DEA REGULATIONS

1
DEA REGULATIONS

• FOR THE VETERINARIAN

Frances Cullen, PC 197 14th Street, NW Suite
250 Atlanta, Georgia 30318 www.francullen.com (404
) 806-6771
2
OVERVIEW

• 1. Regulation of Controlled Substances State
  of Georgia Drug Enforcement Agency (DEA) and
  Georgia Drugs Narcotics (GDNA)
• 2. Purchasing Controlled Substances
• 3. Power of Attorney
• 4. Required Recordkeeping
• 5. Initial Inventory
• 6. Inventory Control

3
OVERVIEW (Contd)

• 7. Administration
• 8. Prescriptions
• 9. Labeling
• 10. Waste disposal
• 11. Documentation
• 12. Security
• 13. Audits
• 14. Addressing Loss or Theft
• 15. Transportation of Controlled Substances
• 16. Diversion drug dependence by all
  professionals

4
DEA REGULATIONS YOU NEED TO KNOW

• 42 CFR section 1301.12(a) - Requirement for
  Separate DEA for Different Locations
• 42 CFR 1301.76 Other Security Measures
• 42 CFR 1304.03,1304.04, 1304.21, 1304.22,
  General Recordkeeping
• 42 CFR 1304.5 DEA Order Forms for Schedule II
  drugs Requirements
• 42 CFR 1304.11 Inventory Requirements-must
  denote open or close-every 2 years

5
DEA REGULATIONS YOU NEED TO KNOW (Contd)

• 42 CFR 1304.22(d) Requirement for Separate
  Records
• 42 CFR 1305 Power of Attorney
• 42 CFR 1305.13 DEA Form 222
• 42 CFR 1307.21 Drug Disposal

6
PURCHASING CONTROLLED SUBSTANCES

• Each provider must have a Valid DEA number
• For Schedule II controlled substances, you must
  use DEA Form 222 Order forms signed by the
  practitioner or another person authorized to
  order controlled substances through a valid Power
  of Attorney
• Controlled Substances may be purchased only from
• Another Registrant, Distributor, or Pharmacy

7
PURCHASING CONTROLLED SUBSTANCES (Contd)

• Purchases and transfers for controlled substances
  in Schedules IIIV only require a transfer form.
  A copy of the transfer form must be maintained by
  both the supplier and the receiver.

8
POWER OF ATTORNEY

• A Registrant can authorize one or more
  individuals to issue orders for Schedule II
  controlled substances on the registrants behalf
  by executing a Power of Attorney (POA)
• The POA must be maintained in the files with
  executed DEA Form 222
• The POA must be available for inspection.

9
REQUIRED RECORD KEEPING

• Documentation is required every time a controlled
  substance changes hands. You must have a paper
  trail.
• The trail is from the manufacturer, to the
  distributor, to the pharmacy and/or the
  practitioner, and to the end user.
• State and Federal controlled substance laws
  require maintenance of controlled substance
  records for period of 2 years from the date of
  each inventory. The GA Board of Veterinary
  Practice requires maintaining records for 3
  years. The Statute of Limitations under FDA law
  is 5 years, so a 5 year retention policy may be
  advisable.

10
RECORD KEEPING

• Records must be maintained at the registered
  practice location and must be readily retrievable
  and open to inspection and copying.
• A registrant must maintain a file of receipt
  records for their receipt of all controlled
  substances.
• Keep records for the receipt of Schedule III-IV
  drugs separate from Schedule II DEA Form 222
  Official Order Forms.
• Keep your logbooks for 5 years, the Federal FDA
  Statute of Limitations.

11
RECORD KEEPING (Contd)

• Keep accessible all DEA Form 222s for Schedule
  II controlled substances
• Keep accessible your invoices for Schedule III-V
  controlled substances.

12
KEY DETAILS FOR RECORD KEEPING

• Registrants MUST maintain the following
  information for all controlled substances
  received
• 1. Date of receipt
• 2. Drug Description
• a. Name c. Dose
• b. Drug strength d. Quantity received
• 3. Name, address and DEA number of the supplier
• 4. Name, address and DEA number of the
  recipient
• 5. Name or initials of employees verifying
  receipt of the drugs

13
DETAILED RECORD KEEPING (Contd)

• Receipt records may be kept in a handwritten or
  typed log, or may be maintained electronically.
• The third copies of all DEA Form 222 Order Forms
  must be signed and dated to verify receipt of the
  Schedule II drugs.

14
INITIAL INVENTORY

• On the date of receipt and stocking of any
  controlled substance, you must perform an initial
  inventory of the controlled substances on hand.
• The following information must be documented
• 1. Date
• 2. Documentation of whether the inventory was
  taken at Opening or Close of business, or if the
  practice location is open 24 hours a day, the
  time of the inventory
• 3. Drug name
• 4. Drug strength
• 5. Dosage form
• 6. Quantity of dosage units on hand

15
INITIAL INVENTORY (Contd)

• The initial inventory of Schedule II drugs must
  be maintained on a separate form and document
  then the initial inventory of Schedule IIIV
  drugs.
• Do not perform an inventory that combines
  Schedule II drug counts with drugs in Schedule
  IIIV, and do not include any non-controlled
  drugs on inventory documents.

16
ANNUAL INVENTORY

• An initial inventory is taken on the first day
  you start stocking controlled substances.
• An annual inventory must be taken on any date
  that is within one year of initial stocking and,
  from then on, on any date within one year of the
  previous annual inventory date.
• The same information must be maintained in the
  annual inventory as is required for an initial
  inventory.

17
CHECKLIST!

• All of the six areas of information listed for
  your initial inventory must be documented.
• Schedule II drugs should be documented on a
  separate form.
• Do not combine non-controlled drugs on the annual
  controlled substance inventory.
• For tax purposes, and to save time and work, you
  may coincide your annual inventory date with the
  date of your business inventory at the end of the
  year.

18
COUNT, COUNT, COUNT!

• Include all controlled substance dosage units in
  your inventory regardless of whether they are in
  stock bottles, have been set aside for
  destruction, are samples, or are outdated.
• You must have an exact count for Schedule II
  controlled substances
• When Schedule II controlled substances are
  counted, they must be hand-counted every time.
  No estimates!
•  

19
COUNTING (Contd)

• Counting Schedules IIIV controlled substances
• -You may open a bottle and estimate the number
  of units if the stock bottle is labeled to
  contain less than 1,000 dosage units.
• -If the stock bottle is labeled to contain 1,000
  units or more, then an individual hand count must
  be performed to provide an exact count.
• If you stock all schedules, you must have two
  annual inventory documents one for Schedule II
  and one for Schedules IIIV.
• You may choose to perform them on the same date.

20
LOG YOUR INVENTORY!

• Many practitioners choose to maintain an ongoing
  log of all drugs administered or dispensed. This
  provides an ongoing count every day of what they
  have used and what they still have on hand.
• Perpetual logs are useful and encouraged, and
  deter theft and diversion, but do not replace the
  requirement to have a specific annual inventory
  document. They are also not required by law.
• Annual inventories must always be separate
  documents that stand-alone and are maintained
  separately.

21
PRESCRIPTIONS

• Prescriptions are written orders provided only to
  patients.
• Prescriptions may not be written to obtain stock
  for administering and dispensing in a clinic.
• A practitioner must establish a legitimate need
  to prescribe controlled substances through an
  assessment utilizing pertinent diagnostic tools
  and the determination that there is a valid need
  for the drug(s) prescribed.
• A patient chart must be maintained!

22
PRESCRIPTIONS (Contd)

• All prescriptions for controlled substances must
  contain the following information
• 1. The date in the upper right hand corner must
  be the date the prescription was written and
  signed.
• 2. Name and address of the patient/pet owner
• 3. The species of the animal.
• 4. Drug name, dosage form, drug strength,
  quantity, and directions for administration.
• 5. Original ink signature of the veterinarian.
• 6. Veterinarians DEA number.
• 7. Name and address of the veterinarian

23
GA BOARD OF PHARMACY LAW

• Effective October 2011, the Georgia Board of
  Pharmacy now requires that all Schedule II
  prescription drugs be sequentially numbered and
  written on approved security paper.
• Keep a separate file of copies of your Schedule
  II prescriptions.

24
ADMINISTRATION/DISPENSING

• Maintain a Controlled Substance Dispensing or
  Administration Log that contains the following
• 1. Date of administration at facility or
  dispensing to patient
• 2. Patient name/owner
• 3. Patient address/owner
• 4. Drug name
• 5. Drug strength
• 6. Dosage form
• 7. Quantity
• 8. Whether it was Administered (A) or Dispensed
  (D)
• 9. Name or initials of employee performing the
  administering/dispensing

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ADMINISTRATION/DISPENSING(Contd)

• This administration/dispensing log should be
  maintained and filed separately from patient
  charts.
• This document should account for the use and
  disposition of all controlled substances utilized
  in the practice.

26
WHATS IN A LABEL?

• Labeling
• All controlled substances must be dispensed in
  child proof containers with required labels and
  stickers.
• Required labeling
• 1. Date of dispensing
• 2. Name and address of dispensing practitioner
• 3. Patients name
• 4. Drug name, drug strength, dosage form and
  quantity
• 5. Directions for administration
•  

27
WHATS IN A LABEL? (Contd)

• Warning labels
• All controlled substances dispensed must bear a
  warning sticker that informs the owner that it is
  illegal to transfer controlled substances to
  anyone other than the patient for whom it was
  dispensed. These stickers are available through
  drug companies or pharmacies.
• Packaging
• Controlled substance samples in FDA approved
  pre-packaged containers are not required to be
  repackaged.
• Controlled substances cannot be dispensed in
  envelopes, plastic bags or other unapproved
  containers.

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DOCUMENT PATIENT CHARTS

• All use of controlled substances must be
  documented in the patients chart.
• Each prescription, administration and dispensing
  chart note must contain
• 1. Date
• 2. Activity
• 3. Drug Name
• 4. Strength
• 5. Dosage Form
• 6. Quantity

29
DOCUMENT PATIENT CHARTS (Contd)

• If you do not stock controlled drugs and you only
  prescribe, then controlled substance
  prescriptions must only be documented in the
  patients charts.
• If you administer and dispense controlled
  substances, you must document this information
  both in the administration/dispensing log and
  then again in the patient chart.

30
WASTE YOUR CONTROLLED

• Controlled substances are wasted or destroyed for
  two reasons
• 1. The drugs are outdated, expired or
  unwanted or
• 2. They have been contaminated by patient
  contact. 
• Only controlled substances contaminated by
  patient contact may be destroyed onsite by a
  practitioner.
• When a drug has been contaminated by patient
  contact it should be destroyed beyond reclamation
  by two people and the required documentation
  should be completed.
• Outdated/expired controlled substances may not be
  destroyed on site by a practitioner without prior
  approval from the United States Drug Enforcement
  Administration. 

31
WASTE YOUR CONTROLLED(Contd)

• When a drug has not been contaminated and is
  expired, outdated, recalled or unwanted, it must
  be sent to a reverse distributor.
• The DEA Website maintains a current list of
  reverse distributors.
• The reverse distributor will inventory the drugs
  you wish to have destroyed, and they will remove
  and destroy the drugs for you.
• They will provide you with a receipt to show that
  
• you transferred the controlled drugs to
  them.
• This document must be maintained for 2 years.

32
TRANSFER OF CONTROLLED SUBSTANCES

• You must maintain transfer records for transfers
  to a reverse distributor or if you sell
  controlled substances to another practitioner.
• There is a pre-printed Transfer of Controlled
  Substances Form on the DEA website.
• All transfers of Schedule II drugs must be
  documented on a DEA Form 222.

33
TRANSFER OF CONTROLLED SUBSTANCES (Contd)

• Schedule IIIV drugs may be transferred on a form
  containing all required documentation
• 1. Name, address and DEA number of the supplier
• 2. Name, address and DEA number of the receiver
• 3. Date of the transfer
• Name, strength, dosage form and quantity of the
  drug(s) transferred
• If both parties have a copy of these documents,
  it can serve as a transfer document for the
  supplier, and also a receipt record for the
  receiver.

34
DOCUMENT YOUR WASTE!

• Any unused portion of a syringe must be
  documented as wastage.
• Wastages may be documented on an
  administration/ dispensing log or on a separate
  document in the same file for the documentation
  of waste.
• When drugs are wasted or destroyed, they must be
  destroyed beyond reclamation.
• Always have a witness to your wasting.

35
DOCUMENT YOUR WASTE (Contd)

• When controlled substances are wasted because of
  contamination by patient contact, the following
  documentation must occur
• 1. Log must have registrants name and address
• 2. Date of wastage
• 3. Time of destruction/wastage
• 4. Patients name
• 5. Drug name, drug strength, and quantity
  destroyed
• 6. The reason for the wastage
• 7. Signature or initials of the person
  performing the destruction
• 8. Signature or initials of the second person
  witnessing the destruction.

36
SECURITY!!!

• All registrants are required to have adequate
  controls in place to detect and prevent the
  diversion of controlled substances.
• Some security measures are physical, such as
  alarms, safes, and locks.
• Other security measures include the
  implementation of good practice and office
  policies, and maintaining required records.

37
SECURITY AND STORAGE

• STORAGE
• All controlled substances must be stored in a
  securely locked and substantially built safe or
  cabinet.
• The security provided must be commensurate with
  the quantity and types of controlled substances
  stocked.
• Controlled substances may not be left out
  unattended and/or where unauthorized persons
  would have access to them.
• Prescription pads should be secured in a locked
  drawer or cabinet.

38
EMPLOYEE SECURITY

• BACKGROUND CHECKS
• Obtain a criminal history or a Georgia Crime
  Information Center (GCIC) Report on all employees
  or potential employees. 
• Employees with a criminal history of a conviction
  or plea to a drug crime may not have access to
  controlled substances unless the DEA grants a
  rule waiver for that person.

39
BEST PRACTICES FOR SECURITY

• Routinely review controlled substance laws and
  regulations so you are familiar with
  requirements.
• 2. Contact DEA authorities when you have
  questions or concerns.
• 3. Implement a written policy to ensure
  compliance with the DEA and to ensure that
  employees know how controlled substances are to
  be handled in your office.
• 4. Conduct periodic training with your staff.
• 5. Conduct periodic reviews and self inspections
  of your own practice.
• 6. Periodically audit and reconcile your drug
  counts against your record keeping to ensure
  that all drugs are accounted for, no drugs are
  missing, and there are no record keeping errors.

40
BEST PRACTICES FOR SECURITY

• 7. Review your invoices from drug companies to
  ensure you authorized the drug purchase.
• 8. When possible, have all controlled drug
  activities performed by two people, not one.
• 9. The person who orders and purchases the drugs
  should be a different person than the person who
  receives, checks them in, and adds them to
  inventory. Ideally, a third person should pay the
  bills.
• 10. Separate the duties of ordering, receiving
  and paying so there are checks and balances.

41
BEST PRACTICES FOR SECURITY (Contd)

• The person who receives controlled substance
  shipments and checks them in should have a second
  person verify what was received and that the
  drugs are accurately being added to the perpetual
  inventory logs.
• Although not required, perpetual inventory logs
  are encouraged to provide an ongoing record of
  what you have dispensed and what you have
  remaining in supply.
• Do not allow patients and visitors access to drug
  supplies! This means if drugs are missing, it is
  an employee who is responsible.

42
POLICIES AND PROCEDURES

• Policies and procedures that require oversight
  and witnesses protect both you, your practice,
  and your employees because if there is a
  discrepancy in the drug count, consistent
  compliance with policies will protect you and
  your practice from theft and potential liability,
  and protect employees from false accusations.
• Restrict the number of people who have access to
  your drugs.
• 3. Have a policy in place requiring random drug
  testing for employees. Even if you do not want
  to conduct random drug testing on a regular
  basis, you should be able to demand a drug test
  during the course of an internal investigation
  should drugs be missing.

43
POLICIES AND PROCEDURES (Contd)

• 4. Periodically you should personally review
  your administration and dispensing logs to make
  sure that an employee has not removed drugs and
  made up the name of a fictitious patient you
  dont remember treating.
• 5. Set up a calendar or reminder system so you
  know when it is time for an annual inventory for
  the renewal of licenses and registrations.

44
HOW TO HANDLE LOSS/THEFT

• There may be small losses in compounding or in
  using a syringe. These are considered
  insignificant losses occurring in the course of
  normal practice. You should document these so
  that your records will always balance.
• A significant loss occurs anytime you are missing
  a controlled substance, you do not know where it
  went, and cannot account for it. These
  significant losses, which may indicate theft and
  diversion of controlled substances, must be
  reported to the DEA immediately upon discovery. 

45
CALL THE DEA GDNA

• 1. When a significant loss or theft is
  discovered, immediately call, fax, or email the
  DEA 1(800)-882-9539. You should also report the
  loss by using DEA Form 106. The DEA form may be
  submitted electronically from their website at
  www.deadiversion.usodj.gov within one business
  day.
• 2. You may also want to call the GA Drugs and
  Narcotics Agency at [phone].

46
TRANSPORTATION OF CONTROLLED SUBSTANCES

• Everyone who orders, dispenses, prescribes or
  administers a controlled substance must be
  registered with the DEA.
• Mobile practitioners should be registered at
  their base of operations storage must occur
  at the base.
• Your drugs must be stored and accounted for in
  accordance with DEA regulations.
• Non-profit status does not exclude any
  practitioner from DEA requirements.

47
TRANSPORTATION OF CONTROLLED SUBSTANCES

• Drugs should be removed from the vehicle when not
  doing ambulatory calls remember hot summer
  weather and cold winter weather can affect drugs.
• You must have a locked tool box in your vehicle
  for such use.

48
EUTHANASIA

• Animal protection laws, along with Federal and
  State law govern euthanasia - O.C.G.A. 4-11-5.1
  et seq.
• DEA Rules and Regulations
• Georgia Board of Pharmacy Law and Rules
• Georgia Board of Veterinary Medicine Law Rules
• Georgia Department of Agriculture Law Rules

49
DEA RULES REGULATIONS

• A veterinarian regularly working in an impound
  facility must have a DEA number attached to the
  facility.
• Controlled substances can be stored at the
  impound facility.
• Veterinarian can issue a Power of Attorney for
  someone at the facility to receive and log in
  controlled substances.
• Facility must have secure double locked storage
  for controlled substances.

50
DEA RULES REGULATIONS(Contd)

• For euthanasia performed part time at an impound
  facility or on-site, the veterinarian must follow
  DEA recordkeeping and security rules for the
  transport of controlled substances.
• In transporting controlled substances, take only
  the amount you anticipate using.
• Have written procedures in place for the
  transportation of controlled substances.

51
GEORGIA BOARD OF VETERINARY MEDICINE

• Board Rule No. 700-14-.03 permits Indirect
  Supervision for certain tasks meaning
• The licensed veterinarian is not on the premises
  but has given either written or oral instructions
  for the treatment of the animal patient

52
GEORGIA DEPARTMENT OF AGRICULTURE RULES

• GA CODE 4-11-5.1(b)(e)
• Euthanasia shall be performed by a licensed
  veterinarian or physician or a lay person who is
  properly trained in the proper and humane use of
  a method of euthanasia. Such lay person shall
  perform euthanasia under the supervision of a
  licensed veterinarian or physician. This shall
  not be construed so as to require that a
  veterinarian or physician be present at the time
  the euthanasia is performed.

53
STAY WITH YOUR SCOPE OF PRACTICE

• Your veterinary license limits your practice to
  animals.
• Treatment of humans is outside the scope of your
  practice.
• Beware! Controlled substance activities outside
  your scope of your practice is illegal drug
  distribution - a felony crime.
• Ensure safe practices for the protection of you,
  your employees, your patients and the public!
•  

54
Keep Current on GA Laws and Rules

• GA Veterinary Laws Rules can be found at
• http//sos.georgia.gov/plb/veterinary/
• GA Veterinary Medical Association can be found
  at www.gvma.net
• Check periodically! The GA Board and GVMA will
  update you on issues pertinent to your practice.

55
FRANCES CULLEN

• Frances E. Cullen is a former assistant attorney
  general and former criminal prosecutor with
  specialized knowledge in representing licensed
  professionals subject to Licensing Board review
  and criminal actions related to professional
  practices.
• Also relevant to Veterinary practice, Ms. Cullen
  has a strong knowledge of Drug Enforcement Agency
  (DEA), Georgia Drugs and Narcotics, and Georgia
  Board of Veterinary Medicine laws and rules.
• For more information, please visit
  www.francullen.com or call us at [phone].