEA Does not have to be turned in but does need to be available upon inspection Keep inventory with other controlled substance records

40 INSTITUTIONAL LICENSEES ADDITIONAL RECORDS Record keeping for Institutional Licensees will be more complex than for individuals Institutional Licensees will need to keep additional records including: Senior Authorized User authorization Transfer to Senior Authorized Users Central receiving and inventory Records of disposal, spills, or loss

41 TRACKING NUMBER It is highly advised, especially for Institutional Licensees, that each commercial unit of controlled substance be given a tracking number Also advised for Individual Licensees with multiple projects and drugs EH&S can provide templates for record keeping

42 STORAGE Needs to be in place before application for license is submitted to NYSDOH Storage requirements depend on: Drug schedule Main or working stock Usually storage must be either a Vault or safe Double door, double locked cabinet Different licensees or senior authorized users cannot share storage cabinets/vaults

43 VAULT OR GSA CLASS 5 SAFE Minimum requirement for main stocks of schedules I & II If it weighs less than 750 lbs, must be bolted or cemented to the floor Various other specifications apply Most Institutional Licensees will need a GSA Class 5 Safe or the equivalent for central departmental storage

44 DOUBLE DOOR, DOUBLE LOCKED CABINET Appropriate for: Working stocks of schedules I-V Main stocks of schedules III-V Specifications: Stainless steel, bolted to wall or a fixed surface Inner and outer door, each with separate keys Combination lock not acceptable Suits many applications at Cornell. Also referred to as a Drug Box or Narcotic Cabinet

45 ACCESS RESTRICTIONS Area in which the controlled substances are kept should be limited in access to a minimum number of personnel Keys for the Narcotic Cabinet or combination for the safe should be under the control of the Licensee

46 DIVERSION, LOSS OR THEFT Authorized Users and Senior Authorized Users should report any knowledge of diversion, loss or theft to the Licensee The Licensee should report any knowledge of diversion, loss or theft to: Cornell Police EH&S In addition, the Licensee is required to report to DEA and NYSDOH immediately and file official forms DEA and DOH-2094 This is the Licensee s responsibility

47 SPILL PROCEDURES RECOVERABLE MATERIAL If there is recoverable material, collect it and dispose of it as described in the disposal slide (coming up)

48 SPILL PROCEDURES NON-RECOVERABLE MATERIAL Non-recoverable breakage or spill constitutes a loss for NYSDOH but not DEA Actions taken must satisfy both DEA: Document the circumstances in the Use and Inventory Records 2 witness who observed the spill/breakage must sign the records NYSDOH: The Licensee must report the spill to NYSDOH using form DOH-2094 Also document loss in records (DEA procedures will satisfy this)

49 IMPORT AND EXPORT This can be very complicated In addition to specific procedures required by DEA, other regulatory bodies, regulations and laws may come into play when bringing controlled substances in or out of different countries or even different states Licensees contemplating import or export must thoroughly research applicable requirements and procedures and submit a proposal to EH&S before proceeding

50 TRANSFER No transfer of controlled substances between research groups is allowed at Cornell

51 DISPOSAL Disposal must be arranged by the Licensee* by either: Return to the distributor or manufacturer Disposal through a reverse distributor Controlled substances cannot be disposed of by EH&S *A Senior Authorized User, working under an Institutional Licensee, cannot independently arrange for disposal

52 RETURN TO MANUFACTURER OR DISTRIBUTOR Some manufacturers or distributors will permit the return of unused controlled substances Must check with the manufacturer/distributor May accept unused or expired substances Unlikely to accept unpackaged items (such as solutions made from controlled substances)

53 REVERSE DISTRIBUTION A Reverse Distributor is a entity permitted to handle unwanted, unusable, or outdated controlled substances acquired from another DEA registrant The substances are then either returned to the manufacturer or properly destroyed

54 REVERSE DISTRIBUTION RECOMMENDED ROUTE This is the recommended route for disposing of controlled substances It is usually done by mail, accompanied by the appropriate forms DOT training is NOT required provided the controlled substance does not also fit the definition of a hazardous material NYSDOH has a list of approved Reverse Distributors Cost is the responsibility of the Licensee

55 ON-SITE DESTRUCTION NYSDOH approval for on-site destruction is limited and given on a case-by-case Cost savings is not one of these circumstances On-site destruction requires authorization from NYSDOH (Form DOH-2340) and prior approval from EH&S

56 POSSESSION WITHOUT A LICENSE Possession of controlled substances by a researcher with an expired DEA registration or NYSDOH license may be considered illegal possession Licensee is responsible for appropriate disposal of any controlled substances prior to letting a license/registration expire

57 ABANDONED SUBSTANCES Abandoned controlled substances are very problematic EH&S will assist departments in disposal of abandoned substances that were obtained PRIOR to the substance being classified as controlled (e.g. clean outs of very old labs)

58 SUBSTANCES ABANDONED BY A LICENSEE Controlled substances left by a Licensee (even if their License is expired or if they have left Cornell) are still the Licensee s responsibility The Licensee s department should make every effort to contact the Licensee If that is unsuccessful, EH&S will provide guidance to the Department as to their options Any associated costs will be borne by the Department

59 SUMMARY This training has provided an overview of regulatory requirements and Cornell expectations. Please remember though, that Requirements can change Specific situations may need to be addressed It is the Licensee s responsibility to be familiar with and adhere to all regulatory requirements For details, links and forms, see the EH&S guidance document Research Use of Controlled Substances EH&S can provide guidance and assistance

60 THANK YOU FOR TAKING THIS TRAINING! To receive credit, go to CU Learn and take the quiz. If you are a: Licensee or Senior Authorized User Take quiz: 5190 (EHS-Research Use of Controlled Substances for Licensee/Senior Authorized Users) Authorized User or Other Take quiz: 5195 (EHS-Research Use of Controlled Substances for Authorized Users) Instructions for accessing CU Learn

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